D.O.S.E.
Delivery & Optimized Sustained Encapsulation
Drug Delivery Encapsulation
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.
Market Size
$8.7B
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
Enterprise Interest
No enterprise interest recorded yet. Companies can indicate their volume and urgency to help guide research priorities.
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%
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
Existing References
Reference list will be published with protocols.
Protected Research Content
This section contains detailed protocols, proposed mechanisms, experiment designs, and safety information.
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