Preparation and In-vitro Evaluation of Pemigatinib Nanosponges Tablets by Box-Behnken Design

Abstract

Objective: Pemigatinib depicted antitumor action in complex and metastatic tumors and it’s a hydrophobic compound having strong pH-reliant solubility. The current work was designed to improve oral solubility of pemigatinib by incorporating into nanosponges (NSs). Methods: Box-Behnken Design optimized the independent parameters of polystyrene NSs formation. Polystyrene NSs were prepared by ultrasound-assisted method using diaryl carbonate as cross-linking agent, which were later characterized and formulated into tablets. Tablets got screened for the respective quality attributes. Results: A number of tests were carried out from the test runs generated by a three-factor, three-level BBD. The range of mean PS was 153 to 316 nm, the range for encapsulation efficiency% was 68.2 to 91.4%, and the value for PDI was 0.273 to 0.445. ZP for the finalized formula was determined to be -29.1 mV. The drug and excipients were compatible as confirmed by FTIR studies. SEM study confirmed that pemigatinib has successfully entrapped in interior of the polymer. In-vitro examination of the pemigatinib loaded NSs tablets were compared with a marked product and satisfactory results were obtained (98.74 ± 2.65% vs. 93.73 ± 1.06%). The prepared formulations were stable during 6 month stability study period. Conclusion: The study findings for pemigatinib NS tablets demonstrated quick dissolution since the changed solubility qualities of the drug, satisfying the intended objective of increased absorption. Formulated pemigatinib-loaded NSs can be beneficial in the treatment of cancers