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Formulation and evaluation of taste mask pellets of granisetron hydrochloride as oro dispersible tablet

机译:盐酸格拉司琼口服分散片口罩颗粒的研制与评价

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Orally disintegrating systems have carved a niche amongst the oral drug delivery systems due to the highest compliance of the patients, especially the geriatrics and pediatrics. In addition, patients suffering from dysphagia, motion sickness, repeated emesis and mental disorders prefer these medications because they cannot swallow large quantity of water. Further, drugs exhibiting satisfactory absorption from the oral mucosa or intended for immediate pharmacological action can be advantageously formulated in these dosage forms. However, the requirements of formulating these dosage forms with mechanical strength sufficient to withstand the rigors of handling and capable of disintegrating within a few seconds on contact with saliva are inextricable. The purpose of this research was to mask the bitter taste of granisetron hydrochloride. To mask the taste Kollicoat(r) Smartseal 30D was used as coating polymer for pellet coating. The coated pellets of the drug was directly compressed with different superdisintegrant as AC-Di-Sol, Explotab and Kollidon CL in different concentration 5.0-7.5% w/w into an ODT. The prepared tablets were evaluated for hardness, friability, weight variation, wetting time, wet absorption ratio, in-vitro disintegration time and in vitro dissolution studies. Tablets exhibited quick disintegration characteristics with Kollidon CL in concentration 7.5% w/w i.e., within 20 seconds, which is characteristic of orally disintegrating dosage forms. More than 98% of drug was released from the formulations within 15 minutes. Formulations subjected to stability testing as per the ICH guidelines for 3 months, indicated stability with no change in taste, hardness, drug content, disintegration time and dissolution profiles. Thus, the results conclusively demonstrated successful masking of taste and rapid disintegration of the formulated dosage forms in the oral cavity.
机译:口腔崩解系统由于患者尤其是老年和儿科患者的最高依从性而在口服药物递送系统中占据了优势。此外,患有吞咽困难,晕车,反复呕吐和精神障碍的患者更喜欢这些药物,因为它们不能吞咽大量的水。此外,可以从这些粘剂剂型中有利地制备表现出令人满意的从口腔粘膜吸收的吸收或用于立即的药理作用的药物。然而,配制具有机械强度足以经受严酷处理并且能够与唾液接触在几秒钟内崩解的剂型的要求是无法解决的。这项研究的目的是掩盖盐酸格拉司琼的苦味。为了掩盖味道,将Kollicoat Smartseal 30D用作粒料包衣的包衣聚合物。将药物的包衣小丸直接以不同的超崩解剂(如AC-Di-Sol,Explotab和Kollidon CL)以5.0-7.5%w / w的不同浓度压制成ODT。评价制备的片剂的硬度,脆性,重量变化,润湿时间,湿吸收率,体外崩解时间和体外溶出度研究。片剂具有浓度为7.5%w / w的Kollidon CL,即在20秒内显示出快速崩解的特征,这是口服崩解剂型的特征。 15分钟内从制剂中释放出超过98%的药物。依照ICH指南进行了3个月稳定性测试的制剂显示出稳定性,其味道,硬度,药物含量,崩解时间和溶出度没有变化。因此,结果最终证明成功掩盖了味道,并且制剂剂型在口腔中迅速崩解。

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