口服法莫替丁干混悬液的配方研制与表征

Sajjad Qaisar, Masood-ur-Rehman Aarbi, Shahiq-uz-zaman, Ammar Sadiq, Talha Rafique
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引用次数: 0

摘要

法莫替丁是H2受体阻滞剂,通常用于治疗胃溃疡和肠溃疡。法莫替丁是液体悬浮液,在保质期内不稳定。液体悬浮液的主要问题是药物的降解、异味和颜色变化。这个问题可以通过将药物配制成干悬浮液来解决。制备了四种不同的法莫替丁干混悬液配方。采用几何混合法制备配方。红外光谱分析显示辅料与原料药无不相容性。用于评估配方的测试包括测定、pH值、粘度、流动特性、沉降体积和再分散性。在所有开发的配方中,F3是最理想的,具有良好的流动性能,100%的药物含量,最佳粘度和pH值。其他配方存在F1粘度高,流动困难,F2含量为94%,F4苦味和低pH值等问题。因此,选择F3配方进行进一步研究,并在稳定室中加速保存6个月,温度为40°C±2和75%±5 R.H.,分别在0、1、2、3、4和6个月取样,以评估干燥配方的稳定性。此外,将配方(F3)加水重组,并在加速条件下放置28天,以检查其稳定性。在0、1、2、3和4周时取样。结果表明,在稳定性研究中,干燥悬浮液和重组悬浮液均未发生变化。综上所述,F3的配方是稳定的,可以在未来使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation development and characterization of famotidine dry suspension for oral use
Famotidine an H2 receptor blocker is generally used to treat ulcers of stomach and intestine. Famotidine is available in liquid suspension that is unstable during shelf life. Degradation of the drug as well as bad smell and color change is major problem in liquid suspension. This problem may be solved by formulating the drug as a dry suspension. We prepared four different formulations of famotidine as dry suspension. Geometric mixing methodology was followed to prepare the formulations. IR-spectroscopy showed no incompatibility between excipients used and API. Tests performed to evaluate formulations include assay, pH, viscosity, flow property, sedimentation volume and re-dispersibility. Among all the developed formulations, F3 was most ideal having excellent flow property, 100% drug assay, optimum viscosity and pH. Other formulations displayed some problems like viscosity of F1 was high that caused difficulty in flow while assay of F2 was 94% and F4 had bitter taste and low pH value. Hence F3 formulation was selected for further studies and kept for six months in stability chamber at accelerated conditions having temperature 40 °C ±2  and 75% ±5 R.H. samples were taken at 0, 1, 2, 3, 4 and 6 months to evaluate stability of the dry formulation. Moreover formulation (F3) was reconstituted with water and placed at accelerated conditions for 28 days to check its stability. Samples were taken at 0, 1, 2, 3, and 4 weeks. Results showed that no change occurred in both dry and reconstituted suspension during stability studies. It can be concluded on the basis of these findings that F3 formulation was stable and can be used in future.
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