Liquid API feeding in pharmaceutical HME: Novel options in solid dosage manufacturing

Area of Science:

• Pharmaceutical Science
• Chemical Engineering
• Materials Science

Background:

• Hot melt extrusion (HME) is a key pharmaceutical manufacturing process.
• Conventional powder feeding methods in HME lack flexibility and can cause API inhomogeneity, especially for low-dose formulations.
• Continuous manufacturing demands agile and precise feeding strategies.

Purpose of the Study:

• To demonstrate the universal applicability of liquid side feeding in pharmaceutical HME.
• To evaluate the impact of liquid feeding on API content uniformity, residual moisture, and solid-state.
• To establish liquid side feeding as a flexible and agile alternative for continuous pharmaceutical manufacturing.

Main Methods:

• Various active pharmaceutical ingredients (APIs) were suspended or dissolved in water.
• These liquid formulations (suspensions, solutions) were side-fed into the anterior part of the extruder.
• Extrudates were analyzed for API content, residual moisture, and API solid-state.

Main Results:

• Uniform API content was achieved in extrudates across different liquid feeding strategies (suspension, various solution concentrations).
• Residual moisture content in extrudates was sufficiently low for further processing.
• The solid-state of the embedded API remained unaffected, ensuring drug product quality.

Conclusions:

• Liquid side feeding is a versatile and effective method for incorporating APIs into polymers via HME.
• This technique enhances process control, enabling accurate and agile API delivery for continuous manufacturing.
• It supports the development of personalized medicines and integrates drug substance and drug product manufacturing.