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DRUGCOAT L 100 [ Enteric coating material- Solvent base ]
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Methacrylic Acid Copolymer, Type A, USP/NF:

DRUGCOAT L 100 is an anionic copolymer based on methacrylic acid and methyl methacrylate. The copolymer corresponds to USP/NF "Methacrylic Acid copolymer, Type A". It becomes soluble in a neutral to weakly alkaline milieu by forming salts with alkalis, thus affording enteric film coatings which are 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 films are colourless and transparent, and made somewhat less brittle by adding the plasticiser. They are insoluble in water, in buffer solutions 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 6.0.

Applications:

»
  Coating of tablets and pills:
  • 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 intestines when mixed with DRUGCOAT-S 100
  • To insulate hygroscopic cores
  • To isolate porous cores
  • For the production of film coatings for lozenges and troches
»  Coating of pellets, granules, powders:
  • For resistance to gastric juice
  • For resistance to gastric juice with delayed drug release in the intestines when mixed with DRUGCOAT-S 100
  • For isolation of incompatible ingredients
  • To improve the keeping properties
»  Granulation with DRUGCOAT L 100
  • For isolation of incompatible ingradients
  • To improve the keeping properties
Additives:
   
» Plasticizer
  It is strongly recommended to add 10-20% plasticizer on dry polymer substance into the organic solutions of DRUGCOAT L 100, 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.
   
Grades of DRUGCOAT L 100 : Download
   
» DRUGCOAT L 12.5:
  Ready to use solution of DRUGCOAT L 100 with 12.5 %( w/w) dry substance in organic solvent like Isopropyl Alcohol.
   
» Characteristics:
 
Appearance Colourless, clear to slightly cloudy solutions
Odour Characteristic odour of Isopropyl Alcohol
Content 12.5% of dry Substance
Self Life 2 Years

Storage:
 
» DRUGCOAT L 100

Protect from damp and moisture, Store at a temperature not exceeding 300C, preferably between 80C - 250C
   
» DRUGCOAT L 12.5

Store in tightly closed containers. Protect from warm temperature (USP, General Notices)

 
Packaging
 
» DRUGCOAT L 100

10 kg net in strong corrugated box with polyethylene lining.

   
» DRUGCOAT L 12.5

25 kg net in HDPE carboy.

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