Enteric Formulations
Enteric Formulations
Enteric coating is aimed to prevent the formulations from gastric fluid in the stomach and release the drug component in the intestinal region or once it has passed into the duodenum. DHARACOAT L 100, DARACOAT L30D-55, DHARACOAT L100-55, DHARACOAT S 100 & DHARACOAT MAE 100P polymers protect active from the gastric fluid and improve drug effectiveness. They are designed to be resistant to stomach acid, and will not get dissolved until the tablet reaches the small intestine. In brief, enteric formulation means acid resistance products. These polymers are pH dependant.
DHARACOAT L 100
DHARACOAT S 100
DHARACOAT L 30D-55
DHARACOAT L 100-55
DHARACOAT MAE 100P
| Polymer | Pharmacopoeia Monograph | Physical Form | Dissolution |
|---|---|---|---|
| DHARACOAT L 100 DHARACOAT L 12.5 |
USP/NF : Methacrylic Acid and Methyl Methacrylate Copolymer (1:1) Ph. Eur. : Methacrylic Acid-Methyl Methacrylate Copolymer (1:1) |
Powder 12.5% Organic Solution |
Dissolution above pH 6.0 |
| DHARACOAT S100 DHARACOAT S12.5 |
USP/NF : Methacrylic Acid and Methyl Methacrylate Copolymer (1:1) Ph. Eur. : Methacrylic Acid-Methyl Methacrylate Copolymer (1:1) |
Powder 12.5% Organic Solution |
Dissolution above pH 7.0 |
| DHARACOAT L 30D-55 | USP/NF : Methacrylic Acid and Ethyl Acrylate Copolymer Dispersion Ph. Eur. : Methacrylic Acid-Ethyl Acrylate Copolymer (1:1) Dispersion 30% |
30% Aqueous Dispersion | Dissolution above pH 5.5 |
| DHARACOAT L 100-55 | USP/NF : Methacrylic Acid and Ethyl Acrylate Copolymer Ph. Eur. : Methacrylic Acid-Ethyl Acrylate Copolymer (1:1) Type A |
Powder | Dissolution above pH 5.5 |
| DHARACOAT MAE 100P | USP/NF : Partially-Neutralized Methacrylic Acid & Ethyl Acrylate Copolymer (1:1) Ph. Eur. : Methacrylic Acid-Ethyl Acrylate Copolymer (1:1) Type B |
Powder | Dissolution above pH 5.5 |
- Plasticizer
It is recommended to add 10-20% plasticizer on dry polymer substance into the COLONCOAT 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 System (COLONCOAT L 100, COLONCOAT S 100)
Isopropyl alcohol and acetone, containing small amount of water. - Solvent For Aqueous System (COLONCOAT L 100-55, COLONCOAT L 30D-55, COLONCOAT MAE 100P)
Purified Water 100%.
Powder : 15/20/35 Kg. in HDPE Drums with double polyethylene linings.
Liquid : 35/60 Kg. in HDPE Carboys.