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PolyStardone® XL

CAS Number
9003-39-8
EC Number
618-363-4
Chemical Name
Polyvinyl Pyrrolidone Copolymer

PolyStardone® XL 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

Healthcare & Pharma — Drug Delivery & Care Solutions
  • Oral

Product Families

Pharmaceuticals & Nutraceuticals — Excipients
  • 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

11 rows
CharacteristicValueUnit
NameCrospovidone (PVPP)—
Peroxidesmax. 100ppm
Molecular formula(C6H9NO)n—
NVPmax. 10ppm
CDE register numberF20180000229—
Sulfated ashmax. 0.1%
Water-solube substancesmax. 1.5%
Typical D50100-120μm
Loss on dryingmax. 5.0%
Nitrogen11.0-12.8%
Typical peroxidemax. 100ppm

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