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SuperTab® 40LL

Breaking through direct compression limits

Hero underline
  • Excellent flow and compaction
  • High dilution potential
  • Agglomerated anhydrous lactose and lactitol monohydrate

SuperTab® 40LL

The pharmaceutical industry is continuously looking, together with partners, at better ways to deliver medication to new patient groups. Mini-tablets are a great example as they allow pediatric and geriatric patients improved comfort in taking their medicines. However the economical production of mini-tablets does put a strain on the formulation. SuperTab® 40LL combines all required functionalities into one single excipient. Consequently, it breaks through the limits of direct compression, making it the excipient of choice for mini-tablet and / or other challenging formulations.

Specifications

Density

Tapped density 655 g/l
Bulk density 544 g/l

Particle size

D10 80 μm
D50 180 μm
D90 350 μm

Hausner ratio

1,2

Production site

Nörten Hardenberg, Germany

Sample size

Default 500 g

Conforms lactose Ph. Eur. / Anhydrous lactose USP-NF, JP with lactitol monohydrate Ph. Eur

Better and faster tablet compression

SuperTab® 40LL has the highest carrying capacity of marketed excipient products. Drug loading was increased until flow became limiting on gravimetric feed tableting press*.

Extremely low lubricant sensitivity

Uniquely, SuperTab® 40LL exhibits high compactability with extremely low lubricant sensitivity for enhanced formulation during scale- up and to reduce capping tendency whilst still maintaining high drug loads.

Improve your formulation robustness

SuperTab® 40LL exhibits superior flow, and therefore formulations with higher drug loading can be tableted using gravimetric feed tableting equipment. It enables an even filling of the inherently small die cavities and to allow faster tabletting.


 

Document Overview

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ALBA

  • ALBA Pharmaceutical lactose

    ALBA Pharmaceutical lactose

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Contaminants

  • Contaminants Pharmatose, Respitose and SuperTab (EU)

    Contaminants Pharmatose, Respitose and SuperTab (EU)

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GMO

  • GMO Statement lactose

    GMO Statement lactose

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Halal certificates

Impurity statements

  • ICHQ3D Elemental Impurities Lactose EU and NZ

    ICHQ3D Elemental Impurities Lactose EU and NZ

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Ingredient Declaration

  • Ingredient declaration lactose

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  • Ingredient declaration SuperTab 40LL

    Ingredient declaration SuperTab 40LL

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MSDS

  • MSDS Lactose monohydrate

    MSDS Lactose monohydrate

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Nutritional

  • Nutritional information lactose

    Nutritional information lactose

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Other quality and regulatory documents

  • Absence of Melamine Lactose

    Absence of Melamine Lactose

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  • BSE Statement Lactose & Inhalation

    BSE Statement Lactose & Inhalation

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  • BSE/TSE Statement SuperTab® 40LL

    BSE/TSE Statement SuperTab® 40LL

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  • Certificate of suitability

    Certificate of suitability

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  • cGMP Statement

    cGMP Statement

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  • Change management

    Change management

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  • Compliance packaging

    Compliance packaging

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  • Contaminants and residues lactose

    Contaminants and residues lactose

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  • Data Integrity

    Data Integrity

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  • Dioxin statement lactose

    Dioxin statement lactose

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  • Free from Foot and Mouth Disease lactose

    Free from Foot and Mouth Disease lactose

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  • Irradiation free

    Irradiation free

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  • Latex free statement

    Latex free statement

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  • Non dangerous substance

    Non dangerous substance

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  • None metal catalyst statement

    None metal catalyst statement

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  • Origin of Milk

    Origin of Milk

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  • Production site statement

    Production site statement

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  • REACH statement

    REACH statement

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  • Statement of business continuity planning

    Statement of business continuity planning

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  • Viral safety statement lactose

    Viral safety statement lactose

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  • World anti-doping code

    World anti-doping code

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Process flow sheets

  • Process Flow Sheet (PFS) Granulated

    Process Flow Sheet (PFS) Granulated

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  • Process Flow Sheet (PFS) Granulated lactose

    Process Flow Sheet (PFS) Granulated lactose

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  • Process Flow Sheet (PFS) SuperTab® 40LL

    Process Flow Sheet (PFS) SuperTab® 40LL

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Product specifications

  • Product Specification SuperTab 40LL

    Product Specification SuperTab 40LL

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Residual solvent

  • Residual solvent lactose

    Residual solvent lactose

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  • Residual solvent lactose SuperTab 40LL

    Residual solvent lactose SuperTab 40LL

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Shelf life

  • Shelf life statement lactose

    Shelf life statement lactose

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Brochures

Product sheets

Technical papers

Technical posters

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