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.
journal_name
Pharm Dev Technoljournal_title
Pharmaceutical development and technologyauthors
Stange U,Führling C,Gieseler Hdoi
10.3109/10837450.2012.757784subject
Has Abstractpub_date
2014-03-01 00:00:00pages
137-47issue
2eissn
1083-7450issn
1097-9867journal_volume
19pub_type
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journal_title:Pharmaceutical development and technology
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