Pharmaceutical lactose, in what form and for what use?

January 08, 2025

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Pharmaceutical lactose, derived from cheese whey or milk permeate, has been a cornerstone excipient in the pharmaceutical industry since the 19th century. Present in 60–70% of oral medicines, it plays a critical role in formulation due to its safety, affordability, stability, and versatility. Lactose is processed through crystallization, purification, milling, and sieving, which define its properties and functionality for various pharmaceutical applications.

Forms of Pharmaceutical Lactose

1. Milled and Sieved Lactose: The most widely used form, ideal for wet granulation. Its controlled particle size ensures consistent flow and compaction.

2. Spray-Dried Lactose: Favored for direct compression, its porous agglomerates promote uniform distribution of active ingredients and compaction.

3. Granulated Lactose: Highly porous, this form is suited for direct compression, offering excellent flow, rapid disintegration, and effective mixing.

4. Anhydrous Lactose: With low moisture content, it excels in dry granulation due to its recompactible properties and high degree of fragmentation.

Applications in Medicine Manufacturing

- Tablets: Lactose supports various manufacturing methods, including wet granulation, direct compression, and dry granulation, ensuring compaction, flow, and ingredient uniformity.

- Capsules and Sachets: Its good flow properties make lactose ideal for filling these oral forms.

Impact on Therapeutic Efficacy

Lactose not only aids in manufacturing but also influences the therapeutic performance of medicines. Its solubility and form impact tablet disintegration and dissolution, which are critical for the timely release of active ingredients. Forms like granulated lactose disintegrate quickly, while anhydrous lactose dissolves slower due to its solubility characteristics.

Future Developments

Manufacturers like Lactalis Ingredients Pharma continue to innovate with products like Lactalpha, a range of milled and sieved lactose, and investments in advanced facilities to meet diverse pharmaceutical demands.

Conclusion
Pharmaceutical lactose is indispensable in oral solid dosage forms (OSDs) for its multifaceted roles as a binder, filler, and flow enhancer. Its consistent quality and adaptability ensure its enduring prominence in the pharmaceutical landscape.