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神圣罗勒种子,一种天然超级崩解剂:尼美舒利速溶片的制剂与评价

Ocimum Sanctum seeds, a natural superdisintegrant: formulation and evaluation of fast melt tablets of nimesulide.

作者信息

Malik Karan, Arora Gurpreet, Singh Inderbir

机构信息

School of Pharmaceutical Sciences, Chitkara University, Solan-174103, Himachal Pradesh, India.

出版信息

Polim Med. 2012;42(1):49-59.

Abstract

BACKGROUND

Fast melt tablets, also known as fast dissolving tablets, disintegrate instantaneously within the mouth and thus can be consumed without water. The present study was aimed to formulate fast melt tablets of nimesulide by using Ocimum Sanctum seeds as a natural tablet superdisintegrant.

MATERIAL AND METHODS

Powdered Ocimum seeds were characterized for powder flow properties (bulk density, tapped density, Carr's consolidation index, Hausner ratio, angle of repose), swelling index, viscosity, pH, loss on drying and microbial load. The prepared tablets were evaluated for different tablet parametric tests, wetting time, water absorption ratio, effective pore radius, porosity, packing fraction, in vitro and in vivo disintegration time, in-vitro dissolution and stability studies.

RESULTS

The swelling index was evaluated to be 1600. An appreciable effect of the natural material was seen on tablet hardness and friability. The water absorption ratio increased from 56.15 +/- 0.85 to 80.76 +/- 0.70 (A1-A4). Water uptake coupled natural polymer swelling could be the most probable mechanism for concentration dependent reduction in disintegration time by the Ocimum Sanctum seeds. Porosity of the formulated tablets was found to increase from batch A1-A4. The in vitro disintegration results were in line with in vivo disintegration results. The f2 values (in comparison with Nimulid MD) of 95.90 and 93.65 were obtained with A3 and A4 batches respectively.

CONCLUSION

It could be concluded that Ocimum Sanctum seeds could be used as a natural superdisintegrant in the formulation of fast melt tablets.

摘要

背景

速溶片,也称为快速溶解片,可在口腔内瞬间崩解,因此无需用水即可服用。本研究旨在使用罗勒种子作为天然片剂超级崩解剂来制备尼美舒利速溶片。

材料与方法

对罗勒种子粉末进行粉末流动性(堆密度、振实密度、卡尔压缩指数、豪斯纳比、休止角)、溶胀指数、粘度、pH值、干燥失重和微生物负荷的表征。对制备的片剂进行不同的片剂参数测试、润湿时间、吸水率、有效孔径、孔隙率、填充率、体外和体内崩解时间、体外溶出度和稳定性研究。

结果

溶胀指数评估为1600。天然材料对片剂硬度和脆碎度有明显影响。吸水率从56.15±0.85增加到80.76±0.70(A1-A4)。水分吸收与天然聚合物溶胀相结合可能是罗勒种子导致崩解时间呈浓度依赖性降低的最可能机制。所制备片剂的孔隙率从A1批次到A4批次逐渐增加。体外崩解结果与体内崩解结果一致。A3和A4批次分别获得了95.90和93.65的f2值(与尼美舒利MD相比)。

结论

可以得出结论,罗勒种子可作为天然超级崩解剂用于速溶片的配方中。

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