Solubility Enhancement of Pioglitazone HCL by Spray Drying Technique and Formulation of Oral Dispersible Tablets

Pioglitazone hydrochloride, a poorly water-soluble antidiabetic agent, poses challenges for oral bioavailability and patient compliance. This study aimed to develop and evaluate orally dispersible tablets (ODTs) of Pioglitazone HCl with enhanced solubility and rapid drug release. Comprehensive pre-formulation analyses, including organoleptic evaluation, solubility profiling, melting point determination, UV spectral analysis, and FTIR-based drug–excipient compatibility studies, confirmed the physicochemical stability and suitability of the drug for ODT formulation. Two ODT formulations were prepared: F1 containing the pure drug and F2 utilizing spray-dried Pioglitazone HCl. Granules were characterized for particle size, flow properties, and compressibility, followed by tablet compression and evaluation of weight uniformity, hardness, friability, disintegration time, drug content, uniformity of dispersion, and in vitro dissolution. F2 exhibited rapid disintegration (30 seconds), uniform dispersion, and near-complete drug release (~105% within 45 minutes), indicating successful solubility enhancement via spray drying. F1 demonstrated acceptable tablet characteristics. Granulation and compression yield further highlighted the superiority of the F2 formulation in processing efficiency. These findings establish spray drying as an effective strategy for enhancing the solubility and dissolution profile of Pioglitazone HCl in ODTs. The optimized formulation offers a fast-dissolving, patient-friendly dosage form with improved therapeutic potential, demonstrating a promising approach for the oral delivery of poorly soluble drugs.