In Vitro Release Testing (IVRT) of Topical Hydrocortisone Acetate Creams: A Novel Approach Using Positive and Negative Controls

Mudyahoto, Nyengeterai Amanda; Rath, Seeprarani; Ramanah, Ashmita; Kanfer, Isadore

doi:10.14227/dt270120p6

Cited by 5 publications

(3 citation statements)

References 7 publications

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“…The basic concepts for validation of the IVRT method are presented in Table 2 . Since 2018, an increasing number of studies deals with validation of IVRT method for different semisolid drug products (e.g., acyclovir cream [ 35 ], diclofenac emulgel [ 36 ], miconazole nitrate cream [ 45 ], hydrocortisone acetate cream [ 46 ], metronidazole cream [ 47 ]). The first comprehensive report in scientific literature on the successful qualification/validation of IVRT was published by Tiffner and coworkers in 2018 [ 35 ].…”

Section: Demonstration Of Extended Pharmaceutical Equivalence Of Topical Semisolid Drug Productsmentioning

confidence: 99%

“…Table 2. IVRT method validation and acceptance criteria according to FDA Draft Guidance on Acyclovir [44], EMA Draft guideline on quality and equivalence of topical products [14] and recent literature reports [35,36,[45][46][47].…”

Section: Evaluation Of Product Performances-in Vitro Release Testmentioning

confidence: 99%

“…The dose depletion ≤30% has no influence on the steady-state conditions for drug release [35,36,[45][46][47] Finally, for the demonstration of extended pharmaceutical equivalence, EMA set the following requirement: "the 90% confidence interval for the ratio of means of the test and comparator products for the parameters (R), (A) should be contained within the acceptance interval of 90-111%" [14]. However, it is important to emphasize that FDA sameness criterion is not too strict, i.e., 90% CIs of in vitro release rate should be within 75-133.33% [38,44].…”

Section: Sensitivity Specificity and Selectivitymentioning

confidence: 99%

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The Implications of Regulatory Framework for Topical Semisolid Drug Products: From Critical Quality and Performance Attributes towards Establishing Bioequivalence

2021

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Due to complex interdependent relationships affecting their microstructure, topical semisolid drug formulations face unique obstacles to the development of generics compared to other drug products. Traditionally, establishing bioequivalence is based on comparative clinical trials, which are expensive and often associated with high degrees of variability and low sensitivity in detecting formulation differences. To address this issue, leading regulatory agencies have aimed to advance guidelines relevant to topical generics, ultimately accepting different non-clinical, in vitro/in vivo surrogate methods for topical bioequivalence assessment. Unfortunately, according to both industry and academia stakeholders, these efforts are far from flawless, and often upsurge the potential for result variability and a number of other failure modes. This paper offers a comprehensive review of the literature focused on amending regulatory positions concerning the demonstration of (i) extended pharmaceutical equivalence and (ii) equivalence with respect to the efficacy of topical semisolids. The proposed corrective measures are disclosed and critically discussed, as they span from mere demands to widen the acceptance range (e.g., from ±10% to ±20%/±25% for rheology and in vitro release parameters highly prone to batch-to-batch variability) or reassess the optimal number of samples required to reach the desired statistical power, but also rely on specific data modeling or novel statistical approaches.

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