pharmaceutical excipients & formulation of a dosage form

Pharmaceutical Excipients & Formulation of a Dosage Form

Presented by Md. Faysal Id: 151-29-760

Cellulose acetate

Non-proprietary name: BP : Cellulose acetate

USP : Cellulose acetate

Chemical name: Cellulose acetate , Cellulose diacetate ,

Cellulose triacetate.

Structure formula: C164H174O111

Functional category:

Coating agent

Extended release agent

Tablet and capsule diluent

Application in pharmaceutical formulation:

Used as a semipermeable coating on tablets.

Used in transdermal drug delivery systems.

Highly absorbent and resistant to moderate temperature.

They don’t shrink or wrinkle.

Stability and storage conditions:

Stable if stored in a well-closed container in a cool, dry place .

Incompatibilities:

Incompatible with strongly acidic or alkaline substances.

Cellulose Acetate Phthalate

Non-proprietary Name:

BP: Cellacefate

USP: Cellacefate

Chemical Name:

Cellulose, acetate, 1,2-benzenedicarboxylate

Structural Formula:

Functional Category : Coating agent

Applications in Pharmaceutical Formulation:

Used as an enteric film coating material.

Used as a matrix binder for tablets and capsules.

Commonly applied to solid-dosage forms.

Stability and Storage Conditions

Stable if stored in a well-closed container in a cool, dry place.

Incompatibilities

Incompatible with ferrous surface, ferric chloride, sodium citrate.

Ceratonia

Non-proprietary Names: None adopted.

Chemical Name : Carob gum , Ceratonia silique.

Structural Formula:

Functional Category:

Controlled-release agent

Suspending agent

Tablet binder

Viscosity-increasing agent


Naturally occurring materials generally used as substitute for tragacanth.

Used as a binder, thickening agent, and stabilizing agent in the cosmetics and food industry.


Stored in a well-closed container in a cool, dry place.

Ceratonia loses not more than 15% of its weight on drying.

Incompatibilities

The viscosity of xanthan gum solutions is increased in the presence of ceratonia.

Ceresin

Non-proprietary Names: None adopted.

Chemical Name: Ceresin

Structural Formula:


Coating Agent

Stabilizing agent

Stiffening agent


Used as a stiffening agent in creams and ointments.

Emulsion stabilizer, viscosity control agent.

Thickener in pharmaceutical protective, topical, and vaginal creams.

Used in cosmetics and personal care products.


Stored in well-closed containers in a cool, dry, well-ventilated place, away from extreme heat and strong oxidizing agents.

Incompatibilities

Incompatible with strong oxidizing agents.

Cetostearyl Alcohol

Non-proprietary Names

BP: Cetostearyl Alcohol

USP-NF: Cetostearyl Alcohol

Structural Formula: CH3(CH2)nOH

Functional Category Emollient

Emulsifying agent

Viscosity-increasing agent


Used in cosmetics and topical pharmaceutical preparations.

Used in the preparation of non aqueous creams sticks, and in non latheringshaving creams.


Stable under normal storage conditions.


Incompatibilities

Strong oxidizing agents and metal salts.

Cetrimide

Non-proprietary Names:

BP: Cetrimide

PhEur: Cetrimide

Structural Formula: C19H42BrN

Functional Category

Antimicrobial preservative

Antiseptic

Cationic surfactant

Disinfectants


Quaternary ammonium compound that is used in cosmetics and pharmaceuticalformulations as an antimicrobial preservative.

Used as a catholic surfactant.


Stable in the dry state, and also in aqueous solution at ambient temperatures.

Bulk material should be stored in a well-closed container in a cool, dry place.

Incompatibilities

Incompatible with soaps, anionic surfactants, high concentrations of non-ionicsurfactants. Aqueous solutions react with metals.

Cetyl Alcohol


BP: Cetyl Alcohol

USP-NF: Cetyl Alcohol

Chemical Name: Hexadecan-1-ol

Structural Formula: C16H34O


Coating agent

Emulsifying agent

Stiffening agent


Used in cosmetics and pharmaceutical formulations such as suppositories,modified-release solid dosage forms, emulsions, lotions, creams.

Used for its water absorption properties in water-in-oil emulsions and ointments.


Stable in the presence of acids, alkalis, light, and air.

It does not become rancid.


Incompatibilities

Incompatible with strong oxidizing agents

Cetylpyridinium Chloride


BP: Cetylpyridinium Chloride

USP: Cetylpyridinium Chloride

Chemical Name:

1-Hexadecylpyridinium chloride

Structural Formula: C21H38ClN


Antimicrobial preservative

Antiseptic

Cationic surfactant

Disinfectant

Solubilizing agent

Wetting agent


Used therapeutically as an antiseptic agent.

Mouthwashes containing cetylpyridinium chloride have been shown to inhibit

plaque formation.


Stable under normal conditions. It should be stored in well-closed containers.

Incompatibilities

Incompatible with strong oxidizing agents and bases.

Chitosan

Non-proprietary Names

BP: Chitosan Hydrochloride

PhEur: Chitosan Hydrochloride

Chemical Name:

Poly-b-(1,4)-2-Amino-2-deoxy-D-glucose

Structural Formula:


Coating agent

Disintegrates

Film-forming agent

Viscosity increasing agent


Used in cosmetics and is under investigation for use in a number ofpharmaceutical formulations.


Stable material at room temperature, although it is hygroscopic after drying.Stored in a tightly closed container in a cool, dry place.

Incompatibilities

Incompatible with strong oxidizing agents

Final weight of tablet=300 mg

API (Ciprofloxacin)=150 mg

Excipients=150 mg

Ingredients Names

Functions Amounts (mg) Amounts (%)

Ciprofloxacin API 150 mg

Ceratonia Tablet binder 12 mg 4%

Microcrystalline Disintegrates 30 mg 10%

Na Stearate Lubricants 3 mg 1%

Cellulose acetate phthalate

Coating agents 4.5 mg 1.5%

Cellulose acetate Diluent 100.5 mg 33.5%

Formulation of Tablet

pharmaceutical excipients & formulation of a dosage form

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