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pH
Independent Polymer For Rapidly Disintegrating Film Coating.
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Description
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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.
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Use |
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For film coating of tablets, pellets, granules, powders. |
For controlled released tablets and pellets. |
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For granulation process and pelletization. |
For transdermal applications. |
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Features |
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Clear colourless transparent lacquer films are formed. Colours can be
given with pigment or food colours. Films permeable in gastric juices.
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Solubility |
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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.
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Applications |
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Coating of tablets, pills for protecting the drug from surrounding
environment, particularly air, moisture, light, thus retaining
required stability. |
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Masking unpleasant taste and odour, thus overcoming resistance to
drug ingestion. Providing product ‘identity’ for
differentiation of products from manufacturing, storage to patient.
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Imparting cosmetic elegance to product appearance, masking, any
noticeable visible differences in tablet core from batch to batch.
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Reducing risk of interactions between incompatible ingredients.
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Improves mechanical integrity, eliminating possibility of abrasions
chipping etc. |
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Isolating porous cores. |
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Extending and improving keeping properties. |
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To improve compression characteristic (hardness during tableting).
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Controlled Release Tablets |
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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.
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Transdermal Systems |
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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.
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Advantages |
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Less proportion of polymer is required. |
Low temperature for film formation. |
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Neutral (pH independent) film formation. |
Stability over a broad temperature range. |
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Exhibits excellent colour value and self shine shade. |
Marginal weight gain in tablets. |
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Hydrophobic. |
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Specification |
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Aqueous Enteric Coat L30D
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Appearance - White, milky liquid. |
Odour - Aromatic. |
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Content - 28.5 to 31.5% w/w dry polymer. |
Acid Value - Nil. |
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Solubility - Water or organic solvent - alcohols, acetone. |
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Toxicity |
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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.
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Plasticizer |
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Controlled/Sustained Release Coat S100 film are brittle to improve
elasticity, use of plasticizer is strongly recommended. The
recommended plasticizer are poly-ethylene glycol, dibutyl phthalate,
Castor Oil, diethyl phthalate, triacetin, triethyl citrate etc…
usually 10% of plasticizer will sufficient, but if necessary, can be
increased to 25%
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Average Requirement |
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8.5 gms. Film Coat E30D per 1 kg. tablets for film coating
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Precaution |
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Coagulation may occur due to electrolytic effect, pH changes, foam
formation, frost, and by high speed stirring.
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Storage |
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At low temperature not exceeding 350c. Keep away from frost.
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Shelf Life |
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Two years from the date of manufacturing.
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Packing |
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5 kg., 20 kg., net in H.D.P.E. drum.
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Certificate of Analysis |
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| 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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