You are on page 1of 33

®

USP TOPICAL DOSAGE FORMS
NOMENCLATURE
Herbert S. Carlin, D.Sc.
Chairman, USP Nomenclature & Labeling
Expert Committee

USPC©2000

1 Job #

08/27/15 07:35 AM

®







Topical Nomenclature History
USP I – XII (1942)
USP XII – XIX (1975)
USP XX NF XV (1980)
USP XXI NF XVI (1985)
USP XXII NF XVII (1990)
USP 23 NF 18 (1995)
USP 24 – 25 NF 19 – 20 (2000 – 2002)

®






USP I – XII (1942)
TITLES IN LATIN
NOMENCLATURE ASSIGNED TO
EXECUTIVE COMMITTEE ON SCOPE
ATTENTION PAID TO:
Existing Monograph Titles
Tradition, and
Coordinate with NF published by APhA

®        USP XXII – XIX (1975) TITLES IN ENGLISH COMMITTEE ON SCOPE SYNONYMS DELETED IN 1965 Lime Water became Calcium Hydroxide Soln Silver Nitrate Pencils–Toughen Silver Nitrate Zinc Gelatin Boot – Zinc Gelatin 1st ROUTE OF ADMINISTRATION added to TITLES [Ophthalmic Solution & Suspension] .

® USP XX NF XV (1980)        NF PURCHASED COMMITTEE ON SCOPE REVISION OF VARIOUS TOPICAL TITLES Aerosol. Solution for Irrigation and Powder ADDITION OF NEW TOPICALS Emulsions & Magma . Solution. Aerosol Solution.

®       USP XXI NF XVI (1985) DRUG NOMENCLATURE COMMITTEE The DNC reviewed past decisions and recommended many changes to make the Titles more user-friendly for healthcare providers. [DRUG] Topical Solution. [DRUG] Gel [DRUG] Topical Suspension [DRUG] Ointment. [DRUG] Cream DELETE LOTION for [DRUG] corresponding DF .

This nomenclature is intended to displace “Lotion” terminology because Lotion has been criticized as difficult to define.®  1985 DRUG NOMENCLATURE COMMITTEE RECOMMENDATIONS # 1 “[DRUG] Topical Solution and [DRUG] Topical Suspension is the general format..” .for monograph titles of topical liquid dosage forms.. with no physical meaning….

” .®  1985 DRUG NOMENCLATURE COMMITTEE RECOMMENDATIONS # 2 “[DRUG] Ointment is a preparation of one or more therapeutic agents in any of the various classes of bases described in chapter <1151> Pharmaceutical Dosage Forms…..

” .®  1985 DRUG NOMENCLATURE COMMITTEE RECOMMENDATIONS # 3 “[DRUG] Cream is a topical preparation that is formulated in an emulsion base. The term Cream preferably pertains to semisolid preparations in waterremovable bases that are oil-in-water (o/w) emulsions….

.®  1985 DRUG NOMENCLATURE COMMITTEE RECOMMENDATIONS # 4 “[DRUG] Gel is a formulation in a watersoluble base and may be regarded as a greaseless ointment….” .

®   USP XXII NF XVII (1990) Joint Meeting of the 1985-1990 & 19901995 Drug Nomenclature Committees ratified actions of previous committee. Publish Stimulus Article “Nomenclature Policies and Recommendations: Review and Current Proposals and Decisions” in January – February 1991 Pharmaceutical Forum. .

®  USP XXII NF XVII (1990) New Monograph Titles:   PLEDGET:is a vehicle that carry a Topical Solution. Veterinary    SOLUBLE POWDER INTRAMAMMARY INFUSION TOPICAL GEL .

®   USP 23 NF 18 (1995) Three Powder Titles changed to TOPICAL POWDERS One Water changed to WITCH HAZEL .

®  USP 24 NF 19 (2000) TWO VETERINARY MONOGRAPHS ADDED CONCENTRATE for DIP UTERINE INFUSION .

  Mineral Oil Enema to Mineral Oil. Light Mineral Oil to Topical Light Mineral Oil when suitably packaged. . Rectal when suitably packaged.®   USP 25 NF 20 (2002) NOMENCLATURE & LABELING EXPERT COMMITTEE Revisions of current Monographs that relate to Packaging.

® USP 26 Monographs SKIN SURFACE (TOPICALS) [310] USPC©2000 16 Job # 08/27/15 07:35 AM .

®  USP 26 TOPICALS LIQUIDS [108]    Emulsions [1] Suspensions [6] Solutions [78]  SEMI-SOLIDS [170]  Collodions [3]  Creams [70]  Foams [1]  Gels [18]  Ointments [72]  Pastes [6] .

® USP 26 TOPICALS  SOLIDS      Gauzes [1] Patches [3] Powders [24] Tapes [1] Tablets [3] .

® USP 26 Topical Emulsions [Drug] Cleansing Emulsions [1] [Drug] Topical Emulsions [0] * * [Drug] Lotions [23] may be changes to: [Drug] Topical Emulsions. or [Drug] Topical Suspensions . [Drug] Topical Solutions.

® USP 26 Topical Solutions [Drug] Cleansing Solutions [1] [Drug] Irrigations [6] [Drug] Liquid Soaps [1] [Drug] Oral/Topical Solutions [2] [Drug] Solutions [4] [Drug] Tinctures [6] (to Topical Solutions) [Drug] Topical Oils [1] [Drug] Topical Solutions [44] * .

® USP 26 Topical Suspensions [Drug] Shampoos [1] [Drug] Topical Suspensions [5] * .

® USP 26 Topical Semi-Solids [Drug] Collodions [3] [Drug] Creams [70] [Drug] Gels [15] [Drug] Topical Gels [3] [Drug] Topical Foams [1] [Drug] Ointments [72] [Drug] Pastes [6] .

® USP 26 Topical Solids POWDERS [Drug] Topical Aerosol [12] [Drug] for Topical Solution [2] [Drug] Dusting Powders [1] [Drug] Topical [2] [Drug] Topical Powders .

®  USP 26 Topical Solids PATCHES [Drug] Film [1] [Drug] Plasters [1] [Drug] Pledgets [1]  GAUZES [Drug] Gauzes [1] .

®  USP 26 Topical Solids TABLETS [Drug] Tablets for Topical Solutions [3]  TAPES [Drug] Tapes [1] .

®   TAXONOMY AND GLOSSARY USP’S 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. .

NOTE: In some dosage forms it may be advisable to preface titles with a descriptor. FIRST TIER Delineated by the tissues to delivered by the dosage form. For example “Topical Cream”. . “Vaginal Insert” or “Otic Solution”.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. which the active is first 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.

Categories of Pharmaceutical Dosage Forms FIRST TIER CATEGORY DELIVERY ROUTE [i. based on tissues to which active delivered] Gastro-intestinal Tract Tissues or Body Fluids [by injection] IM IV SC etc Skin surface otic nasal oral oropharyn geal 4 lungs Mucosal Membranes ophthalmic vaginal urethral transdermal topical rectal 3 4 SECOND TIER CATEGORY DOSAGE FORM [i. based on the general type of dosage form] 7 7 [ Indicates page number of 8 tier] 9 second .e.e.

Categories of Pharmaceutical Dosage Forms Skin surface [Dermal] topical SECOND TIER CATEGORY [NOTE: May preface titles with “topical”. based on the general type of dosage form] 8 collodions suspensions solids semi-solids liquids powders patches solutions plasters foams ointments aerosols films pastes emulsions w/o o/w THIRD TIER CATEGORY creams gels tapes gauzes sticks TYPE OF RELEASE [i. e.e. based on the RELEASE PATTERN OF THE ACTIVE] .e.g. “Topical cream”] DOSAGE FORM [i.

Categories of Pharmaceutical Dosage Forms [possible common Third Tier categorization] THIRD TIER CATEGORY TYPE OF RELEASE [i. [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] . 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.e. The term “immediate” has been widely used in place of the less misleading and more appropriate term “conventional” with reference to dosage form nomenclature.

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.®   CONCLUSIONS OVER THE YEARS. . DISPENSER AND THE PATIENT.

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

®   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 A IMPORTANT IN THE COMMITTEE’S FINAL DECISION.