Smart Long Acting Injectable Drug Delivery System (SLID): Fabrication, Optimization and Functionality Determination

Patient non-adherence is the major concern of the current era. The purpose of this research was to create a tailored smart long acting injectable drug delivery system (SLID) using green materials.

Glipizide (GPZ) was utilized as a model drug being BCS Class II having poor aqueous solubility and half-life of 2–5 h which needs frequent administration. Hence, to reduce the need for frequent administration SLID using Polycaprolactone (PCL) and poly (lactic-co-glycolic acid) 50:50 (PLGA) as release modifier was formulated. PCL was not able to form implants, while PLGA readily formed implants with a drawback of burst release. To mitigate fast release, SLID were formulated with PLGA (50:50), DMSO, Sesame Oil (SO), span 80 (S-80), and tween 80 (T-80), ensuring sustained GPZ release. QbD was implemented to develop SLID. BBD was amalgamated for the optimization of SLID and design SLID were evaluated for its physicochemical characterization.

DSC and FTIR confirmed no GPZ-excipients interactions. QbD improved product quality and mitigated risks through FMEA. The amount of PLGA, S80 and T80 were considered critical material attributes (CMAs) from FMEA. Multivariate tools were identified the high significance of CMAs on gelling time, particle size and % GPZ release. The optimized SLID shown desirable physicochemical parameters having PLGA (125 mg), S80 (75%) and T80 (25%). SLID was able to release GPZ for 30 days. Sterility and stability tests confirmed formulation integrity.

The novel long acting formulation improved the patient convenience by reducing the dose frequency. The SLID shown excellent control on GPZ release. The amount of PLGA, S80 and T80 were considered significant for designing SLID. The SLID will be breakthrough in the treatment of life time chronic diseases and upgraded at industrial scale.