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Primellose®

Hero underline
  • Croscarmellose sodium
  • Fast water uptake
  • Allows intra- granular or extra- granular

Primellose®

Primellose® is DFE Pharma’s product brand name for Croscarmellose
Sodium. It is made in a dedicated pharmaceutical plant in Foxhol,
The Netherlands. Primellose® croscarmellose sodium is suitable for a
variety of tablet and capsule formulations. Primellose® is effective in
combination with both insoluble filler-binders and slightly soluble to
soluble filler-binders at concentrations of 2%w/w - 6%w/w. It is also a
choice for formulations which require non-starch products. Primellose®
is effective when used intragranular and/or extragranular in granular
formulations.

Specifications

Density

Tapped density g/l
Bulk density g/l

Particle size

D10 μm
D50 μm
D90 μm

Hausner ratio

Production site

Foxhol, the Netherlands 

Sample size

Default 500 g

Conforms to USP-NF, Ph.Eur., JP

Superior performance Primellose® can be used in wet granulation, dry granulation or direct compression in combination with nearly any type of API and excipient(s) (soluble or slightly soluble). Wicking is the most important factor in croscarmellose sodium performance, and it was found that the relatively large particle size distribution of Primellose® conferred superior performance compared to many other brands.

 

In wet granulation

We recommend that Primellose® is incorporated at least partly (50%w/w or more) during granulation. This is especially important when a high proportion of insoluble diluent is employed as shown in this example which uses Diclofenac Sodium as the API and dibasic calcium phosphate dihydrate as the main diluent.

 

In direct compression

The recommended starting point is 2%w/w to 6%w/w of Primellose®. Table 1 shows how the disintegration time of various placebo tablets (250 mg / 9 mm tablets containing 4%w/w Primellose® and 0.5%w/w magnesium stearate) is maintained after storage for 6 months at 40˚C / 75% RH in open containers. The disintegration of reference tablets stored for 6 months under ambient laboratory conditions is also shown. This data confirms that Primellose® remains an effective super-disintegrant, even under the most stressful stability storage conditions.

 

Document Overview

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ALBA

  • ALBA Primellose

    ALBA Primellose

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Contaminants

  • Contaminants statement Primellose

    Contaminants statement Primellose

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GMO

  • GMO Statement Primellose

    GMO Statement Primellose

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Halal certificates

  • Halal conformance statement Primellose

    Halal conformance statement Primellose

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Impurity statements

  • ICHQ3D - Elemental Impurities Superdisintegrants

    ICHQ3D - Elemental Impurities Superdisintegrants

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Ingredient Declaration

  • Ingredient declaration Primellose

    Ingredient declaration Primellose

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MSDS

  • MSDS Primellose

    MSDS Primellose

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Nutritional

  • Nutritional information Primellose

    Nutritional information Primellose

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Other quality and regulatory documents

  • Absence of Melamine Pharmacel, SuperStarch, Disintegrants

    Absence of Melamine Pharmacel, SuperStarch, Disintegrants

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  • BSE Statement Superdisintegrants

    BSE Statement Superdisintegrants

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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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  • Data Integrity

    Data Integrity

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  • Dioxin statement lactose

    Dioxin statement 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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  • 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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  • World anti-doping code

    World anti-doping code

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Process flow sheets

  • Process flow sheet (PFS) Primellose®

    Process flow sheet (PFS) Primellose®

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Product specifications

  • Product Specification Primellose

    Product Specification Primellose

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Shelf life

  • Shelf life statement Primojel and Primellose

    Shelf life statement Primojel and Primellose

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Brochures

Kosher

Product sheets

Residual solvent

Technical papers

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