Continuous Feeding and Blending Demonstration with Co-Processed Drug Substance.

Area of Science:

• Pharmaceutical Technology
• Materials Science
• Chemical Engineering

Background:

• Continuous direct compression (CDC) demands powders with excellent flow and compression characteristics.
• Traditional particle engineering methods often fail to impart desired properties to active pharmaceutical ingredients (APIs).
• Co-processing APIs with excipients offers a viable strategy to enhance powder attributes.

Purpose of the Study:

• To evaluate the performance of a co-processed active pharmaceutical ingredient (API) in a continuous feeding and blending process.
• To assess the feasibility of using co-processed theophylline for tablet manufacturing under continuous processing conditions.
• To determine the impact of varying drug loads, flow rates, and blender speeds on process performance.

Main Methods:

• Co-processed theophylline was prepared by precipitating a polymer onto crystalline theophylline particles, forming spherical agglomerates.
• The co-processed API was evaluated in a GEA ConsiGma® Continuous Dosing and Blending Unit (CDB1).
• Experiments were conducted across a range of drug loads (1-25% w/w), flow rates (15-40 kg/h), and blender speeds (220-400 rpm).

Main Results:

• The co-processed API demonstrated successful feeding via a loss-in-weight feeder.
• Effective blending with excipients was achieved in a high-shear blender.
• Tablets produced exhibited acceptable content uniformity across all tested drug loads (1-25% w/w).

Conclusions:

• Co-processing is a highly effective method for enhancing the powder properties of challenging APIs.
• This approach facilitates the successful implementation of continuous manufacturing processes for a wider range of pharmaceutical ingredients.
• The study validates the use of co-processed APIs for producing uniformly blended and compressed solid dosage forms.