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SuperTab® 50 ODT

Reimagine your ODT

Hero underline
  • Fast dissolving speed
  • Pleasant mouthfeel
  • Robust tablet hardness

SuperTab® 50 ODT

SuperTab® 50 ODT is a new product within DFE Pharma’s portfolio. It provides a solution for orodispersible formulations, helping to deliver medication to pediatrics and geriatric patients, or to those who suffer from Dysphagia. SuperTab® 50 ODT is a highly consistent, monohydrate lactose. Due to the porous nature, fast disintegration time can be established. These attributes of SuperTab® 50 ODT, in combination with a superdisintegrant, offer rapid disintegration in the mouth. Therefore SuperTab® 50 ODT is found to be the ideal solution for oral disintegrating tablets (ODT) where fast disintegration and good mouth feel is of key importance.

Specifications

Density

Tapped density 0,73 g/l
Bulk density 0,64 g/l

Particle size

D10 55 μm
D50 130 μm
D90 220 μm

Hausner ratio

1,14

Production site

Borculo, the Netherlands

Sample size

Default 500 g

Conforms to USP-NF, Ph.Eur., JP lactose monohydrate (modified)

100% natural, soluble material

Pharmaceutical lactose is a commonly used excipient in Oral Solid Dosage (OSD) medicines as it is an inert, stable, soluble and palatable product. SuperTab® 50 ODT has a fast disintegration time.

 

Pleasant mouthfeel

SuperTab® 50 ODT has a mildly sweet taste as it is a dissaccaride excipient. Additionally, modification by spray drying offers porosity which enhances a good mouthfeel.

Robust tablet hardness at a given compaction force

Tablets made with SuperTab® 50 ODT have a low friability (< 0.5%w/w) ensuring consistent performance on tablet hardness over time. This combined with a good tensile strength at a given compaction force.

 

Document Overview

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Impurity statements

  • ICHQ3D Elemental Impurities Lactose EU and NZ

    ICHQ3D Elemental Impurities Lactose EU and NZ

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Other quality and regulatory documents

  • BSE Statement Lactose & Inhalation

    BSE Statement Lactose & Inhalation

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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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Brochures

Halal certificates

Product sheets

Technical papers

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