» 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.
- For film coating of tablets, pellets, granules, powders.
- For granulation process and pelletization.
- For controlled released tablets and pellets.
- For transdermal applications.
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.
- Coating of tablets, pills for protecting the drug from surrounding
environment, particularly air, moisture, light, thus retaining required
- 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
- 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
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
- 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.
- 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.
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.
8.5 gms. Film Coat E30D per 1 kg. tablets for film
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
Two years from the date of manufacturing.
5 kg., 20 kg., net in H.D.P.E. drum.
Certificate of Analysis
||An Opaque, White, Slightly
||An Opaque, White, Slightly
||Miscible With Water, Soluble In
Acetone, Ethanol. Ipa.
||1.037 To 1.047
||Nmt 50 M Pa. S
|Appearance Of A Film
|Residue On Evaporation
||28.5% To 31.5%
||Nmt 10 Ppm
||Total Viable Aerobic Count Nmt
103 Micro Organisms Per Gram