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DRUGCOAT L 100 - 55D [ Direct Dispersible Enteric Coating Material - Aqueous Base ]
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Methacrylic Acid - Ethyl Acrylate Copolymer (1:1), Type B, Ph.Eur:

DRUGCOAT L 100-55D is an anionic copolymer based on methacrylic acid and ethyl acrylate. The polymer corresponds to Ph.Eur "Methacrylic Acid - Ethyl Acrylate Copolymer (1:1), Type B". The powder can easily be re-dispersed in aqueous solutions. DRUGCOAT L 100-55D anionic polymer based on methacrylic acid and methacrylic acid esters and are used as film-formers for the production of enteric coatings for solid dosage forms. The ratio of carboxyl groups to ester units is about 1:1.

Characteristics:

Appearance White, Moderately Fine, Free flowing Powder
Odour Faint characteristic odour
Content At least 95 % of dry substance
LOD Max. 5%
Self Life 2 Years

Characteristics of the Film:

DRUGCOAT L100-55D films are colourless and transparent; their brittleness is reduced by the addition of plasticisers. They are insoluble in water, in buffer solution below pH 5.0 and also in natural and artificial gastric juices. They are soluble in the region of the digestive tract where the juices are neutral to weakly alkaline and in buffer solutions above pH 5.5.

Applications:
   
» Coating of tablets and pills: colourless and transparent; coloured with pigments.
» To improve the keeping properties protection against moisture, light and air - coatings stable under tropical conditions.
» For resistance to gastric juice.
» Characteristics:
» For resistance to gastric juice with delayed drug release in the intestine when mixed with DRUGCOAT L 100.
» To insulate hygroscopic cores.
» To isolate porous cores.
» For the production of film coatings for lozenges and troches.
» Protection against atmospheric influences.
» Coating of pellets, granules, powders.
» For isolation of incompatible ingredients.
» Granulation can done with DRUGCOAT L 100-55D.
   
Additives:
   
» Plasticizer
  It is strongly recommended to add 10-20% plasticizer on dry polymer substance into the aqueous solutions of DRUGCOAT L 100-55D, to obtain films of adequate flexibility.
   
» Glidants
  Glidants like talc, micronized amorphous silica and glycerol monostearate facilitate spray application to the cores.
   
» Pigments
  Opaque white or colored coatings can be obtained by adding pigments like titanium dioxide, food colors and iron oxide.
   
Storage:

Protect from damp; store at a temperature not exceeding 300C. Protect from moisture and preferably temperature should be 80C - 250C.

Packaging

10 kg net in Strong Corrugated Box with polyethylene lining.

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