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Preparation and evaluation of enteric-coated delayed-release pellets of duloxetine hydrochloride using a fluidized bed coater

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Abstract

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, Cmax, Tmax, t1/2, Kel, 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.

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Acknowledgments

This study was supported by a grant from the Medical Cluster R&D Support Project of Daegu Gyeongbuk Medical Innovation Foundation, Republic of Korea (2013) (No. HT13C0011).

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    Authors and Affiliations

    1. College of Pharmacy, Yeungnam University, 214-1, Dae-Dong, Gyongsan, 712-749, Republic of Korea

      Yong-Il Kim, Roshan Pradhan, Bijay K. Paudel, Ju Yeon Choi & Jong Oh Kim

    2. Pharm. R&D Institute, Hanmi Pharm. Co., Ltd., Hwasung, 445-913, Republic of Korea

      Yong-Il Kim & Ho Taek Im

    3. School of Pharmacy, Sungkyunkwan University, Jangan-gu, Suwon, 440-746, Gyeonggi-do, Republic of Korea

      Ho Taek Im

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    1. Yong-Il Kim
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    2. Roshan Pradhan
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    4. Ju Yeon Choi
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    Correspondence to Ho Taek Im or Jong Oh Kim.

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    Yong-Il Kim and Roshan Pradhan contributed equally to this study.

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    Kim, YI., Pradhan, R., Paudel, B.K. et al. Preparation and evaluation of enteric-coated delayed-release pellets of duloxetine hydrochloride using a fluidized bed coater. Arch. Pharm. Res. 38, 2163–2171 (2015). https://doi.org/10.1007/s12272-015-0590-y

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