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Primellose®

Croscarmellose sodium

Fast water-uptake and rapid swelling

Excellent disintegration performance in various processes

Oral Solid Dose

Primellose Croscarmellose Sodium Excipients

Product information

Primellose® is DFE Pharma’s product brand name for croscarmellose sodium. It is manufactured in a dedicated pharmaceutical plant in Foxhol, The Netherlands. Primellose® croscarmellose sodium is suitable for various tablet and capsule formulations. Primellose® is effective in combination with both insoluble and soluble filler-binders at concentrations of 2%w/w - 6%w/w. Primellose® is effective in both direct compression and dry/wet granulation, where it is used both intragranularly and/or extragranularly.

Owing to its exceptional performance, Primellose® can be used in wet granulation, dry granulation or direct compression in combination with nearly any type of API and excipient(s). The excellent funtionality of croscarmellose sodium is due to its superior wicking ability.

Packaging

- 35Kg drum with PE liner

- Sample size: 500g

Shelf life

5 years

Production site

Foxhol, The Netherlands

Product types: Croscarmellose sodium
Excipient functionality: Disintegrant
Recommended process: Direct compression, Dry blending, Dry granulation, Wet granulation
Dosage forms: Tablet, Capsule (Oral Solid Dose), Orally disintegrating tablet

Typical product data

Source

Source: Cotton cellulose

pH

pH: 6.6

Disintegration mechanism

Disintegration mechanism: Wicking and swelling

Documentation

ALBA Primellose
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Oral Solid Dose Brochure View
Contaminants statement Primellose
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ICHQ3D - Elemental Impurities Superdisintegrants
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Kosher DFE Foxhol
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Nutritional information Primellose
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GMO Statement Primellose
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Ingredient declaration Primellose
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MSDS Primellose
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DFE Leaflet OSD Primellose View
Product Specification Primellose
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Process flow sheet (PFS) Primellose®
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Free from Foot and Mouth Disease lactose
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Viral safety statement lactose
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Contaminants and residues lactose
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Impact of excipient and blend properties on feeding consistency for continuous manufacturing View
Use of Primojel and Primellose in wet granulation View
Process flow sheet (PFS) Primellose®
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Superdisintegrants Introduction chemistry performance View
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