Spray-Dried Lactose Monohydrate

A direct-compression grade of lactose monohydrate manufactured by spray drying a supersaturated lactose solution containing both crystalline alpha-monohydrate and amorphous lactose. The amorphous fraction provides plastic deformation under compression that crystalline lactose cannot deliver, making this the workhorse direct-compression filler in regulated pharmaceutical markets.

White to off-white free-flowing spherical agglomerates, slightly sweet, freely soluble in water. The characteristic spherical morphology gives excellent flow at high speeds and consistent die-filling on rotary tablet presses.

We supply pharmaceutical-grade Spray-Dried Lactose from manufacturers in China holding ISO, GMP, USP/EP/JP DMF, Halal, Kosher, and other certifications relevant to the product and production.

Common market grades are differentiated by mean particle size (typical D50 of 80 to 120 microns), amorphous fraction (12 to 20 percent for compressibility), bulk density (0.55 to 0.70 g/mL), and degree of agglomeration. The pharmaceutical spray-dried grade is the default direct-compression filler in tablets containing 25 to 80 percent lactose by weight.

Bulk and reduced-MOQ shipments. Batch-level COA covering identification, assay, specific rotation, loss on drying, particle size, bulk and tapped density, amorphous content, microbiology, and full source documentation against USP, EP, JP, and BP monographs.

Spray-Dried Lactose was developed in the 1960s as the first true direct-compression grade of lactose, in response to the formulation industry's need for a free-flowing, compressible filler that could replace wet granulation in tablet manufacturing. It remains the dominant DC lactose grade in regulated pharmaceutical markets.

Production proceeds by atomizing a supersaturated lactose solution into a spray dryer at controlled inlet temperatures, generating spherical agglomerates that contain both alpha-monohydrate crystals (which give the product its identity as lactose monohydrate) and a fraction of amorphous lactose between the crystals (which delivers the plastic deformation under compression).

Listed in USP-NF, EP, JP, and BP monographs. Pharmaceutical-grade Spray-Dried Lactose is fully segregated from food-grade lactose production and supported by manufacturer DMFs filed with the FDA, full BSE/TSE source statements, and allergen control documentation.

The defining functional property is compressibility: at equivalent tablet weight and hardness, spray-dried lactose delivers tensile strength roughly two to three times that of sieved crystalline lactose. The amorphous fraction must be controlled because excessive amorphous content increases hygroscopicity and risks recrystallization on extended storage.

Strategic position: along with MCC PH-102, Spray-Dried Lactose is one of the two reference direct-compression fillers in modern solid-dose manufacturing. A typical DC formulation uses both excipients in combination, exploiting the brittle fracture of lactose and the plastic deformation of MCC.

• Direct-compression filler in solid-dose tablet manufacturing
• High-speed rotary tablet press feed for consistent die filling
• Carrier for low-dose APIs in direct-compression blends
• Diluent in chewable and orally disintegrating tablets
• Capsule diluent in high-speed capsule filling
• Carrier in nutraceutical direct-compression tablets
• Carrier in lozenge and pastille direct-compression formulations
• Sachet and stick-pack filler for direct-fill powder products