The benefits of lactose as an excipient

December 10, 2024

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Pharmaceutical lactose has been a key excipient in the industry for over a century, valued for its safety, versatility, and functional properties. Produced from milk permeate or cheese whey, its preparation involves crystallization, purification, milling, and sieving. Lactose serves multiple roles in drug formulation, including as a flow agent, filler, binder/diluent, and disintegrant .

Main benefits include:

Safety and Availability:

The production process ensures high purity and safety, with no significant adverse effects even for those with lactose intolerance.

Its affordability and wide availability help prevent shortages and keep production costs manageable .

Desirable Properties:

Lactose is stable, inert, odorless, and water-soluble, making it suitable for various formulations. These properties contribute to better drug disintegration, mechanical strength, and compression.

Versatility:

Different forms of lactose, such as milled, sieved, spray-dried, and anhydrous, are tailored to various manufacturing methods like granulation and direct compression. For example, spray-dried lactose offers good flow properties, while granulated lactose is well-suited for compaction and fluidity .

Lactose is widely used in oral medicines, typically comprising 100–200 mg per tablet. The market is growing steadily, reaching $1.67 billion in 2023 and projected to hit $2.63 billion by 2031, driven by increased pharmaceutical production and advancements in manufacturing techniques .

Lactose’s widespread use is due to its reliable properties and adaptability. Products like Lactalpha of Lacatalis, a range of milled and sieved lactose, provide manufacturers with a consistent and high-quality option for pharmaceutical applications .