A microcrystalline cellulose based drug-composite formulation strategy for developing low dose drug tablets

Area of Science:

• Pharmaceutical Manufacturing
• Drug Delivery Systems
• Materials Science

Background:

• Ensuring active pharmaceutical ingredient (API) uniformity is critical for low dose tablet manufacturing.
• Traditional methods for achieving content uniformity can be complex and less robust.
• Potent APIs require specialized formulation strategies to ensure safety and efficacy.

Purpose of the Study:

• To introduce and evaluate a novel Binder Enhanced API-Microcrystalline Cellulose (BEAM) approach.
• To address the challenge of API uniformity in low dose tablet production.
• To demonstrate the versatility of the BEAM approach across a range of API solubilities.

Main Methods:

• Preparation of BEAM powders by spraying a Polyvinylpyrrolidone (PVP) hydro-alcoholic solution containing API onto microcrystalline cellulose (MCC) under high shear.
• Characterization of BEAM powders for flowability, tabletability, and ejection force.
• Direct compression of BEAM powders into tablets without additional excipients.

Main Results:

• BEAM powders demonstrated excellent flowability and tabletability for five model APIs across diverse solubility ranges.
• Tablets produced via the BEAM approach exhibited high API uniformity and rapid disintegration.
• The BEAM method proved effective without the need for additional formulation agents.

Conclusions:

• The Binder Enhanced API-Microcrystalline Cellulose (BEAM) approach offers a robust and simplified solution for manufacturing uniform low dose tablets.
• This platform technology is suitable for producing tablets containing potent APIs.
• The BEAM method enhances tablet quality attributes like uniformity and disintegration, simplifying the manufacturing process.