For enteric coating when
solubility
From ph 7.0 upwards is required.
Description
Controlled / Sustained Release Coat S100 is an anionic
co-polymer which confirms to USP/NF specifications of “Methacrylic Acid
Co-Polymer” Type B. It is insoluble in acids and pure water, soluble in
neutral to weakly alkaline medium.
Use
For sustained release and enteric film coating of tablets, pills,
pellets, granules, powder etc
Features
¤
Appearance : Controlled/Sustained Release
Coat S100 films are colourless and transparent, desired colour can be given
with pigments.
¤
Solubility : Insoluble in
water, in buffer solution below pH 7.0 and 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 7.0
Applications
¤ Enteric coating for resistance to gastric fluid, (to protect
active drug from influence of acids, prevent irritation of gastric mucosa)
or to delay drug release in the intestine, when thick layers are applied.
¤ Enteric 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.
¤
As a binder of film former in the manufacture of porous matrix tablets (wet
granulation) with delayed release of the active substance.
Advantages
¤ Option of solvent or semi aqueous media.
¤ Less
quantity required, reducing volume of solution, so shortning production
time.
¤ Stability over a broad temperature range.
¤
Exhibits excellent colour value.
¤ Marginal weight gain in
tablets.
¤ Hydrophobic.
Specifications
¤ Appearance - White, fine, free flowing powder.
¤
Odour - Weakly aromatic.
¤ Content - Min. 95% dry polymer.
¤
Acid value - 180 - 200 mg KOH/gm dry substance.
¤ Solubility -
Isopropyl alcohol, acetone, methanol, ethanol, methanol/water etc
Toxicity
Controlled/Sustained Release Coat S100 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.
Grades
¤
Controlled/Sustained Release Coat S100 -
Powder form.
¤
Controlled/Sustained Release Coat S12.5 -
Containing 12.5% dry polymer in isopropanol solutions.
Plasticizer
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%
Average
Requirement 40 gms. Controlled/Sustained Release Coat S100 per
1 kg. tablets for enteric coating.
Storage
At low temperature below 400c. Protect from moisture
Shelf
Life Minimum 5 years from manufacturing date.
Packing
5 kg., 20 kg., net in corrugated box.
about
us
Controlled/Sustained
Release Polymer
