Bioequivalence of locally acting lozenges: Evaluation of critical in vivo parameters and first steps towards a bio-predictive in vitro test method

Tietz, Katharina; Gutknecht, Sina Ingrid; Klein, Sandra

doi:10.1016/j.ejpb.2017.11.011

Cited by 5 publications

(1 citation statement)

References 35 publications

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“…However, it should be noted that there are efforts on the horizon to demonstrate local bioavailability of oropharyngeal dosage forms using appropriate in vitro release testing in generic drug product evaluation. A detailed example of the development of a suitable method for a locally acting lozenge formulation comprising the use of a simulated salivary fluid and an apparatus that mimics fluid exchange in the oral cavity as well as mechanical forces that can act on the dosage form has recently been published (34,35). The basic considerations for the design of the cited method can certainly provide a basis for the development of other biorelevant methods, but it should also be clear that the test conditions based on a successful study are not necessarily transferable to all types of lozenges.…”

Section: Biorelevance Of In Vitro Test Conditionsmentioning

confidence: 99%

Testing the In Vitro Product Performance of Mucosal Drug Products: View of the USP Expert Panel

Klein,

Sakagami,

et al. 2023

Dissolution Technol.

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Performance testing of mucosal drug products presents the user with a multitude of challenges. Not only are there many different dosage forms to be distinguished, but also a wide variety of administration routes. The target action effect (local or systemic) is another factor to be considered. Thus, it quickly becomes apparent that there will never be a universal performance test, but the question arises just as quickly whether the method to be used should rather depend on the dosage form or the place of application, or even whether decisions must be made on an individual basis. This Stimuli article is one of a series of Stimuli articles on product performance testing, which focuses on methodological approaches and challenges in the field of performance testing of mucosal drug products. The article should be viewed as a supplement to, but also a critical discussion of the methods listed in USP general chapter Mucosal Drug Products-Performance Tests <1004>. With consideration of major physiologic aspects at the site of administration and the types of dosage forms to be studied, limitations of the methods described here and the need for methodologic updates or innovations are identified. Furthermore, suggestions are made for future activities, all aimed at developing robust, discriminatory, and meaningful test methods for the wide variety of mucosal drug products.

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Section: Biorelevance Of In Vitro Test Conditionsmentioning

confidence: 99%