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DRUGCOAT L 100-55 [ Enteric coating material - Aqueous base ]
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Methacrylic Acid Copolymer, Type C, USP/NF:

DRUGCOAT L 100-55 is an anionic copolymer based on methacrylic acid and ethyl acrylate. It is insoluble in acids and pure water. The polymer corresponds to "Methacrylic Acid Copolymer, Type C" USP/NF.

It becomes soluble in a neutral to weakly alkaline milieu by forming salts with alkalis, thus affording film coatings which are resistant to gastric juice but freely soluble in intestinal juice.

Characteristics:

Appearance White, Moderately Fine, Free flowing Powder
Odour Faint characteristic odour
Content At least 95 % of dry substance
LOD Max. 5%
Self Life 4 Years

Characteristics of the Film:

DRUGCOAT L 100-55 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
  • 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
    •
»  Coating of Capsules:
  • For resistance to gastric juice
  • For protection against atmospheric influences
  • To improve the keeping properties
»  Coating of pellets, granules, powders:
  • For resistance to gastric juice
  • For resistance to gastric juice with delayed drug release in the intestine when mixed with DRUGCOAT L 100.
  • For isolation of incompatible ingredients
  • To improve the keeping properties
»  Granulation with DRUGCOAT L 100-55:
  • For isolation of incompatible ingredients
  • To improve the keeping properties
Additives:
   
» Plasticizer
  It is strongly recommended to add 10-20% plasticizer on dry polymer substance into the aqueous solutions of DRUGCOAT L 100-55, 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:

Store at controlled room temperature (USP, General Notices). Protect against moisture and temperature should not exceed 300C, preferably should be between 80C -250C.

Packaging:

10 kg net in strong corrugated box with polyethylene lining.
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