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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 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
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 - Powder form.
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… 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.
At low temperature below 400c. Protect from moisture
Shelf Life
Minimum 5 years from manufacturing date.
5 kg., 20 kg., net in corrugated box.
Certificate of Analysis
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
Viscosity Bet'n 50 To 200 Cps 102 Cps
Loss On Drying Nmt 5.0% 1.0%
Residue On Ignition Nmt 0.1% Complies
Heavy Metals Nmt 0.002% Complies
Limit of monomers Nmt 0.05% 0.0066%
Organic Volatile Impurities Complies Complies
Assay for Methacrylic Acid Copolymers Content Bet'n 27.60 To 30.70% 29.26%