Novel delivery device for monolithical solid oral dosage forms for personalized medicine

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Materials Science

Background:

• Need for personalized dosing due to variable drug metabolism and narrow therapeutic indexes.
• Existing oral dosage forms lack flexibility for patient-specific dose adjustments.
• Development of novel drug delivery systems is crucial for improving therapeutic outcomes.

Purpose of the Study:

• To develop a novel device and solid oral dosage form for individualized carvedilol dosing.
• To create a system capable of delivering precise, individual doses of monolithic drug carriers.
• To ensure the developed dosage forms are suitable for practical clinical application.

Main Methods:

• Utilized a twin-screw extruder for manufacturing cylindrical solid dosage forms with carvedilol.
• Designed and constructed a novel device with a cutting mechanism for dose adjustment.
• Assessed divided doses for mass variation, cutting properties, and in vitro drug dissolution.
• Evaluated the forces required for dose division against pharmacopoeial standards.

Main Results:

• Successfully extruded cylindrical drug rods using various formulations.
• The novel device enabled precise slicing of the dosage forms.
• Divided doses demonstrated minimal mass variation, meeting pharmacopoeial specifications.
• Carvedilol exhibited sustained release over 7 to 16 hours from the developed formulations.

Conclusions:

• A novel system comprising a device and a cylindrical dosage form was successfully developed.
• This system facilitates patient-specific dosing of carvedilol through precise slicing.
• The developed monolithic solid dosage forms offer sustained drug release for oral administration.