Pharmaceutics – Dosage Forms, Containers, Labeling & Compounding

Question-and-answer flashcards covering key definitions, regulations, container types, labeling, storage, stability, shelf life, drug nomenclature and routes of administration from the pharmaceutics lecture notes.

The science that studies the physical, chemical, and biological factors influencing the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms.

Pharmaceutics

An agent intended for use in the diagnosis, mitigation, treatment, cure or prevention of disease in humans or animals.

Drug

Dosage forms prepared by pharmacists for administration in treating disease, either extemporaneously compounded or manufactured for distribution.

Pharmaceutical Preparations

Another name for dosage forms.

Pharmaceuticals

The two broad ingredient categories that make up a dosage form.

Active pharmaceutical ingredient (API) and excipients (inactive or inert ingredients)

The production, preparation, propagation, conversion or processing of a drug or device either directly or indirectly, often on a large scale.

Manufacturing

The preparation of components into a drug product for an individual patient on the basis of a practitioner–patient–pharmacist relationship or for research, teaching or analysis in pharmacy practice.

Compounding

The standard that includes preparing, mixing, assembling, altering, packaging, and labeling a drug or device pursuant to a prescription or practitioner-initiated request under compounding activities.

According to USP

The core condition under which a pharmacist may compound a commercially available product.

When a pharmacist–patient–prescriber relationship exists and a valid prescription is presented

Whether pharmacists may compound in anticipation of future prescriptions.

Yes, in limited quantities based on a documented history of receiving valid prescriptions within an established relationship

The special label that must accompany compounded medication supplied to a practitioner for office use.

“For Office Use Only,” plus date compounded, use-by date, and name, strength and quantity of active ingredients

Required dosage strengths or forms are not commercially available; patients may be allergic to excipients in marketed products; certain drugs are unstable and must be prepared fresh.

Reasons for compounding patient-specific medications

1) Calculation 2) Weigh/measure ingredients 3) Prepare label/select container 4) Compounding 5) Packaging/labeling 6) Submit worksheet and product.

The six basic steps in compounding

The first step in any compounding procedure.

Calculation of the required quantities

A container that is in direct contact with the drug product at all times.

An immediate container

A container that protects against the entry of extraneous solids and loss of contents under ordinary conditions.

A well-closed container

A container that provides additional protection compared with a well-closed one by preventing contamination by liquids, solids or vapors and protecting from loss, efflorescence, deliquescence or evaporation while allowing tight re-closure.

A tightly-closed container

A container that is impervious to air or any other gas under normal handling, storage and distribution conditions; often used for parenteral preparations.

A hermetic container

A package that holds the amount of drug intended for a single dose and cannot be securely resealed once opened (e.g., ampules, blister packs).

A single-dose container

A container that permits withdrawal of successive portions without altering strength or purity of the remaining product (e.g., vials, multi-dose bottles).

A multiple-dose container

The container used primarily for liquid dosage forms dispensed by community pharmacies.

A round bottle

A bottle designed for applying liquid medication directly to skin or wounds.

An applicator bottle

Two common packages for semi-solid dosage forms such as ointments and creams.

Ointment jars and collapsible tubes

A temperature range not exceeding 8 \text{ °C}.

Cold storage

A temperature range between 8 \text{ °C} and 15 \text{ °C}.

Cool storage

The USP range for this temperature is 15 \text{ °C} to 30 \text{ °C}.

USP Controlled Room Temperature

A temperature range between 30 \text{ °C} and 40 \text{ °C}.

Warm

Storage classified at temperatures above 40 \text{ °C}.

Excessive heat

Physical, Chemical, Microbiological, Therapeutical, and Toxicological stability.

The five types of stability for drug products

The period during which a drug product remains within acceptable potency and quality standards under specified storage conditions.

Shelf life

The usual manufacturer’s shelf life for solid dosage forms like tablets and capsules.

Five (5) years from the date of preparation

The maximum beyond-use date for a non-preserved aqueous compounded preparation.

14 days when stored at controlled cold temperatures unless otherwise indicated

The beyond-use date for a preserved aqueous compounded preparation.

35 days

The beyond-use date that applies to non-aqueous compounded dosage forms.

90 days

The beyond-use date that applies to compounded solid dosage forms.

180 days

This signifies the latest date by which a product is expected to maintain identity, strength, quality, and purity when stored as labeled.

Expiry date or Beyond-Use Date

The non-proprietary name of a drug.

Generic name

The class of drugs that must be prescribed on a YELLOW prescription form.

Dangerous Drugs

The route of administration that involves injection into the body.

Parenteral

This route entails placing medication under the tongue for absorption.

Sublingual route