- Product description
- Product Registration Number: F20180000366Product Description
- Cross-linked povidone, also known as polyvinylpolypyrrolidone, is a homopolymer of N-vinyl-2-pyrrolidone. With N-vinyl-2-pyrrolidone as a monomer, a cross-linked povidone having a molecular weight of more than 1,000,000 can be obtained by a popcorn polymerization method.
- Cross-linked povidone is a white or off-white powder with almost no odor and hygroscopicity. Insoluble in water, ethanol, chloroform or ether. Due to the high microporous structure in the microstructure of crospovidone, it is larger than the surface, and the water absorption is high and rapid. It rapidly expands in water to produce high expansion pressure, and the swelling coefficient is 2.25-2.30, so it is excellent. The effect of super disintegrants. The nonionic disintegrant does not interact with the ionic drug to affect dissolution, and the disintegration performance is not affected by the pH of the gastrointestinal tract.
- Divided into XL and XL-10 models according to particle size distribution
- The disintegrant of tablets, capsules and dispersible tablets is used in the range of 2-5% in the tablet, and the dosage in the capsule is in the range of 10-20%.
- Excellent disintegration performance in wet, dry granulation and direct tableting formulations
- Applicable to internal addition, addition and internal and external addition
- Provide higher dissolution of cationic drugs
- It has high compressibility and can be used as a disintegrant for poor compressibility drugs.
- Lower dosage provides disintegration, especially for high-dose prescriptions
- Provides superior disintegration effects on hydrophobic drug formulations
- Increase tablet hardness and reduce friability
- Used in co-evaporation technology to solubilize drugs
- Finer granules give better taste to orally disintegrating tablets (ODT)
Different types of crospovidone have different water absorption rates and maximum water absorption.Precautions
- The impurities in the industrial grade cross-linked povidone are removed more cleanly through a special refining process; by pulverizing the process, the particle size distribution of the cross-linked povidone is more uniform, and a better content uniformity and fluidity can be achieved.
- The residual peroxide is lower. In the synthesis process of crospovidone, peroxide is produced, and excessive peroxide causes oxidation of the API and affects the safety of the formulated product. Through special refining process, our company can reduce the peroxide value of the product to below 400ppm, which can meet the standards of Chinese, European and American Pharmacopoeia at the same time to ensure the safety of the preparation.
- The residual monomer is low. The synthetic raw material of crospovidone is N-vinyl-2-pyrrolidone, which has an unpleasant odor. If there are more monomer residues in the final product, the product will emit an unpleasant odor and affect the use of the preparation. Our crospovidone products have a peroxide value of at least 0.5ppm.
- Lower water content and hygroscopicity. Cross-linked povidone has strong hygroscopicity, even in the workshops meeting the GMP conditions, there will be obvious moisture absorption, resulting in sticking and hardness instability. The larger the dosage, the more obvious the tablet will be restored by elasticity after water absorption. There is a phenomenon of one-sided protrusion. Therefore, through special packaging materials, our company can keep the water content of the product not more than 5.0%, and will not cause the product to absorb water due to transportation and storage.
- Better disintegration ability. In the European Pharmacopoeia, there are provisions for the functional indicators of crospovidone, mainly in hydration capacity and sedimentation volume. The cross-linked povidone produced by our company has a sedimentation volume of more than 60ml and a hydration capacity of between 3-9. It has excellent functionality and meets the disintegration requirements of the preparation.
- Different particle size specifications. According to the requirements of crospovidone in different preparations, we offer two different particle size specifications, RFXL and RFXL-10, which have met the R&D and production requirements of different formulations. The RFXL type cross-linked povidone has a 100% particle diameter of ≤400 μm, and the RFXL-10 type crospovidone has a 100% particle diameter of ≤74 μm.
- Strong wettability, sampling in a fast and dry environment during sampling and testing, and shortening the detection cycle as much as possible