Preparation and evaluation of enteric-coated delayed-release pellets of duloxetine hydrochloride using a fluidized bed coater
| Autor: | Yong-Il Kim, Ju Yeon Choi, Roshan Pradhan, Jong Oh Kim, Ho Taek Im, Bijay K. Paudel |
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| Rok vydání: | 2015 |
| Předmět: |
Drug Implants
Chromatography Chemistry Chemistry Pharmaceutical Organic Chemistry Pellets Drug Evaluation Preclinical Bioequivalence Duloxetine Hydrochloride Dogs Pharmacokinetics Fluidized bed In vivo Delayed-Action Preparations Drug Discovery Pellet Molecular Medicine Animals Tablets Enteric-Coated Dissolution |
| Zdroj: | Archives of pharmacal research. 38(12) |
| ISSN: | 1976-3786 |
| Popis: | In this study, the enteric-coated delayed-release pellets of duloxetine hydrochloride (DLX) were formulated using a fluidized bed coater. Three separate layers, the drug layer, the barrier layer, and the enteric layer, were coated onto inert core pellets. Among the three formulations (F1-F3), the dissolution profiles of formulation F2 were most similar to those of the marketed product, with similarity and difference factors of 83.99 and 3.77, respectively. In addition, pharmacokinetic parameters of AUC, C(max), T(max), t(1/2), K(el), and MRT of DLX for the developed formulation (F2) did not differ significantly from those for the marketed product in beagle dogs, suggesting that they were bioequivalent. Our results demonstrated that the in vitro dissolution data resembled the in vivo performance of the drug. Therefore, this study has a positive scope for further scale up and development of the formulation for achievement of the generic product. |
| Databáze: | OpenAIRE |
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