Document Detail


Comparative quality tests of two types of sustained release preparation of isosorbide dinitrate.
MedLine Citation:
PMID:  6484369     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Two commercial sustained release preparations of isosorbide dinitrate (ISDN), capsules (preparation A) and tablets (preparation B), were tested for content uniformity and dissolution pattern. The deviations in contents of the single doses from the declared content ranged from -7.7% to +9.7% which conformed to the standard (+/- 15%) of the Japanese Pharmacopeia X (JP X). Dissolution tests were performed using the rotating basket method described in JP X. The dissolution medium were No. 1 and 2 solutions (pH 1.2 and 6.8, respectively) specified in JP X disintegration test, and 0.05 M phosphate buffer solutions (pH 3.0 and 5.0). The dissolution patterns of both preparations were independent on the pH of the medium. However, there was a marked difference between the dissolution rates of the two: after 8 hr of the test, the rates of preparation A were 85-89%, but those of preparation B were only 42-50%. From preparation A a somewhat constant release of ISDN continued until the 6 hr. ISDN was determined by the HPLC method.
Authors:
H Noda; M Minemoto; H Furukawa; Y Kanezaki
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Journal of UOEH     Volume:  6     ISSN:  0387-821X     ISO Abbreviation:  J. UOEH     Publication Date:  1984 Jun 
Date Detail:
Created Date:  1984-11-02     Completed Date:  1984-11-02     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7909645     Medline TA:  J UOEH     Country:  JAPAN    
Other Details:
Languages:  eng     Pagination:  141-7     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Capsules
Chromatography, High Pressure Liquid
Delayed-Action Preparations
Isosorbide Dinitrate / standards*
Solubility
Tablets
Chemical
Reg. No./Substance:
0/Capsules; 0/Delayed-Action Preparations; 0/Tablets; 87-33-2/Isosorbide Dinitrate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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