TAXONOMY AND GLOSSARY

USPS EXPERT COMMITTEES ON PHARMACEUTICAL DOSAGE FORMS (PDF) BIOPHARMACEUTICS (BPC) and NOMENCLATURE and LABELING (NL) are WORKING TOGETHER TO PREPARE A TAXONOMY AND GLOSSARY OF OFFICIAL DOSAGE FORMS. A STIMULUS ARTICLE WILL SOON BE PUBLISHED IN PF.

USP Expert Committee on Pharmaceutical Dosage Forms

Categories of Pharmaceutical Dosage Forms A Taxonomy Proposal

The taxonomy charts given here only incorporate dosage forms that are actually named in monogrphs of the USP/NF.

FIRST TIER Delineated by the tissues to which the active is first delivered by the dosage form.
SECOND TIER The criterion for this grouping is based on the general type of dosage form involved. THIRD TIER Individual dosage forms grouped depending on the release pattern of the active.

NOTE: In some dosage forms it may be advisable to preface titles with a descriptor. For example Topical Cream, Vaginal Insert or Otic Solution.

Categories of Pharmaceutical Dosage Forms

FIRST TIER CATEGORY DELIVERY ROUTE [i.e. based on tissues to which active delivered]

Gastro-intestinal Tract Tissues or Body Fluids [by injection]

Mucosal Membranes IV SC etc

lungs Skin surface

IM

Buccal, Sublingual

nasal

otic

vaginal
Transdermal

oral

ophthalmic

urethral

topical

orophary ngeal

rectal

7 4 3 4 5 6 6

7 6

9 10

SECOND TIER CATEGORY

DOSAGE FORM [i.e. based on the general type of dosage form]

[ Indicates page number of second tier]

Categories of Pharmaceutical Dosage Forms

Skin surface
[Dermal]

topical

[NOTE: May preface titles with topical, e.g. Topical cream]

SECOND TIER CATEGORY

DOSAGE FORM [i.e. based on the general type of dosage form]

liquids

semi-solids

solids

collodions suspensions solutions foams ointments pastes emulsions w/o o/w creams gels

powders

patches
plasters

aerosols

films

gauzes

tapes

sticks

THIRD TIER CATEGORY

TYPE OF RELEASE [i.e. based on the RELEASE PATTERN OF THE ACTIVE]

Categories of Pharmaceutical Dosage Forms

[possible common Third Tier categorization]
THIRD TIER CATEGORY
TYPE OF RELEASE [i.e. based on the RELEASE PATTERN OF THE ACTIVE]

Conventional release

Modified release

(immediate release)

Extended release
[Slower rate]

Delayed release

* Use of conventional release is encouraged.

The term immediate has been widely used in place of the less misleading and more appropriate term conventional with reference to dosage form nomenclature.

[Delayed onset]

Targeted release
[Specific organ/tissue]

Pulsatile release
[Fractions released at time intervals]

Orally disintegrating
[Faster rate than conventional]

Orally dispersing
[Faster rate than conventional]

CONCLUSIONS

OVER THE YEARS, USP HAS CONVERTED OFFICIAL TITLES OF DOSAGE FORMS:

FROM THOSE INDICATING THE FORMULATION AND/OR METHOD OF MANUFACTURE TO THOSE DESCRIBING THE FINISHED PRODUCT IN TERMS BELIEVED TO BE MORE USEFUL TO THE PRESCRIBER, DISPENSER AND THE PATIENT.

CONCLUSIONS

BY ADDING THE ROUTE OF ADMINISTRATION TO THE TITLE. i.e. OPHTHALMIC; OTIC; NASAL; VAGINAL; RECTAL and TOPICAL.
IT SHOULD BE NOTED THAT THE TYPE OF PACKAGING AND LABELING MAY BECOME A MORE SIGNIFICANT PLAYER IN DESIGNING DOSAGE FORM TITLES.

NOTE ON LOTIONS

THE DELETION OF LOTION AS A TITLE IN FAVOR OF TOPICAL SUSPENSION, SOLUTION AND EMULSION HAS BEEN PLACED ON HOLD BY THE USP NOMENCLATURE & LABELING EXPERT COMMITTEE UNTIL THE USP AND FDA HAVE REVIEWED THE MATTER.
THIS MEETING IS IMPORTANT IN THE COMMITTEES FINAL DECISION.

Thank You