Formulation development, optimization, and evaluation of lansoprazole loaded nanosuspension
Abstract
Objective: To address issues with drug release, manufacturing, and drug product stability, the primary objective of this study was to optimize the solubility of poorly soluble lansoprazole medication by using an appropriate nanosuspension formulation.
Methods: The freeze-drying (nanopure) method was used to create lansoprazole nanosuspensions. The formulation and process variables affecting the properties of nanosuspensions (mannitol concentration, drug concentration, and PVP-K30 concentration) were optimized. Particle size, shape, zeta potential, drug content, stability study, and in vitro drug release study were performed on the nanosuspensions.
Results: Out of different batches of nanosuspension, batch F4 displayed the most optimizing parameters, i.e., drug content 97±1.2%, average particle size 125.5 nm, polydispersity index 0.361, and zeta potential-22.7 mV. In comparison to other formulations, the PVP-K30 polymer in F4 demonstrated an effective cumulative drug release of 120 min. In stability studies, optimized nanosuspension displayed favorable results and demonstrated significant stability for the said period of time.
Conclusion: The most promising drug release profile was shown by the optimized (F4) nanosuspension, which also demonstrated increased lansoprazole solubility. We have concluded from the current study that nanosuspension can serve as a better formulation for lansoprazole delivery.
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