Programmable delayed-release container system (PDRCS) for chronotherapeutic delivery: application in personalized...

Area of Science:

• Pharmaceutical Sciences
• Biomaterials Engineering
• Drug Delivery Systems

Background:

• Current oral drug delivery faces challenges with patient variability and technical limitations.
• Chronopharmaceutical systems require precise, time-specific drug release for optimal therapeutic outcomes.
• Existing technologies struggle with pH-dependent release and coating reproducibility.

Purpose of the Study:

• To develop a novel 3D-printed Programmable Delayed-Release Container System (PDRCS).
• To achieve pH-independent, time-specific pulsatile drug delivery.
• To demonstrate chronotherapeutic targeting for primary adrenal insufficiency using hydrocortisone.

Main Methods:

• Utilized fused deposition modeling (FDM) for 3D printing an ethyl cellulose shell.
• Designed a layered core with a swelling hydrogel, barrier, and immediate-release drug tablet.
• Engineered perforations to control water ingress and trigger shell rupture for drug release.

Main Results:

• Achieved variable lag times (12-28 h) by adjusting perforation diameters.
• Demonstrated pH-independent drug release profiles in vitro.
• Validated formulation stability and processing integrity through solid-state characterization.

Conclusions:

• The PDRCS offers a mechanically governed, rupture-based platform for customizable, time-controlled oral drug administration.
• This technology addresses limitations of current delayed-release systems, enabling personalized chronotherapy.
• The system shows promise for improving therapeutic efficacy and minimizing side effects through synchronized drug release.