PolyStardone® XL-10
PolyStardone® XL-10 is unsurpassed in its performance and versatility as a super disintegrant in formulations. It enables dissolution of the bio-active components as a prerequisite for achieving the desired and required bioavailability. PolyStardone® has good compressibility and fluidity, which can be applied to wet granulation, dry granulation and direct compression technologyAs a super disintegretant, it will not form gel and can effectively improve the disintegration time.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Disintegrant
Product families
Applications
- Oral
Product Families
- Binders & Disintegrants
Other characteristics
- Brand
- PolyStardone
- Synonyms
1-Vinyl-2-pyrrolidinone polymer, 1-Vinyl-2-pyrrolidone homopolymer, 1-Vinyl-2-pyrrolidone polymer, 1-Vinylpyrrolidin-2-one homopolymer, n-Octyl mercaptan-N-vinylpyrrolidone copolymer, N-Vinyl-2-pyrolidone homopolymer, N-Vinyl-2-pyrrolidinone homopolymer, N-Vinyl-2-pyrrolidone homopolymer, N-Vinyl-2-pyrrolidone polymer, N-Vinylbutyrolactam polymer, N-Vinylpyrrolidinone homopolymer, N-Vinylpyrrolidinone polymer, N-Vinylpyrrolidone homopolymer, N-Vinylpyrrolidone polymer, Poly(1-vinyl-2-pyrrolidinone), Poly(1-vinyl-2-pyrrolidone), Poly(1-vinylpyrrolidinone), Poly(N-vinyl-2-pyrrolidinone), Poly(N-vinyl-2-pyrrolidone), Poly(N-vinyl-γ-butyrolactam), Poly(N-vinylbutyrolactam), Poly(N-vinylpyrrolidinone), Poly(N-vinylpyrrolidone), Poly(vinylpyrrolidinone), Poly(vinylpyrrolidone), Polyvinyl polypyrrolidone, Polyvinylpyrrolidone, Povidone, Vinylpyrrolidinone polymer, Vinylpyrrolidone homopolymer, Vinylpyrrolidone polymer
- Functions
- Disintegrant
- Certifications & Compliance
Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Summary
The case study demonstrates the effectiveness of PolyStardone® as a super disintegrant for a tablet matrix containing both water-soluble (lactose) and insoluble (dibasic calcium phosphate), mediumcompactable fillers. The performance of PolyStardone® was compared to other crospovidone products in the market. We believe that: PolyStardone® XL and PolyStardone® XL-10 have similar performance to import competitor A and import B, and are better than domestic competitor C and D in terms of compactibility and disintegration capabilities. In this case, PolyStardone® XL ensures rapid disintegration regardless of compaction force. Furthermore, PolyStardone® XL-10 offers additional benefits in increasing tablet tensile strength without a compromise in its disintegration efficiency.
- Features
Physical Properties : Non-ionic polymer High porosity and hydration Easy compression and viscoelastic deformation No gel formation Stable in acids and bases; Performance Impact :; No interaction with ionic APIs (i.e. Ranitidine, Cetirizine) Combines wicking and swelling mechanisms to achieve rapid tablet disintegration at low concentrations(1-5%) Increased tablet tensile strength and reduced friability due to high compressibility. Especially suitable for poorly compressible APIs No gel formation even at higher concentrations (10%), idea for ODTs Suitable for a variety of pH sensitive formulations
- Appearance
- White or yellowish-white powder
- Application
Insoluble in water or common organic solvents, the powder particles are porous microstructures with high specific surface area.. As a super disintegretant, it will not form gel and can effectively improve the disintegration time.
- Dosage Form
- Powder & Powder Blends
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Drums
- Packaging and Storage
Packed in 20 kg fiber drum or 15 kg plastic drum, inner lined with PE bags; Special packing is available according to customer's requirement; Preserve in tight containers
- Certifications and Compliance
- Chinese Pharmacopeia (ChP)
- European Pharmacopeia (Ph. Eur.)
- Japan Pharmacopeia (JP)
- National Formulary (NF)
- United States Pharmacopeia (USP)
Technical data
Table 1 of 1
10 rows| Characteristic | Value | Unit |
|---|---|---|
| Name | Crospovidone (PVPP) | — |
| Water-solube substances | max. 1.5 | % |
| Molecular formula | (C6H9NO)n | — |
| Loss on drying | max. 5.0 | % |
| CDE register number | F20180000229 | — |
| Nitrogen | 11.0-12.8 | % |
| NVP | max. 10 | ppm |
| Typical peroxide | max. 100 | ppm |
| Sulfated ash | max. 0.1 | % |
| Typical D50 | 25-35 | μm |
