Format

Send to

Choose Destination
AAPS J. 2017 Sep;19(5):1348-1358. doi: 10.1208/s12248-017-0112-6. Epub 2017 Jul 5.

Biopharmaceutical Evaluation and CMC Aspects of Oral Modified Release Formulations.

Author information

1
Office of Life Cycle Products, Office of Pharmaceutical Quality, Center of Drug Evaluation and Research, US Food and Drug Administrations, Silver Spring, Maryland, USA.
2
Drug Product Science & Technology, Bristol-Myers Squibb Co., P.O. Box Bldg. 105/Room 2474, One Squibb Drive, New Brunswick, New Jersey, 08903, USA.
3
Drug Product Science & Technology, Bristol-Myers Squibb Co., P.O. Box Bldg. 105/Room 2474, One Squibb Drive, New Brunswick, New Jersey, 08903, USA. munir.hussain@bms.com.

Abstract

This article discusses the range of outcomes from biopharmaceutical studies of specific modified release (MR) product examples in preclinical models and humans. It touches upon five major biopharmaceutical areas for MR drug products: (1) evidence for regional permeability throughout the GI tract, (2) susceptibility to food-effect, (3) susceptibility to pH-effect, (4) impact of chronopharmacology in designing MR products, and (5) implications to narrow therapeutic index products. Robust bioperformance requires that product quality is met through a thorough understanding of the appropriate critical quality attributes that ensure reliable and robust manufacture of a MR dosage form. The quality-by-design (QbD) aspects of MR dosage form design and development are discussed with the emphasis on the regulatory view of the data required to support dosage form development.

KEYWORDS:

CMC; biopharmaceutics; food-effect; modified release; pH-effect; quality-by-design

PMID:
28681160
DOI:
10.1208/s12248-017-0112-6
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Springer
Loading ...
Support Center