首页> 美国卫生研究院文献>Journal of Drug Delivery >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
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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

机译:硫酸沙丁胺醇盐酸西替利嗪的快速崩解片的制剂开发和评价以联合药物剂型:儿科和老年病用新型药物递送的新时代

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摘要

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.
机译:本研究的目的是制备硫酸沙丁胺醇,盐酸西替利嗪的快速崩解片,其组合片剂剂型适用于呼吸系统疾病,如支气管炎,哮喘以及小儿和老人的咳嗽。通过直接压片技术制备片剂。超级崩解剂(如乙醇酸淀粉钠)在最短崩解时间的基础上优化为4%。优化了不同的粘合剂(例如MCC和PVP K-30)以及优化的超崩解剂浓度。基于最小崩解时间,选择1%MCC作为最佳粘合剂浓度。评价片剂的硬度,脆性,重量变化,润湿时间,崩解时间和药物含量均匀性。通过体外溶出试验,药物-赋形剂相容性和加速稳定性研究进一步评估了优化的制剂。重量变化百分比和含量均匀性在可接受的范围内。脆度小于1%。对于所有制剂,润湿时间和崩解时间实际上都很好。 FTIR研究和加速稳定性研究表明,药物和赋形剂之间没有相互作用。结论是,通过使用常用的药物赋形剂,例如超崩解剂,亲水性和溶胀性赋形剂以及适当的填充剂,成功配制了具有所需特性的硫酸沙丁胺醇,盐酸西替利嗪的快速崩解片剂。

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