FORMULATION AND EVALUATION OF RISPERIDONE MUCOADHESIVE BUCCAL TABLETS

Abstract

In the present work, an attempt was made to design efficacious and prolonged release mucoadhesive buccal tablets of Risperidone using various polymers to reduce dosing frequency, decrease gastric irritation and to improve patient compliance. Two polymer combinations (carbopol 943 and PVP K30 as well as carbopol and xanthan gum) were taken at varying proportions. The buccal tablets were tested for weight uniformity, thickness, friability and hardness. Tablets were then evaluated for their swelling index, in vitro drug release, mucoadhesion time (wash-off time) and ex vivo drug permeation. The kinetics and mechanism of the drug permeation through the excised buccal tissue of goat from the buccal tablets were also characterized. The data collected were then analyzed using software to determine the effects of each parameter. The effects of the various parameters involved were then interpreted.The best polymer composite was selected from the various ratios of the polymers. The best polymer ratio was found to be Carbopol 934 and PVP K30 in the ratio 1:2. The mucoadhesive strength of buccal tablets increases as the concentration of secondary polymer increases. The above polymer composite had shown satisfactory results in the parameters such as thickness, hardness, drug content, swelling index, mucoadhesive time, in-vitro dissolution and in-vitro diffusion. The satisfactory formulation shows a zero order drug release profile depending on the regression value and shown a satisfactory dissolution profile. Slow, controlled and maximum release of Risperidone over a period of 6 h was obtained from buccal tablets F2 formulation containing Carbopol 934 and PVP K30. Further work is to be carried out in order to determine its efficacy and safety by long term pharmacokinetic and pharmacodynamic studies in human beings. Key words: Formulation, Evaluation, Risperidone, Mucoadhesive Buccal Tablets