Preparation and Characterization of Pitavastatin Calcium Loaded Biodegradable Porous Starch as Carrier Platform for Drug Delivery

Abstract

Introduction: Poor solubility and low oral bioavailability are major obstacles to the development of efficient drug delivery approaches. Numerous chemical entities fall into the biopharmaceutics classification system II (BCS II) class, categorized by low solubility and high permeability. Consequently, finding alternative solutions for improving drug efficacy becomes crucial. Hence, this study aims to formulate biodegradable porous acetostarch (BPSa) and biodegradable porous ethostarch (BPSe) carriers to augment the solubility profile of the poorly soluble drug candidate pitavastatin calcium (PTC). Method: The biodegradable carriers (BPSa and BPSe) were prepared using the solvent exchange method. Then the PTC was loaded into the prepared carriers (PTC@BPSa and PTC@BPSe) using the passive drug loading procedure. Moreover, the obtained drug-carrier conjugates were evaluated using physiochemical evaluation techniques such as Fourier transform infrared spectroscopy (FTIR), x-ray powder diffraction (XRPD), and differential scanning calorimetry (DSC). Additionally, the surface morphology and drug release characteristics are determined. Result: The experimental findings exhibited high drug content with 75.45% and 71.81% for PTC@BPSa and PTC@BPSe, respectively. The SEM analysis of the prepared conjugates demonstrates asymmetrical morphology with cracks between particles, indicating porous nature of the carriers. As a result of this, PTC@BPSa and PTC@BPSe exhibited modified drug release patterns, with cumulative releases of 78.63% and 78.50%, respectively. Conclusion: The biodegradable porous carriers (BPSa and BPSe) effectively improve the dissolution pattern of PTC, by addressing the challenges associated with poor solubility. This study offers valuable insights into the potential of these biodegradable porous carriers as effective drug delivery platforms for increasing the efficacy of limited soluble medications.