联合剂型硫酸沙丁胺醇盐酸西替利嗪快速崩解片的处方研制与评价:开创了儿科和老年新型给药的新时代。

Journal of drug delivery Pub Date : 2015-01-01 Epub Date: 2015-02-25 DOI:10.1155/2015/640529
Deepak Sharma, Gurmeet Singh, Dinesh Kumar, Mankaran Singh
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引用次数: 0

摘要

本研究的目的是制备硫酸沙丁胺醇盐酸西替利嗪复合片剂快速崩解片,用于小儿和老年病支气管炎、哮喘、咳嗽等呼吸系统疾病。采用直接压片法制备。在崩解时间最短的基础上,将乙醇酸淀粉钠等超崩解剂优化为4%。对MCC和PVP K-30等粘结剂进行了优化,并确定了最佳超崩解剂浓度。以崩解时间最短为基础,选择1% MCC为最佳黏结剂浓度。对其硬度、脆性、重量变化、润湿时间、崩解时间、药物含量均匀性进行了评价。通过体外溶出度试验、药物与赋形剂相容性及加速稳定性研究对优化后的配方进行评价。重量变异性和含量均匀性均在可接受范围内。脆性小于1%。各配方的润湿时间和崩解时间均较好。FTIR研究和加速稳定性研究表明,药物与辅料之间没有相互作用。结果表明,采用常用的超崩解剂、亲水性和可溶胀性辅料和适当的填料,制备了硫酸沙丁胺醇、盐酸西替利嗪复合片剂快速崩解片。
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 evaluation of fast disintegrating tablets of salbutamol sulphate, cetirizine hydrochloride in combined pharmaceutical dosage form: a new era in novel drug delivery for pediatrics and geriatrics.

The objective of the present study was to prepare the fast disintegrating tablet of Salbutamol Sulphate, Cetirizine Hydrochloride in combined tablet dosage form for respiratory disorders such as bronchitis, asthma, and coughing for pediatrics and geriatrics. The tablets were prepared by direct compression technique. Superdisintegrant such as Sodium Starch Glycolate was optimized as 4% on the basis of least disintegration time. Different binders such as MCC and PVP K-30 were optimized along with optimized superdisintegrant concentration. 1% MCC was selected as optimum binder concentration on the basis of least disintegration time. The tablets were evaluated for hardness, friability, weight variation, wetting time, disintegration time, and drug content uniformity. Optimized formulation was further evaluated by in vitro dissolution test, drug-excipient compatibility, and accelerated stability study. Percent weight variation and content uniformity were within the acceptable limit. The friability was less than 1%. The wetting time and disintegration time were practically good for all formulations. FTIR studies and accelerated stability study showed that there was no interaction between the drug and excipients. It was concluded that, by employing commonly available pharmaceutical excipients such as superdisintegrants, hydrophilic and swellable excipients and proper filler, a fast disintegrating tablet of Salbutamol Sulphate, Cetirizine Hydrochloride in combined tablet dosage form, were formulated successfully with desired characteristics.

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Journal of drug delivery
Journal of drug delivery PHARMACOLOGY & PHARMACY-
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