Dosage Forms I - Vocabulary Flashcards

A set of vocabulary flashcards defining key pharmaceutical terms, dosage form classifications, and drug development concepts from the lecture notes.

Pharmaceutics

The discipline encompassing the stages following drug discovery or synthesis—including isolation, purification, and testing—that converts a drug into a medicine.

Drug (Active Pharmaceutical Ingredient)

The pharmacologically active ingredient (API) in a medicine, defined by the Food, Drug, and Cosmetic Act (1938) as an agent intended for use in the diagnosis, treatment, cure, or prevention of disease in humans or animals.

Medicine

A drug-delivery system designed to administer active drugs to the body in a safe, effective, accurate, reproducible, and convenient manner.

Excipients

Additive substances combined with active drug substances to formulate them into dosage forms.

Enteric-Coated Tablets

A dosage form designed to protect the drug substance from the destructive effect of gastric acid in the stomach.

Syrups

Concentrated viscous aqueous preparations of a sugar (sucrose) used as a pleasant-tasting vehicle.

Elixirs

Clear, flavored, sweetened hydroalcoholic liquid preparations intended for oral use.

Aromatic Waters

Clear, saturated aqueous solutions of volatile oils or volatile substances used as flavored or perfumed vehicles.

Gargles

Liquid preparations used to treat sore throats.

Mouthwashes

Liquid preparations used on the mucous membrane of the mouth to refresh and mechanically clean the mouth.

Ointments

Semi-solid dosage forms that provide an occlusive effect by forming a greasy film on the skin to increase skin hydration.

Pastes

Semi-solid dosage forms consisting of ointment bases that contain a high concentration (50% w/w) of dispersed drug.

Creams

Semi-solid oil-in-water (o/w) or water-in-oil (w/o) emulsions that are less greasy and easier to spread and remove than ointments.

Powder

A solid dosage material existing in a finely divided state.

Granules

Solid preparations consisting of powders agglomerated to produce large, free-flowing particles.

Tablets

Solid unit dosage forms of active substances and excipients, usually in powder form, that are pressed or compacted into a solid dose.

Capsules

Solid dosage forms consisting of active substances enclosed within a hard or soft gelatin shell.

Lead Compound

A prototype chemical compound displaying a fundamental desired biologic or pharmacologic activity that serves as a starting point for further optimization.

Preclinical Research

Laboratory and animal testing phase where prospective drugs undergo evaluations for biologic activity, pharmacokinetics (ADME), and safety prior to human testing.

Toxicology

The branch of science dealing with the adverse or undesired effects of drugs.

Phase I Clinical Trials

Clinical trials conducted on 20–100 healthy volunteers to evaluate safety, tolerability, maximally tolerated dose, and drug-drug interactions.

Phase II Clinical Trials

Clinical trials conducted on up to several hundred patient participants to evaluate preliminary efficacy and further assess safety.

Phase III Clinical Trials

Large-scale clinical trials involving several hundred to several thousand patients over 1–4 years to demonstrate safety, effectiveness, optimal dosage, and side effect profiles.

Phase 4 Studies (Postmarketing Surveillance)

Continuous clinical investigations conducted after drug approval to collect ongoing safety data, monitor long-term or rare side effects, and identify new indications.

Generic Drug Product

A therapeutic equivalent to a brand-name reference listed drug (RLD), created and approved via an Abbreviated New Drug Application (ANDA) following patent expiration.