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For Enteric Coating When Solubility
From Ph 6.0 Upwards Is Required.
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Description
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ENTERIC COAT L 100 is an anionic co-polymer which confirms to USP/NF
specifications of "METHACRYLIC ACID CO-POLYMER" TYPE A. It is
insoluble in acids and pure water, soluble in neutral to weakly alkaline
medium.
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Use |
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Enteric film coating of tablets, pills, pellets, granules, powder
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Features |
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Appearance : ENTERIC COAT L 100 films are colorless and
transparent, desired colour can be given with pigments.
Solubility : Insoluble in water, in buffer solution below pH 6.0
natural gastric fluids. Soluble in the region of the intestinal tract,
where the fluids are neutral to weakly alkaline and in buffer solutions
above pH 6.0
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Applications |
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Enteric coating for resistance to gastric fluid, (to protect active
drug from influence of acids, prevent irritation of gastric mucosa). |
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Film 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. |
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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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Insulating hygroscopic cores. |
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Isolating porous cores. |
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Extending and improving keeping properties. |
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Advantages |
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Option of solvent or semi aqueous media. |
Less quantity required, reducing volume of solution, so
shortning production time. |
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Stability over a broad temperature range. |
Exhibits excellent colour value and self shine shade. |
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Marginal weight gain in tablets. |
Hydrophobic. |
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Specification |
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Appearance - White, fine, free flowing powder. |
Odour - Weakly aromatic. |
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Content - Min. 95% dry polymer. |
Acid Value - 300 - 330 mg KOH/gm. dry substance. |
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Solubility - Isopropyl alcohol, acetone, methanol, ethanol,
methanol/water etc.. |
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Toxicity |
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ENTERIC COAT L 100 is a high molecular weight polymer. It is not
absorbed by 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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Grades |
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ENTERIC COAT L 100 - Powder form.
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Alternatives |
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ENTERIC COAT L 30D aqueous dispersion can be also be adopted by
aqueous coating systems. For advantages of aqueous ENTERIC COATING
CLICK L 30D.
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Plasticizer |
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ENTERIC COAT L 100 film are brittle in nature. So to improve film
elasticity use of plasticizer is strongly recommended. The
recommended plasticizers are polyethylene glycol, Castor Oil,
dibutyl phthalate, diethyl phthalate, triacetin, triethyl citrate
etc. usually 10% of plasticizer will sufficient, but if necessary,
can be increased upto 25%.
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Average Requirement |
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40 gms. ENTERIC COAT L 100 per 1 kg. tablets for enteric coating.
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Storage |
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40 gms. ENTERIC COAT L 100 per 1 kg. tablets for enteric coating.
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Shelf Life |
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Minimum 5 years from manufacturing date.
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Packing |
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5kgs, 20 kgs, net in corrugated box
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Quality Control Department - Certificate of
Analysis |
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| Test |
Specification |
Results |
| Description |
White Powder Having A Faint
Characteristic Odor. |
White Powder Having A Faint
Characteristic Odor |
| Solubility |
The Polymer Is Insoluble In
Water In Diluted Acid In Simulated Gastric Fluid |
Solubility In I.P.A. &
Acetone |
| Identification |
A. Complies
B. Complies
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Complies |
| Viscosity |
Bet'n 50 To 200 Cps |
92 Cps |
| Loss On Drying |
Nmt 5.0% |
1.6% |
| Residue On Ignition |
Nmt .1% |
Complies |
| Heavy On Ignition |
Nmt 0.002% |
Complies |
| Limit Of Monomers |
Nmt 0.05% |
0.0113% |
| Organic Volatile Impurities |
Complies |
Complies |
| Assay For Methacrylic Acit
Copolymer Content |
Bet'n 46.00 To 50.60% |
48.35% |
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