Publication: Formulation development of morphine sulfate sustained-release tablets and its bioequivalence study in healthy thai volunteers
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Issued Date
2010-09-01
Resource Type
ISSN
15309932
Other identifier(s)
2-s2.0-78649909296
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Mahidol University
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SCOPUS
Bibliographic Citation
AAPS PharmSciTech. Vol.11, No.3 (2010), 1449-1455
Suggested Citation
Detpon Preechagoon, Viroj Sumyai, Suvatna Chulavatnatol, Poj Kulvanich, Thanee Tessiri, Khanittha Tontisirin, Thaned Pongjanyakul, Verawan Uchaipichat, Sirikul Aumpon, Chaiyasit Wongvipaporn Formulation development of morphine sulfate sustained-release tablets and its bioequivalence study in healthy thai volunteers. AAPS PharmSciTech. Vol.11, No.3 (2010), 1449-1455. doi:10.1208/s12249-010-9518-5 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/28464
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Title
Formulation development of morphine sulfate sustained-release tablets and its bioequivalence study in healthy thai volunteers
Abstract
The objectives of this study were to develop morphine sulfate sustained-release tablet formulations and to evaluate the bioequivalence compared with a commercial brand. The physicochemical properties of the formulated and commercial tablets were determined and compared. The bioequivalence investigation was carried out in 15 healthy male volunteers who received a single dose in a randomized two-way crossover design. After dosing, serial blood samples were collected for a period of 24 h. Morphine concentration was assayed by high-performance liquid chromatography with electrochemical detector. The log-transformed Cmaxand AUCswere statistically compared by analysis of variance, and the 90% confidence intervals (CIs) of the ratio of the log-transformed Cmaxand AUCsbetween the most promising developed formulation and the commercial product were determined. It was found that the dissolution rate profile of a developed formulation was similar to the commercial brand. Their similarity and difference factors were well within limits. In the bioequivalence study, the AUClastand AUCinfbetween the test and the reference products were not statistically different (p=0.227 and p=0.468, respectively), with the 90% CIs of 83.4-102.6% and 87.7-139.4%, respectively. However, the Cmaxof the two formulations was significantly different (p=0.019). The 90% CI of the developed formulation was 72.0-93.0% compared to the commercial product. In vitro dissolution of locally prepared morphine sulfate sustained-release tablets was comparable to commercial brand. However, the results justified the conclusion of lack of bioequivalence of the developed product to the commercial one. © 2010 American Association of Pharmaceutical Scientists.