Kollidon^® 25 – The Original from BASF

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^® 25 as well as Kollidon^® 30 are used as pore-forming agents in film coatings. They also improve the water solubility of the coating.

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.

Kollidon^® 25, as well as Kollidon^® 30 and Kollidon^® 90 F can be used to stabilize oral and topical suspensions with a wide range of active ingredients, e. g. acyclovir, ibuprofen, magaldrate, nystatin, phenytoin, trimethoprim, sulfonamides and antibiotics, as well as sugar-coating suspensions.

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:

• adhesives in adhesive gels, e. g. for dentures
• in controlled release preparations and transdermal systems to regulate the release of active substances
• hydrophilization and pore formation in plastics for medical applications, e. g. “hollow fibres”
• reduction of the toxicity of certain active substances
• cryoprotection, lyophilisation
• enzyme stabilization, e. g. in diagnostics
• vitamin stabilization

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.