Oral Tablet Formulations with Lactoferrin, a Cohesive Biomacromolecule

Area of Science:

• Pharmaceutical Sciences
• Materials Science
• Biotechnology

Background:

• Bovine lactoferrin, a cohesive biomacromolecule, presents formulation challenges.
• Understanding excipient and process impacts is crucial for tablet development.

Purpose of the Study:

• To investigate how excipients, unit operations, and process parameters affect the processability, properties, performance, and stability of lactoferrin tablets.
• To identify optimal formulations and manufacturing approaches for lactoferrin-containing tablets.

Main Methods:

• Tablet formulations with lactoferrin (5-45%) were prepared using microcrystalline cellulose, croscarmellose, lactose, hydroxypropyl methylcellulose, and sodium stearyl fumarate.
• Tablets were manufactured via direct compression or dry granulation followed by tableting.
• Characterization included tensile strength, friability, content uniformity, and drug release performance.

Main Results:

• Acceptable tablets were produced with lactoferrin concentrations from 15-45% using diverse excipients and methods.
• Dry granulation improved content uniformity in some cases.
• Excipient choice and compression force influenced drug release; lactoferrin-excipient compatibility was confirmed for up to 2 years.

Conclusions:

• Robust, scalable tablet production is feasible for bovine lactoferrin.
• Consistent, stable tablets with desired performance were achieved across various formulations and processing conditions.
• Both immediate- and controlled-release profiles are attainable for lactoferrin tablets.