L & S SERIES
ENTERIC COATING FORMULATION

Many API undergo degradation in hostile acidic environment of stomach. Many API irritate the gentle gastric mucosa. This irritation in severe cases can lead to permanent damage to gastric mucosa causing peptic ulcer.

In either case, it is essential to prevent the release of API in stomach and this can be achieved by DRUGCOAT L & S series.

These polymers can additionally be used to deliver API to a specific site in the GI tract. This results in site specific targeted drug delivery.

Product Information

US-
DMF 		DRUGCOAT SERIES MONOGRAPHS PHYSICAL FORM DISSOLUTION PROPERTIES
AQUEOUS ENTERIC COATING
AVAILABLE DRUGCOAT L30D USP/NF: Methacrylic Acid And Ethyl Acrylate Copolymer Dispersion
Ph. Eur.: Methacrylic Acid-Ethyl Acrylate Copolymer(1:1) Dispersion 30% 		Aqueous Dispersion 30% Dissolve above pH 5.5
DRUGCOAT L 100-55 USP/NF: Methacrylic Acid And Ethyl Acrylate Copolymer
Ph. Eur.: Methacrylic Acid- Ethyl Acrylate Copolymer (1:1) Type A 		Powder
DRUGCOAT L 100-55D USP/NF: Partially–Neutralized Methacrylic Acid & Ethyl Acrylate Copolymer
Ph. Eur.: Methacrylic Acid- Ethyl Acrylate Copolymer (1:1) Type B 		Powder
NON AQUEOUS ENTERIC COATING
AVAILABLE DRUGCOAT L 100 USP/NF: Methacrylic Acid And Methyl Methacrylate Copolymer (1:1)
Ph. Eur.: Methacrylic Acid – Methyl Methacrylate Copolymer (1:1) 		Powder Dissolve above pH 6.0
DRUGCOAT L 12.5 Organic Solution 12.5%
COLON TARGETED ENTERIC COATING
DRUGCOAT S 100 USP/NF: Methacrylic Acid And Methyl Methacrylate Copolymer (1:2)
Ph. Eur.: Methacrylic Acid – Methyl Methacrylate Copolymer (1:2) 		Powder Dissolve above pH 7.0
DRUGCOAT S 12.5 Organic Solution 12.5%
Why DRUGCOAT L and S Series?
  • For pH-Dependent drug release
  • For Protection of API from gastric fluid
  • For Protection of gastric mucosa from API
  • To Increase storage stability
  • For GI and colon targeting
  • To insulate hygroscopic cores
  • Better stability compare to phthalate group coating agent.
  • For Enteric coating of API formulation like Diclofenac Sodium, Ketoprofen, Indomethacin, Omeprazole, Pantoprazole, Rebeprazole, Bisacodyl, Aspirin, Sodium valporate etc.
Additives
  • Plasticizer
    It is recommended to add 10-20% plasticizer on dry polymer substance into the DRUGCOAT L and S Series Solution or Dispersion, to obtain films adequate flexibility.
  • Glidant
    Glidants like Talc, Micronized amorphous silica and Glycerol Monostearate facilitates spray application to the cores.
  • Pigments
    Opaque white or colored coating can be obtained by adding pigments like Iron Oxide and Lakes.
  • Solvents For Non Aqueous Base
    Isopropyl alcohol and acetone, containing small amount of water
Packaging

Aqueous Dispersion: 60 kg net in HDPE Carboy.
Powder/ Granules: 10 kg net in Paper fiber Drum with polyethylene lining.
Organic Solution: 25kg net in DRUM.

Storage

Store at controlled room temperature. (USP, General Monograph)