Pharmaceutics, Manufacturing, Physical Pharmacy, and Jurisprudence Review

Vocabulary practice flashcards covering drug delivery systems, pharmaceutical manufacturing, physical pharmacy principles, and jurisprudence based on Module 5 lecture notes.

Drug

An article intended for use in the diagnosis, mitigation, cure, treatment, or prevention of disease in man or animals, or an article (other than food) intended to affect the structure or any function of the body.

Excipient

An inactive ingredient present in a pharmaceutical dosage form.

Dosage Form

A formulation containing a specific quantity of active pharmaceutical ingredient(s) in combination with one or more excipients.

Drug Product

The final dosage form containing the Active Pharmaceutical Ingredient (API), generally, but not necessarily, in association with other ingredients.

Drug Delivery System

Physical carriers used to deliver medications to specific areas of the body in a safe, efficient, reproducible, and convenient manner.

Biopharmaceutics Classification System (BCS)

A system that categorizes drug substances into four classes based on their aqueous solubility and intestinal permeability.

Good Manufacturing Practice (GMP)

Part of Quality Assurance that ensures products are consistently produced and controlled to the quality standards appropriate to their intended use.

Hermetic Container

A container that is impervious to air or any other gas.

Controlled Room Temperature

A temperature maintained between $2$ to $8\,^\circ\text{C}$ that permits temperature excursions between $0$ to $15\,^\circ\text{C}$.

Monograph

A document specifying all the tests to be conducted on a product and/or appropriate references containing details of the procedure and expected result.

Certificate of Analysis

A document providing the results of all tests conducted on material to demonstrate compliance or non-compliance with standard specifications.

Standard Operating Procedure (SOP)

A step-by-step written method detailing how to execute a specific job or task.

Trituration

The comminution of dry substances into a fine powder using a mortar and pestle on a small scale, or the grinding of a medicinal substance with lactose.

Levigation

The process of reducing particle size to form a smooth paste by triturating with a liquid levigating agent in which the solid is insoluble.

Eutectic Mixture

A mixture of solids (such as camphor, menthol, thymol, aspirin, or phenyl salicylate) that liquefies upon blending due to a mutual lowering of their melting points.

Bloom Strength

A measure of gel rigidity, typically $200\text{--}250\,\text{g}$ for hard gelatin capsules and $150\,\text{g}$ for soft gelatin capsules.

Capsule Capacity Table

A standard reference table listing capacities for hard gelatin capsules ranging from size 000 ($1.40\,\text{mL}$) down to size 5 ($0.13\,\text{mL}$).

Enteric Coated Tablet

A tablet coated with polymers (such as cellulose acetate phthalate) that resist disintegration in gastric fluids and release medication in intestinal fluids.

Glidants

Excipients that improve the flow characteristics of a powder mixture from the hopper into the die (e.g., silicon dioxide, colloidal silica, cornstarch, talc).

Lubricants

Excipients that prevent adhesion of tableting material to dies and punches, reduce friction during compression, and assist tablet ejection.

Capping

A tableting defect involving the partial or complete separation of the top or bottom crown from the main body of the tablet.

Lamination

A tableting defect characterized by the separation of a tablet into two or more distinct layers.

Mottling

An unequal or uneven distribution of color on the surface of a tablet.

Thixotropy

A reversible, isothermal gel-sol transformation where a structure breaks down under shear stress and recovers its consistency slowly upon standing.

Syneresis

An instability in gels where the matrix contracts or shrinks, resulting in the squeezing out of liquid.

Imbibition

The absorption of liquid by a gel without a measurable increase in total gel volume.

Swelling

The absorption of liquid by a gel accompanied by a measurable increase in total volume.

Purified Water

Water obtained by distillation, ion-exchange, or reverse osmosis (pH $5\text{--}7$) used for non-parenteral dosage forms.

Water for Injection (WFI)

Pyrogen-free purified water obtained by distillation or reverse osmosis, used as a vehicle for parenterals to be sterilized after preparation.

Bacterial Endotoxin Test (BET)

An official test for pyrogens utilizing Limulus Amebocyte Lysate (LAL) extracted from the horseshoe crab (Limulus polyphemus).

Grade A Cleanroom Zone

A high-risk operational area (e.g., aseptic filling, open ampoules) equipped with a laminar airflow workstation providing HEPA-filtered air.

Faraday-Tyndall Effect

An optical property of colloidal dispersions characterized by the scattering of light as a beam passes through the system.

Zeta Potential

The electrokinetic potential representing the difference in potential between the surface of tightly-bound liquid layers and the electroneutral region of a dispersion.

Creaming

A reversible emulsion instability characterized by the upward or downward movement of dispersed phase droplets relative to the continuous phase.

Cracking

An irreversible emulsion instability characterized by the complete separation of the internal and external liquid phases.

Particle Diameter Measurements

Linear micrometric dimensions including Feret's diameter (distance between parallel tangents) and Martin's diameter (bisecting line distance).

Angle of Repose

A measure of powder flowability calculated using the equation $\tan^{-1}\left(\frac{\text{height}}{\text{radius}}\right)$.

Phase Diagram

A graphic summary representing the states of matter and phase equilibria existing across varying temperature and pressure conditions.

Zero-Order Reaction

A reaction where rate of degradation is constant over time and independent of reactant concentration.

First-Order Reaction

A reaction where rate of degradation is directly proportional to the remaining concentration of the drug.

Shelf-life ($t_{90}$)

The expiration-dating period required for a drug product to decay to $90\%$ of its original concentration ($10\%$ loss).

Republic Act 5921

The Pharmacy Law (as amended by EO 174), regulating the practice of pharmacy and setting standards for pharmaceutical education in the Philippines.

Republic Act 3720

Foods, Drugs, Devices, and Cosmetics Act (as amended by EO 175), ensuring safety, purity, and standard quality of food, drug, and cosmetic supplies.

Republic Act 6675

Generics Act of 1988, promoting, requiring, and ensuring the production, distribution, and use of drugs identified by their generic names.

Republic Act 9165

Comprehensive Dangerous Drugs Act of 2002.

Violative Prescription

A prescription in which the generic name is omitted, illegible while the brand name is legible, or where 'No Substitution' is explicitly stated.