Abstract
The physicochemical characteristics of beta-glycerophosphate-crosslinked chitosan hydrogels were investigated upon long-term storage at ambient, accelerated, and refrigerated conditions and compared to unmodified chitosan formulations. Additionally, the impact of chitosan modification on the ex vivo mucoadhesive performance in contact with porcine vaginal mucosa and on the drug release profile from hydrogels was evaluated. Viscosity and mechanical properties of formulations with unmodified chitosan decreased significantly upon storage regardless of tested conditions as a result of hydrolytic depolymerization. Introduction of ion crosslinker exerted stabilizing effect on physicochemical performance of chitosan hydrogels but only upon storage at refrigerated conditions. Beta-glycerophosphate-modified chitosan formulations preserved organoleptic, rheological behavior, and hydrogel structure up to 3-month storage at 4 ± 2°C. Viscosity variations upon storage influenced markedly mucoadhesive properties and drug release rate from hydrogels.
Highlights
Application of multifunctional polymers as effective excipients in drug delivery systems is a current and attractive concept in pharmaceutical technology [1]
Stability evaluation provides the critical characteristics of the drug dosage form in terms of its physicochemical or biopharmaceutical properties, and it is crucial for the full assessment of product quality during preformulation analysis
The effect of ion crosslinking on CS hydrogel physicochemical characteristics upon storage at 25°C/60% relative humidity (RH) and 40°C/ 75% RH was studied
Summary
Application of multifunctional polymers as effective excipients in drug delivery systems is a current and attractive concept in pharmaceutical technology [1]. With regard to capability of swelling and creating hydrogel matrix, CS may be useful in the development of modified release delivery systems [15, 16]. Particular attention has been directed to the use of CS as an antimicrobial adjunctive [17, 18] This capability of increasing the pharmacological action of an antimicrobial agent provides the opportunity for combination therapy in which CS acts as the effective excipient and simultaneously as an active part of the treatment
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