title: Preparation and evaluation of enteric-coated delayed-release pellets of duloxetine hydrochloride using a fluidized bed coater.
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, 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.
authors.affiliation: College of Pharmacy, Yeungnam University, 214-1, Dae-Dong, Gyongsan, 712-749, Republic of Korea.|Pharm. R&D Institute, Hanmi Pharm. Co., Ltd., Hwasung, 445-913, Republic of Korea.
authors.forename: Yong-Il
authors.initials: YI
authors.lastname: Kim
authors.affiliation: College of Pharmacy, Yeungnam University, 214-1, Dae-Dong, Gyongsan, 712-749, Republic of Korea.
authors.forename: Roshan
authors.initials: R
authors.lastname: Pradhan
authors.affiliation: College of Pharmacy, Yeungnam University, 214-1, Dae-Dong, Gyongsan, 712-749, Republic of Korea.
authors.forename: Bijay K
authors.initials: BK
authors.lastname: Paudel
authors.affiliation: College of Pharmacy, Yeungnam University, 214-1, Dae-Dong, Gyongsan, 712-749, Republic of Korea.
authors.forename: Ju Yeon
authors.initials: JY
authors.lastname: Choi
authors.affiliation: Pharm. R&D Institute, Hanmi Pharm. Co., Ltd., Hwasung, 445-913, Republic of Korea. cellmass@hanmi.co.kr.|School of Pharmacy, Sungkyunkwan University, Jangan-gu, Suwon, 440-746, Gyeonggi-do, Republic of Korea. cellmass@hanmi.co.kr.
authors.forename: Ho Taek
authors.initials: HT
authors.lastname: Im
authors.affiliation: College of Pharmacy, Yeungnam University, 214-1, Dae-Dong, Gyongsan, 712-749, Republic of Korea. jongohkim@yu.ac.kr.
authors.forename: Jong Oh
authors.initials: JO
authors.lastname: Kim
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004285:Dogs; D004353:Drug Evaluation, Preclinical / Q000379:methods; D004343:Drug Implants / Q000138:chemical synthesis* / Q000493:pharmacokinetics*; D000068736:Duloxetine Hydrochloride / Q000138:chemical synthesis* / Q000493:pharmacokinetics*; D013608:Tablets, Enteric-Coated
chemical_list: D003692:Delayed-Action Preparations; D004343:Drug Implants; D013608:Tablets, Enteric-Coated; D000068736:Duloxetine Hydrochloride
keywords: Delayed-release; Duloxetine hydrochloride; Enteric coated; Pellet; Pharmacokinetics