Tablet disintegration involves the fast breakage of a solid dosage structure via contact with water or gastric fluids. It enables dissolution of the bio-active components as a prerequisite for achieving the desired and required bioavailability. VIVAPHARM® PVPP, Crospovidone, is unsurpassed in its performance and versatility as a superdisintegrant in formulations.
VIVAPHARM® PVPP is made up of water-insoluble synthetic crosslinked homopolymers of N-vinylpyrrolidone (Figure 1).
It combines different mechanisms to achieve rapid tablet disintegration at low concentrations (1-5%). Due to its viscoelasticity, VIVAPHARM® PVPP is highly compactable, resulting in robust tablets with increased tensile strength and reduced friability. Scanning electron microscope images of VIVAPHARM® PVPP show a granular and porous structure with a large surface area. It enhances the dissolution of poorly soluble drug actives and due to its non-ionic property, it does not bear any risk of interaction with cationic APIs.
- Granular and highly porous
- Viscoelastic deformation
- High cross-link density
- Free-flowing powder
- High surface area to volume ratio
- Non-ionic polymer
VIVAPHARM® PVPP is available in two particle sizes to serve different application requirements.
|Products||Compendial Type||Typical Average Particle Size [µm]|
|VIVAPHARM® PVPP XL||Type A||125|
|VIVAPHARM® PVPP XL-10||Type B||30|
- Rapid disintegration at low concentrations (1-5%)
- Functions via a combination of disintegration mechanisms: wicking, shape recovery, and swelling, thus imparting its unsurpassed versatility as a superdisintegrant in formulations
- Suitability for direct compression, wet granulation, and dry granulation
- Increased tablet tensile strength and reduced friability due to high compressibility
- No gel formation even at higher concentrations (10%) – ideal for ODTs
- Non-ionic polymer – no ionic interaction with cationic APIs to retard drug release, unlike anionic disintegrants, which may slow dissolution due to interaction with cationic APIs (i.e. Ranitidine, Cetirizine)
VIVAPHARM® PVPP XL
- The standard superdisintegrant for all immediate release tablet formulations.
- A larger particle size and increased porosity leads to rapid wicking and swelling and thus, rapid disintegration.
VIVAPHARM® PVPP XL-10
A finer particle size makes this grade suitable for ODTs and chewable tablet formulations that require smooth mouthfeel and rapid disintegration.
Ideal intra and extra-granular super-disintegrant due to high wetting capacity without gel formation during the granulation process.
Ideal intra- and extra-granular super-disintegrant due to excellent compressibility and high surface area to volume ratio.
Free-flowing property translates to easy handling. Unique, viscoelastic characteristic results in high compressibility which increases tablet tensile strength and reduces friability. Especially suitable for poorly compressible APIs.
Dissolution and bioavailability enhancement of poorly water-soluble BCS Class II APIs, e.g. Mefanamic acid or BCS Class IV, e.g. Furosemide. Solubility and dissolution efficiency can be even more enhanced in combination with PVP K30.
- Conforms to the current Ph. Eur., USP/NF and JP/JPE
- Certificate of Suitability (CEP) by the EuropeanDirectorate for the Quality of Medicines & HealthCare (EDQM)
- DMFs are filed with the US Food and Drug Administration (FDA)
- Halal and Kosher compliant
- Listed in the Inactive Ingredient Database (IID) on the FDA website as an approved ingredient in New Drug Applications (NDA)
- VIVAPHARM® PVPP is listed by the European authorities (E 1202) and in the Food Chemicals Codex (FCC) by the FDA for its application in nutraceutical tablets such as vitamins, herbal extracts, sweeteners, etc.
- Regulatory approvals in all major markets including: USA, Europe, Japan, Mexico, Australia, India, China, and many more
PACKAGING, SAMPLES AND STORAGE
Store in original container. Protect from excessive heat and moisture. Opened containers should be reclosed and stored in a manner which minimizes exposure to oxygen.
All Povidone, Copovidone, and Crospovidone products are known to form peroxides upon prolonged exposure to oxygen. As part of our commitment to ensuring the quality and stability of our products, VIVAPHARM® PVPP is packaged in 20 kg drums with multifoil LDPE/EVOH inliners under tightly controlled packaging conditions. EVOH has been carefully selected due to its outstanding gas barrier properties. Minimizing the entry of oxygen into the primary packaging minimizes the potential of peroxide formation. LDPE remains as the product contact layer. The choice of packaging has a significant impact of prolonging the shelf-life and guaranteeing the stability of VIVAPHARM® PVPP.