Effect of Wet Granulation Technique on Preparation and Characterization of Piroxicam Inclusion Complexation

Abstract

The preparation of any pharmaceutical drug delivery system requires solubility as one of the top most requirements for active pharmaceutical ingredients. Inclusion Complexation has become popular in formulation development of water poor soluble active ingredients. In current study we have selected water poor soluble drug Piroxicam (PX) as the model active pharmaceutical ingredient. To release piroxicam drug from solid dosage forms such as tablets and capsules it requires improvement in its solubility prior to preparation of final dosage form. For large scale production and commercialization process solubility enhancement procedures must be simple, economical and reproducible at different batch size. Objective of this study is to study effect of wet granulation on the complexation of beta-cyclodextrin with Piroxicam using Fourier transform infrared spectroscopy (FT-IR) and X-ray Diffraction and Scanning Electron Microscopic analysis. Inclusion Complex was prepared using beta-Cyclodextrin (BCD) by wet granulation technique. Molecular dispersion prepared was characterized by FTIR, XRD, Phase Solubility and Dissolution Studies. The result confirmed with SEM, XRD and FTIR for formation of Complexation of PX and BCD and increase in solubility was noticed with increase in concentration of complexing agent BCD. Inclusion complexation is very useful and effective strategy to adopt for further improve the solubility along with wet granulation technique. The approach to enhance the solubility becomes more practical and reproducible in industry and commercialization due to well established machines and production procedures for wet granulation technique to form inclusion complex for water poor soluble drugs.