pH Independent Polymer For
Rapidly Disintegrating Film Coating.
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.
Use
¤ For film coating of tablets, pellets, granules, powders.
¤
For granulation process and pelletization.
¤ For controlled
released tablets and pellets.
¤ For transdermal applications.
Features
Clear colourless transparent lacquer films are formed. Colours can be
given with pigment or food colours. Films permeable in gastric juices.
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.
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).
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.
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.
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.
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.
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.
Average
Requirement 8.5 gms. Film Coat E30D per 1 kg. tablets for film
coating.
Precaution
Coagulation may occur due to electrolytic effect, pH changes, foam
formation, frost, and by high speed stirring.
Storage
At low temperature not exceeding 350c. Keep away from frost.
Shelf
Life Two years from the date of manufacturing.
Packing
5 kg., 20 kg., net in H.D.P.E. drum.
about
us
Film
Coating Polymer
