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

July 2014 | Volume 13 | Issue 7 | Supplement Individual Articles | 77 | Copyright © July 2014

James Q. Del Rosso DO FAOCDa and Leon H. Kircik MDb

aLas Vegas Skin and Cancer Clinics/West Dermatology Group, JDRx Dermatology LL C, Henderson, NV;
Touro University College of Osteopathic Medicine, Henderson, NV
bIndiana University School of Medicine, Indianapolis, IN; Icahn School of Medicine at Mount Sinai, New York, NY;
Physicians Skin Care, PLL C, Louisville, KY

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.

J Drugs Dermatol. 2014;13(suppl 7):s77-s83.

INTRODUCTION

Topical corticosteroids (TCSs) are an integral component of the therapeutic armamentarium of the dermatologist. These agents are commonly used to treat a wide variety of cutaneous disease states, such as atopic dermatitis (AD), nummular eczema, contact dermatitis, seborrheic dermatitis, psoriasis vulgaris, and stasis dermatitis. The selection of a TCS is influenced by the anticipated responsiveness and anatomic locations of the disease state involved, the potency of the TCS formulation, and the characteristics of the vehicle formulation. 1-7 The collective factors that ultimately dictate TCS selection by influencing the efficacy, skin tolerability, and patient acceptability of a given TCS formulation are listed as follows:
Compound-related factors: The individual corticosteroid compound and the concentration incorporated into the final formulation.
Disease-state related factors: The specific diagnosis, severity, and anatomic sites involved.
Vehicle-related factors: The general category, such as cream, lotion, ointment, gel, solution, or spray; and the aesthetic characteristics of the final product, especially as viewed by patients.
Formulation-related factors: Specific excipients incorporated to exert certain properties (ie, penetration enhancement, humectancy, occlusivity, solubilization, spreadability, emolliency, product preservation, etc.) and active ingredient release characteristics.
The mid-potency TCS category represents a group of commonly prescribed agents that are used to treat a wide variety of common dermatologic disorders such as AD, irritant contact dermatitis, allergic contact dermatitis (ACD), seborrheic dermatitis (SD), and psoriasis (including chronic plaque psoriasis [CPP] and inverse psoriasis); as well as other eczematous dermatoses such as nummular eczema, asteatotic eczema, and stasis dermatitis. In many cases, CPP and lichenified eczematous plaques warrant treatment with a high-potency or super-high potency TCS, at least initially. However, most of the cutaneous disorders mentioned above respond favorably within a reasonable time frame to a mid-potency TCS that is adaptable for application and does not cause local irritation or cutaneous allergy.1,4,8-11
Among the currently available mid-potency TCS formulations available in the marketplace in the United States, clocortolone pivalate 0.1% cream has been available solely as a brand TCS