Document Detail


Taste masking of naproxen sodium granules by fluid-bed coating.
MedLine Citation:
PMID:  23324020     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
Abstract The taste of oral dosage forms is an important argument regarding patient's compliance and acceptability. For this reason, it is often necessary to mask an undesirable and unpleasant taste of an active pharmaceutical ingredient. The purpose of this study was to mask the taste of naproxen sodium by a new fluid-bed coating approach. Different compositions of coating suspensions were used to coat naproxen sodium granules. It was found that products with the addition of a plasticizer were not stable at 40 °C and tended to agglomerate. Subsequently, formulations without plasticizer were used and the ratio between water and Eudragit® E was varied. Increasing the fraction of water in the suspension from 3% to 14% reduced the effective release of naproxen sodium. An optimum ratio between naproxen sodium granules and Eudragit® E was found to be 1:1.576, where less naproxen sodium was released than the threshold bitter value and an appropriate taste masking for more than 5 min was guaranteed. Investigation of the particle size distribution revealed a d(10) of 138.35 ± 21.52 µm, a d(50 )= 256.40 ± 11.27 µm and a d(90 )= 500.85 ± 69.08 µm, which guarantees an acceptable mouthfeel for patients.
Authors:
Ulrike Stange; Christian Führling; Henning Gieseler
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2013-1-17
Journal Detail:
Title:  Pharmaceutical development and technology     Volume:  -     ISSN:  1097-9867     ISO Abbreviation:  Pharm Dev Technol     Publication Date:  2013 Jan 
Date Detail:
Created Date:  2013-1-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9610932     Medline TA:  Pharm Dev Technol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Division of Pharmaceutics, Freeze Drying Focus Group, University of Erlangen , Erlangen , Germany .
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