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This is a In Vitro Study study.

September 28, 2025Open Access

Polymeric Nanoparticles of Loratadine Betacyclodextrin InclusionComplex: 32 Factorial Design, Optimization and In-vitro Evaluation

Key Points

Formulation LOR-BCD nanoparticles improved drug dissolution, achieving a release of approximately 61.98%.
Particle size measures at 104.2 nm and a PDI of 0.274 highlight the formulation's quality and stability.
Using a 32 factorial design, 9 formulations were evaluated, leading to the selection of the optimized LOR-BCD formulation.
The study confirms the successful formulation through validated designs, enhancing the drug's solubility and release profile.

Abstract

Loratadine (LOR) a second-generation antihistaminic exhibits low water solubility and high permeability. In the presentwork an attempt was made to formulate LOR nanoparticles to enhance dissolution rate and to prolong the release for oraldelivery. With the objective of enhancing solubility of LOR, Loratadine-Betacyclodextrin inclusion complex (LOD-BCD)was prepared by solvent evaporation method. Later based on 32 factorial design 9 LOR-BCD polymeric nano formulations(L1 to L9) was formulated by solvent displacement technique by selecting LOR:BCD and Eudragit RS 100 (ERS) asindependent variables. From in vitro studies the effect of independent variables on responses was found to agree Quadraticmodel and formulation LOR 4 was selected as optimized formulation with the particle size of 104.2nm, PDI of 0.274 andzero order in vitro drug release of 61.98±0.68%. The study concluded that LOR–BCD polymeric nanoparticles weresuccessfully formulated using a validated factorial design, exhibiting improved dissolution and sustained drug release.

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