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Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology.
Acta Pharm. 2009 Mar; 59(1):15-30.AP

Abstract

Extended release formulation of tramadol hydrochloride (TRH) based on osmotic technology was developed and evaluated. Target release profile was selected and different variables were optimized to achieve it. Formulation variables such as the level of swellable polymer, plasticizer and the coat thickness of semipermeable membrane (SPM) were found to markedly affect drug release. TRH release was directly proportional to the levels of plasticizer but inversely proportional to the levels of swellable polymer and coat thickness of SPM. Drug release from developed formulations was independent of pH and agitation intensity but dependent on osmotic pressure of the release media. In vivo study was also performed on six healthy human volunteers and various pharmacokinetic parameters (cmax, tmax, AUC0-24, MRT) and relative bioavailability were calculated. The in vitro and in vivo results were compared with the performance of two commercial TRH tablets. The developed formulation provided more prolonged and controlled TRH release compared to the marketed formulation. In vitro-in vivo correlation (IVIVC) was analyzed according to the Wagner-Nelson method. The optimized formulation (batch IVB) exhibited good IVIV correlation (R = 0.9750). The manufacturing procedure was found to be reproducible and formulations were stable over 6 months of accelerated stability testing.

Authors+Show Affiliations

Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi-221005, U.P. India. pramod_79kumar@rediffmail.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Controlled Clinical Trial
Journal Article

Language

eng

PubMed ID

19304555

Citation

Kumar, Pramod, et al. "Development and Biopharmaceutical Evaluation of Extended Release Formulation of Tramadol Hydrochloride Based On Osmotic Technology." Acta Pharmaceutica (Zagreb, Croatia), vol. 59, no. 1, 2009, pp. 15-30.
Kumar P, Singh S, Mishra B. Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology. Acta Pharm. 2009;59(1):15-30.
Kumar, P., Singh, S., & Mishra, B. (2009). Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology. Acta Pharmaceutica (Zagreb, Croatia), 59(1), 15-30. https://doi.org/10.2478/v10007-009-0010-2
Kumar P, Singh S, Mishra B. Development and Biopharmaceutical Evaluation of Extended Release Formulation of Tramadol Hydrochloride Based On Osmotic Technology. Acta Pharm. 2009;59(1):15-30. PubMed PMID: 19304555.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and biopharmaceutical evaluation of extended release formulation of tramadol hydrochloride based on osmotic technology. AU - Kumar,Pramod, AU - Singh,Sanjay, AU - Mishra,Brahmeshwar, PY - 2009/3/24/entrez PY - 2009/3/24/pubmed PY - 2009/5/14/medline SP - 15 EP - 30 JF - Acta pharmaceutica (Zagreb, Croatia) JO - Acta Pharm VL - 59 IS - 1 N2 - Extended release formulation of tramadol hydrochloride (TRH) based on osmotic technology was developed and evaluated. Target release profile was selected and different variables were optimized to achieve it. Formulation variables such as the level of swellable polymer, plasticizer and the coat thickness of semipermeable membrane (SPM) were found to markedly affect drug release. TRH release was directly proportional to the levels of plasticizer but inversely proportional to the levels of swellable polymer and coat thickness of SPM. Drug release from developed formulations was independent of pH and agitation intensity but dependent on osmotic pressure of the release media. In vivo study was also performed on six healthy human volunteers and various pharmacokinetic parameters (cmax, tmax, AUC0-24, MRT) and relative bioavailability were calculated. The in vitro and in vivo results were compared with the performance of two commercial TRH tablets. The developed formulation provided more prolonged and controlled TRH release compared to the marketed formulation. In vitro-in vivo correlation (IVIVC) was analyzed according to the Wagner-Nelson method. The optimized formulation (batch IVB) exhibited good IVIV correlation (R = 0.9750). The manufacturing procedure was found to be reproducible and formulations were stable over 6 months of accelerated stability testing. SN - 1330-0075 UR - https://www.unboundmedicine.com/medline/citation/19304555/Development_and_biopharmaceutical_evaluation_of_extended_release_formulation_of_tramadol_hydrochloride_based_on_osmotic_technology_ L2 - https://www.degruyter.com/document/doi/10.2478/v10007-009-0010-2 DB - PRIME DP - Unbound Medicine ER -