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USP TOPICAL DOSAGE FORMS

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

USPC2000

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

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

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..

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

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.

USP 26
Monographs
SKIN SURFACE
(TOPICALS)
[310]

USPC2000

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,
[Drug] Topical Solutions, or
[Drug] Topical Suspensions

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
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
delivered by the dosage form.

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.

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]

IM

IV
SC
etc

Skin surface

otic

nasal

oral

oropharyn
geal

lungs

Mucosal Membranes

ophthalmic

vaginal

urethral

transdermal

topical

rectal

SECOND TIER CATEGORY

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

[
Indicates page number of
8 tier]
9
second

Categories of Pharmaceutical Dosage Forms


Skin surface
[Dermal]

topical

SECOND TIER CATEGORY

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

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

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. 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 A IMPORTANT IN THE
COMMITTEES FINAL DECISION.