Design and development of Pregabalin Tablets by preparing its Microspheres with Spray Drying technique

The objective of the current study was to formulate tablets incorporating microspheres containing the drug Pregabalin, using poly (lactic-co-glycolic acid) (PLGA) as the polymer matrix. Microspheres were developed using a factorial design approach with the aid of Design-Expert 12 software (Stat-Ease Inc., USA) to analyze the effects and interactions between independent and dependent variables, ultimately identifying the optimal formulation. A spray drying technique was employed for the preparation of these microspheres. Various characterization parameters were assessed, including zeta potential, particle size, FTIR spectroscopy, scanning electron microscopy (SEM), drug loading, encapsulation efficiency, and in vitro drug release. The optimized formulation, designated as batch F3, exhibited an average particle size of 2600.7 nm. It demonstrated a drug release of 93.36% at the 12-hour mark and an encapsulation efficiency of 35.00%. The reduced particle size of 2600.7 nm contributed to effective drug release, making the formulation both efficient and promising. Tablets were then compressed using granules derived from batch F3. Pre-compression evaluations such as flow properties, and post-compression parameters including weight variation, thickness, hardness, friability, drug content, and release profile were systematically analyzed. Both stability and in vitro studies were conducted on the final tablet formulation, which proved to be stable, patient-friendly, easily administrable, and pharmaceutically elegant.