Libraw PharmaLibraw Pharma
Manufacturer & Exporter of Binding Agent, Lubricants, Solublisers, Coatings, Disintegrant & Super Disintegrant.
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Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.
Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.
Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.

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Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Film Coating PolymerLibraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.

pH Independent Polymer For Rapidly Disintegrating Film Coating.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Description

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.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Use

¤ For film coating of tablets, pellets, granules, powders.
¤ For granulation process and pelletization.
¤ For controlled released tablets and pellets.
¤ For transdermal applications.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Features

Clear colourless transparent lacquer films are formed. Colours can be given with pigment or food colours. Films permeable in gastric juices.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Solubility

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.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Applications

¤ Coating of tablets, pills for protecting the drug from surrounding environment, particularly air, moisture, light, thus retaining required stability.
¤ Masking unpleasant taste and odour, thus overcoming resistance to drug ingestion. Providing product ‘identity’ for differentiation of products from manufacturing, storage to patient.
¤ Imparting cosmetic elegance to product appearance, masking, any noticeable visible differences in tablet core from batch to batch.
¤ Reducing risk of interactions between incompatible ingredients.
¤ Improves mechanical integrity, eliminating possibility of abrasions chipping etc…
¤ Isolating porous cores.
¤ Extending and improving keeping properties.
¤ To improve compression characteristic (hardness during tableting).

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.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.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.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.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Advantages

¤ Less proportion of polymer is required.
¤ Low temperature for film formation.
¤ Neutral (pH independent) film formation.
¤ Stability over a broad temperature range.
¤ Exhibits excellent colour value and self shine shade.
¤ Marginal weight gain in tablets.
¤ Hydrophobic.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Specification

¤ Appearance - White, milky liquid.
¤ Odour - Aromatic.
¤ Content - 28.5 to 31.5% w/w dry polymer.
¤ Acid Value - Nil.
¤ Solubility - Water or organic solvent - alcohols, acetone.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Toxicity

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.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Plasticizer

Plasticizer are not necessary but permeabilities of polymer can be regulated by addition of polyethylene glycois, vinyl alcohol or pyrolidone as water soluble additives.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Average Requirement

8.5 gms. Film Coat E30D per 1 kg. tablets for film coating.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Precaution

Coagulation may occur due to electrolytic effect, pH changes, foam formation, frost, and by high speed stirring.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Storage

At low temperature not exceeding 350c. Keep away from frost.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Shelf Life

Two years from the date of manufacturing.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.Packing

5 kg., 20 kg., net in H.D.P.E. drum.

Libraw Pharma - Manufacturer and Exporter of Binding Agent and Coating Polymers.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
Conforms
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

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