title: Transitioning from brand to generic with topical products and the importance of maintaining the formulation and therapeutic profiles of the original product: focus on clocortolone pivalate 0.1% cream.
abstract: Topical corticosteroids (TCSs) are a major part of the foundation of treatment for a wide variety of eczematous and inflammatory skin disorders in both adults and children. Mid-potency TCSs represent an important category as they are often used to treat eczematous dermatoses, such as atopic dermatitis. The TCS product must effectively release the active ingredient and promote cutaneous penetration so that therapeutic activity can occur. As many topical products eventually become available as generic formulations, it is important to recognize that although the active ingredient and its concentration are the same, the vehicle excipients may differ significantly, occasionally leading to potential differences in irritancy, in allergenicity, in effects on epidermal permeability barrier function, and, possibly, in efficacy. Clocortolone pivalate 0.1% cream is a mid-potency TCS formulated in an emollient formulation that has been shown to be effective and well-tolerated in the management of several corticosteroid-responsive dermatoses. This article outlines the pharmacologic and clinical data achieved with the original brand formulation of clocortolone pivalate 0.1% cream, and discusses the establishment of an authorized generic formulation that is identical in formulation to the original brand.
authors.forename: James Q
authors.initials: JQ
authors.lastname: Del Rosso
authors.forename: Leon H
authors.initials: LH
authors.lastname: Kircik
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004485:Eczema / Q000188:drug therapy / Q000473:pathology; D005079:Excipients / Q000737:chemistry; D005448:Fluocortolone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000473:pathology; D012871:Skin Diseases / Q000188:drug therapy / Q000473:pathology
chemical_list: D003879:Dermatologic Agents; D016568:Drugs, Generic; D005079:Excipients; D005938:Glucocorticoids; D005448:Fluocortolone; C007088:clocortolone pivalate