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Excipients for Drug Formulation

Kollidon® 30 – The Original from BASF

Our medium-molecular povidone is used in endless ways in pharmaceutical formulations 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.

The PVP that started it all. Invented by Walter Reppe over 75 years ago Kollidon® 30 is 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 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. And thanks to the new PeroXeal™ packaging concept that dramatically reduces peroxide levels, Kollidon® 30 can now be used for entirely new applications.

The Kollidon® portfolio of various PVP grades sets new standards in quality, purity and patient safety.

  • The original PVP from the industry’s most experienced team
  • Consistently high quality for reliable performance and formulation stability
  • Cutting-edge PeroXeal™ packaging concept for greater stability & suitability for oxygen-sensitive APIs – opening the door for new applications

Major Applications of Kollidon® 30

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, freeflowing with a low proportion of fines. Binding strength is excellent to achieve hard and stable tablets.

Kollidon® 30 and Kollidon® 25 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. 

Kollidon® 30 is 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® 30 is 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® 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.

In liquid formulations, Kollidon® 30 complexates with the active ingredient providing taste masking and solubilization.

Kollidon® 30 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® 30 can be added to sugar-coating suspensions 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® 30 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.

Kollidon® 30 is used in transdermal patches to solubilize the drug. It also stabilizes certain active ingredients in transdermal systems , such as nitroglycerin.

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.

The new PeroXeal packaging concept for pharmaceutical grades

Improving on a classic: the new PeroXeal packaging concept for Kollidon®

At BASF, we understand that quality and stability are crucial for maximizing patient safety. This is why Kollidon is manufactured to the most exacting of standards in a world-class plant. And our experts continue to innovate, improving and expanding our portfolio. The groundbreaking PeroXeal packaging concept effectively “seals” the product, marking the next stage in Kollidon’s evolution.

The aluminum-free PeroXeal bag features three different functional film layers complemented by inert gas flushing and heat sealing. The result: A significantly lower risk of oxidation and a shelf life of up to four years. This makes worrying about peroxide levels, K values, API degradation and contamination with aluminum flakes a thing of the past. What’s more, Kollidon’s enhanced stability opens the door for entirely new applications. For example, you can now use Kollidon as an alternative to cellulose when working with oxygen-sensitive ingredients. In addition, the bag’s transparent inner lining is compatible with NIR testing – so packaging can remain sealed until the product is actually being used, retaining Kollidon’s freshness. And best of all, the new packaging is available at no additional cost to the customer.
 

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Enhanced stability through PeroXeal™ packaging
Product Details
Chemical name: Polyvinylpyrrolidone
CAS-No: 9003-39-08
INCI: PVP
Regulatory Status: Regulatory 
Status: Kollidon® 30 meets current Ph. Eur., USP/NF and JP/JPE povidone monographs.

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