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Primellose®

Primellose® is cross-linked carboxymethylcellulose sodium. It is a white, free flowing powder. 

Disintegration performance

Cross-linking of carboxymethyl cellulose fibers reduces water solubility, and the resulting material can take up many times its own weight of water and swell power fully without losing its fibrous integrity. The combination of rapid water penetration into tablets through the hydrophilic, fibrous particles and the subsequent development of a strong disintegration force make croscarmellose sodium a very effective superdisintegrant. Primellose® is one of the most effective croscarmellose sodium products available because of the strong swelling force. which it develops. The effectiveness of Primellose® may be attributed to a combination of its particle size and optimal degree of substitution.

Application

Primellose® is suitable for a variety of tablet and capsule formulations. Primellose® is effective in combination with both insoluble filler-binders, such as MCC and dicalciumphosphate and slightly soluble to soluble filler-binders such as mannitol and lactose at concentrations of 2-6%. It is also a choice for formulations which require non-starch products. Primellose® is effective when used as intra-granular or extra-granular superdisintegrant,or when divided between these locations.


Sem of Primellose®

Primellose®

  • Superdisintegrants - General

    What is the difference between Primojel® and Primellose®?

    Both Primojel® and Primellose® are chemically modified natural polymers of glucose. Primojel® is based on starch and Primellose® 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® and Primellose® 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® and Primellose® 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 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® or Primellose® 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® or Primellose® are added during the granulation stage (intra-granular). The remainder can be added after the drying step and before lubrication.

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