Development and Statistical Optimization of Food Protein-Stabilised Irbesartan Microsponges: An Effect of Lyophilisation

Microsponges are porous microscopic particles that are rapidly becoming an emerging drug delivery route. They are small,rounded grains and have a sponge-like appearance and a very large porous surface that can release the drug in apredetermined and anticipated fashion. Irbesartan is a medication with limitations such as poor bioavailability due to a highfirst-pass effect, poor water solubility/dissolution rate, low stability, etc. An improvement in the interaction or nointeraction was observed between the drug and the excipients, as shown in an IR spectrum and standard curve of the puredrug formulation and placebo formulation. Microsponges of various ratios were developed via the solvent method, and thevolume of polymer (ethyl cellulose) (X1) and crosslinker (dichloromethane) (X2) were kept different, along with thestirring speed (X3) being retained in different groups. The factors were selected as independent variables, and %Entrapment efficiency, Particle size, and % cumulative drug release were chosen as dependent variables. The whey proteinis taken as a stabilizer an optimum batch among eight formulations was determined through 23 factorial design and testedon bulk density, tapped density, angle of repose, compressibility Index, Carr’s index, dissolution studies, Entrapmentefficiency, production yield, compatibility studies, powder x-ray diffraction (P-XRD), Differential scanning colorimetric(DSC) and particle size analysis. Therefore, microsponge formulation with a wide range of polymers is a favourablealternative method of enhancing the dissolution rate of Irbesartan.