Document Detail


Release of testosterone from an osmotic pump tablet utilizing (SBE)7m-beta-cyclodextrin as both a solubilizing and an osmotic pump agent.
MedLine Citation:
PMID:  10021487     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A controlled porosity osmotic pump system for poorly water soluble drugs has been developed using sulfobutyl ether-beta-cyclodextrin sodium salt, (SBE)7m-beta-CD, which can act as both a solubilizing and an osmotic agent. The release of testosterone, a poorly water soluble drug (0.039 mg/ml at 37 degrees C), was evaluated using a new model device. The effect of (SBE)7m-beta-CD as the solubilizing and osmotic pump agent was compared with hydroxypropyl-beta-cyclodextrin (HP-beta-CD), a neutral cyclodextrin, and a sugar mixture (osmotic agent only). Testosterone release from the device was significantly faster with (SBE)7m-beta-CD than with HP-beta-CD or the sugar mixture. The solubility of testosterone in the device increased to 76.7 mg/ml through complexation with (SBE)7m-beta-CD in the imbibed water. It appears that testosterone release from the device in the presence of (SBE)7m-beta-CD was mainly due to osmotic pumping while for HP-beta-CD the major contribution appears to be due to diffusion. In the case of the sugar mixture, testosterone was poorly released, presumably due to the absence of a solubilizer. Therefore, it was concluded that (SBE)7m-beta-CD provides novel properties for the development of controlled- porosity osmotic pump tablets for poor solubility drugs.
Authors:
K Okimoto; R A Rajewski; V J Stella
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of controlled release : official journal of the Controlled Release Society     Volume:  58     ISSN:  0168-3659     ISO Abbreviation:  J Control Release     Publication Date:  1999 Mar 
Date Detail:
Created Date:  1999-05-04     Completed Date:  1999-05-04     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8607908     Medline TA:  J Control Release     Country:  NETHERLANDS    
Other Details:
Languages:  eng     Pagination:  29-38     Citation Subset:  IM    
Affiliation:
Fujisawa Pharmaceutical Co., Ltd., Osaka, Japan.
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MeSH Terms
Descriptor/Qualifier:
Algorithms
Carbohydrate Sequence
Cyclodextrins / chemistry*
Delayed-Action Preparations
Diffusion
Kinetics
Membranes, Artificial
Molecular Sequence Data
Osmotic Pressure
Solubility
Tablets
Testosterone / administration & dosage*,  chemistry
beta-Cyclodextrins*
Chemical
Reg. No./Substance:
0/Cyclodextrins; 0/Delayed-Action Preparations; 0/Membranes, Artificial; 0/SBE4-beta-cyclodextrin; 0/Tablets; 0/beta-Cyclodextrins; 58-22-0/Testosterone

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