Kaushikbhai Ghanshyambhai Gajera
PG Research Scholar, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
Anil G Raval
Assistant Professor, Department of Pharmaceutics, Sharda School of Pharmacy, Pethapur, Gandhinagar, Gujarat
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