Pharmaceutical Testing
Classification of Medicines Introduction
One of the clearest taxonomic guides for the classification of pharmaceutical dosage forms is to be found in Chapter <1151> of the US Pharmacopeia (USP) entitled “Pharmaceutical Dosage Forms”. The guide is depicted in “Figure 1. Compendial taxonomy for pharmaceutical dosage forms”, a modified version of which appears below.
This proposes a three tier system with the first tier being based on the region of the body to which the drug is to be administered, i.e. gastrointestinal (oral), mucosal membrane (rectal, vaginal, oropharyngeal, ophthalmic, otic and urethal), skin surface (topical, transdermal), injection including implants (parenteral) or nasal/lungs (pulmonary). The second tier describes the dosage form concerned, e.g. tablet, capsule, suppository, cream, ointment, transdermal patch, injection, inhaler, etc., whilst the third tier describes whether the dosage form concerned is designed for immediate, extended or delayed release. It is the first tier classification which has been used as the basis for the Equipment Selection Guide to be found on page 7. This lists the route of administration, the dosage form and test parameter concerned, the chapter relating to that test parameter in both European and US Pharmacopoeia (where applicable) and, in the final column, the page number in this catalogue where a description of the relevant test instrumentation can be found.
TIER 1
Route of Administration
GASTROINTESTINAL / MUCOSAL / INHALATION / INJECTION / TOPICAL (DERMAL)
TIER 2
Dosage Form
AEROSOLS / CAPSULES / CREAMS / EMULSIONS / FILMS / FOAMS / GASES GELS / GRANULES / GUMS / IMPLANTS / INJECTIONS / INSERTS / IRRIGATIONS LIQUIDS / LOZENGES / OINTMENTS / PASTES / PELLETS / PILLS / PLASTERS POWDERS / SOAPS / SHAMPOOS / SOLUTIONS / SPRAYS / STRIPS SUPPOSITORIES / SUSPENSIONS / SYSTEMS / TABLETS / TAPES
TIER 3
Release Pattern
IMMEDIATE / EXTENDED / DELAYED
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