European Journal of Pharmaceutical Sciences, Год журнала: 2025, Номер unknown, С. 107103 - 107103

Опубликована: Апрель 1, 2025

Treating a chronic condition such as breast cancer usually requires daily oral drug administration for extended periods of time, which is associated with non-adherence to the prescribed therapy that may cause disease progression. New delivery strategies long-acting injectable (LAI) implants have entered picture in order solve drawbacks while improving bioavailability, plasma levels variability or treatment compliance. This has motivated development new polymeric and biodegradable situ forming implant letrozole. formulation provided kit two syringes (one them containing letrozole Poly-Lactic Acid, other one dimethyl sulfoxide solvent reconstitution). Once reconstituted injected into muscle, diffuses tissue fluids insoluble polymer precipitates, semi-solid traps API allows sustained release. In optimize both process, traditional vitro dissolution assessment predictive modelling were conducted identify characteristics show an impact on kinetics release, provide first basis potentially establish vitro-in vivo correlation (IVIVC) pre-clinical clinical data future. Two methods (real-time accelerated) used describe profiles 15 LAI formulations differing their Critical Material Attributes (CMAs). The release best described using Weibull distribution estimating fraction dose loss during injection. rate constant (KD) was increased by 1.87 times case accelerated conditions, 30% reduced 1.34 high low viscosity formulations, respectively. work allowed quantitative characterization related responsible controlling It provides understanding will serve guide robust product quality control specifications.

Язык: Английский