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USPC©2000 1 Job # 04/19/23 01:51 AM
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USP TOPICAL DOSAGE FORMSNOMENCLATURE
Herbert S. Carlin, D.Sc.
Chairman, USP Nomenclature & Labeling Expert Committee
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USPC©2000 2 Job # 04/19/23 01:51 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)
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USPC©2000 3 Job # 04/19/23 01:51 AM
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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USPC©2000 4 Job # 04/19/23 01:51 AM
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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USPC©2000 5 Job # 04/19/23 01:51 AM
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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USPC©2000 6 Job # 04/19/23 01:51 AM
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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USPC©2000 7 Job # 04/19/23 01:51 AM
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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USPC©2000 8 Job # 04/19/23 01:51 AM
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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USPC©2000 9 Job # 04/19/23 01:51 AM
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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USPC©2000 10 Job # 04/19/23 01:51 AM
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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USPC©2000 11 Job # 04/19/23 01:51 AM
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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USPC©2000 12 Job # 04/19/23 01:51 AM
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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USPC©2000 13 Job # 04/19/23 01:51 AM
USP 23 NF 18 (1995)
Three Powder Titles changed to TOPICAL POWDERS
One Water changed to WITCH HAZEL
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USPC©2000 14 Job # 04/19/23 01:51 AM
USP 24 NF 19 (2000)
TWO VETERINARY MONOGRAPHS ADDED
CONCENTRATE for DIPUTERINE INFUSION
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USPC©2000 15 Job # 04/19/23 01:51 AM
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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USPC©2000 17 Job # 04/19/23 01:51 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]
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USPC©2000 18 Job # 04/19/23 01:51 AM
USP 26 TOPICALS
SOLIDS Gauzes [1] Patches [3] Powders [24] Tapes [1] Tablets [3]
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USPC©2000 19 Job # 04/19/23 01:51 AM
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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USPC©2000 20 Job # 04/19/23 01:51 AM
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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USPC©2000 21 Job # 04/19/23 01:51 AM
USP 26 Topical Suspensions
[Drug] Shampoos [1][Drug] Topical Suspensions [5] *
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USPC©2000 22 Job # 04/19/23 01:51 AM
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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USPC©2000 23 Job # 04/19/23 01:51 AM
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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USPC©2000 24 Job # 04/19/23 01:51 AM
USP 26 Topical Solids
PATCHES
[Drug] Film [1]
[Drug] Plasters [1]
[Drug] Pledgets [1]
GAUZES
[Drug] Gauzes [1]
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USPC©2000 25 Job # 04/19/23 01:51 AM
USP 26 Topical Solids
TABLETS
[Drug] Tablets for
Topical Solutions [3]
TAPES
[Drug] Tapes [1]
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USPC©2000 26 Job # 04/19/23 01:51 AM
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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USPC©2000 31 Job # 04/19/23 01:51 AM
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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USPC©2000 32 Job # 04/19/23 01:51 AM
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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USPC©2000 33 Job # 04/19/23 01:51 AM
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.