title: Topical drug classification.
abstract: Current definitions of lotions, gels, creams and ointments vary depending on literature source, market history or traditional use. This often leads to confusion when deciding which dosage form to prescribe and/or purchase. The existing classification of topical dosage forms needs to be re-examined to ensure that definitions for different dosage forms are based on consistent scientific principles and that dosage forms can be distinguished from one another. The purpose of this study is to obtain a scientifically based, systematic classification of dosage forms for topical drugs. A variety of prescription and over-the-counter topical products currently marketed as lotions, gels, creams, and ointments are evaluated using different techniques including rheology (viscosity and shear rate versus shear stress), loss on drying (LOD), specific gravity, surface tension, thermogravimetric analysis (TGA), water absorption, dilution properties, microscopic evaluation, transmittance of visible light, appearance and composition. Rheology is the most discriminating property separating creams and lotions. Water plus volatiles (as measured by LOD) and composition separate ointments and creams. Composition and thermal behavior separate gels from the other dosage forms. Based on these findings, new definitions and a decision tree are presented to assist in the determination of the appropriate nomenclature for a topical dosage form.
authors.affiliation: United States Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Division of Pharmaceutical Analysis, FDA, 1114 Market Street, Room 1002, St. Louis, MO 63101, USA. buhsel@cder.fda.gov
authors.forename: Lucinda
authors.initials: L
authors.lastname: Buhse
authors.forename: Richard
authors.initials: R
authors.lastname: Kolinski
authors.forename: Benjamin
authors.initials: B
authors.lastname: Westenberger
authors.forename: Anna
authors.initials: A
authors.lastname: Wokovich
authors.forename: John
authors.initials: J
authors.lastname: Spencer
authors.forename: Chi Wan
authors.initials: CW
authors.lastname: Chen
authors.forename: Saleh
authors.initials: S
authors.lastname: Turujman
authors.forename: Mamta
authors.initials: M
authors.lastname: Gautam-Basak
authors.forename: Gil Jong
authors.initials: GJ
authors.lastname: Kang
authors.forename: Arthur
authors.initials: A
authors.lastname: Kibbe
authors.forename: Brian
authors.initials: B
authors.lastname: Heintzelman
authors.forename: Eric
authors.initials: E
authors.lastname: Wolfgang
mesh_terms: D000287:Administration, Topical; D006112:Gravitation; D006813:Humidity; D008853:Microscopy; D009824:Ointments / Q000145:classification*; D013500:Surface Tension; D013818:Thermogravimetry; D014783:Viscosity
chemical_list: D009824:Ointments