Abstract

FORMULATION AND EVALUATION OF DRY NASAL MUCOADHESIVE POWDER OF DESMOPRESSIN ACETATE BY USING 32 FULL FACTORIAL DESIGN

Bhoomita G. Hadiya*, Dr. L. D. Patel and Mayur P. Parmar

Abstract

The present work was aimed for the formulation development of stable dry nasal powder of desmopressin acetate using concentration of mucoadhesive polymer HPMC (Methocel E5) and feed rate on the basis of preliminary trials. The 32 factorial design was employed using concentration of HPMC (Methocel E5) and feed rate as independent variables and particle size (PS) and % yield were selected as dependent variables. The optimized batch was selected using Design Expert software employing overlay plot with desirability approach. The dry nasal powder formulation was evaluated for particle size, % yield, mucoadhesive strength, % drug content, scanning electron microscopy, differential scanning calorimetry, ex vivo drug diffusion study, nasal toxicity study, stability study and in-vivo study. The composition of optimized formulation consisted of 15 mg of Desmopressin acetate, 41.32 mg of HPMC (Methocel E5) as mucoadhesive polymer, 1443.68 mg of Mannitol as cryoprotectant and 50 ml of distill water showing particle size (13.23 μm), % yield (65.01), mucoadhesive strength (2709.3 dynes/cm2) and % drug content (61.3 %). Dry nasal powder with mucoadhesive polymer HPMC (Methocel E5) increase the nasal residence time and dry form of formulation improves the stability of desmopressin acetate.

Keywords: Dry nasal powder, Desmopressin acetate, Spray drying, HPMC Methocel E5.