® USPC© Job #8/6/ :54:42 PM USP TOPICAL DOSAGE FORMS NOMENCLATURE Herbert S. Carlin, D.Sc. Chairman, USP Nomenclature & Labeling Expert Committee

® USPC© Job #8/6/ :54:42 PM 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)

® USPC© Job #8/6/ :54:42 PM 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

® USPC© Job #8/6/ :54:42 PM 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 1 st ROUTE OF ADMINISTRATION added to TITLES [Ophthalmic Solution & Suspension]

® USPC© Job #8/6/ :54:42 PM 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

® USPC© Job #8/6/ :54:42 PM 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

® USPC© Job #8/6/ :54:42 PM 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…..”

® USPC© Job #8/6/ :54:42 PM 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 Pharmaceutical Dosage Forms…..”

® USPC© Job #8/6/ :54:42 PM 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 water- removable bases that are oil-in-water (o/w) emulsions….”

® USPC© Job #8/6/ :54:42 PM 1985 DRUG NOMENCLATURE COMMITTEE RECOMMENDATIONS # 4 “[DRUG] Gel is a formulation in a water- soluble base and may be regarded as a greaseless ointment…..”

® USPC© Job #8/6/ :54:42 PM USP XXII NF XVII (1990) Joint Meeting of the & 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.

® USPC© Job #8/6/ :54:42 PM USP XXII NF XVII (1990) New Monograph Titles: PLEDGET:is a vehicle that carry a Topical Solution. Veterinary SOLUBLE POWDER INTRAMAMMARY INFUSION TOPICAL GEL

® USPC© Job #8/6/ :54:42 PM USP 23 NF 18 (1995) Three Powder Titles changed to TOPICAL POWDERS One Water changed to WITCH HAZEL

® USPC© Job #8/6/ :54:42 PM USP 24 NF 19 (2000) TWO VETERINARY MONOGRAPHS ADDED CONCENTRATE for DIP UTERINE INFUSION

® USPC© Job #8/6/ :54:42 PM 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.

® USPC© Job #8/6/ :54:42 PM USP 26 Monographs SKIN SURFACE (TOPICALS) [310]

® USPC© Job #8/6/ :54:42 PM 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]

® USPC© Job #8/6/ :54:42 PM USP 26 TOPICALS  SOLIDS  Gauzes [1]  Patches [3]  Powders [24]  Tapes [1]  Tablets [3]

® USPC© Job #8/6/ :54:42 PM 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

® USPC© Job #8/6/ :54:42 PM 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] *

® USPC© Job #8/6/ :54:42 PM USP 26 Topical Suspensions [Drug] Shampoos [1] [Drug] Topical Suspensions [5] *

® USPC© Job #8/6/ :54:42 PM 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]

® USPC© Job #8/6/ :54:42 PM USP 26 Topical Solids POWDERS [Drug] Topical Aerosol [12] [Drug] for Topical Solution [2] [Drug] Dusting Powders [1] [Drug] Topical [2] [Drug] Topical Powders

® USPC© Job #8/6/ :54:42 PM USP 26 Topical Solids PATCHES [Drug] Film [1] [Drug] Plasters [1] [Drug] Pledgets [1] GAUZES [Drug] Gauzes [1]

® USPC© Job #8/6/ :54:42 PM USP 26 Topical Solids TABLETS [Drug] Tablets for Topical Solutions [3] TAPES [Drug] Tapes [1]

® USPC© Job #8/6/ :54:42 PM 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.

Categories of Pharmaceutical Dosage Forms USP Expert Committee on Pharmaceutical Dosage Forms FIRST TIER Delineated 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 CATEGORYDELIVERY ROUTE [i.e. based on tissues to which active delivered] SECOND 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 dermal trans- almic urethral 4 7 IV IM etc SC oro- phary ngeal 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/o creams tapes o/w gels sticks

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. *

® USPC© Job #8/6/ :54:42 PM 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.

® USPC© Job #8/6/ :54:42 PM 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.

® USPC© Job #8/6/ :54:42 PM 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.