For Enteric Coating When Solubility
From Ph 6.0 Upwards Is Required.

Description

ENTERIC COAT L 100 is an anionic co-polymer which confirms to USP/NF specifications of "METHACRYLIC ACID CO-POLYMER" TYPE A. It is insoluble in acids and pure water, soluble in neutral to weakly alkaline medium.

Use

Enteric film coating of tablets, pills, pellets, granules, powder

Features

¤ Appearance : ENTERIC COAT L 100 films are colorless and transparent, desired colour can be given with pigments.

¤ Solubility : Insoluble in water, in buffer solution below pH 6.0 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 6.0

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

¤ 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 and self shine shade.
¤ Marginal weight gain in tablets.
¤ Hydrophobic.

Specification

¤ Appearance - White, fine, free flowing powder.
¤ Odour - Weakly aromatic.
¤ Content - Min. 95% dry polymer.
¤ Acid Value - 300 - 330 mg KOH/gm. dry substance.
¤ Solubility - Isopropyl alcohol, acetone, methanol, ethanol, methanol/water etc..

Toxicity

ENTERIC COAT L 100 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 any pronounced physiological action and is non-toxic.

Grades

ENTERIC COAT L 100 - Powder form.

Alternatives

ENTERIC COAT L 30D aqueous dispersion can be also be adopted by aqueous coating systems. For advantages of aqueous ENTERIC COATING CLICK L 30D.

Plasticizer

ENTERIC COAT L 100 film are brittle in nature. So to improve film elasticity use of plasticizer is strongly recommended. The recommended plasticizers are polyethylene glycol, Castor Oil, dibutyl phthalate, diethyl phthalate, triacetin, triethyl citrate etc. usually 10% of plasticizer will sufficient, but if necessary, can be increased upto 25%

Average Requirement

40 gms. ENTERIC COAT L 100 per 1 kg. tablets for enteric coating.

Storage

At low temperature not exceeding 350c. Protect from moisture.

Shelf Life

Minimum 5 years from manufacturing date.

Packing

5 kgs, 20 kgs, net in corrugated box

Quality Control Department - 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	Complies
Viscosity	Bet'n 50 To 200 Cps	92 Cps
Loss On Drying	Nmt 5.0%	1.6%
Residue On Ignition	Nmt .1%	Complies
Heavy On Ignition	Nmt 0.002%	Complies
Limit Of Monomers	Nmt 0.05%	0.0113%
Organic Volatile Impurities	Complies	Complies
Assay For Methacrylic Acit Copolymer Content	Bet'n 46.00 To 50.60%	48.35%