One olymer for pplicationsP Multiple A

VIVAPHARM PVA®

Poly(vinyl alcohol), Ph. Eur. / Polyvinyl Alcohol, NFPartially Hydrolyzed Polyvinyl Alcohol, JPE

Tablet CoatingWet Granulation

Hotmelt ExtrusionM Moreany

2

Introduction

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VIVAPHARM PVA®

Polyvinyl Alcohol

Fig 1 Chemical tructure of. S VIVAPHARM PVA fine® 05

The main characteristics of VIVAPHARM PVA fine® 05

are degree of hydrolysis and degree of polymerization.Solubility is controlled by the degree of hydrolysis and ishighest at 88 mol% hydrolysis. Viscosity is controlled bythe degree of polymerization. A low degree of polymer-ization indicates low viscosity.

VIVAPHARM PVA fine® combines high water solubili-05

ty with low viscosity making it perfectly suited for tabletcoating and wet granulation.

VIVAPHARM PVA fine® is supplied as free flowing05

powder. Due to its non-ionic property, risk ofthere is nointeraction with ionic APIs.

Physico-Chemical Properties

� Excellent ilm ormerF F

� High oisture & as arrierM G B

� Highly dhesive at ow iscosityA L V

� Soluble in aterW

� High urityP

� Chemical tably S le

� Non-toxic

Tab. 1 VIVAPHARM PVA fine® 05Specification of

VIVAPHARM PVA fine® 05

Degree of Hydrolysis (mol%) 85-89

Viscosity (4 % , mPas) 4.6-6.0in water

pH (4 % in water) 5.0-6.5

Type fine powder

Benefits

• Tablet Coating:

M B PExcellent oisture arrier erformance

O M AGood dor asking bility

BOxygen arrier

V E H S C CLow iscosity nabling igh olid ontent in oatingSuspensions

A TGood dhesion to ablets

• Wet Granulation:

P L VHigh roductivity because of ow iscosity

A S E L BHigh dhesive trength nables ow inderConcentration

T H L FHigh ablet ardness and ow riability

C H D L dsPrevention of apping especially at igh rug oa

PNo eroxides

Polyvinyl Alcohol is a well-established polymer in thepharmaceutical industry. Due to its unique properties,it is used in various applications. The most widely usedapplications are tablet coating and wet granulation,but PVA also plays an important role in solubilityenhancement, transdermal patches and emulsions.VIVAPHARM PVA fine

® is a water soluble synthetic05polymer. It is synthetized by polymerization of inyl-vacetate and subsequent partial hydrolysis.

CH2 CH

OH

CH2 CH

OC=0CH3

m n

hydrophobichydrophilic

3 www.jrspharma.com

500 µmFig. 2 Typical Scanning Electron Micrograph of VIVAPHARM PVA fine

® 05

Applications

• Tablet Coating

• Moisture and xygen arrierO B

• Wet Granulation

• Hotmelt Extrusion

• Thickener

• Emulsions

• Transdermal Patches

Statements:

ISO 9001; ISO 14001

BSE/TSE free

GMO free

Regulatory Information

VIVAPHARM PVA fine® 05 is produced according to the

GMP guideline issued by IPEC Japan. VIVAPHARM PVA®

05 fine conforms to the current Ph.Eur., USP/NF, JPE.

US Drug master file: No. 30236.

Listed in the Inactive Ingredient Database (IID) on theFDA as an approved ingredient in New Drug Applications.

VIVAPHARM PVA fine® 05 is listed by the European

authorities (E 1203) and in the Food Chemicals Codexby the FDA.

Packaging, Storage and Samples

Packaging:VIVAPHARM PVA fine

® 05 is packaged in 20 kg kraftpaper bag with polyethylene inliner. The inliner and theouter bag are heat-sealed separately. The outer bagscan be easily opened with tear tape and stripped.

Storage:sProtect from excessive heat and moisture.

Opened containers should be re-sealed.

Sample Size:500 g

Case Studies:Case studies are available upon request.

contactPlease contact your sales for more information.

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www.jrspharma.comJRS PHARMA GMBH & CO. KGBusiness Unit Coatings andMR Technologies73494 Rosenberg (Germany)Phone: +49 7967 152-444Filmcoating@JRSPharma.de