ArticleAAPS PharmSciTech2026
Evaluation of Critical Quality Attributes of Topical Foam Formulations.
Article in AAPS PharmSciTech, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
6 authors.
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Abstract
Topical foams are widely utilized in dermatology for both cosmetic and therapeutic purposes, owing to their superior spreadability, ease of application over large skin areas, and enhanced patient compliance. As with other topical products, generic foams must exhibit physicochemical properties comparable to their reference listed drug (RLD or innovator products) to establish pharmaceutical equivalence. However, foams possess distinct characteristics that set them apart from other topical formulations. This study aimed to develop and evaluate characterization methods specific to topical foams. A clobetasol propionate 0.05% hydro-alcoholic solution type foam, Olux (RLD), and its generic were used as model foams to develop characterization methods. Critical quality attributes such as pH, In-vitro drying study, time-to-break, foam firmness, work of adhesion, and rheological properties were characterized. The results showed no significant differences in quality attributes between the generic and RLD foams. This study clearly demonstrates the utility of simple, effective characterization techniques for assessing the similarity between generic foam products and their RLD counterparts.
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Registered trials
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