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Primojel®

Hero underline
  • Sodium starch glycolate
  • Strong swelling force
  • Allows intra- granular or extra- granular

Primojel®

Primojel® Sodium starch glycolate is a superdisintegrant suitable for a variety of tablet and capsule formulations. In higher concentrations, Primojel® can act as a dissolution enhancing agent. Primojel® is highly 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

Disintegration performance

Primojel® takes up more than 20 times its own weight of water. Rapid water penetration into the tablets and powerful swelling results in rapid disintegration. The swelling actions makes Primojel® most effective in non-soluble matrices. Studies show that Primojel® takes up more water than comparative products on the market and develops a strong disintegrating force making it a highly effective product. The botanic source, degree of cross-linking and degree of substitution of Primojel® have been optimized in order to give rapid water uptake by the polymer without the formation of a viscous gel that may impede water penetration into the tablet.

 

In direct compression

The recommended starting point is 2%w/w to 4%w/w of Primojel®. The figure shows how the disintegration time of various placebo tablets (250 mg / 9 mm tablets containing 4%w/w Primojel® 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 Primojel® remains an effective superdisintegrant.

In wet granulation

We recommend that Primojel® is incorporated at least partly (50% or more) during the granulation. This is especially important when a high proportion of insoluble diluent is employed. The intragranular components were wet granulated (high shear), dried, sieved and blended with the extragranular portion of Primojel® and magnesium stearate. Tablets were compressed at 250 mg and dissolution tested in 900ml of water using USP apparatus 2. Dissolution of Diclofenac Sodium is slower when Primojel® is used only in the extragranular phase. If lactose is used instead of dibasic calcium phosphate, then the effect of Primojel® location is greatly reduced.

Document Overview

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ALBA

  • ALBA Primojel

    ALBA Primojel

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Contaminants

  • Contaminants statement Primojel

    Contaminants statement Primojel

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GMO

  • GMO statement Primojel

    GMO statement Primojel

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Halal certificates

  • Halal Conformance Statement Primojel

    Halal Conformance Statement Primojel

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Impurity statements

  • ICHQ3D - Elemental Impurities Superdisintegrants

    ICHQ3D - Elemental Impurities Superdisintegrants

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MSDS

  • MSDS Primojel

    MSDS Primojel

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Nutritional

  • Nutritional information Primojel

    Nutritional information Primojel

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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) Primojel®

    Process flow sheet (PFS) Primojel®

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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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