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The quality signature of superdisintegrants

Your medicines are based on extremely precise formulations. They need to do what they are supposed to do. Always. Our market leading superdisintegrants ensure your formulation will disintegrate. Showing the quality signature of our superdisintegrants. 

We continuously invest in advanced production technologies and to offer a reliable supply of high-end products from our production site in Foxhol, the Netherlands. Here we operate a state-of-the-art, purpose built factory, where a highly skilled, dedicated team delivers superior product quality. DFE Pharma is committed to delivering you the very best superdisintegrants available and assist you with the technical support you need.

DFE Pharma superdisintegrants are well suited for use in tablets and capsules. DFE Pharma offers the following superdisintegrants:

  • Primojel®: sodium starch glycolate
  • Primellose®: croscarmellose sodium

Stages of disintegration

 

The quality signature of superdisintegrants

The quality signature of superdisintegrants

  • Superdisintegrants - General

    What is the difference between Primojel® and Primellose®?

    Both Primojel® and Primellose® are chemically modified natural polymers of glucose. Primojel® sodium starch glycolate is based on starch and Primellose® croscarmellose sodium is based on cellulose. The two modifications are introduction of carboxymethyl groups (to promote water ingress) and cross-linking of the polymer chains (to prevent dissolution and development of viscosity).

    Does wet granulation affect the efficiency of Primojel® and Primellose®?

    No. In fact we recommend that the disintegrants are included, at least in part, during granulation. Tablets containing high levels of insoluble material can suffer from slow disintegration and slow dissolution if all the disintegrant is added in the extragranular phase.

    What is the mechanism of Primojel®’s super-disintegrant action?

    Both Primojel® sodium starch glycolate and Primellose® croscarmellose sodium work by taking up water and swelling. The combination of these two mechanisms is responsible for the superdisintegrant action.

    How are Primojel® and Primellose® packed?

    Both products are packed in HDPE plastic drums. Size of Primojel®: 50kg, Size of Primellose®: 35kg.

    Where are Primojel® and Primellose® produced? Who does release the product?

    Primojel® sodium starch glycolate and Primellose® croscarmellose sodium are produced in our own production facilities in Foxhol, The Netherlands. After quality inspection, the product is released for shipment to the customer by DFE Pharma QA.

    What is the shelf-life of Primojel® and Primellose®?

    Both Primojel® and Primellose® have a shelf-life of 5 years.

    Which disintegrants should I use with different filler/binders?

    With the SuperTab® SD, GR and Lactopress Spray Dried and Granulated range of filler binders we recommend either Primojel® sodium starch glycolate or Primellose® croscarmellose sodium at a starting level of 2% to 4% by weight of the formulation. 

    With SuperTab® AN and Lactopress® Anhydrous, Primellose® is preferred. For other commonly used filler-binders either Primellose® or Primojel® may be used, and levels of 2 – 4% by weight are usual. Primellose® is preferred when the formulation contains high levels of calcium phosphate.

    How should Primojel® and Primellose® be added to a formulation?

    It is advised to pass the disintegrants through a sieve before adding. In direct compression simply blend the Primojel® or Primellose® into the compression mix at a point before lubrication.

    In wet granulation we recommend that at least 50% of the Primojel® sodium starch glycolate or Primellose® croscarmellose sodium are added during the granulation stage (intra-granular). The remainder can be added after the drying step and before lubrication.

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