Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations

Techniques of thermal and isothermal stress testing (IST) were used to evaluate the compatibility of isosorbide mononitrate (IMN) with selected excipients used in the development of extended release formulations. In the first phase of the study, differential scanning calorimeter (DSC) was used as a...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 2004-05, Vol.35 (3), p.449-458
Main Authors: Verma, Rajan K, Garg, Sanjay
Format: Article
Language:English
Subjects:
Analysis
Analytical, structural and metabolic biochemistry
Biological and medical sciences
Chemistry, Pharmaceutical
Delayed-Action Preparations - analysis
Delayed-Action Preparations - chemistry
Delayed-Action Preparations - pharmacokinetics
Dissolution
Drug–excipient interaction
Excipients - analysis
Excipients - chemistry
Excipients - pharmacokinetics
Extended release
Fundamental and applied biological sciences. Psychology
General pharmacology
Incompatibility
Isosorbide Dinitrate - analogs & derivatives
Isosorbide Dinitrate - analysis
Isosorbide Dinitrate - chemistry
Isosorbide Dinitrate - pharmacokinetics
Isosorbide mononitrate
Medical sciences
Pharmacology. Drug treatments
Stability
Tablets, Enteric-Coated
Technology, Pharmaceutical - methods
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Summary:Techniques of thermal and isothermal stress testing (IST) were used to evaluate the compatibility of isosorbide mononitrate (IMN) with selected excipients used in the development of extended release formulations. In the first phase of the study, differential scanning calorimeter (DSC) was used as a tool to detect any interaction. In the next phase, excipients defined in the prototype formula were tested for their compatibility with IMN using IST. Based on the results, cellulose acetate and MCC were found to show interaction with IMN. Results of IST demonstrated incompatibility between IMN and cellulose acetate. All the excipients defined in the prototype formula were found to be compatible with IMN. Using the excipients that were found to be compatible with IMN, formulations were optimized. The optimized formulation was found to be stable after 3 months of storage at accelerated stability conditions (40 °C and 75% RH). In conclusion, tools of DSC, and IST were successfully employed to evaluate the compatibility of IMN with selected excipients.
ISSN:0731-7085
1873-264X
DOI:10.1016/j.jpba.2004.01.012