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Presented at the Advisory Committee for Pharmaceutical Science meeting on March 12, 2003 by Lucinda Buhse, Ph.D.

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Presentation on theme: "Presented at the Advisory Committee for Pharmaceutical Science meeting on March 12, 2003 by Lucinda Buhse, Ph.D."— Presentation transcript:

1 Presented at the Advisory Committee for Pharmaceutical Science meeting on March 12, 2003 by Lucinda Buhse, Ph.D.

2 Topical Drug Nomenclature Objective: To establish a scientific basis for a systematic and coherent classification of dosage forms for topical drugs. Working Group (ONDC/OGD/DPA): Cindy Buhse, Gil Jong Kang, Saleh Turujman, Mamta Gautam Basak, Chi Wan Chen DPA Laboratory Team: Dick Kolinski, Nick Westenberger, Anna Wokovich, Jack Spencer

3 Current FDA Definitions Cream: A semisolid dosage form containing one or more drug substances dissolved or dispersed in a suitable base. Gel: A semisolid system consisting of either suspensions made up of small inorganic particles or large organic molecules interpenetrated by a liquid. Lotion: "The term lotion" has been used to categorize many topical suspensions, solutions and emulsions intended for application to the skin. Ointment: A semisolid preparation intended for external application to the skin or mucous membranes.

4 What are the distinguishing properties? Physico-chemical Viscosity Loss on Drying (LOD) Specific Gravity Surface Tension Water Solubility Water Absorption Drying Properties Thermogravimetric Analysis (TGA) Chemical Base Composition Physical Properties Appearance Feel Microscopy

5 Appearance Clear, translucent or opaque viscous Greasy vs. non-greasy Cooling sensation Feel Physical Properties Microscopy - 400x No Peak Soft PeakStiff Peak

6 Creams and Lotions: Multivariate Analysis of Selected Physico-chemical Properties Viscosity is potentially a significant variable. ScoresLoadings LotionsCreams

7 Lotions are pourable (viscosity <30,000 cp at 5 rpm and 25ºC).

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9 Ointments 50%.

10 Ointments have %hydrocarbon or Polyethylene Glycols >50%.

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12 Common Characteristics of Most Marketed Gels Viscosity: low (10, ,000 cp) Loss on Drying : high (70-99%) Solubility : water soluble Water Absorption : no specific trend Drying Properties : no specific trend Thermogravimetric Analysis : fewer transitions Composition : contains gelling agents (carbomer) Appearance : clear Feel : non greasy, cooling Microscopy : no specific trend

13 Gel formulations have fewer transitions than the creams. Thermogravimetric Analysis of Selected Products Drug BDrug C Cream Gel Lotion Cream Gel

14 Classification of Topical Drugs Lotions: –pourable with viscosity <30,000 cp (at 5 rpm and 25ºC) –Loss on Drying > 50% Ointments: –Loss on Drying < 20% –hydrocarbon or polyethylene glycols content > 50% Gels: –contain sufficient gelling agent to form 3D matrix


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