» Aqueous Enteric Coating Polymer
Aqueous Enteric Coating Polymer
Aqueous Enteric Coat L30D is an aqueous dispersion of
a neutral co-polymer which confirms to USP/NF specifications of Methacrylic
Acid Co-Polymer, Type C.
Aqueous Enteric Coat L100D is spray dried powder of Aqueous Enteric Coat
L30D dispersion. It is an anionic polymer which confirms to USP/NF
specification of Methacrylic Acid Co-Polymer, Type C.
Enteric coating of tablets, pills, pellets,
granules, and powders.
Appearance : Aqueous Enteric Coat L30D forms
colourless and transparent film in presence of plasticizers, colour can be
given with pigments.
Solubility : The Aqueous Enteric Coat L30D films formed are
insoluble in pure water, in buffer solutions below pH 5.5 and natural
gastric juices. Aqueous Enteric Coat L30D films are soluble in neutral to
weakly alkaline region of the digestive tract, in intestinal fluids and
buffer solutions above pH 5.5
- Enteric coating for resistance to gastric fluid, (to protect active
drug from influence of acids, prevent irritation of gastric mucosa).
- Film 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
- Insulating hygroscopic cores.
- Isolating porous cores.
- Extending and improving keeping properties.
- It eliminates fire hazard in your factory.
- It eliminates toxicity inhaling for coater.
- It reduces cost of solvents and indirectly reducing your cost of
production without compromising the quality.
- Miscible with water in any proportion.
- Less quantity required, hence reducing volume of dispersion for
- Low temperature required for film forming.
- Exhibits excellent colour value.
- Stability over a broad temperature range.
- Marginal weight gain in tablets.
Aqueous Enteric Coat L30D
Aqueous Enteric Coat L100D
- Appearance - White, milky liquid
- Odour - Weakly aromatic.
- Content - 28.5 to 31.5% w/w dry polymer.
- Acid value - 300 - 330 mg KOH/mg dry polymer.
- Solubility - Water or organic alcohols, acetone.
- Appearance - Off white powder.
- Odour - Weakly aromatic.
- Content - 95% Min. dry polymer.
- Acid value - 300 - 330 mg KOH/gm dry.
- Solubility - Water or organic alcohols, acetones.
Aqueous Enteric Coat L30D 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 pronounced physiological action and is non-toxic.
Solvent Enteric L100 solvent system can be adopted.
Aqueous Enteric Coat L30D film is brittle in nature.
To improve film elasticity use of plasticizer is strongly recommended. The
recommended plasticizers are polyethylene glycol, triacetin, triethyl
usually 10% of plasticizer is sufficient, but if
necessary, can be increased to 25%
Aqueous Enteric Coat L30D : 135 gms. Enteric
L30D per 1 kg. tablets for enteric coating.
Aqueous Enteric Coat L100D : 40 gms. Enteric L100D per 1 kg. tablets
for enteric coating.
At low temperature below 400c and keep away from
Two years for Aqueous Enteric Coat L30D & five
years for Aqueous Enteric Coat L100D from the date of manufacturing. Keep
the container in tightly closed condition.
Aqueous Enteric Coat L30D : 5 kg, 20 kg, net
in H.D.P.E. drum.
Aqueous Enteric Coat L100D : 5 kg, 20 kg, in corrugated box.
Certificate of Analysis
||Milky White Liquid of Low Viscosity
||Milky White Liquid Of Low Viscosity
||Soluble in Acetone Alcohol, IPA
||Soluble In I.P.A. & Acetone
|Viscosity Dry Polymers
||BETN 100 TO 200
||BETN 2.0 TO 3.0
|Acid Value (mgKOH/gms dry substance)
||BETN 300 TO 330
|Residue on Ignition
|Limit of monomers
||The Weight Of The Residue Does Not Exceed 1000 Mg.
|Assay for Methacrylic Acid Copolymers Content
||Bet'n 46.0 To 50.6%
||28.50 To 31.50%
||Nmt 15 Cps