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Development of gastroretentive drug delivery system for cefuroxime axetil: in vitro and in vivo evaluation in human volunteers.
Pharm Dev Technol. 2013 Sep-Oct; 18(5):1230-7.PD

Abstract

The objective of this investigation was to develop the cefuroxime axetil sustained-release floating tablets to prolong the gastric residence time and compare their pharmacokinetic behavior with marketed conventional tablets (Zocef). The floating tablets were developed using polymers like HPMC K4M and HPMC K100M alone, and polymer combination of HPMC K4M and Polyox WSR 303 by effervescent technique. Tablets were prepared by slugging method and evaluated for their physical characteristics, in vitro drug release, and buoyancy lag time. The best formulation (F10) was selected based on in vitro characteristics and used in vivo radiographic and bioavailability studies in healthy human volunteers. All the formulations could sustain drug release for 12 h. The dissolution profiles were subjected to various kinetic release models and it was found that the mechanism of drug release followed Peppas model. The in vivo radiographic studies revealed that the tablets remained in stomach for 225 ± 30 min. Based on in vivo performance, the developed floating tablets showed superior bioavailability than Zocef tablet. Based on in vivo performance significant difference was observed between Cmax, tmax, t1/2, AUC0-∞, and mean residence time of test and reference (p<0.05). The increase in relative bioavailability of test was 1.61 fold when compared to reference.

Authors+Show Affiliations

Department of Pharmacy, University College of Pharmaceutical Sciences, Kakatiya University, Warangal, India.No affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

22348334

Citation

Bomma, Ramesh, and Kishan Veerabrahma. "Development of Gastroretentive Drug Delivery System for Cefuroxime Axetil: in Vitro and in Vivo Evaluation in Human Volunteers." Pharmaceutical Development and Technology, vol. 18, no. 5, 2013, pp. 1230-7.
Bomma R, Veerabrahma K. Development of gastroretentive drug delivery system for cefuroxime axetil: in vitro and in vivo evaluation in human volunteers. Pharm Dev Technol. 2013;18(5):1230-7.
Bomma, R., & Veerabrahma, K. (2013). Development of gastroretentive drug delivery system for cefuroxime axetil: in vitro and in vivo evaluation in human volunteers. Pharmaceutical Development and Technology, 18(5), 1230-7. https://doi.org/10.3109/10837450.2012.660698
Bomma R, Veerabrahma K. Development of Gastroretentive Drug Delivery System for Cefuroxime Axetil: in Vitro and in Vivo Evaluation in Human Volunteers. Pharm Dev Technol. 2013 Sep-Oct;18(5):1230-7. PubMed PMID: 22348334.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development of gastroretentive drug delivery system for cefuroxime axetil: in vitro and in vivo evaluation in human volunteers. AU - Bomma,Ramesh, AU - Veerabrahma,Kishan, Y1 - 2012/02/21/ PY - 2012/2/22/entrez PY - 2012/2/22/pubmed PY - 2014/2/4/medline SP - 1230 EP - 7 JF - Pharmaceutical development and technology JO - Pharm Dev Technol VL - 18 IS - 5 N2 - The objective of this investigation was to develop the cefuroxime axetil sustained-release floating tablets to prolong the gastric residence time and compare their pharmacokinetic behavior with marketed conventional tablets (Zocef). The floating tablets were developed using polymers like HPMC K4M and HPMC K100M alone, and polymer combination of HPMC K4M and Polyox WSR 303 by effervescent technique. Tablets were prepared by slugging method and evaluated for their physical characteristics, in vitro drug release, and buoyancy lag time. The best formulation (F10) was selected based on in vitro characteristics and used in vivo radiographic and bioavailability studies in healthy human volunteers. All the formulations could sustain drug release for 12 h. The dissolution profiles were subjected to various kinetic release models and it was found that the mechanism of drug release followed Peppas model. The in vivo radiographic studies revealed that the tablets remained in stomach for 225 ± 30 min. Based on in vivo performance, the developed floating tablets showed superior bioavailability than Zocef tablet. Based on in vivo performance significant difference was observed between Cmax, tmax, t1/2, AUC0-∞, and mean residence time of test and reference (p<0.05). The increase in relative bioavailability of test was 1.61 fold when compared to reference. SN - 1097-9867 UR - https://www.unboundmedicine.com/medline/citation/22348334/Development_of_gastroretentive_drug_delivery_system_for_cefuroxime_axetil:_in_vitro_and_in_vivo_evaluation_in_human_volunteers_ L2 - https://www.tandfonline.com/doi/full/10.3109/10837450.2012.660698 DB - PRIME DP - Unbound Medicine ER -