Document Detail

Effects of solid-state reaction between paracetamol and cloperastine hydrochloride on the pharmaceutical properties of their preparations.
MedLine Citation:
PMID:  17118591     Owner:  NLM     Status:  MEDLINE    
Tablets containing both paracetamol (PM) and cloperastine hydrochloride (CLH) in a combination formulation prepared by standard vertical granulation technology were found to have altered pharmaceutical properties. The hardness and disintegration time of tablets containing both PM and CLH gradually increased during storage, and the cross-screw did not operate smoothly during preparation of the mixed powder. The objective of the present study was to investigate the mechanism of formation of eutectic mixtures consisting of PM and CLH. Binary mixtures of PM and CLH in various proportions were prepared as physical mixtures and analyzed by DSC to study their thermal behavior. Phase diagrams obtained from the endothermic peaks due to melting of physical mixtures of PM and CLH demonstrated the formation of eutectic mixtures with eutectic temperatures of 86.9-110.2 degrees C depending on the ratio of constituents. The formation of the eutectic mixture was studied for a 50:50 mol.% ratio of PM and CLH. PXRD analysis revealed that the eutectic mixture of PM and CLH is structurally different from native PM and CLH. The most probable interaction sites between PM and CLH were demonstrated by DSC analysis of a binary mixture of PM and CLH prepared by melt quenching.
Yukoh Sakata; Eishi Tanabe; Toshiharu Sumikawa; Sumihiro Shiraishi; Yoshihiro Tokudome; Makoto Otsuka
Publication Detail:
Type:  Journal Article     Date:  2006-10-29
Journal Detail:
Title:  International journal of pharmaceutics     Volume:  335     ISSN:  0378-5173     ISO Abbreviation:  Int J Pharm     Publication Date:  2007 Apr 
Date Detail:
Created Date:  2007-04-02     Completed Date:  2007-06-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7804127     Medline TA:  Int J Pharm     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  12-9     Citation Subset:  IM    
Healthcare Research Institute, Wakunaga Pharmaceutical Co., Ltd., 1624 Shimokotachi, Kodacho, Akitakatashi, Hiroshima 739-1195, Japan.
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MeSH Terms
Acetaminophen / chemistry*
Analgesics, Non-Narcotic / chemistry*
Antitussive Agents / chemistry*
Calorimetry, Differential Scanning
Chemistry, Pharmaceutical
Crystallography, X-Ray
Drug Combinations
Drug Stability
Hydrogen Bonding
Microscopy, Electron, Scanning
Phase Transition
Piperidines / chemistry*
Spectroscopy, Fourier Transform Infrared
Technology, Pharmaceutical
Time Factors
Reg. No./Substance:
0/Analgesics, Non-Narcotic; 0/Antitussive Agents; 0/Drug Combinations; 0/Piperidines; 0/Powders; 0/Tablets; 103-90-2/Acetaminophen; 3703-76-2/cloperastine

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

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