Formulation and Evaluation of Salbutamol Sulphate Taste Masked Oral Disintegrating Tablets

Y. Kumar, K. M., H. S, M. M
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Abstract

Salbutamol is a short acting, selective beta2-adrenergic receptor agonist used in the treatment of astama and COPD. The aim of this study is to formulate oral disintegrating tablets of salbutamol sulphate to achieve rapid dissolution, absorption and further improving the bioavailability of the drug. Oral disintegrating tablets of salbutamol sulphate were designed with a view to enhance the patient compliance and provide a quick onset of action. The oral disintegrating tablets were prepared by using different synthetic polymers by direct compression method. Development of the formulation in the present study was based on the concentration of superdisintegrants and the properties of the drug. Nine batches of tablets were formulated and evaluated for various parameters: drug content, weight variation, water absorption ratio, wetting time, in vitro disintegration, hardness, friability, thickness uniformity, and in vitro dissolution. A fourier-transform infrared spectroscopy (FTIR) study showed that there were no significant interactions between the drug and the excipients. The prepared tablets were good in appearance and showed acceptable results for hardness and friability. The in vitro disintegrating time of the formulated tablets was found to be 14.39-32.41 sec and the drug content of tablets in all formulations was found to be between 87.48-99.96 %, which complied within the limits established in the Indian pharmacopeia. The study concluded that taste of the drug was masked with the help of sodium saccarhin, flavor and the concentration of super disintegrating agent increases the disintegration time of tablets get decreases. The formulation (F9) had a minimum disintegration time of 14.39 sec and 99.96 % of the drug was released within 20 min.
硫酸沙丁胺醇味掩盖口腔崩解片的研制及评价
沙丁胺醇是一种短效、选择性β -肾上腺素能受体激动剂,用于治疗哮喘和慢性阻塞性肺病。本研究的目的是研制硫酸沙丁胺醇口服崩解片,使其快速溶出吸收,进一步提高药物的生物利用度。口服硫酸沙丁胺醇崩解片的设计,以提高患者的依从性,并提供快速起效。以不同合成聚合物为原料,采用直接压缩法制备口腔崩解片。本研究中配方的开发是基于超崩解剂的浓度和药物的性质。对9批制剂的药物含量、重量变化、吸水率、润湿时间、体外崩解、硬度、脆性、厚度均匀性、体外溶出度等参数进行评价。傅里叶变换红外光谱(FTIR)研究表明,药物与辅料之间没有明显的相互作用。所制片剂外观美观,硬度和脆度均可接受。制剂的体外崩解时间为14.39 ~ 32.41秒,各制剂中药片的药物含量在87.48 ~ 99.96%之间,符合印度药典的规定。研究表明,糖精钠的加入掩盖了药物的口感,风味和超级崩解剂的浓度增加,片剂崩解时间缩短。F9最短崩解时间为14.39秒,20 min内释药99.96%。
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