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<p>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, <i>In-vitro</i> 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.</p> Graphical Abstract <p></p>

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Evaluation of Critical Quality Attributes of Topical Foam Formulations

  • 期刊论文

  • 发表日期：

    2026年2月21日

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  • Srinath Rangappa,
  • Srinivas Ajjarapu,
  • Vijay Kumar Shankar,
  • Anandavalli Varadarajan,
  • Santanu Kundu,
  • S. Narasimha Murthy

摘要

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.

Graphical Abstract