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“Development of Fixed Dose Combination Products” Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy

Hens, Bart; Corsetti, Maura; Bermejo, Marival; L�benberg, Raimar; Gonz�lez, Pablo M.; Mitra, Amitava; Desai, Divyakant; Chilukuri, Dakshina Murthy; Aceituno, Alexis

Authors

Bart Hens

MAURA CORSETTI Maura.Corsetti@nottingham.ac.uk
Clinical Associate Professor

Marival Bermejo

Raimar L�benberg

Pablo M. Gonz�lez

Amitava Mitra

Divyakant Desai

Dakshina Murthy Chilukuri

Alexis Aceituno



Abstract

The gastrointestinal (GI) tract is one of the most popular and used routes of drug product administration due to the convenience for better patient compliance and reduced costs to the patient compared to other routes. However, its complex nature poses a great challenge for formulation scientists when developing more complex dosage forms such as those combining two or more drugs. Fixed dose combination (FDC) products are two or more single active ingredients combined in a single dosage form. This formulation strategy represents a novel formulation which is as safe and effective compared to every mono-product separately. A complex drug product, to be dosed through a complex route, requires judicious considerations for formulation development. Additionally, it represents a challenge from a regulatory perspective at the time of demonstrating bioequivalence (BE) for generic versions of such drug products. This report gives the reader a summary of a 2-day short course that took place on the third and fourth of November at the Annual Association of Pharmaceutical Scientists (AAPS) meeting in 2018 at Washington, D.C. This manuscript will offer a comprehensive view of the most influential aspects of the GI physiology on the absorption of drugs and current techniques to help understand the fate of orally ingested drug products in the complex environment represented by the GI tract. Through case studies on FDC product development and regulatory issues, this manuscript will provide a great opportunity for readers to explore avenues for successfully developing FDC products and their generic versions.

Citation

Hens, B., Corsetti, M., Bermejo, M., Löbenberg, R., González, P. M., Mitra, A., …Aceituno, A. (2019). “Development of Fixed Dose Combination Products” Workshop Report: Considerations of Gastrointestinal Physiology and Overall Development Strategy. AAPS Journal, 21(4), 1-16. https://doi.org/10.1208/s12248-019-0346-6

Journal Article Type Article
Acceptance Date May 30, 2019
Online Publication Date Jun 6, 2019
Publication Date 2019-07
Deposit Date Jun 7, 2019
Publicly Available Date Mar 28, 2024
Journal AAPS Journal
Print ISSN 1550-7416
Publisher American Association of Pharmaceutical Scientists
Peer Reviewed Peer Reviewed
Volume 21
Issue 4
Article Number 75
Pages 1-16
DOI https://doi.org/10.1208/s12248-019-0346-6
Public URL https://nottingham-repository.worktribe.com/output/2160215
Publisher URL https://link.springer.com/article/10.1208/s12248-019-0346-6

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