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For enteric coating when solubility
From ph 7.0 upwards is required.
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Description
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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.
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Use |
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For sustained release and enteric film coating of tablets, pills,
pellets, granules, powder etc
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Features |
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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
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Applications |
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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. |
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Enteric coating of tablets, pills for protecting the drug from
surrounding environment, particularly air, moisture, light, thus
retaining required stability. |
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Masking unpleasant taste and odour, thus overcoming resistance to
drug ingestion. Providing product ‘identity’ for
differentiation of products from manufacturing, storage to patient.
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Imparting cosmetic elegance to product appearance, masking, any
noticeable visible differences in tablet core from batch to batch.
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Reducing risk of interactions between incompatible ingredients.
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Improves mechanical integrity, eliminating possibility of abrasions
chipping etc. |
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Insulating hygroscopic cores. |
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Isolating porous cores. |
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Extending and improving keeping properties. |
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As a binder of film former in the manufacture of porous matrix
tablets (wet granulation) with delayed release of the active
substance. |
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Advantages |
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Option of solvent or semi aqueous media. |
Less quantity required, reducing volume of solution, so
shortning production time. |
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Stability over a broad temperature range. |
Exhibits excellent colour value and self shine shade. |
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Marginal weight gain in tablets. |
Hydrophobic. |
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Specification |
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Appearance - White, fine, free flowing powder. |
Odour - Weakly aromatic. |
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Content - Min. 95% dry polymer. |
Acid Value - 300 - 330 mg KOH/gm. dry substance. |
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Solubility - Isopropyl alcohol, acetone, methanol, ethanol,
methanol/water etc.. |
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Toxicity |
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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.
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Grades |
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Controlled/Sustained Release Coat S100: Powder form.
Controlled/Sustained Release Coat S12.5: Containing 12.5%
dry polymer in isopropanol solutions.
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Plasticizer |
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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%
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Average Requirement |
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40 gms. Controlled/Sustained Release Coat S100 per 1 kg. tablets for
enteric coating.
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Storage |
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At low temperature below 400c. Protect from moisture
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Shelf Life |
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Minimum 5 years from manufacturing date.
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Packing |
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5kgs, 20 kgs, net in corrugated box
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Certificate of Analysis |
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| 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 |
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% |
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