Development And Evaluation Of Nanosponges Based Controlled Release Tapentadol Tablets By Box-Behnken Design

Abstract

Objective: The goal of this work was to create a tapentadol-controlled release formulation using cyclodextrin-based nanosponges as a carrier system.
Methods: Based on the early trials, a three-factor, three-level Box-Behnken design was used to investigate the influence of each independent variable on the dependent variables. Five different forms of cyclodextrin nanosponges (NS1-NS5) were created. The freeze-drying process was used to load tapentadol into nanosponges. The nanosponges were analysed, made into tablets, and tested.
Results: The particle diameters of tapentadol-loaded nanosponges range from 51.38 to 154.56 nm, with encapsulation efficiency ranging from 51.12 to 92.56 percent and drug release percentage at 6 hours ranging from 51.62 to 82.34 percent. Tapentadol interaction with nanosponges was validated by FTIR, DSC, and XRPD investigations. The spherical shape of drug-loaded nanosponges was revealed by TEM imaging. The drug may be maintained and released gradually over time by the nanosponge structure.The nanosponges were formulated in to tablets and evaluated for weight variation, hardness, friability and disintegration studies and obtained satisfactory results. In-vitro release of drug from tablet showed controlled release behavior for a period of 12 h. The maximum quantity of the drug was released within 2 hours from the marketed tablet, while the percentage of tapentadol released from nanosponges tablets after 12 hours was 86.58 percent and finally stability studies indicated no significant changes within 6months.
Conclusion: Cyclodextrin-based nanosponges tablet formulation demonstrated enhanced complexing ability, stability as well as higher solubility of poorly soluble Tapentadol for regulated drug administration, potentially reducing dose frequency.