Pharmaceutics III Lecture I

alchemist04's version from 2016-04-05 02:49

Section 1

Question Answer
Drug SubstanceBiologically active molecule. E.g. Hydrochloroquine
Dosage Formhow drug desired dose is introduced into the system by specific route e.g Aqueous solution, Tablet (PO), Parenteral (IM,SC,ID)
Drug ProductContains drug substance, formulation, dosage form, and packaging. E.g. 0.5% Hydrochloroquine Oral Syrup, 50mL in amber bottle
Drug formulationspecific amount of drug substance at specific dose plus excipients. E.g. Quine hydrochloride in 5% sucrose solution buffered at pH 4.5 using acetate
Which one is more specific, drug product or drug substance?Drug product

Section 2

Question Answer
What are the reasons for dosage form?(1) ease of administration for non compliance patients (2) ease of dispensing for pharmacist (3) alternatives route of administrations via various routes and orifices (4) to maximize bioavailability and reduce variability. (5) for fast onset (IV), and Sustained release (tablets). (6) introduces specific dose of a given drug into (or onto) the body in a reproducible manner
What are the reasons for putting drug in dosage form?(1) assures drug purity and stability (2) assures dose accuracy (3) maximize dosing reproducibility [efficacy]. (4) Maximize bioavailability [scope of availability]
What are the other reasons for drug in dosage form?(1) increase duration of therapy. (2) provide dilution of potent substance (3) provide homogenous preparations to improve dosing accuracy/reproducibility (4) Protect drug substances from degradation (5) Provide for temporal/spatial dosing

Section 3

Question Answer
What are the compositions of drug formulation?(1) Specific drug substance and specific concentration (2) Specific excipients and specific amount (3) Specific manufacturing process and procedure (4) Specific packaging
Why is excipient added to drug ingredients?To alter the duration of drug effects (Rapid onset vs Slow onset)
Why is drug packaging important in drug formulation?(1) prevent drug from light/moisture/air, if necessary. (2) To prevent adsorption to container, if necessary.

Section 4

Question Answer
What are factors to consider in drug formulation(1) Bioavalaibilty/availability optimization. (2) Stability Optimization and testing (3) Sterilization and preservation
3 things about drug formulation's sterilization and preservation(1) sterilization by heat or filtration to kill microbia (2) preservation by adding antimicrobia, antioxidant (3) must minimize drug decomposition
3 things about drug formulation's stability optimization and testing(1) Use accelerated testing to predict long term shelf life. (2) Use inert excipients and prepare drug solutions/mixtures at most stable pH (3) use acceletared stability studies to screen excipients and identify acceptable processing conditions

Section 5

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