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Dilactose R is a Japanese Pharmacopeia, Lactose Hydrate (granulated powder) developed by our unique fluid bed granulation method. It is useful as an excipient for directly compression. F (Fine) is small particle size grade Dilactose. In comparison with the existing grades, both formability and disintegration have been improved.

Chemical Name: Lactose Hydrate

CAS Number: 64044-51-5

Functions: Filler

Dosage Form: Capsules, Granules, Tablets

Certifications & Compliance: Japan Pharmacopeia (JP)

Synonyms: D-(+)-Lactose monohydrate, Microtose, Respitose

    Knowde Enhanced TDS

    Identification & Functionality

    Chemical Name
    Pharma & Nutraceuticals Functions
    CAS No.
    64044-51-5

    Features & Benefits

    Product Highlights

    Dilactose R - Product Highlights

    • Well-balanced between compressive formability and disintegration

    Lactose manufactured by high-shear granulation is generally inferior in compressive formulation. On the other hand, lactose manufactured by the spraydry method has excellent compressive formability but conversely tends to be inferior in disintegration. In comparison, Dilactose®, which is manufactured by the fluid bed granulation method, is excellent on both counts so it is possible to obtain tablets with high hardness and fast disintegration.

    • Excellent Mixability and Fluidity

    Even though the particle size of Dilactose® S is very fine in order to enhance mixability with API, , it has excellent fluidity. This comes from the manufacturing process because lactose crystals are all finely granulated.

    • Excellent Storage Stability

    Absorbency is not as good as spray dry lactose so there is extremely low potential for the occurrence of caking over time.

    Applications & Uses

    Manufacturing Technology

    Properties

    Physical Form
    Typical Properties
    ValueUnitsTest Method / Conditions
    Particle Size Distribution (D10)83μm
    Particle Size Distribution (D50)171μm
    Particle Size Distribution (D90) 254μm
    Bulk density 0.56g/ml
    Angle of repose37°
    Angle of Repose37°C

    Regulatory & Compliance

    Certifications & Compliance

    Technical Details & Test Data

    Particle Size Distribution
    • 500μm on Not more than 2%
    • 500-75μm Not less than 80%
    • 75μm pass Not more than 20%




     

    SEM Image

    Dilactose R - Sem Image