Drug Delivery Encapsulation
report_problem Problem Statement
Controlled drug delivery microparticles and nanoparticles rely on synthetic polymers (PLGA, PLA, polycaprolactone) with organic solvent-based encapsulation processes (dichloromethane, chloroform) that leave toxic residual solvents and produce batch-to-batch variability in release kinetics. A bio-based encapsulation system using food-grade crosslinking agents could enable aqueous-phase microencapsulation with tunable release profiles and inherent biocompatibility for oral and topical drug delivery.
trending_up Market Size
$8.7B
gavel Regulatory Drivers
FDA 21 CFR 314 (drug applications) excipient requirements; ICH Q3C residual solvent guidelines (Class 2 limits); EU Directive 2001/83/EC (medicinal products); USP <467> residual solvents; FDA GRAS status for excipient ingredients; EMA Guideline on excipients in dossier for application (EMEA/CHMP/QWP/396951/2006); Japan JP XVII excipient monographs
corporate_fare Enterprise Interest
No enterprise interest recorded yet. Companies can indicate their volume and urgency to help guide research priorities.
flag Success Criteria
Achieve encapsulation efficiency ≥70% for both model drugs, mean particle size 10-100 μm with span <2.0, sustained release over 8-24 hours with <30% burst release in first hour, zero residual organic solvents per USP <467>, and Caco-2 cell viability >85%
precision_manufacturing Equipment Needed
Overhead stirrer with controllable RPM, laser diffraction particle sizer, UV-Vis spectrophotometer, USP dissolution apparatus II (paddle), SEM (or outsource), cell culture facility with Caco-2 cells, pH meter, simulated GI fluids (USP), syringe pump for dripping method, lyophilizer, gelatin, sodium alginate, model drugs
menu_book Existing References
Reference list will be published with protocols.
Protected Research Content
This section contains detailed protocols, proposed mechanisms, experiment designs, and safety information.
Already have an account? Login