Development of impact resistant immediate release amorphous solid dispersion via hot-melt extrusion and injection molding

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Current immediate release amorphous solid dispersion (ASD) tablet manufacturing involves multiple complex steps, increasing production time and cost.
• Hot melt extrusion (HME) is a key step, but subsequent processing limits efficiency.

Purpose of the Study:

• To explore a more efficient method for producing immediate release ASD tablets by combining HME with injection molding (IM).
• To evaluate the quality and stability of ASD tablets produced via HME-IM using moxidectin as a model drug.

Main Methods:

• Developed IR-ASD tablets using HME coupled with IM.
• Utilized moxidectin, a BCS class II drug, for formulation.
• Characterized tablets for content uniformity, friability, dissolution, and amorphous state stability using PXRD.
• Produced custom tablet geometries using stereolithography-based molds.

Main Results:

• HME-IM tablets met USP quality standards for content uniformity (±2% of label claim) and dissolution (>90% API release in 1 hour).
• ASD within the tablets exhibited excellent stability at room temperature.
• The resulting tablets were found to be porous and exceptionally tough.
• Demonstrated the capability to produce tablets in various geometries.

Conclusions:

• The HME-IM process is a viable and efficient alternative for manufacturing IR-ASD tablets.
• HME-IM tablets possess desirable properties, including excellent drug stability and mechanical strength.
• These tablets are promising candidates for abuse-deterrent formulations, particularly for controlled substances.