dimensional stability

The purpose of this study was to develop a gastroretentive controlled release drug delivery system with mucoadhesive properties of Propafenone HCl. Propafenone HCl has a short elimination half-life, a narrow absorption window and is mainly absorbed in proximal areas of gastro intestinal tract. Tablets were prepared by using controlled release polymers HPMC E5 and HPMC K100M. Mucoadhesive matrix tablet contains sodium carboxy methyl cellulose as a mucoadhesive polymer. The formulations were evaluated for pharmacopoeial quality control tests and all the physical parameters evaluated were within the acceptable limits. All formulations were evaluated for mucoadhesive strength, which showed good detachment force up to 12 h. Mucoadhesion studies via rotating paddle method and In-vitro drug release studies were conducted in 0.1 N HCl (pH 1.2) at 37 ± 0.5 ºC. Formulation M11 was proved to be good mucoadhesion, dimensional stability and drug release up to 12 h as compared to the other formulations.  Stability studies were carried out on the optimized formulation for period of 3 months at 400c/75 %RH. Finally it was observed that there was no change in physiochemical and physical properties as well as in drug release profile even after storage at 45 °C and 75 % for three months.