Formulation Development and Evaluation of MDF of Cariprazine

Abstract

Mouth dissolving film is now a days preferred route of drug administration due to patient compliance.  The developed film formulation is a patient-friendly formulation that would be useful for people who have difficulty of swallowing. The results have shown that the HPMC-K4M is good film former and shows bioadhesion property. In combination with PEG-400, it has shown promising fast drug release within 10 min. and good folding endurance. Hence a semi-synthetic cellulose derivative which is affordable and abundantly available can be used as a potential drug release modifier and also used to improve flexibility and processability in the mouth dissolving films. Successful formulation of Cariprazine mouth dissolving films may prevent first pass metabolism to a large possible extent. From the present study it can be concluded that HPMC-K4M based mouth dissolving films of Cariprazine can be successfully prepared with considerable good stability and improved bioavailability