Assessment of a Semi-solid Extrusion Based Compounding System Solution for Personalized Ondansetron Dosage Forms...

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems
• Analytical Chemistry

Background:

• Personalized pediatric medicine requires adaptable drug formulations.
• Semi-solid extrusion (SSE) offers a promising 3D printing approach for customized medications.
• Ondansetron is a critical medication for managing nausea and vomiting in children.

Purpose of the Study:

• To assess an automated SSE-based Compounding System Solution (CSS) for manufacturing customized Ondansetron tablets.
• To develop and validate a non-destructive quality control method using Raman Spectroscopy (RS) and partial least square (PLS) analysis for these tablets.

Main Methods:

• Manufacturing of 400 mg Ondansetron tablets with varying dosages (2-10 mg) and sizes (200-500 mg) using CSS technology.
• Testing tablets according to European and US Pharmacopoeia standards, including HPLC analysis.
• Developing and validating a Raman Spectroscopy (RS)-based partial least square (PLS) model for predicting active pharmaceutical ingredient (API) content.

Main Results:

• The CSS technology produced tablets with high mass uniformity (99.2% for varying drug content, 98.8% for different sizes).
• Tablets demonstrated excellent stability over six months and met in-vitro dissolution standards (over 85% drug release in 30 min).
• The RS-based PLS model accurately predicted API content with high correlation to HPLC (R²Pred = 0.96).

Conclusions:

• The automated SSE-based CSS technology is effective for producing high-quality, personalized Ondansetron tablets.
• Pharmacopoeia tests, HPLC, and the developed RS-based PLS model validate the quality and feasibility of this approach.
• This study highlights the potential of SSE and RS for individualized pediatric drug formulations and quality control.