Design, optimization and pharmacokinetics of novel prolonged gastroretentive drug delivery system of quetiapine fumarate

Dharmik M. Mehta; Punit B. Parejiya; Hetal K. Patel; Palak J. Trivedi; Disha D. Suthar; Pragna K. Shelat

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자료유형: 학술저널

저자정보: Dharmik M. Mehta (K. B. Institute of Pharmaceutical Education and Research India) Punit B. Parejiya (K. B. Institute of Pharmaceutical Education and Research India) Hetal K. Patel (K. B. Institute of Pharmaceutical Education and Research India) Palak J. Trivedi (K. B. Institute of Pharmaceutical Education and Research India) Disha D. Suthar (K. B. Institute of Pharmaceutical Education and Research India) Pragna K. Shelat (K. B. Institute of Pharmaceutical Education and Research India)

저널정보: 한국약제학회 Journal of Pharmaceutical Investigation Journal of Pharmaceutical Investigation 제46권 제5호

발행연도: 2016.8

수록면: 453 - 465 (13page)

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연구배경

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연구방법

🏆

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Present study attempts to overcome pH-dependent solubility, a limitation for oral delivery of poorly soluble BCS class-II drugs. A pH independent, patient compliant, dual working gastroretentive drug delivery system of model drug quetiapine fumarate (QF) was fabricated by unique combination approach of mucoadhesion and floating. Bilayer tablets comprising floating adhesive layer (FL) and matrix layer (ML) was systematically optimized by applying 32 full factorial experimental designs. Selected variables for FL: Polyox 303WSR (X1FL) and alginate beads (X2FL), and for ML: HPMC K100M (X1ML) and fumaric acid (X2ML) were studied against responses for FL: floating lag time (R1FL), total floating time (R2FL) and adhesion force (R3FL) and for ML: percentage drug released at 2 h—Q2h (R1ML), 8 h—Q8h (R2ML), and 18 h—Q18h (R3ML), respectively. Optimized batch (OP) showed floating lag time (6.5 h), total floating time (14 h), adhesion force (0.82 N) and Q18h ([90 %). Pharmacokinetic study of OP and immediate release market product demonstrated improved bioavailability (*12 % higher AUC0–?) of OP. In a nutshell, developed drug delivery system can be fabricated as a platform for QF and similar BCS class-II drugs with pH dependent solubility.

#Quetiapine fumarate #GRDDs #pH-independent release #Microenvironment pH #Response surface methodology

참고문헌 (29)

참고문헌 신청

Ahmed I. / 2007 / Bioavailability of riboflavin from a gastric retention formulation / Int J Pharm 330(1?2):146~154

Al Remawia M. / 2013 / Application of excipient made from Chitosan-Xanthan as a single component for the controlled release of ambroxol tablet / J Excipients Food Chem 4(2):48~57

Awasthi R. / 2014 / Development of novel gastroretentive drug delivery system of gliclazide : hollow beads / Drug Dev Ind Pharm 40(3):398~408

Bomma R. / 2009 / Development and evaluation of gastroretentive norfloxacin floating tablets / Acta Pharm 59(2):211~221

Chinthala S. / 2012 / Formulation and evaluation of gastroretentive floating tablets of gabapentin using effervescent technology / Int J Pharm Biomed Res 3(4):202~208

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