Kollidon^® VA64

A copovidone used in granulation and as a dry binder in tablets, capsules and granules, as a film-forming agent in tablet coatings and subcoatings, and as a film-forming agent in topical sprays. Soluble copovidones are widely used for instant release formulation and is suitable in hot melt extrusion processes.

Kollidon^®VA 64 is a vinylpyrrolidone-vinyl acetate copolymers. It is used as dry binder for direct compression tableting, as granulating agent, as retarding and as a film-forming agent as well as in taste-masking applications. As copovidone with an exceptionally high binding capacity, Kollidon^®VA 64 can be used as a dry binder for direct compression tableting and as a soluble binder for granulation. These properties make it an attractive and cost-effective alternative to natural binders. In addition, it is ideal as a solubilizer in hot-melt extrusion processes. Kollidon^® VA 64 is especially suitable for markets with higher humidity exposure.

Benefits of Kollidon^® VA 64

The original PVP from the industry’s most experienced team
Especially suitable for direct compression, roller compaction, hot melt extrusion processes as well as for markets with high humidity exposure
Superior plasticity for very hard tablet production
Compliant with the current monographs for copovidone
Consistently high quality for reliable performance and formulation stability

Applications for Kollidon^® VA64

Binder for tablets and granules

Kollidon^® VA 64 is an excellent binders for tablets and granules. Between 2% and 8%, as a proportion of the final weight of the preparation, is usually used. An important property of Kollidon^® VA 64 in this application is the plasticity, which distinguishes the products from povidone (e.g. Kollidon^® 30). This property often gives granules and mixtures that are less susceptible to capping during tableting, and tablets that are less brittle.

Dry binder for direct compression

Kollidon^® VA 64 have been found to be excellent dry binder for direct compression. The hardness, friability, porosity and disintegration time of lactose and starch placebo tablets produced with Kollidon^® VA 64 are directly related to the compression force used. Kollidon^® VA 64 can be added to materials such as sorbitol, mannitol, starch, or direct compression aids, e.g. micro crystalline cellulose, whose own binding strength is inadequate, to give tablets with very good properties.

Wet granulation

Kollidon^® VA 64 can also be used as a binder in wet granulation for the production of tablets and granules, since it is readily soluble in all the usual solvents. It can then be added either as a solution during granulation, or dry to the other ingredients, in which case the solvent is added alone during granulation. Trials so far conducted with both methods, using equal quantities of liquid, produced tablets of much the same hardness. A combination of the two methods, i.e. mixing some of the Kollidon^® VA 64 with the active ingredient, and dissolving the rest in the solvent, sometimes gives the best results. This is particularly recommended if the active ingredient does not readily absorb the solvent. Since it is less hygroscopic than povidone (e.g. Kollidon^® 25 or Kollidon^® 30), Kollidon^® VA 64 gives granules that have less tendency to stick to the punches of the tableting machine, when operating under humid conditions. The binding power of Kollidon^® VA 64 is comparable to that of Kollidon^® 25 and Kollidon^® 30.

Film-coating

Kollidon^® VA 64 forms films that are soluble at all pH values. They are less hygroscopic and more elastic than those formed by povidone (e.g. Kollidon 30). Nevertheless, Kollidon^® VA 64 usually still absorbs too much water, so that it can seldom be used as the sole film-forming agent in a formulation. It is therefore recommended to combine it with less hygroscopic substances such as cellulose derivatives, shellac or polyethylene glycol. Plasticizers are normally not required. Kollidon^® VA 64 significantly improves their brittleness and solubility when it is combined with cellulose derivatives. When it is used in film coatings based on shellac, the properties of the film are more consistent.

Subcoating

If it is intended to coat tablet cores with aqueous solutions or suspensions, it is recommended to provide them with a barrier if they contain a water-sensitive active ingredient or a highly effective disintegrant (e.g. Kollidon^® CL) that is activated by water. This also applies if the cores are too soft or if their adhesive properties are inadequate for aqueous coatings. The cores are warmed to about 35 °C and sprayed with a 10% solution of Kollidon^® VA 64 dissolved in an organic solvent, e.g. isopropanol, ethanol, ethyl acetate or acetone. As soon as a barrier film of adequate thickness has been built up, the aqueous coating can be applied.

Sugar-coating

Kollidon^® VA 64 is used in sugar-coating to improve the adhesion of the coating to the surface of the tablet core and to increase the capacity of the coating solution for pigments and improve their dispersibility. However, Kollidon^® VA 64 helps not only in the application of sugar coatings but also in the automation of the sugar–coating process.

Application in topical sprays

Controlled-release preparations

Kollidon^® VA 64 is frequently cited in the literature as a matrix material for instant release and for sustained release dosage forms. Formulations with cellulose derivatives, polyacrylic acid, stearyl alcohol or polyhydroxyethyl methacrylate have been described for sustaining or controlling release. The formulations can be treated in various ways, e.g. freeze-dried or extruded, to produce a granulate, or melted and extruded, to produce pellets. Any relevant patents must be respected.

Hot melt extrusion processes

The solubility and bioavailability of poorly soluble APIs is often enhanced when they are molecularly dispersed in a polymeric carrier. This makes hot melt extruision (HME) a valuable technology for the pharmaceutical industry – and opens new doors for formulators working with promising actives that cannot otherwise be solubilized. HME also grants manufacturers a great amount of flexibility, as the viscous fluid obtained from the extrusion process can be directly shaped into any desired form. In addition, the extrudates usually have a high density, which makes them suitable for producing controlled-release dosage forms. Kollidon^® VA 64 is especially suitable for hot melt extrusion processes. In matrices it acts as solubilizing agent, dispersant, crystallization inhibitor as well as is suitable in immediate-release matrices.

Crystallization inhibitor for softgels

Product Details
Chemical name:	Vinylpyrrolidone-vinyl acetate copolymer
CAS-No:	25086-89-9
INCI:	PVP/VA Copolymer
Regulatory Status:	Kollidon^® VA 64 meets current Ph. Eur., USP monograph "Copovidone" and the JPE monograph "Copolyvidone"
Applications:	The main application is as soluble binder for granulation and as dry-binder in direct compression technology, as a film-forming agent in sprays and as pore-former in coating and taste-masking applications, as well as solubilizer in hot melt extrusion processes.
Solubility:	Kollidon^® VA 64 readily dissolves in all hydrophilic solvents. Solutions of more than 10% concentration can be prepared in water, ethanol, isopropanol, methylene chloride, glycerol and propylene glycol It is less soluble in ether, cyclic, aliphatic and alicyclic hydrocarbons.

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Related Process Technologies

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Melt Granulation

Melt granulation is a great process option in a formulators' biovailability enhancement arsenal. A meltable binder is used to agglomerate drug and other ingredients to reduce recrystallization potential through separation. BASF offer all functional materials required for a successful formulation using melt granulation.

Coating / Layering

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Crystallization Inhibition

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Direct Compression

Direct compression (DC) is the most economic way to produce a tablet as it is the shortest and most direct way to get from powder mix to final dosage form. BASF offers all functional excipients to successfully develop a DC process for your drug, including key elements like appropriate binder and lubricant.

Dry Granulation

Dry granulation is a great choice to produce solid oral dosage forms if cost and process efficiency are essiential. BASF offers the most effective dry binders available, along with all other functional materials and expertise required to help you develop your process successfully.

Hot Melt Extrusion

Hot-melt extrusion has been used in the plastics & food industries for decades. In the 1980s, BASF became the first company to apply it to the production of pharmaceuticals for enhancing the solubility and bioavailability of poorly soluble actives. Today, HME is an accepted process for creating solid dispersions of APIs.

Spray Drying

Spray drying is an established technology in the pharmaceutical industry to create amorphous, soluble forms of active ingredients. Key for a successful process is the use of the right functional polymer to ensure a stable solid dispersion. BASF offers a wide range of functional polymers to choose from, along with all other excipients typically used in the formulation.

Wet Granulation

BASF offers the key functional materials required to achieve great wet granulation results.

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Excipients for Parenteral Use

For our parenteral excipients we provide comprehensive documentation including toxicological assessments, regulatory & quality packages, certificates and more.

Foams

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A common way to improve the solubility of active ingredients is to formulate them in a liquid form - i.e. dispersion, solution, suspension or emulsion. Although each approach has its differences, they all share the need for functional excipients. BASF offers a comprehensive range of trusted functional excipients to make them work.

Ointments

BASF offers an extensive portfolio of excipients for topical formulations enabling you to create the ideal skin delivery solution for ointment formulation. We are committed to maintaining the highest level of quality. Our range of solubilizers and penetration enhancers support effective delivery of the target API - the number-one priority when designing any dermatological product.

Orally Disintegrating Tablets (ODT)

Orally disintegrating tablets (ODT), are an innovative solid oral dosage form that is becoming more and more important in the pharmaceutical market, both for prescription and over-the-counter medications. In contrast to classical tablets, ODTs are specifically designed to disintegrate directly in the patient's mouth.

Solid Dispersions

In a solid dispersion the drug is dispersed in a carrier with the system appearing to be in a solid state. Target is an increase in solubility & bioavailability. BASF offers both an comprehensive portfolio and process expertise to consult you in finding the best formulation for your poorly soluble drug using a solid dispersions.

Suppositories

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Transdermal Patches

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Instant & Modified Release Platform

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Solubilization Platform

Effective solubilization in solid & liquid dosage forms.

Kollidon® VA64

Benefits of Kollidon® VA 64

Applications for Kollidon® VA64