FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF PALIPERIDONE

International Journal of Pharmaceutical and Biological Science Archive Pub Date : 2019-04-24 DOI:10.32553/ijpba.v7i2.116

Kaushikbhai Ghanshyambhai Gajera, Anil G. Raval

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引用次数: 1

Abstract

Optimized orally disintegrating tablets (ODTs) containing Paliperidone were prepared by direct compression method. Two factors, three levels (32) full factorial design was used to optimize the effect of superdisintegrant (crospovidone; X1) and; Binder (PVP K30S; X2) on tablet properties. The prepared ODTs were characterized for their drug content, hardness, friability and wetting time. The optimized ODT formulation (P4) was evaluated in term of in vitro disintegration and dissolution. The manufactured ODTs were complying with the pharmacopeia guidelines regarding hardness, friability, weight variation and content. PVP K30 had a very slightly enhancing effect on tablets disintegration. However, the effects of both Crospovidone (X1) and PVP K30 (X2) on ODTs drug release (Y1) were significant (p < 0.05). Moreover, X1 exhibited significant effect on the disintegration time. Furthermore, the optimized ODTs formula showed 1 month stability, and in vitro disintegration time of this formula was about 33 s. Key Words: Paliperidone, orally disintegrating tablets

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帕利哌酮口腔分散片的研制与评价

采用直接压缩法制备含帕利哌酮口腔崩解片。采用两因素三水平(32)全因子设计优化超崩解剂(交叉聚维酮;X1);粘结剂(PVP K30S;X2)片剂性质。对制备的odt进行了药物含量、硬度、脆性和润湿时间的表征。对优化后的ODT制剂(P4)进行体外崩解度和溶出度评价。生产的odt在硬度、脆性、重量变化和含量方面符合药典指南。PVP K30对片剂崩解有轻微的促进作用。而crosspovidone (X1)和PVP K30 (X2)对ODTs药物释放(Y1)的影响均显著(p < 0.05)。此外，X1对崩解时间有显著影响。优化后的处方稳定性为1个月，体外崩解时间约为33 s。关键词:帕立酮;口腔崩解片

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International Journal of Pharmaceutical and Biological Science Archive

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