Formulation of Herbal Fast Disintegrating Tablets and its ex-vivo Study for Anti-histaminic Activity in Guinea Pig Ileum.

IF 3.2 Q2 Pharmacology, Toxicology and Pharmaceutics

Current clinical pharmacology Pub Date : 2018-01-01 DOI:10.2174/1574884713666180309153942

Dinesh Puri, Anil Bhandari, Praveen Kumar Gaur, Mohammad Yasir, S Sadish Kumar, Deepak Choudhary, Prasoon Kumar Saxena

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引用次数: 2

Abstract

Objective: The aim of present research work was to develop a herbal fast disintegrating tablet containing Fagonia schweinfurthii Hadidi dried extract and determining its antihistaminic activity using guinea pig ileum.

Method: The tablets were formulated by wet granulation technique using three different superdisintegrants (croscarmillose, crospovidone and sodium starch glycolate) at three different levels. The tablets were evaluated for various physical properties like hardness, friability weight variation etc. and various mechanical properties like disintegration time, wetting time to select the best superdisintegrant. The selected superdisintegrant was further used as intra as well as extra granulating agent to develop fast disintegrating tablets of Fagonia schweinfurthii Hadidi dried extract. The optimized formulation was subjected to stability study as per the ICH guidelines. Finally, Ex-vivo antihistaminic study was conducted on guinea pig ileum for optimized formulation and compared with marketed tablet containing cetrizine HCl as API (Stanhist-10, Ranbaxy, Pvt. Ltd).

Results: Physical properties of all tablet batches were found to be acceptable and comply with various official specifications. The disintegration time and wetting time of optimized formulation (F'3) were found to be 1.15±0.08 and 0.56±0.04 min respectively. Results of Ex-vivo study showed a comparable histamine inhibition between optimized tablet (15%) and marketed tablet formulation (18.8%) in a dose of 5 µg/ml.

Conclusion: On the basis of in-vitro and Ex-vivo studies, it was concluded that prepared herbal fast disintegrating tablets were stable and had potent antihistaminic activity.

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中药快速崩解片的研制及其对豚鼠回肠抗组胺活性的体外研究。

目的:研制一种中药快速崩解片，并利用豚鼠回肠测定其抗组胺活性。方法:采用三种不同的超崩解剂(交联蜜糖、交联维酮和乙醇酸淀粉钠)以不同的浓度，采用湿法制粒。通过对崩解时间、润湿时间等物理性能及硬度、破碎重量变化等力学性能的评价，优选出最佳的超崩解剂。将所选的强力崩解剂作为内粒剂和外粒剂，研制了麻花荞麦干浸膏快速崩解片。根据ICH指南对优化后的制剂进行稳定性研究。最后在豚鼠回肠进行离体抗组胺研究，优化处方，并与市售盐酸头孢嗪原料药片(Stanhist-10, Ranbaxy, ptt . Ltd .)进行比较。结果:各批次片剂的物理性能均可接受，符合官方规定。最佳配方F′3的崩解时间和润湿时间分别为1.15±0.08 min和0.56±0.04 min。离体实验结果显示，在5µg/ml的剂量下，优化片剂的组胺抑制率为15%，与市售片剂的组胺抑制率为18.8%。结论:在体外和离体实验的基础上，制备的中药快崩解片稳定性好，具有较强的抗组胺活性。

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来源期刊

Current clinical pharmacology PHARMACOLOGY & PHARMACY-

CiteScore

3.60

自引率

0.00%

发文量

期刊介绍： Current Clinical Pharmacology publishes frontier reviews on all the latest advances in clinical pharmacology. The journal"s aim is to publish the highest quality review articles in the field. Topics covered include: pharmacokinetics; therapeutic trials; adverse drug reactions; drug interactions; drug metabolism; pharmacoepidemiology; and drug development. The journal is essential reading for all researchers in clinical pharmacology.