FORMULATION, DEVELOPMENT OF FAST DISSOLVING SUBLINGUAL WAFERS OF AN ANTIEMETIC DRUG USING FILM FORMER

Jayesh Kelodiya, S. Shah, C. Tyagi, Prabhakar Budholiya
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Abstract

The aim of the present research work is development and characterization of fast dissolving oral Wafers of Meclizine hydrochloride. Meclizine hydrochloride containing fast dissolving wafers were fabricated by the solvent casting method. Drug content was analyzed by UV-Visible spectrophotometer at 232 nm. The percentage drug content was between 95.65±0.23% and 99.12±0.61%, which proved uniform drug distribution within the Meclizine hydrochloride wafers.All preparations absorb moisture at a very fast rate and they disintegrate as soon as they come in contact with water. The formulated Meclizine hydrochloride wafers showed a disintegration time in the range of 6±1-15±1sec. Formulation F7 showed the least disintegration time of 6±1 sec. Formulations containing only Xanthan gum, Gelatin and Gum acacia showed highest disintegration time of 15±1sec seconds.The in vitro drug release studies were carried out on formulated Meclizine hydrochloride wafers formulation F7. The drug release data showed a drug release of 36.65%, 48.89%, 64.56%, 72.32%, 85.65% and 98.15% respectively at the 60, 120, 180, 240, 300 and 360 sec of study period. This faster release of the drug can be accounted to the optimum ratio of the wafer forming polymers used having both properties of gelation and fast melt. The drug release was found to be much faster than that of the permeation for the same formulations due to the fact that a much larger sink condition was maintained during the drug release studies which lead to a much faster release of the drug into the media.
快速溶解止吐药舌下晶片的研制
本研究的目的是研制快速溶出的盐酸美甲嗪口服晶片。采用溶剂铸造法制备了盐酸美氯嗪快溶晶片。用紫外可见分光光度计在232 nm处测定药物含量。药物含量在95.65±0.23% ~ 99.12±0.61%之间,说明药物在盐酸美唑嗪片内分布均匀。所有的制剂都以非常快的速度吸收水分,一旦接触到水就会分解。配制的盐酸美唑嗪晶片崩解时间为6±1 ~ 15±1sec。配方F7的崩解时间最短,为6±1秒。仅含黄原胶、明胶和金合欢胶的配方崩解时间最长,为15±1秒。对盐酸美唑嗪硅片F7进行了体外释药研究。药物释放数据显示,研究周期60、120、180、240、300和360秒的药物释放率分别为36.65%、48.89%、64.56%、72.32%、85.65%和98.15%。这种药物的快速释放可以归因于所使用的具有凝胶和快速熔化特性的晶圆形成聚合物的最佳比例。由于在药物释放研究中保持了一个更大的吸收条件,导致药物更快地释放到介质中,因此发现相同配方的药物释放比渗透快得多。
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