International Journal of Drug Delivery Technology
Volume 15, Issue 3

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

Priyanka E Doke1, A Vijayalakshmi1*, Om M Bagade2 

1School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies (VISTAS), Pallavaram, Chennai-600117, Tamil Nadu, India

2Department of Pharmaceutics, Vishwakarma University School of Pharmacy, Pune-48, Maharashtra, India 

Received: 9th May, 2025; Revised: 2nd Aug, 2025; Accepted: 14th Aug, 2025; Available Online: 25th Sep, 2025 

ABSTRACT

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 a predetermined and anticipated fashion. Irbesartan is a medication with limitations such as poor bioavailability due to a high first-pass effect, poor water solubility/dissolution rate, low stability, etc. An improvement in the interaction or no interaction was observed between the drug and the excipients, as shown in an IR spectrum and standard curve of the pure drug formulation and placebo formulation. Microsponges of various ratios were developed via the solvent method, and the volume of polymer (ethyl cellulose) (X1) and crosslinker (dichloromethane) (X2) were kept different, along with the stirring 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 protein is taken as a stabilizer an optimum batch among eight formulations was determined through 23 factorial design and tested on bulk density, tapped density, angle of repose, compressibility Index, Carr’s index, dissolution studies, Entrapment efficiency, 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 favourable alternative method of enhancing the dissolution rate of Irbesartan.

Keywords- Particle size, Entrapment Efficiency, whey protein, cumulative drug release, factorial design, antihypertension.

How to cite this article: Priyanka E Doke, A Vijayalakshmi, Om M Bagade. Development and Statistical Optimization of Food Protein-Stabilised Irbesartan Microsponges: An Effect of Lyophilisation. International Journal of Drug Delivery Technology. 2025;15(3):975-84. doi: 10.25258/ijddt.15.3.10

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