Volume : 13, Issue : 10, October – 2026

Title:

FORMULATION AND EVALUATION OF SOLID LIPID
FORMULATION AND IN VITRO EVALUATION OF ASENAPINE MALEATE USING NANOPARTICLES

Authors :

Pravat Ranjan Guru, Kumar Tanmaya Sahoo, Sayed Tashkilur Rashedin, Satya Ranjan Dalai, Rajat Kumar Kar

Abstract :

Asenapine Maleate is an atypical antipsychotic drug used in the management of schizophrenia and bipolar disorder. However, its therapeutic effectiveness is limited by extensive first-pass metabolism and poor oral bioavailability, necessitating the development of an advanced drug delivery system capable of improving drug release and therapeutic efficacy. The present study was undertaken to formulate and evaluate Asenapine Maleate-loaded nanoparticles using different polymers at varying drug-to-polymer ratios to achieve a sustained drug release profile.
Nanoparticle formulations (F1–F9) were prepared using suitable polymers in different concentrations and ratios. Prior to formulation, compatibility studies between the drug and excipients were carried out and confirmed the absence of significant drug–excipient interactions. The prepared formulations were evaluated for pre-compression parameters, including angle of repose, bulk density, tapped density, Carr’s index, and Hausner’s ratio. The results indicated good flowability and compressibility, with all values falling within the acceptable limits specified by the Indian Pharmacopoeia (IP), ensuring suitability for further processing.
The formulated nanoparticles were subjected to comprehensive post-formulation evaluation, including percentage yield, particle size, zeta potential, drug content, entrapment efficiency, surface morphology, and in vitro drug release studies. All formulations exhibited satisfactory physicochemical properties, with the evaluated parameters remaining within acceptable IP limits. The type and concentration of polymers had a marked influence on nanoparticle characteristics and drug release behaviour. An increase in polymer concentration resulted in enhanced entrapment efficiency and prolonged drug release due to the formation of a denser polymeric matrix.
Among all the formulations, F6 was identified as the optimized formulation because it exhibited the most desirable sustained-release profile. The optimized formulation achieved a cumulative drug release of 99.48% over 12 hours, indicating effective control of drug release while maintaining formulation stability and acceptable pharmaceutical characteristics. The release profile suggested that the selected polymer combination and optimized drug-to-polymer ratio were suitable for sustaining the release of Asenapine Maleate over an extended period.
Keywords: Asenapine Maleate, Nanoparticles

Cite This Article:

Please cite this article in press Pravat Ranjan Guru et al., Formulation And Evaluation Of Solid Lipid Formulation And In Vitro Evaluation Of Asenapine Maleate Using Nanoparticles.,. Indo Am. J. P. Sci, 2026; 13(10).

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