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EASTMAN™ CAP
(also known as Cellacefate) enteric coating material is a pH-sensitive cellulose derivative designed for coating pharmaceutical tablets or granules. It may also be used as a matrix material in solid dose forms. EASTMAN™ CAP enteric coating material withstands prolonged contact with acidic gastric fluids, but dissolves readily in the mildly acidic to neutral environment of the small intestine. It can be applied to tablets or granules from solutions of organic solvents. It is the subject of U.S. Drug Master File 8.
EASTMAN™ CAP meets USP / NF and EP-specifications and is available in powder and pellet form.
pH-dependent dissolution behavior
EASTMAN™ CAP contains around 33% of acetyl- and around 24% of phthalyl-groups, calculated on the anhydrous acid-free basis, and exhibits a pKa of approx. 4.5. Both the pKa value and the acetyl
and phthalyl content influence the pH-dependent dissolution behaviour of the polymer. EASTMAN™ CAP coated tablets and capsules withstand 2 hours in the strongly acidic gastric environment, but dissolve completely within minutes at pH 6.5. The required coating thickness varies with the shape
of the coated tablets or capsules, but around 3 mg/cm2 tablet surface are in most cases a suitable
range to assure sufficient acid-resistance and a fast dissolution in the intestine.
Beside the more common application as coating polymer, EASTMAN™ CAP can also be used in combination with other polymers as matrix former for sustained release tablets or to form gastric
resistant solid dispersions.
Application and handling
EASTMAN™ CAP is best soluble in organic solvents like acetone or ethyl acetate. Suitable solvent systems are e.g. acetone:water (97:3), ethyl acetate:ethanol (50:50) or ethyl acetate:isopropanol (50:50). Due to the water-free coating solution, EASTMAN™ CAP is especially suitable as coating polymer for moisture-sensible API’s.
The properties of coatings made with EASTMAN™ CAP enteric polymer may be modified by adding a plasticizer to the polymer solution before coating. Plasticizers add film toughness (increased resistance to chipping or cracking) while lowering the Tg (glass transition temperature or softening point) of the polymeric film. In general, the optimum concentration of plasticizer is the minimum amount which provides the necessary flexibility to form a continuous coating. Suitable plasticizers are diethyl phthalate, dibutyl phthalate or triacetin in a polymer to plasticizer ratio of around 1 to 0.25 (w/w).
Safety
EASTMAN™ CAP is widely used for decades as enteric coating material and is generally regarded as well tolerated non-toxic material.
Packing and storage
| Packing | 50 kg fiber drum with inner PE-lining |
| Shelf life | 36 months (Pellets), 24 months (Powder) |
| Storage | At ambient temperature, protected from moisture. |
Identifier
| CAS-No.: | 9004-38-0 |
| INCI: | Cellulose Acetate Phthalate |
Material Safety Data Sheet for EASTMAN™ CAP
 | EASTMAN™ CAP Data Sheet
|
Further product information can also be found via the following links:
| EASTMAN™ - CAP Pellets |
| EASTMAN™ - CAP Powder |
You are also welcome to contact us directly at any time.
