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首页> 外文期刊>Asian Journal of Pharmaceutical and Clinical Research >FORMULATION DEVELOPMENT AND EVALUATION OF MOUTH DISSOLVING TABLET OF TRAMADOL HYDROCHLORIDE
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FORMULATION DEVELOPMENT AND EVALUATION OF MOUTH DISSOLVING TABLET OF TRAMADOL HYDROCHLORIDE

机译:盐酸曲马多盐溶性片剂的配方开发与评价

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摘要

The objective of the research work undertaken was to develop a dosage form which would give more rapid onset of action compared to oral conventional dosage forms and to improve patient compliance. Suitable analytical method (UV Spectroscopy) was established and validated in phosphate buffer solution, pH 6.8. 10 batches of orodispersible tablets of Tramadol hydrochloride were prepared by superdisintegrant addition method. The superdisintegrants, sodium starch glycolate (0.5%, 5% and 2%), croscarmellose sodium (2%, 3% and 5%) and crospovidone (2% and 5%) were used in different proportions and in different combinations. Prepared formulations were evaluated for pharmacopoeial and non pharmacopoeial tests. For orodispersible tablets in vitro release was carried out in phosphate buffer solution, pH 6.8, using USP type II apparatus at 50 rpm. Based on the results, formula ‘G’ containing combination of croscarmellose sodium (5%) and crospovidone (5%) was identified as the most effective formulation amongst all formulations developed for orodispersible tablets. In vitro release of optimized formulation of Tramadol hydrochloride orodispersible tablets (G) was almost found to be 99% within 15 min. with in vitro dispersion time being 15 sec and 35 sec. Formulation ‘G’ of Tramadol hydrochloride orodispersible tablets were taken for comparison with marketed conventional tablet of Tramadol hydrochloride. The conclusion arrived from the work indicated that the orodispersible tablet of Tramadol hydrochloride prepared in this investigation released drug better than that of conventional tablets , based on in vitro release studies.
机译:进行研究工作的目的是开发一种与口服常规剂型相比起效更快的剂型,并改善患者的依从性。建立了合适的分析方法(紫外光谱),并在pH 6.8的磷酸盐缓冲液中进行了验证。采用超崩解剂添加法制备了10批次的盐酸曲马多口腔分散片。超崩解剂,淀粉乙醇酸钠(0.5%,5%和2%),交联羧甲基纤维素钠(2%,3%和5%)和交聚维酮(2%和5%)以不同的比例和不同的组合使用。评价制备的制剂的药典和非药典测试。对于口腔分散片剂,使用USP II型设备以50rpm在pH 6.8的磷酸盐缓冲溶液中进行体外释放。根据结果​​,在为口分散片开发的所有配方中,含有交联羧甲基纤维素钠(5%)和交聚维酮(5%)的配方“ G”被认为是最有效的配方。盐酸曲马多口服分散片(G)优化配方的体外释放在15分钟内几乎达到99%。体外分散时间分别为15秒和35秒。盐酸曲马多口服分散片的配方“ G”与市售的盐酸曲马多常规片剂进行比较。这项工作得出的结论表明,根据体外释放研究,本研究制备的盐酸曲马多的口腔分散片比常规片剂释放的药物更好。

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