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PRODUCTC AT A L O GC O M P O U N D I N G
www.Humco.com +1 (855) 925-4736
HUMCO GLOBAL HEADQUARTERS201 West 5th Street Floor 12Austin, TX 78701
PHONE & FAX+1 (855) 925-4736 - toll free+1 (512) 474-7400+1 (512) 474-7414 - fax
ONLINE ORDERINGwww.Humco.com
PROFESSIONAL SERVICE HOURSMonday-Friday, 8:30 AM - 5:30 PM Central Standard Time
CONTACT PHARMACEUTICAL RESOURCE CENTER & CUSTOMER SERVICE+1 (855) 925-4736 - toll free+1 (512) [email protected]• Formulation questions• Stability testing & BUD data• Penetration studies• Request a sample• Certificate of Analysis
REMIT PAYMENTS TO7400 Alumax DriveTexarkana, TX 75501
SHIPPING - FREEUPS Ground Service is free for DTP (Direct-to-Pharmacy) accounts on orders of more than $100 and weighing less than 200 pounds in the lower 48 states. For orders less than $100, shipping charges based on weight will apply.
Excludes hazardous materials, oversized (larger than 84”) items, drop shipped, and any items requiring special handling.
ALASKA & HAWAIIUS published rate
HAZARDOUS MATERIALSPer package fee of $25 in addition to air or ground shipping charge.
BACK ORDERSWe will notify you if any items are un-available to ship. All back orders will be shipped free, UPS 3 day service, unless otherwise specified.
MSDS & BUD STUDIESAvailable online at www.Humco.com
2 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 3
CONTENTSABOUT HUMCOHUMCO COMPOUNDINGPRODUCT LISTACTIVE PHARMACEUTICAL INGREDIENTSVALIDATED STABILITY STUDIESCREAMS & LOTIONSGEL BASES & OINTMENTSBULK COMPOUNDING DRUG SUBSTANCESPRE-MIXED EXCIPIENT BASESORAL VEHICLESMISCELLANEOUS INGREDIENTS
4568
10123337404147
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Humco, founded in 1872, is a diversified global pharmaceutical company. Humco is focused on developing, manufacturing and commercializing inn- ovative pharmaceuticals and high-quality over-the- counter (OTC) medicines for patients around the world.
With headquarters in Austin, TX, Humco serves over 45,000 pharmacies through its Pharmaceutical Segment and its Consumer OTC Products franchise. The Company is anchored by its leading non-ster-ile compounding delivery vehicles, including topical and transdermal creams, syrups and suspensions. Humco also serves consumers through its established and diverse Consumer OTC Products business of over 160 items with product placement in all major drug, food, and mass-market retail chains, along with independent, locally owned pharmacies.
Humco’s leading team of pro-fessionals have strong expertise ranging from product development to commercialization in the Com-pany’s state-of-the-art FDA regis-tered, cGMP compliant facilities.
With a presence in ap- proximately 20 coun- tries, Humco is com- mitted to working with pharmacists, physicians, healthcare providers and patients to deliver innovative and meaningful treat- ments that help peo- ple around the world live longer, healthier lives.
ABOUT HUMCO HUMCO COMPOUNDING
Humco proudly manufactures and distributes a diversified line of phar-maceutical products. We focus on developing products that offer dynam-ic solutions and help to fulfill unmet patient and pharmacist needs.
Humco has a vast por- tfolio of pharmaceuti- cals that aid in impera- tive solutions across several key therapeutic categories including:
• Pain Management• Infectious Disease• Hormone Replacement Therapy• Wound Care• Dermatology and Aesthetics Humco has established a leading reputation for developing, manufac-turing, and commercializing a diversi-fied line of non-sterile topical and oral pharmaceutical compounding delivery vehicles. Our patented compounding products range from ready-to-use
topical creams and gels to oral syr-ups and suspensions. Our products are designed to provide an optimal delivery system for a variety of formu-lations based on the desired route of administration and therapeutic intent. Humco’s delivery vehicles are tailored to meet pharmacist’s non-sterile com- pounding needs while reducing the compounding preparation time and improving therapeutic out- comes for patients.
In addition to our delivery ve- hicles, Humco offers an ex- tensive selection of Active Pharmaceutical Ingredients (“APIs”) that are conveniently pack-aged in a variety of sizes to effectively accommodate the needs of pharma-cists, hospitals, and pharmaceutical companies.
OUR APPROACH:
•We can be counted on•We get the job done•We take responsibility•We find a better way•We succeed as a team
Sorbitol Solution70% USP SYRUP
Item No. Size Price 3913-16 16 oz $4.96
Syrpalta (Red) SYRUP VEHICLE
Item No. Size Price 3920-16 16 oz $12.04
Syrpalta (No Color)SYRUP VEHICLE
Item No. Size Price 3927-16 16 oz $12.64
Versa Free™SYRUP VEHICLE
Item No. Size Price 0125-16 16 oz $10.470125-28 1 gal $75.00
Versa Plus™SUSPENDING VEHICLE
Item No. Size Price 0126-16 16 oz $10.470126-28 1 gal $75.00
Buffer Cream™BUFFERING AGENT FOR ORAL SUSPENSIONS
Item No. Size Price 3926-01 1 lb $28.60
Cherry Syrup™ SYRUP VEHICLE
Item No. Size Price 2662-16 16 oz $9.302662-28 1 gal $56.00
Flavor Blend™SYRUP & SUSPENDING VEHICLE
Item No. Size Price 0089-16 16 oz $9.550089-28 1 gal $62.00
Flavor Plus™SUSPENDING VEHICLE
Item No. Size Price 0091-16 16 oz $9.550091-28 1 gal $62.00
Flavor Sweet-SF™SYRUP VEHICLE
Item No. Size Price 0094-16 16 oz $9.550094-28 1 gal $62.00
Flavor Sweet™SYRUP VEHICLE
Item No. Size Price 0090-16 16 oz $9.550090-28 1 gal $62.00
Mouthwash-AF™ ALCOHOL FREE MOUTHWASH BASE
Item No. Size Price 6050-98 8 oz $9.74
Mouthwash-GP™ GENERAL PURPOSE MOUTHWASH BASE
Item No. Size Price 6030-98 8 oz $9.74
Mouthwash-OM™ MOUTHWASH BASE FOR ORAL MUCOSITIS
Item No. Size Price 6040-98 8 oz $9.74
Raspberry SyrupSYRUP VEHICLE
Item No. Size Price 2664-16 16 oz $9.83
Simple SyrupSYRUP VEHICLE
Item No. Size Price 2661-16 16 oz $8.422661-28 1 gal $42.502661-75 5 gal $129.00
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TOPICAL BASES & VEHICLESOur compounding bases and vehicles are ready-made with wetting agents already incorporated into the base. Most formulations will not require any additional wetting or milling; greatly reducing the compounding preparation time.
CREAMS & LOTIONSAnhydrous Base™VERSATILE TOPICAL CREAM
Item No. Size Price 6013-01 1 lb $50.00
GENEDERM™ DERMATOLOGICAL TOPICAL CREAM
Item No. Size Price 6026-56 500 g $500.006026-57 4500 g $4500.00
HRT Botanical™HORMONE THERAPY TOPICAL CREAM
Item No. Size Price 6001-01 1 lb $38.006001-79 10 lb $240.00
HRT Heavy™HORMONE THERAPY TOPICAL CREAM
Item No. Size Price 6002-01 1 lb $38.006002-79 10 lb $240.006002-81 40 lb $660.00
Liposomal Heavy™VERSATILE TOPICAL CREAM
Item No. Size Price 6004-01 1 lb $50.006004-79 10 lb $365.006004-81 40 lb $1310.00
Liposomal Regular™VERSATILE TOPICAL CREAM
Item No. Size Price 6003-01 1 lb $50.006003-79 10 lb $365.006003-81 40 lb $1310.00
Multibase™ VERSATILE TOPICAL CREAM
Item No. Size Price 6015-01 1 lb $45.006015-79 10 lb $380.006015-81 40 lb $1400.00
PENcream™ VERSATILE TOPICAL CREAM
Item No. Size Price 6010-01 1 lb $25.006010-79 10 lb $250.006010-81 40 lb $1000.00
RECURA™ANTIFUNGAL TOPICAL CREAM
Item No. Size Price 6020-56 500 g $1000.006020-59 2500 g $5000.00
SALTSTABLE LO™ PAIN MANAGEMENT TOPICAL CREAM
Item No. Size Price 6009-01 1 lb $70.006009-79 10 lb $450.006009-81 40 lb $1600.00
SALTSTABLE LSADVANCED™PAIN MANAGEMENT TOPICAL CREAM
Item No. Size Price 6021-56 500 g $90.006021-57 4500 g $525.006021-58 18000 g $1890.00
Sanare Advanced™ SCAR THERAPY BASE
Item No. Size Price 0112-56 500 g $307.200112-59 2500 g $1372.800112-31 5800 g $2825.00
GEL BASES & OINTMENTSLavare™WOUND WASH GEL
Item No. Size Price 7001-62 100 g $166.407001-56 500 g $661.607001-59 2500 g $2870.40
PLO20 Flowable™VERSATILE TOPICAL LIGHT CREAM
Item No. Size Price 0135-01 1 lb $65.00
PLO20 Non-Flowable™ VERSATILE TOPICAL CREAM
Item No. Size Price 6008-01 1 lb $50.006008-79 10 lb $365.006008-81 40 lb $1310.00
Universal Water Gel™VERSATILE TOPICAL GEL
Item No. Size Price 6017-01 1 lb $21.006017-79 10 lb $165.00
BULK COMPOUNDING DRUG SUBSTANCESDiclofenac Sodium 3% CreamTOPICAL CREAM
Item No. Size Price 6120-59 2500 g Call for
Pricing
Lidocaine-Prilo-caine Cream, USPTOPICAL CREAM
Item No. Size Price 6110-31 5800 g Call for6110-58 18000 g Pricing
Lidocaine 5% Ointment, USPTOPICAL OINTMENT
Item No. Size Price 6130-59 2500 g Call for
Pricing
PRE-MIXED EXCIPIENT BLENDSEmulsion Concentrate™VISCOSITY ENHANCER
Item No. Size Price 6016-94 4 oz $35.006016-98 8 oz $57.006016-28 1 gal $800.00
USP GUIDELINESIt is the responsibility of the pharmacists to follow USP Guidelines on proper compounding procedures and techniques. Compounders should know and keep current on USP Chapter <795> and <1075>, which relate to non-sterile compounding. Its purpose is to help define good compounding practice and provide general information to enhance the compounder’s ability to compound preparations that are of acceptable strength, quality and purity.
ORAL VEHICLES
*Prices are current at time of printing-September 2016, however, pricing and specifications are subject to change without notice. Please contact the Resource Center or visit the website for updated pricing.
BULK PRICING AVAILABLEContact us for pricing on bulk quantities
+1 (855) 925-4736
Before Humco considers purchasing an API, we pre-qualify our suppliers to ensure that they manu-facture the API under current Good Manufacturing Practices, as expected in ICH Q7A requirements.
Once the API is received, a statistical sample is taken and tested in our on-site laboratories. Through comprehensive and thorough testing, we ensure the identity of the API and that the potency meets the USP requirements and are comparable to the manufacturer’s CofA.
We use qualified and calibrated state-of-the-art analytical equipment under the Laboratory Controls delineated in 21 CFR 211. A few examples of these include:
Humco is committed to adhering to the highest quality standards to ensure that our products are consistently valued as the best option for patients and pharmacists.
Amantadine Hydrochloride, USP
Item No. Size Price 8058-19 25 g $30.008058-62 100 g $100.008058-43 1000 g $585.00
Amitriptyline Hydrochloride, USP
Item No. Size Price 8048-19 25 g $35.008048-62 100 g $105.008048-43 1000 g $599.00
Baclofen, USP Item No. Size Price 8032-62 100 g $275.008032-43 1000 g $1150.00
Benzocaine, USP Item No. Size Price 8049-62 100 g $15.008049-43 1000 g $85.00
Bupivacaine Hydrochloride, USP
Item No. Size Price 8050-19 25 g $105.008050-62 100 g $339.008050-43 1000 g $1795.00
CyclobenzaprineHydrochloride, USP
Item No. Size Price 8051-62 100 g $455.008051-43 1000 g $1300.00
Diclofenac, USP Item No. Size Price 8052-62 100 g $65.008052-43 1000 g $399.00
Doxycycline Hyclate, USP
Item No. Size Price 8059-19 25 g $22.008059-62 100 g $83.008059-43 1000 g $490.00
Estradiol, USP(Micronized)
Item No. Size Price 8065-19 25 g $136.008065-62 100 g $460.00
Estriol, USP(Micronized)
Item No. Size Price 8066-19 25 g $504.008066-62 100 g $1394.00
Estrone USP Item No. Size Price 8067-19 25 g $143.008067-62 100 g $328.00
Flurbiprofen, USP Item No. Size Price 8053-19 25 g $109.008053-62 100 g $225.008053-43 1000 g $790.00
ACTIVE PHARMACEUTICAL INGREDIENTS
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Fluconazole, USP Item No. Size Price 8036-19 25 g $119.008036-62 100 g $305.00
Fluticasone Propionate, USP (Micronized)
Item No. Size Price 8054-35 5 g $1695.008054-19 25 g $3900.00
Gabapentin, USP Item No. Size Price 8055-62 100 g $260.008055-43 1000 g $550.00
Ibuprofen, USP Item No. Size Price 8038-19 25 g $9.008038-62 100 g $14.008038-43 1000 g $65.00
Ketoprofen, USP Item No. Size Price 8056-62 100 g $55.008056-43 1000 g $385.00
Lidocaine Hydrochloride, USP
Item No. Size Price 8040-19 25 g $11.008040-62 100 g $32.008040-43 1000 g $150.00
Miconazole, USP Item No. Size Price 8041-19 25 g $39.008041-62 100 g $120.00
Phenytoin Sodium, USP
Item No. Size Price 8043-19 25 g $14.008043-62 100 g $29.00
Progesterone, USP(Micronized)
Item No. Size Price 8063-62 100 g $135.008063-43 1000 g $685.00
Promethazine Hydrochloride, USP
Item No. Size Price 8064-19 25 g $18.008064-62 100 g $61.00
Tetracaine Hydrochloride, USP
Item No. Size Price 8046-19 25 g $18.008046-62 100 g $59.008046-43 1000 g $425.00
Verapamil Hydrochloride, USP
Item No. Size Price 8057-19 25 g $27.008057-62 100 g $86.008057-43 1000 g $699.00
API Standards & Testing
• Fourier Transform Infrared Spectrophotometer (FTIR)
• Ultra Violet/Visible Light Spectrophotometer (UV/Vis)
• Identification by Chemical Reactions
• Identification by Flame
• High Pressure Liquid Chromatography (HPLC)
• Gas Chromatograph (GC)
• Thin Layer Chromatography
• Titrations
Active Ingredient HRT Botanical
HRTHeavy
LiposomalHeavy
LiposomalRegular
Multi-base
PEN-cream
PLO20Non-Flowable
PLO20 Flowable
RECURA SaltStable LO
SaltStable LS Advanced
Amitriptyline HCl 90
Baclofen 90
Benzocaine 90
Bupivacaine HCl 90
Capsaicin 90
Clomipramine HCl 90 90
Cyclobenzaprine HCl 90 90
Dehydroepiandrosterone 90
Dexamethasone 90
Diclofenac 90
Diclofenac Na 90
Diltiazem 90 90
Diphenhydramine HCl 90
Estradiol 90 150
Estriol 120 180
Estrone 150 120
Fluconazole 180
Fluoxetine HCl 90 90
Flurbiprofen 90
Gabapentin 90 90 90 90 90 90
Haloperidol 90 90
Hydroquinone 90
Ibuprofen 90 60 90 90
Ketamine HCl 90
Ketoprofen 90 90 90 90
Lactic Acid 90
Lidocaine 90 90 90
Lidocaine HCl 90
Menthol 90
Methimazole 90 90 90 90
Methyl Salicylate 90
Metoclopramide 90
Metronidazole 90 90 90 90
Miconazole 180
Pentoxifylline 90
Phenytoin 90
Piroxicam 90 60 60
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The Beyond-Use-Date study evaluates the potency and stability of a formula over a course of time, from 30 days to 180 days. Below is an alphabetical listing of the API’s studied for stability with correlating bases used for the compounded preparations. Please note, strength depends on percentage of API used. See appropriate product page for details.
VALIDATED STABILITY STUDIES
Active Ingredient Flavor Blend
Flavor Sweet/SF
Flavor Plus
Versa Free
Versa Plus
Acetazolamide 60 60
Allopurinol 60 60
Alprazolam 60 60
Amiodarone HCl 91 91
Amlodipine Besylate 91 91
Atenolol 60 60
Captopril 14 14
Clonidine HCl 60 60
Chloroquine HCl 60 60
Cisapride 60 60
Dapsone 91 91
Diltiazem HCl 60 60 90 90
Dipyridamole 60 60
Enalapril Maleate 60 60
Flecainide Acetate 60 60
Flucytosine HCl 60 60
Hydralazine HCl 92 92
Ketoconazole 60 60
Lactic Acid 60 60
Lamotrigine 91 91
Metolazone 60 60
Metoprolol Tartrate 60 60
Nifedipine 91 91
Procainamide HCl 60 60
Pyrazinamide 60 60
Quinidine Sulfate 60 60
Rifampin 28 28
Sildenafil Citrate 91 91
Spironolactone 60 60
Tetracycline 90 28 28
Verapamil HCl 60 60
Prednisolone 90 90
Prednisone 90 90
Progesterone 180 180 180
Promethazine 90 90 90 90
Testosterone 180 180 180
Tetracaine HCl 90 90
Verapamil HCl 90
Active Ingredient HRT Botanical
HRTHeavy
LiposomalHeavy
LiposomalRegular
Multi-base
PEN-cream
PLO20Non-Flowable
PLO20 Flowable
RECURA SaltStable LO
SaltStable LS Advanced
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Creams &
LotionsGENEDERM™
GENEDERM™ provides a firming effect on the skin - tightening and smoothing fine lines and wrinkles. It is uniquely formulated with Sodium Polystyrene Sulfonate, a film forming polymer that creates a matrix and provides excellent binding to the skin, allowing the base to adapt to changes in facial expressions and movement without cracking or peeling. GENEDERM™ can be used to reduce the appearance of fine lines and wrinkles. GENEDERM™ BENEFITS:• Suitable for all skin types• Comfortable - Allows skin to breathe• Can be worn for 4-8 hours, including night-time application• Can be applied without API’s for wrinkle treatment• Visible results after first application
DERMATOLOGICAL BASE FOR WRINKLESItem No. NDC No. Size Price6026-56 00395-6026-56 500 g $500.00
Item No. NDC No. Size Price6013-01 00395-6013-01 1 lb $50.00 Humco’s Anhydrous Base™ is designed for low-load hydrophilic and
high-load lipophilic actives that are unstable in water. Intense studies validate its compatibility with numerous drugs across a broad range of applications. It is cosmetically elegant with an exceptional sensory evaluation profile over other anhydrous bases, providing a smooth, light, and silky feel.
ANHYDROUS BASE™ BENEFITS:• Contains absolutely no water• Non-greasy • Validated & proven drug compatibility• Cosmetically elegant – smooth, light, silky feel• Preservative-free & petroleum-free• Easy to use – actives can be directly incorporated without wetting• 180-day BUD with all API’s• Fragrance-free & dye-free
VERSATILE TOPICAL CREAM
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ANHYDROUS BASE™Wound
&Scar
Creams &
Lotions ANHYDROUS BASE™
ANHYDROUS BASE™ PROPERTIES
Specific Gravity 0.95 g/cm³
Color Light Beige
Transdermal Penetration + + +
API Compatibility Hydrophilic 10% & Lipophilic 20% Total API Load - 20%
Typical Applications• Dermatology • HRT • Immunotherapy • Pain Management • Sports Medicine • Veterinary Medicine • Wound Care
Glutathione 20% Topical Glutathione (L) Reduced 20% Anhydrous Base qs 100% Recommended Penetration Enhancer: 50% Lecithin in Isopropyl Palmitate
Methimazole 5% Topical Methimazole 5% Anhydrous Base qs 100%
Recommended Wetting Agent: Emu Oil
SAMPLE FORMULAS:
Mixing Tips• Mixing Speed - 1000 rpm for 2-5 minutes • If Dispensing in a Pump, Airless Pump Dispensers are Recommended
Sensory Evaluation Profile
of Anhydrous Base™ compared to other standard anhydrous bases:
Humco’s base is superior in all areas - wetness,
absorbency, gloss & silkiness
GENEDERM™ PROPERTIES
pH 5.0 - 6.0
Viscosity 50,000 - 100,000 cps
Physical Format Light Cream
Color Opaque, Off-White
API Compatibility Hydrophilic 10% & Lipophilic 10% Total API Load - 20%
Typical Applications • Dermatology • Wrinkles
Anti Wrinkle:Alpha-Lipoic Acid 5%Ascorbyl Palmitate 2%Estriol Micro Powder 0.3%Niacinamide 2%Tretinoin 0.025%Propylene Glycol 10%GENEDERM qs 100%
SAMPLE FORMULA:
Common Actives in Wrinkle Care:
Vitamin E – 200IU/g Antioxidant to reduce the signs of aging and photo-aging
Vitamin C – 2-10% (as Ascorbyl Palmitate) Antioxidant to reduce the signs of aging
Niacinamide – 2% Stabilizing effect on epidermal barrier function, seen as the reduction in trans-epidermal water loss
Estradiol – 0.01% and Estriol 0.3% After treatment for 6 months, elasticity and firmness of the skin had markedly improved; wrinkle depth and pore sized had decreased by 61-100%; skin moisture had increased and wrinkle depth decreased significantly
Alpha-Lipoic Acid – 5% Twelve weeks treatment with a cream improves clinical characteristics related to photo-aging of facial skin
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GENEDERM™CLINICAL STUDY
Clinical Study
STUDYEvaluation of Key Parameters on Outer Parts of 30 Panelist's Eyes, In Vivo, Using Image Analysis
In one of the most innovative research projects ever undertaken in medical aesthetics, ‘The Consumer Product Testing Company' captures the PRIMOS and VISIA image analysis, and opinions on wrinkle length, number, and area from 30 female subjects, ages 35 to 65, with mild to moderate crow's feet (coarse wrinkles) in the outer canthus eye area. The relative skin surface was ana-lyzed as a composite and as a single point in any plane thereby making it possible to examine and compare several cutaneous parameters. The outer parts of the eyes of thirty panelists were used to evaluate several key parameters over eight weeks.
RESULTS'The Consumer Product Testing Company' key findings:• For women seeking aesthetic treatment, opinions found (89%) positive response for “softened line/wrinkles around eyes, (89%) positive response for “made skin feel firmer/tighter”, and (100%) positive response for “easy to use as daily skin care regimen”. • PRIMOS image analysis found (71%) of women with wrinkle length decrease.• VISIA image analysis found (82%) of women with wrinkle num-ber decrease and (79%) of women with wrinkle area decrease.
"Product is non-
irritating and
reduces visibility
of fine lines...
a small amount
goes a long way…
easy to use…
skin feels soft,
smooth, refreshed
and firm…it is not
greasy and has
pleasant smell…it
felt high quality.”
GENEDERM™ Dermatological Wrinkle Basehas been proven to reduce or decrease five key parameters in relation to wrinkle reduction.
View Full Study at www.Humco.com>
"The evaluation of parameters indicates that the use of Genederm™ produced smoothing and restructuring of the skin’s surface after seven days of product application." - Advanced Scientific Imaging Consulting, leading analytical laboratory
Parameter Genederm®Roughness 14% DecreaseResidual Length 9% DecreaseAverage Amplitude 10% Decrease Primary Wrinkle 9% DecreaseNumber of Peaks 10% Reduction
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Creams &
LotionsHRT HEAVY™
HRT Heavy™ is a heavier cream base than HRT Botanical™; it provides deeper skin penetration. It is specifically designed for male and female hormone restoration formulations and has a low to moderate API carrying capacity. HRT HEAVY™ BENEFITS:• Sustained skin penetration• Paraben-free• Natural ingredients• Cosmetically elegant• Ideal for intra-vaginal preparations• Validated stability/potency of >90 days for all hormone APIs
HRT BASE WITH 180 DAY BUDItem No. NDC No. Size Price6002-01 00395-6002-01 1 lb $38.00 6002-79 00395-6002-79 10 lb $240.00 6002-81 00395-6002-81 40 lb $660.00
Item No. NDC No. Size Price6001-01 00395-6001-01 1 lb $38.00 6001-79 00395-6001-79 10 lb $240.00
HRT Botanical™ is an oil-in-water, light cream, certified hypoallergenic base, with all natural ingredients and antioxidants. It has a lotion consistency and provides sustained skin penetration. Ideal for high lipophilic API concentrations.
HRT BOTANICAL™ BENEFITS:• Sustained skin penetration• Paraben-free & fragrance-free• Natural ingredients & natural preservatives• Added antioxidants, botanicals, and herbal extracts• Certified hypoallergenic• Cosmetically elegant• Ideal for vaginal preparations
CERTIFIED HYPOALLERGENIC HRT BASE
HRT BOTANICAL™
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Wound &
Scar
Creams &
Lotions
HRT BOTANICAL™ PROPERTIES
pH 6.5
Specific Gravity 1.00 g/cm³
Viscosity 60,000 cps
Physical Format Light Cream
Color Light Beige
Transdermal Penetration + +
API Compatibility Lipophilic - 20%
Typical Applications • Hormone Replacement
Published Studies – Beyond-Use-Date (BUD)
ACTIVE INGREDIENT BUD
Estradiol – 1% – (Estriol, Estrone) 90 Days
Estriol – 1% – (Estradiol, Estrone) 120 Days
Estrone – 0.5% – (Estradiol, Estriol) 150 Days
Prednisolone 5% 90 Days
Progesterone – 20% 180 Days
Testosterone – 5% 180 Days
HRT HEAVY™ PROPERTIES
pH 7.5
Specific Gravity 1.04 g/cm³
Viscosity 165,000 cps
Physical Format Cream
Color White
Transdermal Penetration + + +
API Compatibility Lipophilic - 20%
Typical Applications • Hormone Replacement
Published Studies – Beyond-Use-Date (BUD)
ACTIVE INGREDIENT BUD
Estradiol – 1% – (Estriol, Estrone) 150 Days
Estriol – 1% – (Estradiol, Estrone) 180 Days
Estrone – 0.5% – (Estradiol, Estriol) 120 Days
Metronidazole - 2% 90 Days
Progesterone – 20% 180 Days
Testosterone – 5% 180 Days
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Transdermal Study
PROGESTERONETRANSDERMAL STUDY
PENcream™, Anhydrous Base™, HRT Botanical™, and HRT Heavy™have been proven to transport Progesterone into and through human skin, performing significantly more effectively than our competitor's base.
5% PROGESTERONE
Transdermal Study
StudyEvaluation of the Percutaneous Absorption of Progesterone, In Vitro, Using the Epiderm Skin Model
The progesterone study evaluated the percutaneous absorption pharmacokinetics of progesterone in the following Humco bases: HRT Botanical™, HRT Heavy™, Anhydrous Base™ and PENCream™. Absorption was measured in human epidermal cultures, in vitro, using the finite dose technique and Franz Diffusion Cells.
Formulas were tested on standardized sections for the percuta-neous absorption of progesterone over a 12-hour dose period. At pre-selected times after dose application, the dermal receptor solution was completely removed and replaced with fresh recep-tor solutions; and an aliquot was saved for subsequent analysis. Samples were analyzed for progesterone content by High Performance Liquid Chromatography (HPLC).
The in vitro human Epiderm skin model is a proven tool, valuable for the study of percutaneous absorption and determination of pharmacokinetics of topically applied drugs. The model uses human epidermal skin mounted in specially designed diffusion cells that allow the skin to be maintained at a temperature and humidity that match typical in vitro conditions. A finite dose of formulation is applied to the outer skin surface, and drug ab-sorption is measured by monitoring the rate of appearance in the receptor solution bathing the inner surface of the skin. Data defining total absorption, as well as rate of absorption, can be accurately determined in this model.
Transdermal Drug Absorption:
• Avoids hepatic first pass effect, reducing adverse reactions to certain drugs
• Reduces minor gastrointestinal tract irritation and systemic toxicity
• Helps avoid possible drug interactions with food and intestinal flora
• Can be applied to different parts of the body (site rotation)
Humco’s PENcream™, Anhydrous
Base™, HRT Heavy™,
and HRT Botanical™
are Validated Transdermal
Vehicles
ResultsThe data did indicate that progesterone penetrated into and through human epidermal cultures, in vitro, from the test formulations provided. The absorption profiles indicate a steady penetration to a peak flux occurring at approximately 12 hours after dose application. HRT Botanical™, HRT Heavy™, Anhydrous Base™, and PENCream™ delivered more progesterone than our competitor's base.
The total percent of applied dose that penetrated past the stratum corneum with our competitor’s base is 20% less than Humco’s HRT Botanical™, HRT Heavy™, Anhydrous Base™, and PENcream™.
Flux
(ug/
cm2/
hr)
Time
Progesterone Flux VS Time
0.00
0.05
0.10
0.15
0.20
0.25
0.30 Competitor’s Base
HRT Botanical
HRT Heavy
Anhydrous Base
PENCream
1284
% Progesterone Permeation Through the Stratum Corneum
% P
erm
eatio
n
Progesterone
Com
petit
or’s
Base
HRT
Bot
anic
al™
HRT
Hea
vy™
Anhy
drou
s Ba
se™
PEN
Crea
m ™
Competitor’s BaseHRT BotanicalHRT Heavy
Humco's Anhydrous BasePENCream
0.40
0.20
0.00
1.00
0.80
0.60
1.60
1.40
1.20
View Full Study at www.Humco.com>
20 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 21
LIPOSOMAL HEAVY™
Liposomal Heavy™ is formulated with additional emulsifiers to allow for higher API loads and solvent concentrations to be incorporated. Added emollients provide excellent moisturization—an ideal choice for dry and/or dehydrated skin. LIPOSOMAL HEAVY™ AND LIPOSOMAL REGULAR™ BENEFITS:• Cosmetically elegant – excellent moisturizing effect • Faster absorption & deeper penetration than HRT bases• API compatibility – virtually all actives• Natural preservatives• Water & oil-soluble• Ideal for cosmetic facial applications• Paraben-free
MOISTURIZING TRANSDERMAL LIPOSOMAL BASE
Item No. NDC No. Size Price6004-01 00395-6004-01 1 lb $50.00 6004-79 00395-6004-79 10 lb $365.006004-81 00395-6004-81 40 lb $1310.00
Creams &
LotionsLIPOSOMAL REGULAR™
Liposomal Regular™ and Liposomal Heavy™ are cosmetically elegant, liposomal transdermal bases with excellent skin penetration and mois-turizing capabilities. They are formulated to incorporate lipophilic and hydrophilic actives and penetrate faster than HRT bases.
TRANSDERMAL LIPOSOMAL BASEItem No. NDC No. Size Price6003-01 00395-6003-01 1 lb $50.00 6003-79 00395-6003-79 10 lb $365.00 6003-81 00395-6003-81 40 lb $1310.00
Creams &
Lotions
pH 6.0 7.5
Specific Gravity 1.00 g/ml 1.00 g/ml
Viscosity 250,000 cps 120,000 cps
Format Heavy Cream Light Cream
Color White Off-White
Transdermal Penetration + + + + + + +
API CompatibilityHydrophilic – 10%Lipophilic – 10%Total API Load – 20%
Hydrophilic – 5%Lipophilic – 5%Total API Load – 10%
Typical Applications• Dermatology• Pain Management • Immunotherapy• Sports Medicine
• Dermatology• Pain Management• Hormone Therapy• Veterinary Medicine
Recommended Use• Higher API Loads• Dry/Dehydrated Skin• Chemical Peels• Pigmentation Treatments
• Lower API Loads• Cosmetic Preparations
PROPERTIES LIPOSOMAL HEAVY™ LIPOSOMAL REGULAR™
Published Studies – Beyond-Use-Date (BUD)
ACTIVE INGREDIENT LIPOSOMAL REGULAR™ BUD
LIPOSOMAL HEAVY™ BUD
Dehydroepiandrosterone – 1.25% 90 Days —
Dexamethasone – 1.5% – (Haloperidol, Lorazepam) — 90 Days
Diclofenac – 4% — 90 Days
Diltiazem – 2% — 90 Days
Estradiol – 0.5% – (Estriol) 60 Days —
Gabapentin – 6% — 90 Days
Gabapentin – 12.5% 90 Days —
Haloperidol – 0.1% – (Dexamethasone, Lorazepam) — 90 Days
Hydroquinone – 5% – (Glycolic Acid) — 90 Days
Methimazole – 5% 90 Days —
Piroxicam – 0.5% — 90 Days
Progesterone – 5% 90 Days —
Promethazine – 5% — 90 Days
Mixing Tip• Recommended to Reduce Oxidation: Sodium Bisulfite - 0.5%
22 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 23
MULTIBASE™
A versatile, oil-in-water natural vanishing cream that uses oleosomic emulsifiers and penetration enhancers. It is a great oil-free moisturizing base that provides natural skin penetration. MultiBase™ is designed for both hydrophilic and lipophilic actives and exhibits superior stability in the presence of low and high pH, high salt, high ethanol, and high polar compounds, allowing for flexible compounding and formulation options.
MULTIBASE™ BENEFITS:• Mineral oil-free, gluten-free, and propylene glycol-free• Noncomedogenic• Enhanced drug absorption & penetration• Ideal for vaginal preparations• Stable over a broad range pH• API compatibility – hydrophilic & lipophilic• Natural ingredients – moisturizers derived from berries, grapes, plums, and pears; emulsifiers derived from vegetable fatty acids & palm oil; thickening agents derived from coconut oil
HIGHLY VERSATILE OIL-IN-WATER CREAM BASE
Item No. NDC No. Size Price6015-01 00395-6015-01 1lb $45.00 6015-79 00395-6015-79 10 lb $380.006015-81 00395-6015-81 40 lb $1400.00
Creams &
LotionsPENCREAM™
PENCream™ is an elegant oil-in-water vanishing cream formulated for enhanced transdermal penetration. This elegant alternative to PLO, with added emollients, provides a better rub-in and longer-lasting moisturizing effects without irritation. PENCream™ is highly compatible with a diverse range of hydrophilic and lipophilic actives, has a high API load capacity, and is ideal for hybrid formulations.
PENCREAM™ BENEFITS:• Free of BHT, EDTA, parabens, and urea• Enhanced penetration capability – efficacious API absorption• Hydrophilic & lipophilic compatibility – high loads• Natural ingredients – less irritation than PLO• Cosmetically elegant – lasting moisturizing effect• Applies easily – no sticky residue• Validated API compatibility
TRANSDERMAL OIL-IN-WATER VANISHING BASE
Item No. NDC No. Size Price6010-01 00395-6010-01 1 lb $25.00 6010-79 00395-6010-79 10 lb $250.00 6010-81 00395-6010-81 40 lb $1000.00
Creams &
Lotions
PENCREAM™ PROPERTIES
pH 7.0
Specific Gravity 0.96 g/cm³
Viscosity 300,000 cps
Physical Format Heavy Cream
Color White
Transdermal Penetration + + + +
API Compatibility Hydrophilic & Lipophilic - Total API Load - 30%
Typical Applications• Pain Management • Veterinary Medicine • Immunotherapy
Published Studies – Beyond-Use-Date (BUD)ACTIVE INGREDIENT BUD
Clomipramine HCl– 7.5% 90 Days
Fluoxetine HCl– 7.5% 90 Days
Gabapentin – 6% – (Ketoprofen, Lidocaine) 90 Days
Ibuprofen – 10% 90 Days
Ketoprofen - 10% - (Gabapentin, Lidocaine) 90 Days
Lidocaine – 15% – (Gabapentin, Ketoprofen) 90 Days
Methimazole – 7.5% 90 Days
Metoclopramide – 2% 90 Days
Metronidazole – 3% 90 Days
Promethazine – 5% 90 Days
Tetracaine HCl– 2% 90 Days
Pain Management Cream:Gabapentin 5%Lidocaine 15%Ketoprofen 10%Dimethyl Sulfoxide 5%PENCream qs 100%
SAMPLE FORMULA:
Mixing Tips• Water Soluble Powders: Levigate with Alcohol, Dimethyl Solfoxide (DMSO), Glycerin, Polyethylene Glycol (PEG) 300 or 400 or Purified Water
• Oil-Soluble Powders Can be Directly Incorporated
MULTIBASE™ PROPERTIES
pH 7.0
Specific Gravity 0.90 g/cm³
Viscosity 250,000 cps
Physical Format Heavy Cream
Color White
Transdermal Penetration + +
API CompatibilityHydrophilic 10% & Lipophilic 20% Total API Load - 30%
pH Compatibility 3.0 - 11.0
Salt Tolerance Salt Forms - 10%
Solvent Compatibility Polar & Non-Polar
Typical Applications• Hormone Replacement • Dermatology • Pain Management • Sports Medicine
Published Studies – Beyond-Use-Date (BUD)ACTIVE INGREDIENT BUD
Capsaicin – 1.2% – (Menthol, Methyl Salicylate) 90 Days
Lactic Acid – 8.5% 90 Days
Lidocaine – 8% – (Metronidazole, Phenytoin) 90 Days
Menthol – 8% – (Capsaicin, Methyl Salicylate) 90 Days
Methyl Salicylate – 20% – (Capsaicin, Menthol) 90 Days
Metronidazole – 8% – (Lidocaine, Phenytoin) 90 Days
Phenytoin – 8% – (Lidocaine, Metronidazole) 90 Days
Progesterone – 10% 180 Days
Testosterone - 2% 180 Days
HRT Cream:Progesterone 20%Glycerin 10%Multibase qs 100%
Analgesic Cream:Capsicum Oleoresin 0.6% Methyl Salicylate 10%Menthol 4%Multibase qs 100%
Anti-Wrinkle Cream:Retinoic Acid 0.05% Glycerin 10%Multibase qs 100%
SAMPLE FORMULAS:
24 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM
RECURA™Creams
&Lotions
RECURA™ topical cream is an innovative compounding delivery vehicle created for creams compounded to treat conditions such as onychomycosis. Utilizing penetration enhancers, RECURA™ provides good penetration into toenails, fingernails, and skin, works well with a variety of antifungal agents, and compounds easily. It has been intensively studied, patented, and peer-reviewed in order to validate the compatibility of the cream with a number of active ingredients.
RECURA™ BENEFITS:• Penetration Ability - contains penetration enhancers and natural oils to facilitate active drug absorption• Drug Compatibility - both oil and water soluble powders can be levigated with alcohol• Compound Diversity - contains penetrating agents for better nail absorption, natural oils for better skin absorption, and is alcohol- dispersible for viscosity adjustment
TOPICAL BASE FOR ANTIFUNGAL ACTIVESItem No. NDC No. Size Price6020-56 00395-6020-56 500 g $1000.006020-59 00395-6020-59 2500 g $5000.00
Creams &
Lotions
Your Compounding Vehicle to help you
TOPICAL COMPOUNDING CREAM
ABOUT RECURA• RECURA can be formulated to hold and help in the delivery of various antifungal active ingredients
• In Vitro testing in a novel nail model suggests the potential utility of RECURA topical cream to enhance delivery of antifungal actives across the nail
• Peer reviewed study1 in in vitro nail models comparing drug absorption with RECURA vs. marketed prescription solutions
• RECURA is for topical use only and is not for oral, ophthalmic, or intravaginal use
1 Turner R et al., A Novel Vehicle for Enhanced Drug Delivery Across the Human Nail for the Treatment of Onychomycosis, INTL. J. PHARM. COMPOUNDING 2016;20(1):71-80
Manufactured By:
Humco | 512 E 11th St, Ste 201, Austin, Texas 78701 - USATel. (512)474-7400 | Fax (512)474-7414
[email protected] | www.Humco.com
RECURA topical cream is an innovative compounding delivery vehicle created for creams compounded to treat conditions such as onychomycosis.
WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 25
RECURA™ PROPERTIES
pH 7.0 - 9.0
Physical Format Viscous Cream
Color Opaque, Light Lavender
Typical Applications Fungal treatment on toenails, fingernails, and skin
Nail Cream 1:Miconazole 3 gRECURA 27 g
Nail Cream 2:Fluconazole 3 g RECURA 27 g
Skin Cream:Clotrimazole 0.6 g Ibuprofen 0.6 gRECURA 28.8 g
SAMPLE FORMULAS:
RECURA™ Peer Reviewed Study in IJPC Jan/Feb 2016 Issue Pgs
71-80
View Full Study at www.Humco.com>
Published Studies – Beyond-Use-Date (BUD)
ACTIVE INGREDIENT BUD
Fluconazole – 10% 180 Days
Miconazole – 10% 180 Days
26 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 27
SALTSTABLE LO™Creams
&Lotions
SaltStable LO™ is a ready-to-use transdermal cream base providing an elegant alternative to traditional PLOs. It’s uniquely designed for long shelf, temperature, and physical stability; it will not separate in the presence of high levels of ionic substances or when refrigerated. It uses emulsifiers and hydrocolloids that provide a chemical penetration enhancer (CPE) value superior to a PLO. SaltStable LO™ is cosmetically elegant and compatible with both hydrophilic and lipophilic APIs allowing for compounding flexibility.
SALTSTABLE LO™ BENEFITS:• Efficacious active drug absorption• Validated in vitro transdermal penetration & API compatibility• Temperature stable & two-year shelf stable• Hydrophilic compatibility – high levels of ionic powders can be directly incorporated • Lipophilic compatibility – moderate levels of oil-soluble powders can be levigated with glycerin, propylene glycol, polyethylene glycol (PEG) 300 or 400, or alcohol• Cosmetically elegant – not tacky or sticky
READY-TO-USE TRANSDERMAL PAIN BASEItem No. NDC No. Size Price6009-01 00395-6009-01 1 lb $70.00 6009-79 00395-6009-79 10 lb $450.00 6009-81 00395-6009-81 40 lb $1600.00
Creams &
LotionsSALTSTABLE LS ADVANCED™
SaltStable LS Advanced™ is an extension and enhancement of SaltStable LO™. SaltStable LS Advanced™ is a scientifically advanced, extremely durable, robust and versatile transdermal cream base formulated with a silogel that provides a smooth, silky dry feel. SSLS Advanced™ is designed for all actives and is non-specific to salt; it also exhibits superior API carrying capacity (high loads) of multiple actives in one formulation. SaltStable LS Advanced™ demonstrates excellent stability without the need to add emulsifiers.
SALTSTABLE LS ADVANCED™ BENEFITS:• Increased stability with a high percent of APIs & multiple actives• Validated in vitro transdermal vehicle up to 8 APIs in one formulation • Less sticky & less tacky because of silogel (silicone-based organogel)• Off-white, cosmetically elegant cream• API compatibility – compatible with all actives, non-specific to salt• Time saving – ready-to-use base, no need for wetting or adding thickening agents • Ideal for formulations with multiple actives & high API loads
READY-TO-USE TRANSDERMAL PAIN BASEItem No. NDC No. Size Price6021-56 00395-6021-56 500 g $90.00 6021-57 00395-6021-57 4500 g $525.00 6021-58 00395-6021-58 18000 g $1890.00
SALTSTABLE LO™ PROPERTIES
pH 7.0
Specific Gravity 1.00 g/cm³
Viscosity 300,000 cps
Physical Format Heavy Cream
Color Light Beige
Transdermal Penetration + + + +
API CompatibilityHydrophilic 35% & Lipophilic 10% Total API Load - 35%
Typical Applications• Pain Management • Veterinary Medicine • Sports Medicine
Published Studies – Beyond-Use-Date (BUD)ACTIVE INGREDIENT BUD
Amitriptyline HCl – 2% – (Lidocaine) 90 Days
Benzocaine – 20% – (Lidocaine, Tetracaine) 90 Days
Clomipramine HCl– 5% 90 Days
Cyclobenzaprine HCl – 2% 90 Days
Diphenhydramine HCl– 10% 90 Days
Fluoxetine HCl– 5% 90 Days
Gabapentin – 6% 90 Days
Ketoprofen – 10% 90 Days
Lidocaine – 10% – (Benzocaine, Tetracaine) 90 Days
Methimazole – 5% 90 Days
Metronidazole – 2% 90 Days
Promethazine – 5% 90 Days
Tetracaine HCl– 4% – (Benzocaine, Lidocaine)
90 Days
SALTSTABLE LS ADVANCED™ PROPERTIES
pH 7.1 - 7.5
Specific Gravity 0.90 g/cm³
Viscosity 1,200,000 cps
Physical Format Heavy Cream
Color Off White
Transdermal Penetration + + + +
API CompatibilityHydrophilic 30% & Lipophilic 40% Total API Load - 40%
Typical Applications• Pain Management • Veterinary Medicine • Sports Medicine
Published Studies – Beyond-Use-Date (BUD)ACTIVE INGREDIENT BUD
Baclofen – 2% 90 Days
Bupivacaine HCL – 1% 90 Days
Cyclobenzaprine HCl– 2% 90 Days
Diclofenac Na – 5% 90 Days
Flurbiprofen – 10% 90 Days
Gabapentin – 10% 90 Days
Ibuprofen – 3% 90 Days
Ketamine HCl – 10% 90 Days
Ketoprofen – 20% 90 Days
Licocaine HCl – 5% 90 Days
Pentoxyfylline – 3% 90 Days
Verapamil HCl– 10% 90 Days
28 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 29
Transdermal Study
Creams &
Lotions
STUDYEvaluation of the Percutaneous Absorption of Pentoxifylline + Ketamine HCl + Ibuprofen + Cyclobenzaprine HCl + Diclofenac Na + Baclofen + Bupivacaine HCl + Gabapentin, In SaltStable LS Advanced™, Into Human Skin, In Vitro, Using the Franz Skin Finite Dose Model
Using Humco’s SaltStable LS Advanced™, the study was designed to evaluate the percutaneous absorption pharmacoki-netics of pentoxifylline, ketamine HCl, ibuprofen, cyclobenzaprine HCl, diclofenac Na, baclofen, bupivacaine HCl and gabapentin in a single formulation using Humco’s SaltStable LS Advanced™ base. Absorption was measured in human epidermal cultures, in vitro, using the finite dose technique and Franz Diffusion Cells. The eight drugs were selected due to their frequent use in com-pounding topical pain formulations along with compoundingmultiple actives in one formulation. The formula was tested on standardized sections with Humco’s SaltStable LS Advanced™ transdermal compounding base, for the percutaneous absorption of the formula over a 48-hour dose period. At pre-selected times after dose application, the dermal receptor solution was removed in its entirety, replaced with fresh receptor solution, and an aliquot saved for subsequent analysis. High Performance Liquid Chromatography (HPLC) analyzed the samples for pentoxifylline, ketamine HCl, ibuprofen, cyclobenzaprine HCl, diclofenac Na, baclofen, bupivacaine HCl and gabapentin content.
The in vitro human Epiderm skin model has proven to be a valu-able tool for the study of percutaneous absorption and the de-termination of the pharmacokinetics of topically applied drugs. The model uses human epidermal skin mounted in specially designed diffusion cells that allow the skin to be maintained at a temperature and humidity that match typical in vitro conditions. A finite dose of formulation is applied to the outer surface of the skin and drug absorption is measured by monitoring the rate of appearance in the receptor solution bathing the inner surface of the skin. Data defining total absorption, as well as rate of absorp-tion can be accurately determined in this model.
SALTSTABLE LS ADVANCED™TRANSDERMAL STUDY
TESTED FORMULA
Baclofen.......................2%Bupivacaine ................1% Cyclobenzaprine HCl.2% Diclofenac Na..............5% Gabapentin..................6% Ibuprofen.....................3% Ketamine HCl............10% Pentoxifylline...............3%SaltStable LS Advanced.....qs 100%
Breakthrough Study: SaltStable LS Advanced™has been proven to deliver eight drugs simultaneously through human skin in-vitro.
RESULTS Humco’s SaltStable LS Advanced™ compound-ing base is a proven transdermal delivery vehicle able to deliver multiple drugs beyond the stratum corneum, simultaneously into and through the human skin after a single dose. The data indicates that Humco’s SaltStable LS Advanced™ delivered pentoxifylline, ketamine HCl, ibuprofen, cycloben-zaprine HCl, diclofenac Na, baclofen, bupivacaine HCl, and gabapentin simultaneously (and intact) into and through human epidermal cultures, in vitro, from the test formulation provided. The absorption profiles indicate pent-oxifylline, ketamine HCl, ibuprofen, diclofenac Na, and bupivacaine HCl had a steady penetration occurring for 32 hours after dose application. And cyclobenzaprine HCl, baclofen and gabapentin had a steady penetration occurring for 48 hours after dose application.
Flux
(ug/
cm2/
hr)
Time
Baclofen Flux VS Time
0.000
0.005
0.010
0.015
0.020
0.025
0.030SaltStable LS
ActiveMax
48322412842
Flux
(ug/
cm2/
hr)
Time
Bupivacaine Flux VS Time
0.00
0.05
0.10
0.15SaltStable LS
ActiveMax
483224128420
Flux
(ug/
cm2/
hr)
Time
Cyclobenzaprine Flux VS Time
Flux
(ug/
cm2/
hr)
Time
Diclofenac Flux VS Time
Flux
(ug/
cm2/
hr)
Time
Gabapentin Flux VS Time
Flux
(ug/
cm2/
hr)
Time
Ibuprofen Flux VS Time
Flux
(ug/
cm2/
hr)
Time
Ketamine Flux VS Time
Flux
(ug/
cm2/
hr)
Time
Pentoxifylline Flux VS Time
0.00
0.05
0.10
0.15
0.20
0.25
0.30
0.35SaltStable LS
ActiveMax
483224128420 0.00
0.20
0.40
0.60
0.80
1.00
4832241284200.000
0.020
0.040
0.060
0.080SaltStable LS
ActiveMax
483224128420
0.0
1.0
2.0
3.0
4.0SaltStable LS
ActiveMax
4832241284200.0
1.0
2.0
3.0
4.0SaltStable LS
ActiveMax
4832241284200.0
2.0
4.0
6.0SaltStable LS
ActiveMax
483224128420
SANARE ADVANCED™ Scar Therapy Base
- -
WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 31
STUDYEvaluation of the Percutaneous Absorption of Flurbiprofen + Lidocaine
The study evaluated the percutaneous absorption pharma-cokinetics of Humco’s Sanare Advanced™ Scar Base. Absorption was measured in human epidermal cultures, in vitro, using the finite dose technique and Franz Diffusion Cells.
The formula was tested on stan-dardized sections with two different transdermal compounding bases. At pre-selected times after dose application, the dermal receptor solution was completely removed and replaced with fresh receptor solution; and an aliquot was saved for subsequent analysis. Samples were analyzed for flurbiprofen and lidocaine content by High Performance Liquid Chromatography (HPLC).
The in vitro human Epiderm skin model is a proven tool, valuable for the study of percutaneous absorption and determination of pharmacokinetics of topically applied drugs. The model uses human epidermal skin mounted in specially designed diffusion cells that allow the skin to be maintained at a temperature and humidity that match typical in vitro conditions. A finite dose of formulation is applied to the outer skin surface, and drug absorption is measured by monitoring the rate of appearance in the receptor solution bathing the inner surface of the skin. Data defining total absorption, as well as rate of absorption, can be accurately determined in this model.
Transdermal Study
SANARE ADVANCED™--
TRANSDERMAL STUDY
30 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM
0
5
10
15
20
25
30
35
40
45Sanare Advanced
Competitor's Base
483224128420
Flurbiprofen Flux VS Time
10% FLURBIPROFEN
Transdermal Study
5% LIDOCAINE
Transdermal Study
has been proven to transport multiple drugs into and through human skin, performing significantly more effectively than our competitor’s base.
TESTED FORMULA
Flurbiprofen ...............................10%Lidocaine ......................................5%Sanare Advanced™...........qs 100%
Lidocaine Flux VS Time
0
2
4
6
8
10Sanare Advanced
Competitor's Base
483224128420
RESULTSThe data did indicate that flurbiprofen penetrated into and through human epidermal cultures, in vitro, from the test formulations provided. The absorption profiles indicate a steady penetration for 48 hours after dose application. Sanare Advanced™ performed significantly better than our competitor's base at delivering flurbiprofen through human skin.
The data also indicated that lidocaine penetrated into and through human epidermal cultures, in vitro, from the test formulations provided. The absorption profiles indicate a steady penetration for 48 hours after dose application. Humco’s Sanare Advanced™ performed significantly better than our competitor’s base at delivering lidocaine through human skin.
The total percent of applied dose that penetrated past the stratum corneum with our competitor’s base is 23% less with flurbiprofen and 28% less with lidocaine than Humco’s Sanare Advanced™.
Sanare
Advanced™
out-performs
Competitor’s
Base
by 23-28%
View Full Study at www.Humco.com>
Flux
(ug/
cm2/
hr)
Time
Flux
(ug/
cm2/
hr)
Time
Common Actives in Scar Care:
Pentoxifylline – 0.1 – 0.5% Decreases collagen production, increases activity of Collagenase in dermis, inhibits fibroblast hyperactivity
Betamethasone – 0.1% Steroid and anti-inflammatory
Dimethyl Sulfone – 2% Anti-inflammatory
EGCg – 0.1 – 0.5% – Antioxidant
Caffeine – 0.1 – 1% Induces differentiation and proliferation in epidermal keratino-cytes
Collagenase – 350 u/g Reduces collagen production
Hyaluronidase – 250 u/g Breaks down collagen
Tranilast – 1 – 10% Anti-collagen
32 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 33
Creams &
Lotions
Gel Bases &
Ointments
TOPICAL SILICONE BASE FOR SCAR THERAPY & OTHER CONDITIONS
SANARE ADVANCED™--
Sanare Advanced™ is an elegant, topical anhydrous silicone gel designed for scar therapy treatment and management. It is uniquely formulated with Carapa Guaianensis Seed Oil found in the Amazon rainforest, an exceptional ingredient that promotes skin renewal, inflammation reduction, and healing. Added emollients and emulsifiers allow for versatile compounding for scar and other skin conditions.
SANARE ADVANCED™ BENEFITS:• Provides barrier protection• Increased skin penetration• Formulated for higher loads of polar salt APIs• Skin renewal and inflammation reduction• Soy, gluten, and irritant free
SANARE ADVANCED™ PROPERTIES
Specific Gravity 1.12 g/mL
Physical Format Viscous Gel
Solubility in Water Insoluble
Color Opaque, Off-White
Typical Applications• New Scars • Old Scars • Surgical Scars • Acne Scars • Keloids • Stretch Marks • Scar Tissue
Keloids & Hypertrophic Scars:Betamethasone Valerate 0.1%Tranilast 1%Sanare Advanced qs 100%
Post–Surgical Scars/ New Scars:Collagenase 350 u/gHyaluronidase 250 u/gSanare Advanced qs 100%
Post–Surgical Scars with Pain:Gabapentin 15%Lidocaine 3%Prilocaine 3%Sanare Advanced qs 100%
Age Spots & Wrinkles:Hydroquinone 8%Hydrocortisone 1%Kojic Acid 4%Tretinoin 0.05%Sanare Advanced qs 100%
Rosacea:Metronidazole 1%Niacinamide 4%Sanare Advanced qs 100%
Acne Scars:Lipoic Acid 0.5%Tretinoin 0.1%Sanare Advanced qs 100%
SAMPLE FORMULAS:
Dosage: Apply 2-6 grams topically to affected area 2-4 times daily for 10 to 14 weeks or as directed.
Mixing Tips• Recommended Wetting Agent: Fatty Acid Esters (Isopropyl Palmitate), Fatty Alcohols (Oleyl Alcohol), or Anhydrous Alcohol (Ethanol 200 Proof) Maximum Amount 10%
• Recommended to Reduce Stickiness: Cyclomethicone 5 - 10%
Lavare™ is a Polyethylene Glycol (PEG) based occlusive, water-soluble gel specifically formulated for wound management by promoting a moist environment allowing for optimal healing. Lavare™ contains organic Meadowsweet Extract potentially providing germicidal anti-inflammatory and healing properties along with the ability to deliver APIs topically to sensitive wound sites.
LAVARE™ BENEFITS:• Adherent base – occlusive• Water-washable allowing for easy cleaning and debridement• Maintains a moist wound site providing an optimal healing environment• API Compatibility – hydrophilic and lipophilic actives• Soy and gluten free
WATER-WASHABLE WOUND CARE BASEItem No. NDC No. Size Price7001-62 00395-7001-62 100 g $166.40 7001-56 00395-7001-56 500 g $661.607001-59 00395-7001-59 2500 g $2870.40
LAVARE™-
LAVARE ™ PROPERTIES
pH 6.0
Specific Gravity 1.12 g/cm³
Physical Format Non-Flowable Gel
Solubility in Water Complete
Color White
Typical Applications • Wounds • Ulcers • Burns • Cuts • Abrasions • Dermatological Applications
No Odor/ No Pain:Misoprostol 0.0024%Phenytoin 5%Lavare Gel qs 100%
Odor / No Pain:Misoprostol 0.0024% Phenytoin 5% Metronidazole 2% Lavare Gel qs 100%
No Odor / Pain:Misoprostol 0.0024% Phenytoin 5%Lidocaine 4%Lavare Gel qs 100%
Infected Wound:Misoprostol 0.0024%Phenytoin 5%Gentamicin 0.2%Lavare Gel qs 100%
Infected Wound: Gentamicin 0.1%/gClindamycin 0.1%/gPolymyxin 2,000 u/gLavare Gel qs 100%
Wound Care:Ketoprofen 2%Lidocaine 2%Misoprostol 0.0024%Phenytoin 2%Aloe Vera 0.2%Lavare Gel qs 100%
SAMPLE FORMULAS:
Dosage: Apply up to 4 grams topically 3 times daily as directed, up to 12 grams per day.
Misoprostol – 0.0024% Synthetic analogue of prostaglandin E1, attenuate the inflammatory process and promote collagen formation by inhibiting IL-1 and TNF, modulates inflammation and decreases wound healing time
Phenytoin – 5% Stimulates collagen deposition, fibro-blast proliferation, glucocorticoid antagonism, and has antibacterial activity
Lidocaine – 4% – Topical anesthetic
Metronidazole – 2% Deodorizing effect of Metronidazole correlate with eradication of anaerobic infection
Nifedipine – 2% Ca2+ channel blocker that greatly improves tissue perfusion and improves healing time
Gentamicin – 0.2% – Antibiotic
Common Actives in Wound Care:
Mixing Tip• Recommended Wetting Agent: Glycerin, Maximum Amount 10%
Item No. NDC No. Size Price0112-56 00395-0112-56 500 g $307.20 0112-59 00395-0112-59 2500 g $1372.800112-31 00395-0112-31 5800 g $2825.00
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PLO20 FLOWABLE™Gel Bases
&Ointments
PLO20 Flowable™ is a robust, ready-to-use transdermal base that rep-resents the next generation of pluronic lecithin organogel (PLO) bases. This cosmetically elegant base has a lotion consistency that allows for incorporating high levels of APIs. It contains the same stability properties as PLO20 Non-Flowable™, allowing for versatile compound-ing. PLO20 Flowable™ provides enhanced chemical penetration that allows a deeper skin permeation than does PLO20 Non-Flowable™. This product is designed to accept the incorporation of high levels of lipophilic actives and moderate levels of hydrophilic actives.
PLO20 FLOWABLE & PLO20 NON-FLOWABLE™ BENEFITS:• Enhanced penetration – more efficacious drug absorption• API compatibility – high lipophilic & moderate hydrophilic carrying capacity• Adjustable viscosity – PLO20™ & PLO20 Flowable™ may be blended• Temperature & shelf stable• Cosmetically elegant• Validated API compatibility & penetration• No wetting or milling – high levels of oil-soluble powders & moderate levels of water-soluble powders may be directly incorporated
PRE-MADE FLOWABLE PLOItem No. NDC No. Size Price0135-01 00395-0135-01 1 lb $65.00
Gel Bases &
OintmentsPLO20 NON-FLOWABLE™
PLO20 Non-Flowable™ and PLO20 Flowable™ are ready-to-use, absorp-tion-enhanced transdermal vehicles that are elegant alternatives to PLO transdermal systems. They contain penetration enhancers to facilitate more efficacious active drug absorption, emollients for a better rub-in, preservatives for increased mold resistance, along with emulsifiers allowing for better cold-temperature stability. PLO20 Non-Flowable™ and PLO20 Flowable™ may be blended for viscosity optimization without wetting agents or milling to thin the formula, thus allowing for versatile compounding.
PRE-MADE PLOItem No. NDC No. Size Price6008-01 00395-6008-01 1 lb $50.00 6008-79 00395-6008-79 10 lb $365.00 6008-81 00395-6008-81 40 lb $1310.00
PROPERTIES PLO20 NON-FLOWABLE™ PLO20 FLOWABLE™
Published Studies – Beyond-Use-Date (BUD)ACTIVE INGREDIENT PLO20 NON-FLOWABLE™ PLO20 FLOWABLE™
Diltiazem – 2% 90 Days –
Gabapentin – 6% 90 Days –
Haloperidol – 2% – 90 Days
Ibuprofen – 10%– (Piroxicam) 60 Days –
Ibuprofen – 20% – (Piroxicam) 90 Days 90 Days
Ketoprofen – 10% – (Piroxicam) 90 Days –
Methimazole – 5% – 90 Days
Piroxicam – 1% – (Ibuprofen, Ketoprofen) 60 Days –
Piroxicam – 2% – (Ibuprofen, Ketoprofen) – 60 Days
Prednisolone– 5% 90 Days –
Prednisone – 5% 90 Days –
Prednisone – 10% – 90 Days
Promethazine – 5% 90 Days –
Anti-Nausea/Pain Management Cream:Promethazine 5%
SAMPLE FORMULA:
Humco's PLO20 Flowable™ ............ 44%Competitor’s Base ........... 39%Traditional PLO ................. 17%
Cumulative % Permeation of Methimazole through the
Stratum Corneum
HUMCO'S PLO20 FLOWABLE™
VS TRADITIONAL PLO
& COMPETITOR'S BASE
• When you want more efficacious active drug absorption.• When you want to incorporate high levels of lipophilic substances.• When you want a creamier base than a traditional PLO that is more cosmetically elegant and less sticky.• When you want a penetrating cream that can be shipoed in cold temperatures.
WHEN DO YOU NEED PLO20™ OR PLO20 FLOWABLE™?
pH 7.0 7.0
Specific Gravity 0.97 g/ml 0.97 g/ml
Viscosity 300,000 cps 30,000 cps
Format Heavy Cream Light Cream/Lotion
Color Light Yellow Light Yellow
Transdermal Penetration + + + + + + + + +
API CompatibilityHydrophilic – 10%Lipophilic – 10%Total API Load – 10%
Hydrophilic – 10%Lipophilic – 30%Total API Load – 30%
Best Use Low Levels of Lipophilics High Levels of Lipophilics
Typical Applications• Pain Management• Sports Medicine• Diabetes & Wound Care• Veterinary Medicine
• Pain Management• Sports Medicine• Immunotherapy• Veterinary Medicine
DICLOFENAC SODIUM 3% CREAM, USP
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Diclofenac Sodium 3% Cream, USP is a creamy emulsion provided in bulk form as a base for prescription compounding that contains Diclofenac Sodium 3% in a cosmetically elegant cream. Diclofenac 3% Cream, USP was designed specifically to hold additional API's for further compounding, including API's that a pharmacist may choose to aid in pain management. Conveniently packaged with the pharmacist in mind, Diclofenac 3% Cream, USP is available in bulk packaging to save time and money and increase efficiency in place of compounding from unit of use package sizes.
DICLOFENAC SODIUM 3% CREAM, USP BENEFITS:• Penetration Ability - Contains penetration enhancers to facilitate API absorption• Time saving - Packaged in bulk to save time compounding• Applies Easily - No sticky residue
TOPICAL BASE
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UNIVERSAL WATER GEL™
Gel Bases &
Ointments
Universal Water Gel™ is an oil and salt tolerant blend using hydro-phobic-inclusive cyclodextrins and electrolyte-tolerant polymers that greatly increases the water solubility and stability of incompatible drugs. Ideal for formulas containing higher levels of oils, botanical ingredients, or poorly soluble actives. It provides improvements in solubility, increase in speed of dissolution, together with physical and chemical stability.
UNIVERSAL WATER GEL™ BENEFITS:• API compatibility – hydrophilic & lipophilic• Excellent electrolyte tolerance• Bioavailability enhancement• Improves active stabilization & compatibility• Highly stable across a broad pH range• Masks the odor of unpleasant actives • Cosmetically elegant
VERSATILE TOPICAL GEL BASEItem No. NDC No. Size Price6017-01 00395-6017-01 1 lb $21.00 6017-79 00395-6017-79 10 lb $165.00
UNIVERSAL WATER GEL™ PROPERTIES
pH 7.0
Specific Gravity 0.95 g/cm³
Viscosity 750,000 cps
Physical Format Gel
Color Translucent
Transdermal Penetration +
API Compatibility Hydrophilic & Lipophilic Total API Load - less than 10%
Typical Applications• Dermatology • Pain Management • Diabetes & Wound Care
DICLOFENAC SODIUM 3% CREAM, USP PROPERTIES
pH 6.0 - 8.0
Physical Format Viscous vanishing topical cream
Color Brilliant White
Typical Applications Compounding Base
Bulk Compounding
Drug SubstancesNDC 0395
CAS # Diclofenac Sodium 15307-79-6
Not in Dosage Unit Form
Diclofenac Sodium Cream 3%, USP
Manufactured by:Humco Holding GroupTexarkana, TX 75501Made in USA
Diclofenac Sodium, USP....................................................3.0%Cream....................................................................................97.0%
WARNING: Harmful if swallowed. Causes serious eye irritation. Prevention: Wash thoroughly after handling. Do not eat, drink or smoke when using this product. Wear eye/face protection. Response: If swallowed: call a poison center/doctor/medical professional/ if you feel unwell. Rinse mouth. If in eyes. Rinse cautiously with water for several minutes. Remove contact lenses. If present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Disposal: Dispose of contents/container to an approved disposal site. Do Not Use if Sealing Pins are Broken or Removed. Store at: Controlled Room Temperature (20°C – 25°C).
FOR PRESCRIPTION COMPOUNDING ONLY
rectangle - Pantone 3135C
Item No. NDC No. Size Price6120-59 00395-6120-59 2500 g Call for
Pricing
NOT IN DOSAGE UNIT FORM
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LIDOCAINE 5% OINTMENT,USP
Lidocaine 5% Ointment, USP is a water washable ointment provided in bulk form as a base for prescription com-pounding that contains Lidocaine 5% in a cosmetically elegant cream. Humco’s Lidocaine 5% Ointment, USP is a water soluble base containing polyethylene glycol (PEG) 400, polyethylene glycol (PEG) 330, propylene glycol, zinc acetate, and botanical extracts. Lidocaine 5% Ointment, USP was designed specifically to hold additional APIs for further compounding including APIs that a pharmacist may choose to aid in pain management. Conveniently packaged with the pharmacist in mind, Lidocaine 5% Ointment, USP is available in bulk packaging to save time and money and increase efficiency in place of compounding from unit of use package sizes.
LIDOCAINE 5% OINTMENT, USP BENEFITS:• Adherent base - occlusive• Time saving - packaged in bulk to save time compounding• Water washable and soluble• Applies Easily - No sticky residue
TOPICAL BASE
Item No. NDC No. Size Price6130-59 00395-6130-59 2500 g Call for
Pricing
WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 39
Bulk Compounding
Drug Substances
LIDOCAINE AND PRILOCAINE CREAM, USP
Lidocaine and Prilocaine Cream, USP is provided in bulk form as a base for prescription compounding that contains Lidocaine 2.5% and Prilocaine 2.5% in a cosmetically elegant cream. Lidocaine and Prilocaine Cream, USP was designed specifically to hold additional APIs for further compounding including APIs that a pharmacist may choose to aid in pain management. Conveniently packaged with the pharmacist in mind, Lidocaine and Prilocaine Cream, USP is available in bulk packaging to save time and money and increase effi-ciency in place of compounding from unit of use package sizes.
LIDOCAINE AND PRILOCAINE CREAM, USP BENEFITS:• Penetration Ability - Contains penetration enhancers to facilitate API absorption• Applies Easily - No sticky residue• Drug Compatibility - Can hold both hydrophilic & lipophilic APIs• Time Saving - Packaged in bulk to save time compounding
TOPICAL BASE
Item No. NDC No. Size Price6110-31 00395-6110-31 5800 g Call for6110-58 00395-6110-58 18000 g Pricing
LIDOCAINE AND PRILOCAINE CREAM, USP PROPERTIES
pH 8.7 - 9.7
Viscosity 800,000 - 1,600,000 cps
Physical Format Viscous Cream
Color Opaque, Off-White
Typical Applications Compounding Base
Common Actives for Compounding with
Lidocaine and Prilocaine Cream, USP:
Amitriptyline – 2%
Diclofenac Sodium – 2-6%
Gabapentin – 6%
Meloxicam – 0.2% - 0.375%
Topiramate – 1.25%
Cyclobenzaprine HCl – 2%
Baclofen – 2%
Ketamine – 5 - 20%
Bulk Compounding
Drug Substances
LIDOCAINE 5% OINTMENT, USP PROPERTIES
pH 6.0 - 8.0
Physical Format Viscous, water-soluble ointment
Color Translucent White
Typical Applications Compounding Base
Diclofenac Sodium –2 - 6%
Baclofen – 2%
Ketamine HCL – 5 - 10%
Gabapentin – 5 - 10%
Common Actives for Compounding:
NDC 0395CAS # Lidocaine
Not in Dosage Unit Form
Lidocaine Ointment 5%, USP
Manufactured by:Humco Holding GroupTexarkana, TX 75501Made in USA
Lidocaine, USP.......................................................................5.0%Ointment..............................................................................95.0%
WARNING: Harmful if swallowed. Causes serious eye irritation. Prevention: Wash thoroughly after handling. Do not eat, drink or smoke when using this product. Wear eye/face protection. Response: If swallowed: call a poison center/doctor/medical professional/ if you feel unwell. Rinse mouth. If in eyes. Rinse cautiously with water for several minutes. Remove contact lenses. If present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention. Disposal: Dispose of contents/container to an approved disposal site. Do Not Use if Sealing Pins are Broken or Removed. Store at: Controlled Room Temperature (20°C – 25°C).
FOR PRESCRIPTION COMPOUNDING ONLY
rectangle - Pantone 3135C
NOT IN DOSAGE UNIT FORM NOT IN DOSAGE UNIT FORM
Emulsion Concentrate™ is a pH and salt-tolerant emulsifier/hydrocolloid blend that greatly increases emulsification, stability, and thickness of broken emulsions, and separated and thin formulations. It quickly forms emulsions that are fresh, elegant, fast-absorbing, and non-greasy. EMULSION CONCENTRATE™ BENEFITS:• Ready-to-use polymer in fluid form• API compatibility – virtually all APIs• Elegant sensory profile • Low & high temperature resistant (-5º C – 80º C)• Ingredient compatibility • Broad range of applications
COMPOUNDING ENHANCER
EMULSION CONCENTRATE™
40 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM
Pre-Mixed Excipient
Bases
Item No. NDC No. Size Price6016-94 00395-6016-94 4 oz $35.00 6016-98 00395-6016-98 8 oz $57.00 6016-28 00395-6016-28 1 gal $800.00
EMULSION CONCENTRATE™ PROPERTIES
pH 4.5 - 6.5
Viscosity 75,000 cps
Physical Format Viscous Gel
Color Opaque
Intended Use
• Emulsify all types of oily phases• Stabilize mineral additives• Thicken in adverse conditions – very acidic or very alkaline, oxidizing• Develop fresh formulas that melt on contact with the skin
API Compatibility Virtually all APIs
pH Compatibility 2.0 - 12.0
Salt Tolerance Salt Forms – 35%
Solvent Compatibility Polar & Non-Polar
Temperature Stability Low & High Temperatures
ApplicationsEthanol, Propylene Glycol, Butylene Glycol, Glycerin, Hexylene Glycol, Methylpropane Diol, Acetone, Vegetable Oils, Silicone Oils, Mineral Oils, Esters & Sun Filters
DIFFERENT VISCOSITIES ARE ACHIEVED BY VARYING THE AMOUNT OF EMULSION CONCENTRATE:
3% FOR LOTIONS 5% FOR CREAMS
Item No. NDC No. Size Price3926-01 00395-3926-01 1 lb $28.60
Buffer Cream™ is a sweetened buffering agent in powder form developed to provide an alkaline buffer for compounding oral proton pump inhibitor (PPI) suspensions. It provides immediate release and rapid absorption of PPI actives and is free of milk and protein. Buffer Cream is highly palatable with added sweeteners for either flavored or unflavored alkaline solutions to help overcome patient compliance difficulties.
BUFFER CREAM™ BENEFITS:• Alkaline buffer• Immediate release & rapid absorption• Validated long-term stability• Masks unpleasant tastes• API compatibility – all PPIs• Flavor versatility
SWEETENED BUFFERING AGENT FOR ORAL SUSPENSIONS
BUFFER CREAM™ PROPERTIES
Physical Format White Powder with Translucent Sheen
Suspension Stability Up to 35 days
API Compatibility All PPI’s (Proton Pump Inhibitors)
Flavor Versatility Any Flavor
Long-Term StabilityACTIVE INGREDIENT STABILITY
Lansoprazole Stable - 21 Days at 25° C
Omeprazole Stable - 35 Days at 25° C
Pantoprazole Stable - 7 Days at 25° C
SAMPLE FORMULA:
Instructions: 1. Add omeprazole to 90 mL - 8.4% sodium bicarbonate, refrigerate for at least 1 hour and mix until dissolved.2. Add ompreazole solution to Humco Buffer Cream to qs volume - 120 mL and shake well.3. Add flavor is desired.
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Oral VehiclesBUFFER CREAM™
Omeprazole 10 mg/mL Suspension:Humco Buffer Cream 54 gOmeprazole 1.2 g8.4% Sodium Bicarbonate qs 120 mL
WHEN DO YOU NEED HUMCO'S BUFFER CREAM?
• When you want a sweet-ened buffer product for preparing oral suspensions• When you want an alkaline buffer• When you want palatability• When you want a product that contains no milk or protein
42 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 43
MOUTHWASH-GP™Oral
Vehicles
Mouthwash-GP™ is a mouthwash base designed to simplify and standardize the extemporaneous compounding of formulations for delivery to the oral cavity. The pH of Mouthwash-GP™ is buffered to match the natural pH of saliva. The viscous nature of the Mouth-wash-GP product allows the pharmacist to dissolve and/or suspend most of the common actives that are prescribed in “Magic Mouth-wash”. Mouthwash-GP™ is designed to dissolve or suspend a high amount of active ingredients - maintaining its viscosity when actives are added - such that the oral cavity is coated with medication. The Mouthwash-GP™ packaging container has added head space which allows for mixing of actives by shaking the container.
MOUTHWASH-GP™ BENEFITS:• Oral moisturizer• Coats the mouth• Container head space for mixing • Dye and flavor free• Easily tailored with flavors and colors to improve palatability• Compatible with flavors/dyes that are available for taste-masking of bitter or unpleasant tasting actives
GENERAL PURPOSE MOUTHWASH BASEItem No. NDC No. Size Price6030-98 00395-6030-98 8 oz $9.74
Oral VehiclesMOUTHWASH-OM™
Mouthwash-OM™ is a mouthwash base designed to aid symptoms of Oral Mucositis associated with cancer therapy and certain dental condi-tions. In addition to being alcohol-free, Mouthwash-OM™ contains excipients that are compatible with water-soluble drugs for the treatment of oral pain, mouth sores, and oral infections. MOUTHWASH-OM™ BENEFITS:• Soothing oral moisturizer• Alcohol-free - no burn• Container head space for mixing • Dye and flavor free• Contains botanical extracts• Compatible with flavors/dyes that are available for taste-masking of bitter or unpleasant tasting actives
MOUTHWASH BASE FOR ORAL MUCOSITISItem No. NDC No. Size Price6040-98 00395-6040-98 8 oz $9.74
MOUTHWASH-GP™ PROPERTIES
pH 5.0 - 7.0
Viscosity 1,500 - 4,000 cps
Physical Format Viscous Liquid Solution
Color Clear Liquid
Alcohol Content 10.6% w/w
Intended Use• Chemotherapy mouth ulcers• Bacterial/viral oral infections• Gingival irritation caused by braces • Throat/esophageal sores
API Compatibility Compatible with most “Magic Mouthwash” actives
Delivery Method Can be expectorated or swallowed
BLM Magic Mouthwash:Diphenhydramine HCl 0.1% Lidocaine HCl 1%Aluminum Hydroxide/ Magnesium Hydroxide/ Simethicone Suspension 37.5%Mouthwash-GP qs 100%
Mary’s Magic Mouthwash:Diphenhydramine HCl 0.25% Hydrocortisone 0.05% Nystatin 0.5% Tetracycline HCl 0.65% Mouthwash-GP qs 100%
Anti-Viral Mouth Rinse:Acyclovir 5% Mouthwash-AF 45% Lidocaine HCl 1% Deoxy D-Glucose 2% Mouthwash-GP qs 100%
SAMPLE FORMULAS:
Flavoring Suggestions?
• For formulations containing Diphenhydramine HCL, use: Banana, Apple, Bubble Gum
• For formulations containing Nystatin/Bio-Statin Suspension, use: Sour Apple, Watermelon, Cherry
• For formulations containing Cortisone Steroids, use: Bubble Gum, Grape, Apple
• For formulations containing Antibiotics, use: Grape, Watermelon, Strawberry
MOUTHWASH-AF™ALCOHOL-FREE MOUTHWASH BASE FOR HYDROPHOBIC ACTIVESMouthwash-AF™ is a mouthwash base designed to provide solubility of hydrophobic active ingredients while being compatible with the oral mucosa. In addition to being alcohol-free, Mouthwash-AF™ contains excipients that dissolve and coat the mouth with drugs for the treatment of oral pain, mouth sores, and oral infections. MOUTHWASH-AF™ BENEFITS:• Solubilizers for hydrophobic actives• Alcohol-free - no burn• Container head space for mixing • Dye and flavor free• Compatible with hydrophobic and hydrophilic actives• Compatible with flavors/dyes that are available for taste-masking of bitter or unpleasant tasting actives
Item No. NDC No. Size Price6050-98 00395-6050-98 8 oz $9.74
SAMPLE FORMULAS:
Pain Relief Gargle: Lidocaine HCl 1.5%Sucralfate 5%Diphenhydramine HCl 0.5%Mouthwash-OM qs 100%
Xerostomia Rinse: Pilocarpine HCl 1%Mouthwash-OM qs 100%
SAMPLE FORMULAS:
Esophageal Suspension:Budesonide 0.1%Mouthwash-GP or AF qs 100%
Anti-Infective Mouthwash: Nystatin 1% Tetracycline HCl 2% Acyclovir 5% Deoxy D-Glucose 2%Mouthwash-AF qs 100%
44 HUMCO • +1 (855) 925-4736 • WWW.HUMCO.COM WWW.HUMCO.COM • +1 (855) 925-4736 • HUMCO 45
FLAVOR SWEET™Oral Vehicles
Flavor Sweet™ is a cherry-flavored syrup vehicle formulated to simplify the preparation of oral extemporaneous delivery systems. It may be used alone or in conjunction with other agents to give flavor and sweetness while increasing the suspension’s physical stability. Flavor Sweet™ contains suitable preservatives and is buffered to a slightly acidic pH to provide a dependable and consistent vehicle. • Pink colored, cherry flavored syrup• pH 4.5 – pH 5.0• Recommended use – hydrophilic, acid-stable & hydrophobic actives
SYRUP VEHICLE
Item No. NDC No. Size Price0090-16 00395-0090-16 16 oz $9.55 0090-28 00395-0090-28 1 gal $62.00
Oral VehiclesFLAVOR PLUS™
ORAL SUSPENDING VEHICLE
FLAVOR SWEET-SF™
Flavor Sweet SF™ is a sugar-free and alcohol-free cherry flavored syrup. It may be used alone or in conjunction with other agents to give flavor and sweetness while increasing the suspension’s physical stabil-ity. Flavor Sweet SF™ contains suitable preservatives and is buffered to a slightly acidic pH to provide a dependable and consistent vehicle. • Pink colored, cherry flavored, sugar-free syrup• pH 4.5 – pH 5.0• Recommended use – hydrophilic, acid-stable & hydrophobic actives• Ideal for diabetic preparations
SUGAR-FREE SYRUP VEHICLE
VERSA FREE™
Versa Free ™ is a dye-free, flavor-free, paraben-free, sugar-free, gluten-free and saccharin-free syrup vehicle resulting in fewer patient allergic reactions. Virtually no aftertaste.• Flavor-free clear liquid syrup• pH 4.5 – pH 5.0• Natural ingredients & natural preservatives• Recommended use – hydrophilic, acid-stable & hydrophobic actives• Ideal for diabetic & allergy-sensitive patients• Soy & gluten-free
DYE-FREE, CHEMICAL-FREE, AND SUGAR-FREE SYRUP VEHICLE
Item No. NDC No. Size Price0094-16 00395-0094-16 16 oz $9.55 0094-28 00395-0094-28 1 gal $62.00
Item No. NDC No. Size Price0125-16 00395-0125-16 16 oz $10.47 0125-28 00395-0125-28 1 gal $75.00
Flavor Plus™ is a unique flavor-free, aqueous based suspending vehicle used to simplify the process of compounding oral non-soluble suspen-sions. It is buffered to an acidic pH providing a uniform, consistent and stable vehicle.• Flavor-free, white liquid suspension• pH 3.5 – pH 4.0• Recommended use – hydrophilic, acid-stable & hydrophobic actives• Ideal for diabetic preparations
FLAVOR BLEND™ALL-IN-ONE SYRUP/SUSPENDING VEHICLEFlavor Blend™ is a uniquely formulated flavored oral suspending vehicle designed to simplify the extemporaneous compounding process of oral suspensions. It combines the flavoring agents of Flavor Sweet™ and the suspending agents of Flavor Plus™, along with preservatives and an anti-foam agent to provide an easy preparation of smooth, elegant oral suspensions. • Easy to use• Light pink liquid blend with a cherry flavor• pH 4.5 – pH 5.0• Recommended use – hydrophilic, acid-stable & hydrophobic actives• Incorporate virtually all medicated powders or crushed tablets• Ideal for pediatric & geriatric preparations
VERSA PLUS™DYE-FREE, CHEMICAL-FREE, AND SUGAR-FREE SUSPENSION VEHICLEVersa Plus ™ is a dye-free, flavor-free, paraben-free, sugar-free, gluten-free and saccharin-free suspension vehicle resulting in fewer patient allergic reactions. Virtually no aftertaste.• Flavor-free white liquid suspension• pH 3.5 – pH 4.0• Natural ingredients & natural preservatives• Recommended use – hydrophilic, acid-stable & hydrophobic actives• Ideal for diabetic & allergy-sensitive patients• Soy & gluten-free
Item No. NDC No. Size Price0091-16 00395-0091-16 16 oz $9.55 0091-28 00395-0091-28 1 gal $62.00
Item No. NDC No. Size Price0089-16 00395-0089-16 16 oz $9.55 0089-28 00395-0089-28 1 gal $62.00
Item No. NDC No. Size Price0126-16 00395-0126-16 16 oz $10.47 0126-28 00395-0126-28 1 gal $75.00
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ADDITIONAL ORAL VEHICLES
Oral Vehicles
Miscellaneous Ingredients
ADDITIONAL CMPDG INGREDIENTS
Cherry Syrup™Recommended Use: Ionic & Hydrophilic Actives
Sucrose 82% w/v, purified water, artificial cherry flavors, citric acid, FDC Red #40, sodium benzoate as a preservative, inert ingredients and natural preservatives
Item No. Size Price 2662-16 16 oz $9.302662-28 1 gal $56.00
Raspberry SyrupRecommended Use: Ionic & Hydrophilic Actives
Sucrose 82% w/v, purified water, artificial raspberry flavors, citric acid, FDC Red #40, FDC Blue #1, sodium benzoate as a preservative, inert ingredients and natural preservatives.
Item No. Size Price 2664-16 16 oz $9.83
Simple SyrupRecommended Use: Ionic & Hydrophilic Actives
Sucrose 85% w/v, citric acid, purified water, methyl paraben as a preservative along with natural preservatives.
Item No. Size Price 2662-16 16 oz $9.302662-28 1 gal $56.00
Sorbitol Solution70%, USPRecommended Use: Ionic & Hydrophilic Actives, Diabetic Additives
Natural ingredients and preservatives— 70% solution of sorbitol and purified water.
Item No. Size Price 3913-16 16 oz $4.96
Syrpalta (red)Recommended Use: Ionic & Hydrophilic Actives
Sucrose 83% w/v, purified water, glycerin, artificial flavors, 0.2% alcohol, 0.1% sodium benzoate, 0.001% benzal-konium chloride as a preservative and inert ingredients.
Item No. Size Price 3920-16 16 oz $12.04
Syrpalta (without color)Recommended Use: Ionic & Hydrophilic Actives
Sucrose 83% w/v, purified water, artificial flavors, 0.2% alcohol, 0.1% sodium benzoate, 0.001% benzalko-nium chloride as a preservative, inert ingredients and natural preservatives.
Item No. Size Price 3927-16 16 oz $12.64
Product Ingredients Ordering Information Almond Oil Sweet, NF Item No. Size Price 1907-91 1 oz $5.691907-16 16 oz $40.43
Arnica Tincture Item No. Size Price 0115-94 4 oz $34.48
Barium Sulfate Powder USP Item No. Size Price 0200-01 1 lb $53.45
Benzoin Compound Tincture USP Item No. Size Price 0243-92 2 oz $6.230243-16 16 oz $42.34
Bismuth Bicarbonate Powder Item No. Size Price 0261-01 1 lb $136.83
Coal Tar Topical Solution USP Item No. Size Price 0617-16 16 oz $24.18
Glycerin USP Item No. Size Price 1031-96 6 oz $5.821031-28 1 gal $102.161031-75 5 gal $150.07
Iodine Tincture, Mild 2% USP Item No. Size Price 1213-91 1 oz $2.451213-16 16 oz $23.17
Mineral Oil Light Item No. Size Price 1673-28 1 gal $101.68
Olive Oil Item No. Size Price 1997-94 4 oz $7.701997-28 1 gal $46.55
Peruvian Balsam Item No. Size Price 2255-94 4 oz $34.56
Polyethylene Glycol 300 Item No. Size Price 2335-75 5 gal $238.67
Propylene Glycol Item No. Size Price 2327-28 1 gal $36.48
Salicylic Acid Powder USP Item No. Size Price 2625-94 4 oz $12.312625-01 1 lb $39.03
Strong Iodine Solution (Lugol's) * Item No. Size Price 2775-16 16 oz $56.20
* To purchase this item you must have a DEA license on file
HUMCO GLOBAL HEADQUARTERS201 West 5th Street Floor 12Austin, TX 78701
+1 (855) 925-4736 www.Humco.com