Stardone® VA64

Identification & Functionality

Chemical Name

Copovidone

Pharma & Nutraceuticals Functions

Binder,

Film Former

CAS No.

25086-89-9

EC No.

607-540-1

Technologies

Pharmaceuticals & Nutraceuticals

Product Families

Pharmaceuticals & Nutraceuticals — Excipients

Binders & Disintegrants,

Pharmaceutical Coatings

Features & Benefits

Features

Physical Properties:
Non-ionic polymer
Low hygroscopic
Good plastic deformation
Good fluidity and compressibility
Low glass transition temperature

Performance Impact:

No interaction with ionic APIs
The vinyl acetate component in Stardone®VA64 reduces the hydrophilicity
The vinyl acetate component has greatly improved the plasticity of Stardone®VA64, making it exceptionally well as a binder for direct compression
Hollow particle morphology provides good fluidity of Stardone®VA64, and large surface area enhances the bonding and compressibility of particles
Ideal glass transition temperature(Tg) for hot melt extrusion

• Direct Compression : Excellent binder at 2-10% with other direct compression binder-fillers such as MCC, dicalcium phosphate, etc.
• Dry Granulation :Can be used as a binder in dry granulation(roller compaction).
• Wet Granulation:Enables wet granulation of moisture sensitive due to low hygroscopicity.
• Hot Melt Extrusion: Acts as a polymer matrix for solid dispersions/solutions via hot melt extrusion due idea glass transition temperature at 105℃
• Film Coating: Ideally suited as co-film-former

Summary

A direct compression formulation of acetylsalicylic acid was achieved with Stardone®VA64. Although acetylsalicylic acid is known to be poorly compressible, the formulation resulted in robust tablets with low friability at all compaction forces, as well as good disintegration times. Stardone®VA64 has similar performance to import competitor A and import B in terms of tablet hardness, friability, and disintegration time.

Applications & Uses

Markets

Healthcare & Pharma

Applications

Healthcare & Pharma — Drug Delivery & Care Solutions

Oral

Manufacturing Technology

Direct Compression,

Dry Granulation,

Wet Granulation

Properties

Physical Form

Powder,

Solid

Regulatory & Compliance

Certifications & Compliance

Chinese Pharmacopeia (ChP),

European Pharmacopeia (Ph. Eur.),

Japan Pharmacopeia (JP),

National Formulary (NF),

United States Pharmacopeia (USP)

Grade

Pharma Grade

Technical Details & Test Data

Technical Analysis

Case Study

A direct compression formulation of acetylsalicylic acid, a poorly compressible API, was selected to compare the functionality of Stardone®VA64 against other PVP/VA 64 products on the market.

Tablet Data (n=6)

Packaging & Availability

Packaging Type

Bags,

Drums