Cem Çalışkan, Onur Çakır, Muge Guleli, Yavuz Selim Toksöz, H. I. Uğraş
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In this context, the effects of buffers, pH, and different surfactants were evaluated, and it was found that Polyoxyethylene 23 lauryl ether (Brij-35), a nonionic surfactant, increased the solubility. The results were obtained with RP-HPLC method using Kromasil C18 150 mm x 4.6 mm, 5 µm column with a flow rate of 1.5 ml/min at 210 nm wavelength in 7 minutes for Racecadotril, which dissolves at least 60% of the label value after 45 minutes after the dissolution studies performed with a type II apparatus at 37°C. A suitable dissolution medium was found for sachet drug forms containing Racecadotril, and the analytical method was validated in accordance with the ICH Q2 (R1) guideline. In addition, the difference factor (f 1 ) and similarity factor (f 2 ) were calculated to compare the dissolution profiles of the reference product and samples in this determined dissolution medium.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2023-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"In-vitro release study of Racecadotril from granule sachets: influence of Brij-35\",\"authors\":\"Cem Çalışkan, Onur Çakır, Muge Guleli, Yavuz Selim Toksöz, H. I. 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引用次数: 0
摘要
:对于含有Racecadotril的小袋剂型,其可自由溶于甲醇和二氯甲烷,但实际上不溶于水,用作止泻剂,文献和专著中没有符合当局要求参数的合适溶解介质。因此,根据研究中使用的参考产品和样品的指南和溶解特性,确定了合适的溶解介质。对这些剖面进行了比较,并对该方法进行了验证。为了确定最适合释放药物产品的培养基,在由类似胃肠道(GIT)pH的不同缓冲液制备的培养基和含有Brij 35的培养基中进行体外溶出试验。在这种情况下,评估了缓冲液、pH和不同表面活性剂的影响,发现非离子表面活性剂聚氧乙烯23十二烷基醚(Brij-35)增加了溶解度。结果通过RP-HPLC法获得,使用Kromasil C18 150 mm x 4.6 mm,5µm柱,流速为1.5 ml/min,波长为210 nm,用于Racecadotril,在37°C下用II型仪器进行溶解研究后,45分钟后溶解至少60%的标记值。为含有Racecadotril的小袋剂型找到了合适的溶出介质,并根据ICH Q2(R1)指南验证了分析方法。此外,还计算了差异因子(f1)和相似因子(f2),以比较参考产品和样品在该确定的溶解介质中的溶解特性。
In-vitro release study of Racecadotril from granule sachets: influence of Brij-35
: For sachet drug forms containing Racecadotril, which are freely soluble in methanol and methylene chloride but practically insoluble in water, used as an anti-diarrhea, suitable dissolution media meeting the parameters requested by the authorities are not available in the literature and monographs. For this reason, a suitable dissolution medium was determined in accordance with the guidelines and the dissolution profiles of reference product and samples used in the study. The profiles were compared, and the method was validated. In order to determine the most suitable medium for the release of drug product, in vitro dissolution tests were performed in media prepared by different buffers similar to the pH of the gastrointestinal tract (GIT) and media containing Brij 35. In this context, the effects of buffers, pH, and different surfactants were evaluated, and it was found that Polyoxyethylene 23 lauryl ether (Brij-35), a nonionic surfactant, increased the solubility. The results were obtained with RP-HPLC method using Kromasil C18 150 mm x 4.6 mm, 5 µm column with a flow rate of 1.5 ml/min at 210 nm wavelength in 7 minutes for Racecadotril, which dissolves at least 60% of the label value after 45 minutes after the dissolution studies performed with a type II apparatus at 37°C. A suitable dissolution medium was found for sachet drug forms containing Racecadotril, and the analytical method was validated in accordance with the ICH Q2 (R1) guideline. In addition, the difference factor (f 1 ) and similarity factor (f 2 ) were calculated to compare the dissolution profiles of the reference product and samples in this determined dissolution medium.