A Comparison Between Lab-Scale and Hot-Melt-Extruder-Based Anti-inflammatory Ointment Manufacturing

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Hot-melt extrusion (HME) is widely used for continuous manufacturing of solid dosage forms, including amorphous solid dispersions.
• Its application in the continuous manufacturing of semi-solid topical formulations remains largely unexplored.
• Developing continuous manufacturing processes for semi-solids can enhance efficiency and product quality.

Purpose of the Study:

• To explore the applicability of hot-melt extrusion (HME) for the continuous manufacturing of topical semi-solid formulations.
• To assess HME's suitability for producing ointments containing two active pharmaceutical ingredients (APIs): triamcinolone acetonide and lidocaine hydrochloride.

Main Methods:

• Formulations were designed using quality target product profile (QTPP) and critical quality attributes (CQAs) with design of experiments (DoE).
• Selected ointment formulations were manufactured using both a lab-scale fusion method and HME.
• Characterization included work of adhesion, stiffness, apparent pH, content uniformity, DSC, stability, and in vitro drug release.

Main Results:

• Selected formulations manufactured by HME met the predefined design characteristics.
• HME demonstrated successful continuous manufacturing of semi-solid formulations with two APIs.
• Characterization studies confirmed the quality and performance of HME-produced semi-solids.

Conclusions:

• Hot-melt extrusion is applicable for the continuous manufacturing of topical semi-solid formulations.
• HME offers a promising alternative for producing complex semi-solid dosage forms with multiple APIs.
• This study validates HME as a potential technology for advancing continuous manufacturing in semi-solid dosage forms.