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Stardone® K30 is a classic wet binder with optimal balance between adhesive strength and ease of handing. It is the ideal binder in all wet granulation processes by any of the methods like wet addition as granulation solution(binder + solvent), Dry addition as Dry mixture of API and binder, Solvent is added to the dry mix, Combination with Some binder is mixed with the API, and the rest is dissolved in the granulation solution with the preferred choice if the amount of solvent is restricted.

Chemical Name: Polyvinyl Pyrrolidone Copolymer

CAS Number: 9003-39-8

Functions: Binder, Dispersant, Film Former, Stabilizer

Dosage Form: Tablets

Certifications & Compliance: Chinese Pharmacopeia (ChP), European Pharmacopeia (Ph. Eur.), Japan Pharmacopeia (JP), National Formulary (NF), United States Pharmacopeia (USP)

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

Technical Data Sheet

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Knowde Enhanced TDS

Identification & Functionality

Pharma & Nutraceuticals Functions
CAS No.
9003-39-8
EC No.
618-363-4

Features & Benefits

Product Properties
  • Excellent solubility
  • water and a range of organic solvents
  • Low viscosity solution
  • High binding efficiency
  • Forming complex with APIs
  • Non-ionic polymer
Summary

In this case, Stardone® K30 has similar performance to that of import competitor A and B, and is better than domestic competitor C and D in terms of tablet compressibility, tensile strength, friability, and disintegration time.

Applications & Uses

Dosage Form
Performance Impact
  • Fast dispersibility in solvents (including water). Aqueous solution are preferred to solvent-based systems but may not be suitable for drugs which are degraded hydrolysis. Hence solubility in a range of organic solvents is favorable.
  • Ease of handing→high viscosity binder solution may cause clogging of spray nozzle
  • Lower use levels required to produce tablets with higher breaking force and lower friability at potentially lower compaction force
  • No effect on drug dissolution, can improve the drug dispersion and water solubility
  • no contraindication risk of compatibility with ionic pharmaceutical ingredients

Properties

Physical Form

Regulatory & Compliance

Technical Details & Test Data

Technical Analysis

Chongqing Star-Tech Specialty Products Stardone K30 Technical Analysis

Formulation Result of Naproxen

Chongqing Star-Tech Specialty Products Stardone K30 Formulation Result of Naproxen - 1

Chongqing Star-Tech Specialty Products Stardone K30 Formulation Result of Naproxen - 2

Case Study

Naproxen, whose bioavailability is rate-limited due to its poor solubility was chosen as a model API. It is typically wet granulated because of its poor compactibility. In many cases, the addition of other binder-fillers before tableting is necessary in order to achieve suitable tablet hardness with low friability. In this case study, wet granulation of Naproxen was performed with 5% of Povidone K30 as a binder solution.
Stardone®K30 against other similar products on the market was compared.

Packaging & Availability

Packaging Type