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Background <p>An important risk factor for cardiovascular illnesses, hyperlipidaemia is defined by increased lipid levels and frequently need long-term medication. Because of its limited water solubility and substantial first-pass metabolism, rosuvastatin calcium, a powerful lipid-lowering medication, has a low oral bioavailability (~ 20%). </p> Objective <p>In order to increase the bioavailability and sustained release of rosuvastatin calcium, this study set out to create and assess a liposomal mucoadhesive buccal film. </p> Methods and Results <p> Thin film hydration was used to make the liposomes, and Box-Behnken Design (BBD) was used to optimize them. The sonication time, cholesterol content, and lipid concentration were all considered independent variables. The improved formulation showed an entrapment effectiveness of 84.42%, a zeta potential of -24.73 mV, and a vesicle size of 164.3&#xa0;nm. Through solvent casting, the liposomes were integrated into mucoadhesive buccal films using HPMC K4M and HPMC E5. The films were assessed for their physical characteristics, drug content, mucoadhesive strength, swelling index, and in vitro and ex vivo drug release. Superior properties, such as 80.23% in vitro drug release and 80.96% ex vivo permeation over 24&#xa0;h, were shown by formulation F1 (containing HPMC K4M), which followed Higuchi kinetics. Under expedited settings, stability experiments verified constant medication release and film integrity after three months. </p> Conclusion <p>The liposomal buccal film exhibited sustained In vitro drug release, indicating its potential as a patient-friendly formulation approach for the effective delivery of rosuvastatin calcium in hyperlipidaemia.</p>

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Formulation and Evaluation of Rosuvastatin Calcium Liposomal Mucoadhesive Buccal Film

  • 期刊论文

  • 发表日期：

    2025年12月27日

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  • Vinayak Halasagi,
  • Panchaxari Dandagi,
  • M Anusha

摘要

Background

An important risk factor for cardiovascular illnesses, hyperlipidaemia is defined by increased lipid levels and frequently need long-term medication. Because of its limited water solubility and substantial first-pass metabolism, rosuvastatin calcium, a powerful lipid-lowering medication, has a low oral bioavailability (~ 20%).

Objective

In order to increase the bioavailability and sustained release of rosuvastatin calcium, this study set out to create and assess a liposomal mucoadhesive buccal film.

Methods and Results

Thin film hydration was used to make the liposomes, and Box-Behnken Design (BBD) was used to optimize them. The sonication time, cholesterol content, and lipid concentration were all considered independent variables. The improved formulation showed an entrapment effectiveness of 84.42%, a zeta potential of -24.73 mV, and a vesicle size of 164.3 nm. Through solvent casting, the liposomes were integrated into mucoadhesive buccal films using HPMC K4M and HPMC E5. The films were assessed for their physical characteristics, drug content, mucoadhesive strength, swelling index, and in vitro and ex vivo drug release. Superior properties, such as 80.23% in vitro drug release and 80.96% ex vivo permeation over 24 h, were shown by formulation F1 (containing HPMC K4M), which followed Higuchi kinetics. Under expedited settings, stability experiments verified constant medication release and film integrity after three months.

Conclusion

The liposomal buccal film exhibited sustained In vitro drug release, indicating its potential as a patient-friendly formulation approach for the effective delivery of rosuvastatin calcium in hyperlipidaemia.