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USP TOPICAL DOSAGE FORMSNOMENCLATURE

Herbert S. Carlin, D.Sc.

Chairman, USP Nomenclature & Labeling Expert Committee

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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)

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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

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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]

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USP XX NF XV (1980)

NF PURCHASED COMMITTEE ON SCOPE REVISION OF VARIOUS TOPICAL

TITLES Aerosol; Aerosol Solution; Solution; Solution for Irrigation and Powder ADDITION OF NEW TOPICALS Emulsions & Magma

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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

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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. This nomenclature is intended to displace “Lotion” terminology because Lotion has been criticized as difficult to define, with no physical meaning…..”

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1985 DRUG NOMENCLATURECOMMITTEE

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…..”

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1985 DRUG NOMENCLATURECOMMITTEE

RECOMMENDATIONS # 3

“[DRUG] Cream is a topical preparation that is formulated in an emulsion base. The term Cream preferably pertains to semisolid preparations in water-removable bases that are oil-in-water (o/w) emulsions….”

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1985 DRUG NOMENCLATURECOMMITTEE

RECOMMENDATIONS # 4

“[DRUG] Gel is a formulation in a water-soluble base and may be regarded as a greaseless ointment…..”

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USP XXII NF XVII (1990)

Joint Meeting of the 1985-1990 & 1990-1995 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.

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USP XXII NF XVII (1990)

New Monograph Titles: PLEDGET:is a vehicle that carry a Topical

Solution. Veterinary

SOLUBLE POWDER INTRAMAMMARY INFUSION TOPICAL GEL

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USP 23 NF 18 (1995)

Three Powder Titles changed to TOPICAL POWDERS

One Water changed to WITCH HAZEL

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USP 24 NF 19 (2000)

TWO VETERINARY MONOGRAPHS ADDED

CONCENTRATE for DIPUTERINE INFUSION

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USP 25 NF 20 (2002)

NOMENCLATURE & LABELING EXPERT COMMITTEE

Revisions of current Monographs that relate to Packaging.

Mineral Oil Enema to Mineral Oil, Rectal when suitably packaged.

Light Mineral Oil to Topical Light Mineral Oil when suitably packaged.

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USP 26Monographs

SKIN SURFACE(TOPICALS)

[310]

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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]

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USP 26 TOPICALS

SOLIDS Gauzes [1] Patches [3] Powders [24] Tapes [1] Tablets [3]

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USP 26 Topical Emulsions

[Drug] Cleansing Emulsions [1][Drug] Topical Emulsions [0] *

* [Drug] Lotions [23] may be changes to:[Drug] Topical Emulsions,[Drug] Topical Solutions, or[Drug] Topical Suspensions

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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] *

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USP 26 Topical Suspensions

[Drug] Shampoos [1][Drug] Topical Suspensions [5] *

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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]

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USP 26 Topical Solids

POWDERS

[Drug] Topical Aerosol [12]

[Drug] for Topical Solution [2]

[Drug] Dusting Powders [1]

[Drug] Topical [2]

[Drug] Topical Powders

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USP 26 Topical Solids

PATCHES

[Drug] Film [1]

[Drug] Plasters [1]

[Drug] Pledgets [1]

GAUZES

[Drug] Gauzes [1]

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USP 26 Topical Solids

TABLETS

[Drug] Tablets for

Topical Solutions [3]

TAPES

[Drug] Tapes [1]

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TAXONOMY ANDGLOSSARY

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.

Categories of Pharmaceutical Dosage FormsUSP Expert Committee on Pharmaceutical Dosage Forms

FIRST TIERDelineated by the tissues to which the active is first delivered by the dosage form.

SECOND TIER

A “Taxonomy” Proposal

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”.

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

Categories of Pharmaceutical Dosage Forms

nasal otic

ophth-

vaginal

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

6

6

7SECOND TIER CATEGORY DOSAGE FORM [i.e. based on the general type of dosage form]

Mucosal Membranes

[ Indicates page number of second tier]

oral

4 3

rectal

Skin surface

8

9

topical

dermaltrans-

almicurethral

4

7

IVIM

etcSC

oro-pharyngeal

6

Gastro-intestinal Tract lungs

10

Tissues or Body Fluids[by injection]

5

solutions

solids

[Dermal]

semi-solids

8

ointments

patches

plasters

powders

liquids

aerosols

suspensions

films

pastes

gauzes

foams

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

Categories of Pharmaceutical Dosage Forms

Skin surface

topical

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

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

emulsions

collodions

w/ocreams tapes

o/w gelssticks

Conventional release Modified release

Extended release

Delayed release

Orally disintegrating

Pulsatile release

Targeted release

[Slower rate]

[Delayed onset]

[Specific organ/tissue]

[Faster rate than conventional]

Categories of Pharmaceutical Dosage Forms

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

(immediate release)

[possible common Third Tier categorization]

[Fractions released at time intervals]

Orally dispersing

[Faster rate than conventional]

* 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.

*

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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.

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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.

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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.