Patent on solid oral dosage form comprising antibodies for sustained release in the lower gastrointestinal tract

Abstract

The patent “Solid oral dosage form comprising antibodies for sustained release in the lower gastrointestinal tract” (US20250127722A1 [1]) presents a novel pharmaceutical formulation. It uses microcrystalline cellulose pellets, called CELLETS®, as inert starter cores for controlled-release drug delivery systems. Moreover, these CELLETS® act as a stable foundation, ensuring uniform layering of active pharmaceutical ingredients (APIs). Consequently, the formulation achieves consistent drug delivery in the lower gastrointestinal tract.

Importance of Cellets® in the Application

CELLETS® play a key role in this pharmaceutical formulation because of their unique physical and chemical properties. They act as neutral carriers and consist entirely of microcrystalline cellulose, which is inert and insoluble. This inertness prevents unwanted interactions with the active ingredients, preserving the medication’s stability and efficacy.

Moreover, their high sphericity and narrow particle size distribution support a consistent and reproducible layering process. This uniformity is essential for achieving controlled and sustained release of the APIs. In addition, their mechanical strength and low friability reduce the generation of fines during processing. These fines can otherwise cause inconsistencies in drug release and dosing.

Furthermore, CELLETS® resist abrasion, which benefits the coating process. This property helps the pellets maintain their integrity and shape. As a result, the API layers are applied more efficiently and uniformly. Altogether, these characteristics make CELLETS® ideal MCC starter beads for controlled-release formulations requiring precise dosing and reliable performance.

Specific Type of Cellets® Used

In this application, the formulation uses CELLETS® 127, which have a particle size between 100 µm and 160 µm. This size range optimizes the surface area for API layering while maintaining good flow and compressibility. Moreover, choosing CELLETS® 127 ensures a balance between mechanical strength and drug release kinetics. As a result, the final product delivers improved therapeutic outcomes.

Conclusion

The formulation in patent US20250127722A1 uses CELLETS® 127 (100 µm to 160 µm) as inert starter cores. This choice highlights the importance of selecting appropriate excipients for controlled and sustained drug release. Additionally, their unique properties support the stability, efficacy, and reproducibility of the final dosage form. Therefore, CELLETS® 127 are a valuable component in advanced drug delivery systems.

Document information

References

[1] Patent; SOLID ORAL DOSAGE FORM COMPRISING ANTIBODIES FOR SUSTAINED RELEASE IN THE LOWER GASTROINTESTINAL TRACT

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