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Advances in in-vitro bioequivalence testing methods for complex ophthalmic generic products
Jwala Renukuntla1, Sushesh Srivatsa Palakurthi2, Pradeep Kumar Bolla3
1Department of Basic Pharmaceutical Sciences, Fred Wilson School of Pharmacy, High Point University, High Point, NC 27268, USA.
International Journal of Pharmaceutics
|September 26, 2022
Summary
Demonstrating bioequivalence for generic ophthalmic drugs is challenging. This review discusses in-vitro drug release testing (IVRT) methods to support biowaiver criteria for complex formulations like emulsions and suspensions.
Area of Science:
- Pharmaceutical Sciences
- Ophthalmology
- Drug Delivery
Background:
- The USFDA requires pharmaceutical and bioequivalence (BE) proof for generic topical ocular products.
- Unlike oral drugs, ocular BE testing presents significant challenges.
- Generic products are compared against a Reference Listed Drug (RLD).
Purpose of the Study:
- To review in-vitro drug release testing (IVRT) methods for complex ophthalmic formulations.
- To discuss biowaiver criteria for generic ophthalmic products based on FDA guidance.
- To address the difficulties in demonstrating bioequivalence for topical ocular products.
Main Methods:
- Review of existing literature on IVRT for ophthalmic formulations.
- Analysis of USFDA guidance on biowaiver criteria.
- Discussion of challenges in differentiating generic ophthalmic products based on physicochemical properties and drug release.
Main Results:
- Current IVRT methods are often insufficient to differentiate performance of complex ophthalmic products.
- A single in-vitro test is frequently inadequate for proving BE of topical ophthalmic formulations.
- Elaborated discussion on various IVRT methods is necessary for complex generics.
Conclusions:
- Demonstrating bioequivalence for complex ophthalmic products requires advanced IVRT strategies.
- Biowaiver criteria need to accommodate the unique challenges of ophthalmic formulations.
- Further development of biorelevant IVRT is crucial for efficient generic ophthalmic product development.
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