Generic Development of Topical Dermatologic Products: Formulation Development, Process Development, and Testing of Topical Dermatologic Products

Abstract

This review presents considerations which can be employed during the development of a semi-solid topical generic product. This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality attributes to the reference-listed drug (RLD) and ensure batch to batch consistency through commercial production. This encompasses the concept of reverse-engineering to copy the RLD as a strategy during product development to ensure qualitative (Q1) and quantitative (Q2) formulation similarity, as well as similarity in formulation microstructure (Q3). The concept of utilizing in vitro skin permeation studies as a tool to justify formulation differences between the test generic product and the RLD to ensure a successful pharmacodynamic or clinical endpoint bioequivalence study is discussed. The review concludes with a discussion on drug product evaluation and quality tests as well as in vivo bioequivalence studies.

A science based approach to topical drug classification system (TCS)

“…Moreover, IVR test has also been recognized as a reasonable and useful test to consider for product release and stability testing (Chang et al, 2013). In vitro nonsimilarity could be a signal of altered in vivo performance (SUPAC-SS, 1997; USP37-NF32, 2014).…”

Comprehensive evaluation of carboxylated nanodiamond as a topical drug delivery system

“…Among the ingredients, the permeation enhancer increases the drug delivery by promoting the diffusion, partitioning, or solubility of an active ingredient through the stratum corneum. 17 Ideal penetration enhancers need to meet the following requirements: 1) absorption enhancement should be immediate and unidirectional, and the duration of the effect should be specific, predictable, and suitable; 2) after removal of the material from the applied area, the tissue should recover its normal barrier properties fully and immediately; 3) the enhancer should show no systemic or toxic effects; 4) the enhancer should not irritate or damage the skin surface; and 5) the enhancer should be physically compatible with a wide range of drugs and pharmaceutical excipients. 18 Together with excellent dispersibility in aqueous solution, ND may have ideal properties as a permeation enhancer for topical drug delivery systems.…”

Release of rosmarinic acid from semisolid formulations and its penetration through human skin ex vivo

“…During the fi rst stage of the study, we evaluated the infl uence of the semisolid bases and the addition of the extract on the rheological characteristics of the formulations by determining their consistency index and fl ow behavior index. Modifi cation of viscosity is an important part of the preparation of semisolid formulations and is regarded to be a critical quality a ribute in the development stage of the product (11). To evaluate the possible eff ect of temperature on the structure of semisolid formulations during their storage period, we selected the temperature of 30 o C, which was approximate to the melting temperature of the experimental formulations as well as to the skin surface temperature.…”