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Dexamethasone Loaded Liposomes by Thin-Film Hydration and Microfluidic Procedures: Formulation Challenges.

ABSTRACT: Liposomes have been one of the most exploited drug delivery systems in recent decades. However, their large-scale production with low batch-to-batch differences is a challenge for industry, which ultimately delays the clinical translation of new products. We have investigated the effects of formulation parameters on the colloidal and biopharmaceutical properties of liposomes generated with a thin-film hydration approach and microfluidic procedure. Dexamethasone hemisuccinate was remotely loaded into liposomes using a calcium acetate gradient. The liposomes produced by microfluidic techniques showed a unilamellar structure, while the liposomes produced by thin-film hydration were multilamellar. Under the same remote loading conditions, a higher loading capacity and efficiency were observed for the liposomes obtained by microfluidics, with low batch-to-batch differences. Both formulations released the drug for almost one month with the liposomes prepared by microfluidics showing a slightly higher drug release in the first two days. This behavior was ascribed to the different structure of the two liposome formulations. In vitro studies showed that both formulations are non-toxic, associate to human Adult Retinal Pigment Epithelial cell line-19 (ARPE-19) cells, and efficiently reduce inflammation, with the liposomes obtained by the microfluidic technique slightly outperforming. The results demonstrated that the microfluidic technique offers advantages to generate liposomal formulations for drug-controlled release with an enhanced biopharmaceutical profile and with scalability.

SUBMITTER: Al-Amin MD

PROVIDER: S-EPMC7084920 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: A dramatic growth in the prevalence of chronic wounds due to diabetes has represented serious global health care and economic issues. Hence, there is an imperative need to develop an effective and affordable wound dressing for chronic wounds. Recent research has featured the potential of bioactive compound gallic acid (GA) in the context of wound recovery due to their safety and comparatively low cost. However, there is a scarcity of research that focuses on formulating GA into a stable and functional hydrocolloid film dressing. Thus, this present study aimed to formulate and characterise GA-loaded alginate-based hydrocolloid film dressing which is potentially used as low to medium suppurating chronic wound treatment. Methods: The hydrocolloid composite films were pre-formulated by blending sodium alginate (SA) with different combinations of polymers. The hydrocolloid films were developed using solvent-casting method and the most satisfactory film formulation was further incorporated with various GA concentrations (0.1%, 0.5% and 1%). The drug-loaded films were then characterised for their physicochemical properties to assess their potential use as drug delivery systems for chronic wound treatment. Results: In the pre-formulation studies, sodium alginate-pectin (SA-PC) based hydrocolloid film was found to be the most satisfactory, for being homogenous and retaining smoothness on surface along with satisfactory film flexibility. The SA-PC film was chosen for further loading with GA in 0.1%, 0.5% and 1%. The characterisation studies revealed that all GA-loaded films possess superior wound dressing properties of acidic pH range (3.97-4.04), moderate viscosity (1600 mPa-s-3198 mPa-s), optimal moisture vapor transmission rate (1195 g/m 2/day, 1237g/m 2/day and 1112 g/m 2/day), slower moisture absorption and film expansion rate and no chemical interaction between the GA and polymers under FTIR analysis. Conclusion: An SA-PC hydrocolloid film incorporated with gallic acid as a potentially applicable wound dressing for low to medium suppurating chronic wounds was successfully developed.

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Dexamethasone Loaded Liposomes by Thin-Film Hydration and Microfluidic Procedures: Formulation Challenges.

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