» Controlled/Sustained Release Polymer
Controlled/Sustained Release Polymer
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.
For sustained release and enteric film coating of
tablets, pills, pellets, granules, powder etc
Appearance : Controlled/Sustained Release
Coat S100 films are colourless and transparent, desired colour can be given
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
- 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
- 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.
- Option of solvent or semi aqueous media.
- Less quantity required, reducing volume of solution, so shortning
- Stability over a broad temperature range.
- Exhibits excellent colour value.
- Marginal weight gain in tablets.
- 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,
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.
Controlled/Sustained Release Coat S100 -
Controlled/Sustained Release Coat S12.5 - Containing 12.5% dry
polymer in isopropanol solutions.
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
10% of plasticizer will sufficient, but if necessary, can be increased to 25
40 gms. Controlled/Sustained Release Coat S100 per 1
kg. tablets for enteric coating.
At low temperature below 400c. Protect from moisture
Minimum 5 years from manufacturing date.
5 kg., 20 kg., net in corrugated box.
Certificate of Analysis
||White Powder Having A Faint
||White Powder Having A Faint
||The Polymer Is Insoluble In Water
In Diluted Acid In Simulated Gastric Fluid
||Solubility In I.P.A & Acetone
||Bet'n 50 To 200 Cps
|Loss On Drying
|Residue On Ignition
|Limit of monomers
|Organic Volatile Impurities
|Assay for Methacrylic Acid
||Bet'n 27.60 To 30.70%