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

Autor: Raimar Löbenberg, Divyakant Desai, Amitava Mitra, Marival Bermejo, Bart Hens, Dakshina Murthy Chilukuri, Pablo M. González, Maura Corsetti, Alexis Aceituno
Rok vydání: 2019
Předmět:
Drug
formulation prediction
Computer science
media_common.quotation_subject
Fixed-dose combination
Pharmaceutical Science
Administration
Oral
Pharmacy
Bioequivalence
030226 pharmacology & pharmacy
PHARMACEUTICAL EXCIPIENTS
Dosage form
03 medical and health sciences
fixed dose combination drug products
0302 clinical medicine
in vivo predictions
INTESTINAL PERMEABILITY
Drug Development
IN-VITRO METHODOLOGY
ABSORPTION
Humans
Pharmacology & Pharmacy
DRUG
WEAK BASES
media_common
Active ingredient
bioequivalence
Science & Technology
business.industry
Gastrointestinal Physiology
Congresses as Topic
MODEL
Drug Combinations
Risk analysis (engineering)
Pharmaceutical Preparations
Gastrointestinal Absorption
030220 oncology & carcinogenesis
New product development
gastrointestinal physiology
MIGRATING MOTOR COMPLEX
IMMEDIATE-RELEASE
business
Life Sciences & Biomedicine
VIVO DISSOLUTION
Tablets
Zdroj: The AAPS journal. 21(4)
ISSN: 1550-7416
Popis: 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. ispartof: AAPS JOURNAL vol:21 issue:4 ispartof: location:United States status: published
Databáze: OpenAIRE
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