Kollidon® 25 – The Original from BASF
Our medium-molecular povidone is used in endless ways in pharmaceutical formulation as binder, pore former, stabilizer, thickener, as solubilizing agent, crystallization inhibitor and many more. And with our trusted quality, it will always serve exactly what you intended it for.
Kollidon® 25 has been used successfully for decades in pharmaceutical formulations – the adhesive, film-forming, dispersing and thickening properties of soluble Kollidon® are used in tablet binding, sugar coating, film coating, solubilization, stabilization and numerous other ways.
The improvement in the solubility of active ingredients brought by complexation or association, and the thickening effect find use mainly in the manufacture of liquid dosage forms. The grade of Kollidon® that is selected depends mainly on its molecular weight, as this dictates the viscosity, binding effect, the complexation capacity and how readily it is eliminated by the body.
|Regulatory Status:||Kollidon® 25 meets the requirements of the current harmonised monographs for povidone in Ph. Eur., USP/NF and JP.|
When applied for granulation in high shear mixers or fluid-bed granulators the resulting granules with Kollidon® 25, Kollidon® 30 and Kollidon® 90 F are hard, free flowing with a low proportion of fines. Binding strength is excellent to achieve hard and stable tablets.
Kollidon® 25 and Kollidon® 30 require binder quantities of 2% and 5% related to the tablet weight. As Kollidon® 90 F has a higher binding capacity the required quantities are 2% or even less. The high viscosity of binder solutions of Kollidon® 90F sometimes requires precautions to ensure the granules to be evenly wetted.
Kollidon® 25, 30 and 90 F are also suitable for the direct compression of tablets without granulation. This technique requires a certain relative humidity, as the powder mixture must have a certain moisture content to bind properly. If Kollidon® is used in addition to microcrystalline cellulose, it not only makes the tablets harder but also gives them stronger edges. For best results in direct compression, all the excipients should have a certain moisture content. This applies to starch, micro- crystalline cellulose and lactose monohydrate as fillers.
Kollidon® is also suitable as a binder for modern processes such as fluidized-bed granulation. Thanks to their relatively low viscosity, solutions of Kollidon® 25 and Kollidon® 30 can be prepared relatively quickly, and sprayed easily, to quickly give hard dust-free uniform granules. If the spray includes pigments, Kollidon® improves their distribution.
Kollidon® can be combined with all the usual film-forming agents such as polyvinyl acetate, cellulose derivatives or methacrylates. Alcoholic pigment suspensions can be prepared with a mixture of shellac and soluble Kollidon®, and these give homogeneous coatings particularly in modern spray-coating and fluidized-bed machines. The addition of Kollidon® 25 or Kollidon® 30 improves the rate of disintegration in aqueous solution, as the film-forming agents usually used have poor solubility in water. In most cases, it is recommended to strongly dilute the suspension for spraying.
The good film-forming properties, great adhesive strength and very good dispersing action of Kollidon® are very useful in both traditional and automatic sugar-coating processes. Kollidon® 25 and Kollidon® 30 can be added to sugar-coating suspensions to prevent crazing of the sugar-coating, and it also ensures that any pigments in the coating are evenly distributed and that the suspension remains stable. The sugar coating often develops crazing if the tablets are dried very quickly, resulting in a moisture gradient between the outside and the inside of the tablet, which can also happen if the suspension contains large quantities of pigment. Kollidon® prevents the pigment particles from aggregating again and promotes the homogeneity of the sugar layer. Kollidon® can also be used to prevent the migration of soluble dyes.
Kollidon® delivers multiple functionalities when used for solubilization.
In solid dispersions it serves as solubilizing agent, dispersant, crystallization inhibitor and provider of immediate release matrix functionality.
In liquid dispersions, solutions, emulsions & micro emulsions it acts as solubilizing agent, dispersant & crystallization inhibitor.
Apart from the applications described above, the soluble grades of Kollidon® can be used for the following purposes:
In 1995, soluble polyvinylpyrrolidone (povidone) with k-values of 25 and higher was assigned Europe number E 1201 for use in dietetic tablets, e. g. vitamin and dietary fibre tablets, and in sweeteners.
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