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