Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development

被引：10

作者：

Li, Min ^{[1
]}

Sander, Sanna ^{[2
]}

Duan, John ^{[1
]}

Rosencrance, Susan ^{[3
]}

Miksinski, Sarah Pope ^{[4
]}

Yu, Lawrence ^{[5
]}

Seo, Paul ^{[1
]}

Rege, Bhagwant ^{[2
]}

机构：

[1] US FDA, Div Biopharmaceut, Off New Drug Prod, Off Pharmaceut Qual, Silver Spring, MD USA

[2] US FDA, Div Modified Release Prod, Off Lifecycle Drug Prod, Off Pharmaceut Qual, Silver Spring, MD 20993 USA

[3] US FDA, Off Lifecycle Drug Prod, Off Pharmaceut Qual, Silver Spring, MD USA

[4] US FDA, Off New Drug Prod, Off Pharmaceut Qual, Silver Spring, MD USA

[5] US FDA, Off Pharmaceut Qual, Silver Spring, MD USA

来源：

AAPS JOURNAL | 2016年 / 18卷 / 06期

关键词：

Biopharmaceutics; Clinically relevant specifications; Control strategy; Modified release; Product and process understanding; WATER-SOLUBLE DRUGS; DOSAGE FORMS; ABSORPTION; DELIVERY; DISSOLUTION; QUALITY; DESIGN; SYSTEM; TOOL; FORMULATIONS;

D O I：

10.1208/s12248-016-9974-2

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

引用

页码：1406 / 1417

页数：12

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