Crospovidone
(Croslinked PVP)

Crospovidone

Crospovidone, also known as Crosslinked PVP or PVPP, is presented as a white or creamy white powder with a slight characteristic odor. Its hydrophilic nature allows it to form complexes with substances like phenol, enhancing its utility in various applications. Notably, due to its high crosslink density, it remains completely insoluble and does not form gels that could hinder disintegration, dissolution, or drug release processes. This unique combination of properties has led to its acceptance in significant pharmacopeias, including Ph Eur 5.0 and USP/NF 28th editions.

Product Details

01

Overview

Crospovidone, known for its white or creamy white powder form with a faint characteristic odor, is extensively utilized in both the beverage and pharmaceutical industries due to its unique properties. In the beverage sector, PVPP plays a critical role in enhancing the quality and shelf-life of beers by efficiently absorbing polyphenyls and tannoids, preventing the undesirable ‘pinking’ and ‘browning’ in white and sparkling wines, and enriching the aroma and flavor profiles of red wines. Its application is hailed as a cost-effective and safe solution in the beer industry, thanks to its complete insolubility in the beverage, suitability across all beer types, and minimal dosage requirement for higher efficacy.

Additionally, Crospovidone’s ease of use, excellent handling characteristics, and positive impact on dispersion and sedimentation further streamline production processes, offering improved filter run lengths and compatibility with existing equipment, all without compromising the beer’s foam, flavor, or other quality aspects.

In the realm of pharmaceuticals, Crospovidone’s hydrophilic nature ensures rapid disintegration in a broad spectrum of oral solid dosage formulations, making it particularly valuable in wet granulation tablet processes, and for use with poorly compressible drug actives in direct compression tablet processes. It showcases outstanding performance in manufacturing tablets with ionic, acidic, and alkaline drug actives, including quick dissolve and chewable tablets, and is effective in treating gastrointestinal disorders as an anti-diarrhea agent.

Beyond human healthcare, PVPP’s ability to enhance solubility and, consequently, bioavailability extends to veterinary applications, underscoring its versatility and essential role in improving drug efficacy and patient outcomes across the board.

02

Pharmaceutical Grade Crospovidone

Our pharmaceutical-grade Crospovidone, with its hygroscopic nature, comes in Type A and B, differentiated by particle size for specific applications. It excels in absorbing moisture quickly without dissolving, making it ideal for uses requiring fast moisture uptake. Insoluble in water, acids, alkalis, and most solvents, it’s versatile and safe, thanks to its non-toxic and chemically inert properties. Additionally, it boasts excellent flowability, plasticity, and compressibility. Compliant with major pharmacopeias like USP/NF, EP, BP, JPE, and CP2010, PVPP is a reliable choice across various industries.

Main Applications:

Our PVPP products are extensively utilized in the pharmaceutical industry for their exceptional versatility and performance in several key applications:

  1. Super Disintegrant: Applied within formulations to rapidly swell and disintegrate the preparation, significantly enhancing drug dissolution and bioavailability. Our PVPP is adaptable for both wet granulation and direct compression processes. The choice of particle size affects disintegration time and the appearance of tablet surfaces, allowing for tailored application based on specific manufacturing needs.

  2. Adsorbent and Complexing Agent: In formulations, it acts by stabilizing active pharmaceutical ingredients through complexation, improving drug release rates and bioavailability. The varying particle sizes of our product lead to noticeable differences in drug release, offering flexibility in formulation design to achieve desired release profiles.

  3. Suspension Stabilizer: It minimizes the settling of drug particles and enhances the re-dispersibility of settled liquids in suspensions, ensuring uniformity and consistency in liquid formulations.

  4. Complexant for Polyphenols and Tannins: Especially useful in extract formulations, our PVPP binds with polyphenols and tannins, stabilizing these components and improving the formulation’s stability and effectiveness.

Application Features:

Our Crospovidone showcases a unique molecular structure characterized by a highly physically crosslinked network. This structure endows it with exceptional capillary activity, allowing it to absorb water swiftly. It boasts a large specific surface area, providing a strong capacity for water absorption and expansion without forming a high-viscosity gel.

This product exhibits excellent plastic deformability and fluidity, ensuring good compressibility. Notably, the disintegration time of tablets is minimally affected by compression force, making it a reliable choice for consistent disintegration performance in pharmaceutical formulations.

Moreover, our Crospovidone demonstrates robust reprocessing capabilities. Even after several wetting/drying cycles, it retains its full potential to rapidly disintegrate, ensuring the sustained effectiveness of the pharmaceutical products in which it’s used. This combination of properties makes Crospovidone an indispensable component in the development of high-quality, effective pharmaceutical applications.

Specifications:

Product

Crospovidone Type A

Crospovidone Type B

Appearance

White or yellowish-white powder or flakes

Identification

Meet ID Tests

Solubility

Practically insoluble in water,in alcohol and in methylene chloride

Water-soluble substance

1.0% max

1.0% max

pH(1% in water)

5.0 –8.0

5.0 –8.0

Loss on Drying

5.0% max.

5.0% max.

Sulphated Ash

0.1% max.

0.1% max.

Nitrogen content

11.0 -12.8 %

11.0 -12.8 %

Impurity A

10 ppm max.

10 ppm max.

Peroxide(As H2O2)

400 ppm max.

1000 ppm max.

Heavy Metal

10 ppm max.

10 ppm max.

Particle Size(μm), ≥80%

50-300

5-50

03

Food Grade Crospovidone

Our food-grade Copovidone product addresses a common challenge in the beer industry: sedimentation over time, even after filtration, which limits the shelf life of beer. This issue is primarily due to polyphenols in beer, which have a strong propensity to cause haze. By effectively removing these polyphenolic compounds, our Copovidone not only prevents the formation of unstable haze but also significantly enhances the beer’s clarity and sensory appeal. The result is a noticeable improvement in both the visual and taste experiences of the beer, extending its shelf life and maintaining its quality for a longer period. This solution presents a valuable advancement for brewers seeking to ensure their beer remains clear, refreshing, and enjoyable well beyond the traditional storage timeline.

Mechanism of beer clouding:

Fresh beer contains a simple structure of flavanoid polyphenols and various proteins, these polyphenols and proteins can easily form weak hydrogen bonds between them, thus forming compounds, which are invisible to the naked eye due to their small relative molecular mass. These compounds are invisible to the naked eye due to their small relative molecular mass. 3 to 6 weeks later, these flavanes are oxidized and polymerized to form a polyphenol-protein complex with every 3 to 4 chain segments. The polyphenol-protein complexes are capable of producing gelatinous particles that can be seen with the naked eye. Since the hydrogen bonds holding the polyphenols together are weak, the bonds break when the temperature rises, and the cloudiness disappears, a phenomenon known as “cold clouding”.

As the storage period increases, some ionic and covalent bonds are formed between the flavanes and the proteins, and since these bonds are strong, an increase in temperature cannot cause them to break, so a permanent precipitate is formed.

Mechanism of action for polyphenol removal:

Polyphenols contain a large number of hydroxyl groups, and the carbonyl group in PVPP adsorbs these polyphenols by forming hydrogen bonds with them, and removes them by filtration.

Specifications:

Product

PVP-P

Appearance

White to off-white,hygroscopic,free-flowing powder

Nitrogen Content

11.0-12.8%

Lead

2 ppm max.

Arsenic

3 ppm max.

Heavy Metals

10 ppm max.

pH(1% Suspension)

5.0-8.0

Residue on Ignition

0.4% max.

Peroxides

400 ppm max.

N-Vinylpyrrolidone

10 ppm max.

N,N’-Divinyl-imidazolidone

2pp max.

Water-Soluble substance

0.5% max.

Acid/Ethanol Soluble substances

1.0% max.

Water

5.0% max.

Particle Size

Based on Data Sheet

04

Storage & Transport

Storage: It should be stored indoor in a well ventilated and dry room. Prevent exposure to dampness, sunlight and rain.

Transportation: During transportation, the products should be moved gently to prevent damaging the packing drums. Avoid direct contact with naked flame, when they are caught with a fire, use any fire extinguishers to put out the fire.

05

Inquiry & Sample Request

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