Description
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.
Use
Enteric coating of tablets, pills, pellets, granules, and powders.
Features
¤
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
Applications
¤ 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 chipping etc…
¤ Insulating hygroscopic cores.
¤ Isolating porous
cores.
¤ Extending and improving keeping properties.
Advantages
¤ 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
coating.
¤ Low temperature required for film forming.
¤
Exhibits excellent colour value.
¤ Stability over a broad
temperature range.
¤ Marginal weight gain in tablets.
¤
Hydrophobic.
Specifications
Aqueous Enteric Coat L30D ¤
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.
Aqueous Enteric Coat L100D¤
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.
Toxicity
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.
Alternatives
Solvent Enteric L100 solvent system can be adopted.
Plasticizer
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 citrate etc…
usually 10% of plasticizer is sufficient, but if necessary, can be increased
to 25%
Average
Requirement ¤
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.
Storage
At low temperature below 400c and keep away from frost.
Shelf
Life 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.
Packing
¤
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.
about
us
Aqueous
Enteric Coating Polymer
