Libraw Pharma
Libraw Pharma
Libraw PharmaLibraw PharmaLibraw Pharma
Libraw Pharma
Libraw Pharma
Home » Tablets » Film Coating Polymer

Film Coating Polymer

Film Coat E30D is an aqueous dispersion of a neutral co-polymer which confirms to Ph. Europe. Solubility is not pH dependent and films readily permeable in gastric juices.
Clear colourless transparent lacquer films are formed. Colours can be given with pigment or food colours. Films permeable in gastric juices.
The aqueous dispersion is miscible with water in any proportion. A clear or slightly opalescent viscous can be obtained by mixing one part of Film Coat E30D with five parts of acetone or isopropanol.
Controlled Release Tablets
As a binder of film former in the manufacture of porous matrix tablets (wet granulation) with delayed release of the active substance. As a film former, mixed with other dispersions to control permeability.
Transdermal Systems
To regulate release of drug from transdermal systems on the membrane principle. Odour - Weakly aromatic. ¤ To improve the skin tolerability of trnasdermal therapeutic systems with occlusive properties.
Film Coat E30D is a high molecular weight polymer. It is not absorbed by the body tissues and is totally safe for human oral consumption. Test for toxicological tolerance show that it does not have any pronounced physiological action and is non-toxic.
Plasticizer are not necessary but permeabilities of polymer can be regulated by addition of polyethylene glycois, vinyl alcohol or pyrolidone as water soluble additives.
Average Requirement
8.5 gms. Film Coat E30D per 1 kg. tablets for film coating.
Coagulation may occur due to electrolytic effect, pH changes, foam formation, frost, and by high speed stirring.
At low temperature not exceeding 350c. Keep away from frost.
Shelf Life
Two years from the date of manufacturing.
5 kg., 20 kg., net in H.D.P.E. drum.
Certificate of Analysis
Test Specification Results
Description An Opaque, White, Slightly Viscous Liquid An Opaque, White, Slightly Viscous Liquid
Solubility Miscible With Water, Soluble In Acetone, Ethanol. Ipa. Conforms
Identification A. Complies
B. Complies
C. Complies
D. Complies
Relative Density 1.037 To 1.047 Conforms
Appearance Viscosity Nmt 50 M Pa. S 6 Cps
Appearance Of A Film Complies Complies
Particular Matter Complies Complies
Residue Monomers Nmt 0.1% 0.00545%
Residue On Evaporation 28.5% To 31.5% 30.4%
Heavy Metals Nmt 10 Ppm Complies
Sulphated Ash Nmt 0.04% Complies
Microbial Contamination Total Viable Aerobic Count Nmt 103 Micro Organisms Per Gram Complies