Professional Documents
Culture Documents
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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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]
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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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[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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[DRUG] Gel is a formulation in a watersoluble base and may be regarded as a greaseless ointment..
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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.
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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)
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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 26 Monographs
SKIN SURFACE (TOPICALS) [310]
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USP 26 TOPICALS
LIQUIDS [108]
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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PATCHES [Drug] Film [1] [Drug] Plasters [1] [Drug] Pledgets [1]
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FIRST TIER Delineated by the tissues to which the active is first delivered by the dosage form. 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.
Mucosal Membranes
IM
SC
nasal
otic
vaginal transdermal
oral
ophthalmic rectal
urethral
topical
orophary ngeal
7 4 3 4 5 6 6
7 6
9 10
topical
liquids
semi-solids
solids
collodions suspensions solutions foams ointments pastes emulsions w/o o/w creams gels
powders
patches plasters
aerosols
films
gauzes
tapes
sticks
Conventional release
Modified release
(immediate release)
Extended release
[Slower rate]
Delayed release
[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.
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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 COMMITTEES FINAL DECISION.
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