8/10/2019 Drug Del Rev

1/4

Drug del

Chapter 1

Drug-an agent intended for use in thediagnosis, mitigation, treatment, cure orprevention of disease in humansMydriatic drugs-dilate the pupil of the eyeMiotics-constrict or diminish pupillary sizeEmetics-induce vomitingAntiemetic drugs-prevent vomitingDiuretic drugs-increases the ow of urineE pectorant drugs- increases the respiratorytract uidCathartics! la atives- evacuate the "owel#asic pharmacology- nature and mechanismof action of the drug on the "iologic system

$the only di%erence "etween a drug and apoison is the dose&

'he pharmacist is entrusted with the legalresponsi"ility for the procurement, storage,control, and distri"ution of e%ectivepharmaceutical products and for thecompounding and (lling of the prescriptionorders)

*t was in the preparation of medicinalmaterials that the art of apothecaryoriginated)

+harma on- where the word +harmacy wasderived

- in omeric epics, it connotes acharm or a dug that can "eused for good or for evil

+lace"o therapy- a su"stance or procedurethat is o".ectively without speci(c activity forthe condition "eing treated/umerian clay ta"let- form 0 rd millennium #C

-world s oldestprescriptionE"ers papyrus- scroll 23ft) long and a foot

wide dating to 12th

century #C- now preserved at 4niversity of5eipzig

- named after the 6ermanEgyptologist 6eorg E"ersdiscovered it in the tom" of amummy and partly translated itduring the last half of the 17 th century

- dominated "y drug formulas, w!more than 833 formulas orprescriptions "eing descri"ed

and more than 933 drugsmentionedippocrates :;23-099 #C-1982 Drug del 'he federal =ood, Drug and Cosmetic act, asregulated through title >1 of the 4/ Code offederal regulations, reFuires a new drug to

"e approved "y the =DA "efore it may "elegally introduced in the interstatecommerce

'o gain approval for mareting, a drug ssponsor must demonstrate, throughsupporting scienti(c evidence, that the newdrug or drug product is safe and e%ective

Lnly when the preclinical studiesdemonstrate adeFuate safety and the newagent shows promise as a useful drug will

the drug s sponsor (le an *ID application w!the =DA for initial testing on humans)

GE=EG 'L (g) >)1 LI ' E #LL

'reatment *ID :investigational drug

8/10/2019 Drug Del Rev

4/4

dosage and dosing freFuency, have optimalonset and duration of activity e hi"it no sidee%ects#ioassays- used to di%erentiate the e%ectand potency of the test agent from thosecontrols of nown actions and e%ectMolecular Modi(cation- chemical alteration of a nown and previously characterizedorganic compound for the purpose ofenhancing the usefulness of drugsCimetidine- (rst commercial histamineGanitidine- an inhi"itor of histamine5ead compound- prototype chemicalcompound that has fundamental desired"iologic or pharmacologic activity+rodrug- a compound that reFuires meta"olic"iotransformation after administration toproduce the desired pharmacologically activecompound

=DA s def) of a new drugIew drug- any drug that is not recognized as"eing safe and e%ective in the conditionsrecommended for its use in the la"elingamong the e perts who are Fuali(ed "yscienti(c training and e perience

+age ;7 >)1 and >)>

Chapter 0Amorphous powders- crystals of variousmorphologic structure

- where pharm) *ngr) Lccur insolid state

+owders- intimate mi tures of dry, (nelydivided drugs and chemicals that may "eintended for internal and e ternal use

6ranules- prepared agglomerates of thepowdered materials of powdered materialsIonmedicated powders- serves as a carrierfor meds#ul - pac aged in setsDivided powder- already divided according to

dose+owders- can "e medicated or nonmedicated*n characterizing the particle size- very coarse, coarse, moderately coarse,(ne and very (ne

Hery Coarse :no) 8< All particles pass througha no) 8 sieve and not more than >3O passthrough a Io) 23 sieveCoarse :no) >3< All particles pass through ano) >3 sieve and not more than ;3O passthrough a Io) 23 sieveModerately coarse :no) ;3< All particles passthrough a no) ;3 sieve and not more than;3O pass through a Io) 83 sieve=ine :no) 23< All particles pass through a no)23 sieve and not more than ;3O passthrough a Io) 133 sieveHery (ne :no) 83< All particles pass through ano) 83 sieve) 'here is no limit to greater(neness

ow particle size can in uence variety offactors

- Dissolution rate, drugmicronization can increase thedissolution rate and its"ioavaila"ility

- /uspenda"ility of particles- 4niform distri"ution- +enetra"ility of particles- 5ac of grittiness

*n determining the particle size/ieving- particles pass "y through

mechanical sha ingMicroscopy- uses a cali"rated grid

"ac ground or other measuring devices/edimentation rate- size is determined

"y measuring the terminal settling velocity of particles

5ight energy di%raction or lightscattering- "y reduction of light reaching thesensor

- light pass through5aser holography -(red through an

aerolized particle spray photographed 0Dwith a holographic camera

Cascade impaction-Micromeritics- science of small particles