Optimisation of microstructured biodegradable finasteride formulation for depot parenteral application.

Area of Science:

• Biomaterials Science
• Pharmaceutical Technology
• Drug Delivery Systems

Background:

• Benign prostatic hyperplasia (BPH) is a common condition requiring effective long-term treatment.
• Current BPH treatments, like oral finasteride (FIN), can have limitations in sustained drug delivery.
• Biodegradable polymers offer potential for controlled drug release applications.

Purpose of the Study:

• To develop and optimize injectable finasteride (FIN) microspheres using biodegradable polymers for BPH treatment.
• To evaluate the in vitro and in vivo performance of these FIN microspheres.
• To compare the pharmacokinetic profile of injectable FIN microspheres with oral FIN suspension.

Main Methods:

• FIN microspheres were prepared using an emulsion-solvent evaporation/extraction technique.
• Box-Behnken experimental design was employed for process optimization.
• In vitro drug release studies and in vivo pharmacokinetic studies in albino rabbits were conducted.

Main Results:

• Optimized FIN microspheres demonstrated a sustained release profile with reduced initial burst release.
• Cumulative FIN release after 25 days varied between 27.83% and 73.18%.
• In vivo studies confirmed sustained release and minimal burst release in rabbits.

Conclusions:

• Injectable biodegradable FIN microspheres are a promising formulation for sustained BPH treatment.
• The optimized formulation offers an improved drug delivery profile compared to oral administration.
• This approach holds potential for enhanced patient compliance and therapeutic efficacy.