Physical aging in pharmaceutical polymers and the effect on solid oral dosage form stability

被引：25

作者：

Kucera, Shawn A. ^{[1
]}

Felton, Linda A. ^{[2
]}

McGinity, James W. ^{[3
]}

机构：

[1] Merck KGaA, D-64293 Darmstadt, Germany

[2] Univ New Mexico, Hlth Sci Ctr, Coll Pharm, Albuquerque, NM 87131 USA

[3] Univ Texas Austin, Coll Pharm, Austin, TX 78712 USA

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICS | 2013年 / 457卷 / 02期

关键词：

Physical aging; Polymers; Film coating; Stability; ANNIHILATION LIFETIME SPECTROSCOPY; DRUG-RELEASE RATES; POSITRON-ANNIHILATION; THEOPHYLLINE PELLETS; FREE-VOLUME; AQUEOUS DISPERSIONS; STORAGE-CONDITIONS; MECHANICAL-PROPERTIES; ORGANIC SOLUTIONS; DISSOLUTION RATE;

D O I：

10.1016/j.ijpharm.2013.01.069

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

The application of a polymeric film to a solid oral dosage form can be an effective technique to modify drug release. Most polymers used for such purposes are amorphous in nature and are subject to physical aging. This physical aging phenomenon has been shown to cause changes not only in the mechanical and drug release properties of polymeric films, but also the permeability of these films due to a densification and decrease in free volume of the polymer as the material relaxes to an equilibrated thermodynamic state. Temperature, humidity, and additional excipients in the coating formulations have been shown to influence the aging process. This review article discusses the process of physical aging in films prepared from aqueous dispersions, describes various analytical techniques that can be used to investigate the aging process, and highlights strategies to prevent such aging. (C) 2013 Elsevier B. V. All rights reserved.

引用

页码：428 / 436

页数：9

共 56 条

[1]

Ageeva M.G., 1970, Pharmaceutical Chemistry Journal, V4, P342

[2]

American Society for Testing and Materials, 2005, E96E96M05 ASTM

[3]

Amighi K, 1996, EUR J PHARM BIOPHARM, V42, P29

[4]

Anderson W., 1976, J PHARM PHARM S22, V28