Document Detail


Pseudoephedrine hydrochloride sustained-release pellets prepared by a combination of hot-melt subcoating and polymer coating.
MedLine Citation:
PMID:  18785047     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Pseudoephedrine hydrochloride is an active very highly water soluble substance. In order to control release of a drug with this property, we developed the application of a combination of hot-melt subcoating and polymer coating was developed. The main objective was to investigate the influence of this combination on the release of highly water soluble drug and how it works. Hot-melt subcoating was achieved by using a coating pan. Subsequently, the outer polymer coating was prepared by fluidized bed, and the drug release was determined by high-performance liquid chromatograph (HPLC) method. Hot-melt subcoating can form a barrier between the drug-loaded pellets and the polymer coating layer, which prevents migration of the drug during film application. Consequently, the level of polymer coating can be reduced significantly, and the effectiveness of the polymer coating increased. In this study, the release profile of pellets with a 10% hot-melt subcoating and 5% polymer coating weight gain met the dissolution requirement of USP29 for pseudoephedrine hydrochloride extended-release capsules. Compared with pellets only polymer coated (10% level), the polymer coating level of pellets prepared by this technology was reduced by half due to hot-melt subcoating. By means of this hot-melt subcoating and polymer coating, sustained-release pellets containing pseudoephedrine hydrochloride were successfully prepared.
Authors:
Zi Yi Yang; Yan Lu; Xing Tang
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Drug development and industrial pharmacy     Volume:  34     ISSN:  1520-5762     ISO Abbreviation:  Drug Dev Ind Pharm     Publication Date:  2008 Dec 
Date Detail:
Created Date:  2008-11-18     Completed Date:  2009-01-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7802620     Medline TA:  Drug Dev Ind Pharm     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1323-30     Citation Subset:  IM    
Affiliation:
College of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR, China.
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MeSH Terms
Descriptor/Qualifier:
Delayed-Action Preparations
Microscopy, Electron, Scanning
Pseudoephedrine / administration & dosage,  chemistry*
Solubility
Technology, Pharmaceutical*
Chemical
Reg. No./Substance:
0/Delayed-Action Preparations; 90-82-4/Pseudoephedrine

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


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