Formulation development of chewable albendazole tablets with improved dissolution rate

Area of Science:

• Pharmaceutical Sciences
• Drug Formulation
• Medicinal Chemistry

Background:

• Albendazole is a broad-spectrum anthelmintic used for soil-transmitted helminths, hydatidosis, and neurocysticercosis.
• Current albendazole formulations may have limitations in dissolution rate, impacting bioavailability.

Purpose of the Study:

• To develop and optimize a chewable albendazole tablet formulation.
• To enhance the dissolution rate of albendazole for improved therapeutic efficacy.

Main Methods:

• Formulation development and optimization using wet granulation.
• Evaluation of tablet parameters including assay, dissolution, friability, hardness, weight variation, and disintegration.
• Analysis using High-Performance Thin-Layer Chromatography (HPTLC).
• Design of Experiments (DOE) software for optimization.

Main Results:

• Five out of ten formulations met all acceptable parameters.
• An optimized formulation with Sodium Lauryl Sulphate (SLS), Polyvinylpyrrolidone (PVP-K30), and Sodium Croscarmellose (CCM) was identified.
• The optimized tablet showed 99.23% assay, 91.5% dissolution in 30 min, 2-5 min disintegration, and 0.45% friability.
• The formulation demonstrated similarity (f2=62) and difference (f1=6) factors to the reference product.

Conclusions:

• A novel generic albendazole tablet with enhanced dissolution rate was successfully developed.
• The optimized formulation using wet granulation is stable and comparable to the market reference product.