Development, intra-gastric performance and pharmacokinetic study of gastroretentive drug delivery system for cefdinir in human volunteers

作者: Ramesh Bomma , Kishan Veerabrahma

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摘要: The objective of this study was to develop sustained-release floating tablets cefdinir (CFDN) using effervescent technique prolong gastric residence time (GRT) and compare their pharmacokinetics with immediate release (IR) conventional sustained (SR) tablets. were designed CaCO 3 as gas-former three grades polyethylene oxide release-retardants further evaluated for physical characters, in vitro drug buoyancy studies. optimized formulation (F3) found be physically stable when stored at 40 o C/75% RH months. In vivo radiographic imaging F3 revealed a mean GRT 4.83 ± 0.57 h (n=3). Comparative pharmacokinetic performed F3, IR SR CFDN humans. Based on performance, the difference between t max , AUC 0-∞ 1/2 MRT statistically significant (p < 0.05). C tablet significant, but not significant. relative bioavailability 1.71 fold 1.24 SR. This improved is due combined effect increased GRT.

参考文章(30)
Lucy Wan Sai Cheong, Paul Wan Sia Heng, Lee Fun Wong, Relationship between polymer viscosity and drug release from a matrix system. Pharmaceutical Research. ,vol. 9, pp. 1510- 1514 ,(1992) , 10.1023/A:1015883501871
Kazue Ohkubo, Makoto Tanaka, Yasunobu Okada, Oral drug delivery systems ,(1987)
Arati A. Deshpande, Navnit H. Shah, Christopher T. Rhodes, Waseem Malick, Development of a Novel Controlled-Release System for Gastric Retention Pharmaceutical Research. ,vol. 14, pp. 815- 819 ,(1997) , 10.1023/A:1012171010492
Herbert A. Lieberman, Leon Lachman, Joseph L. Kanig, The Theory and Practice of Industrial Pharmacy ,(1970)
Ramesh Bomma, Kishan Veerabrahma, None, Development of gastroretentive drug delivery system for cefuroxime axetil: in vitro and in vivo evaluation in human volunteers Pharmaceutical Development and Technology. ,vol. 18, pp. 1230- 1237 ,(2013) , 10.3109/10837450.2012.660698
L. Whishead, J.T. Fell, J.H. Collett, Development of a gastroretentive dosage form. European Journal of Pharmaceutical Sciences. ,vol. 4, ,(1996) , 10.1016/S0928-0987(97)86558-X
Richard W. Korsmeyer, Robert Gurny, Eric Doelker, Pierre Buri, Nikolaos A. Peppas, Mechanisms of solute release from porous hydrophilic polymers International Journal of Pharmaceutics. ,vol. 15, pp. 25- 35 ,(1983) , 10.1016/0378-5173(83)90064-9