呼吸系统疾病用硫酸沙丁胺醇快速崩解片的处方研制与评价。

ISRN Pharmaceutics Pub Date : 2013-07-15 eCollection Date: 2013-01-01 DOI:10.1155/2013/674507
Deepak Sharma
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引用次数: 64

摘要

快速崩解片剂的最新发展为吞咽片剂有困难的儿科和老年患者提供了给药方便。本研究的目的是制备用于儿科呼吸系统疾病的硫酸沙丁胺醇快速崩解片。由于剂量的准确性和患者的依从性成为长期治疗的重要先决条件,因此需要开发一种药物配方,以克服诸如吞咽困难,旅行时给药不方便以及患者的可接受性等问题。因此,本研究旨在开发一种快速崩解的硫酸沙丁胺醇片剂,以提供一系列具有期望特性和预期效益的新产品。对乙醇酸淀粉钠等强力崩解剂进行了优化。对不同粘结剂进行了优化,并确定了最佳超崩解剂浓度。采用直接压片法制备。对其硬度、脆性、重量变化、润湿时间、崩解时间和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。结果表明:研制成功的硫酸沙丁胺醇快崩解片具有崩解快的特点;提供迅速的行动;提高了患者的便利性和依从性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Formulation development and evaluation of fast disintegrating tablets of salbutamol sulphate for respiratory disorders.

Recent developments in fast disintegrating tablets have brought convenience in dosing to pediatric and elderly patients who have trouble in swallowing tablets. The objective of the present study was to prepare the fast disintegrating tablet of salbutamol sulphate for respiratory disorders for pediatrics. As precision of dosing and patient's compliance become important prerequisites for a long-term treatment, there is a need to develop a formulation for this drug which overcomes problems such as difficulty in swallowing, inconvenience in administration while travelling, and patient's acceptability. Hence, the present investigation were undertaken with a view to develop a fast disintegrating tablet of salbutamol sulphate which offers a new range of products having desired characteristics and intended benefits. Superdisintegrants such as sodium starch glycolate was optimized. Different binders were optimized along with optimized superdisintegrant concentration. The tablets were prepared by direct compression technique. The tablets were evaluated for hardness, friability, weight variation, wetting time, disintegration time, and uniformity of content. Optimized formulation was evaluated by in vitro dissolution test, drug-excipient compatibility, and accelerated stability study. It was concluded that fast disintegrating tablets of salbutamol sulphate were formulated successfully with desired characteristics which disintegrated rapidly; provided rapid onset of action; and enhanced the patient convenience and compliance.

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