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HERO ID
5098728
Reference Type
Journal Article
Title
Disintegrating agents in hard gelatin capsules. Part 1. Mechanism of action
Author(s)
Botzolakis, JE; Augsburger, LL
Year
1988
Is Peer Reviewed?
Yes
Journal
Drug Development and Industrial Pharmacy
ISSN:
0363-9045
EISSN:
1520-5762
Volume
14
Issue
1
Language
English
Abstract
IPA COPYRIGHT: ASHP AcDiSol (croscarmellose sodium; I), Primojel (sodium starch glycolate), Polyplasdone XL-10 (crospovidone) and corn starch were evaluated as disintegrants in lactose and calcium phosphate dibasic based hard gelatin capsule formulations. Hydrochlorothiazide, used as a model drug with low water solubility, was released fastest in formulations containing I. A minimum disintegrant concentration was necessary to produce primary particles upon disintegration and significantly affect dissolution. Swelling characteristics of the disintegrant were most important for improved dissolution and overall disintegrant effectiveness.
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