NDLI: Hydroxypropyl Methylcellulose Acetate Succinate: Potential Drug

Content Provider	Springer Nature Link
Author	Dong, Zedong Choi, Duk Soon
Copyright Year	2008
Abstract	The stability of hydroxypropyl methylcellulose acetate succinate (HPMC-AS) and its potential incompatibility with active pharmaceutical ingredients (API) carrying hydroxyl group(s) were investigated in this research. HPMC-AS may undergo hydrolysis under harsh processing conditions with the generation of succinic acid and acetic acid, which can form ester bond(s) with the hydroxyl group(s) in API. In this case, the hot-melt extrusion (HME) product prepared from HPMC-AS and our model compound (compound A) was tested after heating at 140°C up to 5 h. The succinate esters of compound A and its epimer were found in the product, suggesting potential drug–excipient incompatibility during formulation development. In addition, dyphylline was also tested with HPMC-AS and the potential incompatibility was further confirmed.
Starting Page	991
Ending Page	997
Page Count	7
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	9
Issue Number	3
e-ISSN	15309932
Language	English
Publisher	Springer US
Publisher Date	2008-08-29
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	drug–excipient incompatibility hot-melt extrusion hydroxypropyl methylcellulose acetate succinate (HPMC-AS) solid dispersion succinic acid Pharmacy Biochemistry Biotechnology Pharmacology/Toxicology
Content Type	Text
Resource Type	Article

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Hydroxypropyl Methylcellulose Acetate Succinate: Potential Drug–Excipient Incompatibility