Spray-dried lactose has been widely used as a direct compression excipient in tablet manufacturing since the 1960s, and it remains one of the most commonly used materials today. With numerous manufacturers producing various types and specifications of spray-dried lactose, understanding the factors that influence its compressibility is essential for pharmaceutical companies to select the right product and ensure high-quality tablet performance.
The particle size of lactose plays a significant role in tablet strength. Small particles tend to improve tablet hardness. Spray-dried lactose is produced by spray-drying a saturated suspension of α-lactose monohydrate crystals, resulting in a narrow particle size distribution and excellent flow properties. It contains both crystalline and amorphous components, with approximately 15–20% amorphous material. In a saturated solution, lactose exists as two optical isomers—α and β—with α-lactose making up 40% and β-lactose 60%. This ratio remains unchanged during spray drying, especially at higher temperatures. The β-lactose is mainly found in the amorphous matrix, accounting for about 9–12% of the final product.
Compressibility varies depending on the particle size of spray-dried lactose. While α-lactose monohydrate provides good flowability, it is brittle. However, when particle size is reduced below 45 μm, it becomes more plastic, leading to different compressibility behaviors. The initial particle size of α-lactose monohydrate is determined through techniques like ultrasonic dispersion in isopropyl alcohol followed by laser diffraction analysis.
A recent study compared 15 types of spray-dried lactose with varying particle sizes and amorphous content. Under consistent conditions (10 kg pressure, 13 mm die, 500 mg tablet weight), smaller particles significantly increased tablet hardness. For example, lactose with average particle sizes of 34 μm and 20 μm showed a 30–50% improvement in hardness, which is highly beneficial for formulations with poor compressibility.
Moisture control is critical during production. Unlike microcrystalline cellulose, where moisture can enhance compressibility, spray-dried lactose shows a more complex relationship. At low moisture levels (0.1–0.3%), tablet hardness increases, but beyond 0.6%, it drops sharply. This is due to moisture absorption by the amorphous portion, which affects the glass transition temperature. When moisture reaches a critical point (0.4–0.5%), the amorphous phase transforms into α-lactose monohydrate, reducing compressibility. Therefore, moisture should be strictly controlled at around 0.15% during production, and sealed packaging is recommended to prevent long-term moisture absorption.
Looking ahead, stable lactose formulations are gaining attention. Some companies are exploring new packaging solutions to prevent amorphous recrystallization. Researchers are also working on rapid crystallization methods to produce more stable spray-dried lactose. Recent findings show that under specific temperature and humidity conditions, amorphous lactose can crystallize quickly into a stable α/β mixed form, improving stability without compromising compressibility.
At 20°C, traditional spray-dried lactose absorbs moisture rapidly between 20% and 50% RH, while stable versions show minimal moisture increase even at 90% RH. This makes stable spray-dried lactose a promising option for direct compression applications, offering better performance and reliability in pharmaceutical manufacturing.
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