Product Description

Aquacoat CPD, an enteric coating, is a 30 percent by weight aqueous dispersion containing cellulose acetate phthalate (CAP) polymer. Enteric coatings can be used to allow acid sensitive drugs to pass through the stomach unaffected or to keep stomach upsetting drugs, like aspirin for some people, from releasing in the stomach. Although CAP polymer is hydrophobic, the Aquacoat CPD process allows the product to be delivered in a totally aqueous pseudo-latex form that is easy to use and easy to clean up with equivalent performance to a solvent coating.

Applications

Aquacoat CPD performance has been demonstrated in a wide variety of applications, inclusing aspirin, diclofenac sodium, sulfasalizine, antibiotics, brompheniramine maleate and sodium fluoride. It has also been demonstrated in nutritional products like garlic and herbal tablets.

Enteric Coated Tablets
Appearance for even embossed tablets. A functional and stable film can be achieved with 6 to 10 percent coating level by weight.

Enteric Beads for Capsules and Tablets
Aquacoat CPD can be coated onto beads which can be used in hard gelatin capsules. The high degree of film flexibility in Aquacoat CPD also allows formulation into compressed bead tablets. Additional coating is necessary for high surface area dosage forms like beads. Typically 10 to 15 percent coating levels are used for beads.

Enteric Coated Capsules
Aquacoat CPD has been successfully demostrated on both hard and soft gelatin capsules.

Wet Granulation
Aquacoat CPD can also be used in wet granulation where granulation and enteric properties need to be achieved.

Benefits

• Completely water-based system, allows solvent-free coating.
• Easy to use. Easy to clean up. No talc needed.
• Performs equivalent to a solvent coated CAP in terms of film properties and stability over time.
• Equivalent appearance to a CAP solvent coating.
• Prevents logo bridging.
• Odorless and tasteless. No ammonia used.
• Low viscosity and non-tacky features.
• Coat with a 30 percent solids level for a faster coating rate and lower overall production time.
• Acceptable for pharmaceutical use in the U.S., Europe and Japan.

Detailed Product Information

Formulation, Processing Conditions and Equipment for Aquacoat CPD

How to Choose a Plasticizer and Why
Plasticizers need to be used with Aquacoat CPD for most applications. Plasticizers are non-volatile, high boiling liquids used to impart flexibility to otherwise hard or brittle polymeric materials. Aquacoat CPD offers you your choice of plasticizers to allow you to tailor your formulation for your particular drug. Recommended plasticizers include diethyl phthalate (DEP), triethyl citrate (TEC) and triacetin (GTA or glyceryl triacetate).

Plasticizers soften and swell the polymer (latex spheres) which aids in overcoming their resistance to deformation. The film forming temperature is reduced by decreasing the glass transition temperature (Tg) which is the temperature at which the polymer undergoes marked changes in physical properties. The glass transition temperatures for Aquacoat CPD with various levels of plasticizer addition are given below. For most applications, we recommend that plasticizers be added at 20-24 percent of the the latex solids.

Fig. 1 - Glass transition temperatures for Aquacoat CPD and recommended plasticizers

Superior Coating Appearance
Aquacoat CPD films provide a smooth and elegant appearance on either plain or engraved tablets. Clear detailed printing can be done on the coating. The film appearance is superior to a CAP solvent coating.

Color Addition
Color can be added as a separate coating on top of the Aquacoat CPD or added as part of Aquacoat CPD dispersion.

Compatible with all Types of Equipment
Aquacoat CPD can be coated onto tablets, capsules or beads. Side-vented and conventional coating pans are typically used for tablets or capsules. For beads, a fluid bed coater or a modified coating pan can be used.

Coating Preparation
For most applications, up to a 30 percent weight dispersion of Aquacoat CPD and plasticizer can be used as the coating dispersion. Aquacoat CPD's low viscosity will give excellent coating results. The high solids content will mean quicker coating times and lower energy costs for water evaporation. And no talc needed. Plasticizer should be added and allowed to mix for 30 minutes. Use only moderate mixing speeds to avoid air inclusion. A propeller blade will give the best results.

Drying
After spraying, allow the beads or tablets to rotate in the coater and maintain the bed temperature for an additional 10 minutes to assure the beads or tablets are dry in order to avoid bead or tablet sticking problems.

Formulation Using Aquacoat CPD
The following describes conditions and equipment used for a typical enteric applicaton for Aquacoat CPD on aspirin tablets. The example will give you a general idea of conditions. For information on your specific application, please contact your nearest representative.

Formulation

		Liquid (grams)	Suspension (grams)	Percent (%)
	Aquacoat CPD	2277.0	683.1	80.6
	Plasticizer (24% DEP)	164.0	164.0	19.4
	Water	3206.1	-	-
		5647.1	847.1	100.0

Preparation

• Weigh the amounts of Aquacoat CPD, plasticizer and water.
• Mix moderately the Aquacoat CPD with a propeller mixer.
• Add the plasticizer slowly to the Aquacoat while mixing.
• Mix for 30 minutes.
• Add the water and mix for an additional 10 minutes.
• Maintain moderate mixing while applying the coating.

Equipment
Coater	24" Accela-Cota®
Spray guns	2 Binks, Model 650
Pump	peristaltic pump

Coating Conditions
Product	1/2" round, standard, concave 325 mg ASA
Product charge	9 kg
Application rate	60 mL/min average
Atomizing air pressure	25 psi/gun
Temperature, inlet	80°C
Temperature, outlet	38 - 42°C
Bed temperature	32 - 36°C
Relative humidity of inlet air	40%
Prewarm tablet bed	10 min.
Spray time	91 min.
Drying time after coating	10 min.
Coating level (theoretical)	8%

Regulatory Status of Aquacoat CPD
Cellulose acetate phthalate, a component of Aquacoat CPD, meets the standards set forth in the United States Pharmacopeia/National Formulary and the European Pharmacopoeia and the Japanese Pharmacopoeia. Poloxamer meets the standards of the current USP/NF and the Japanese Pharmaceutical excipients book. FMC BioPolymer has characterized Aquacoat CPD to be a "Generally Recognized as Safe" substance when used as a coating for dietary supplement tablets or capsules. FMC BioPolymer has characterized Aquacoat CPD as GRAS in accordance with the Federal Food, Drug and Cosmetic Act, as Amended and applicable regulations. FMC BioPolymer maintains a Drug Master File at the U.S. Food and Drug Administration to support the use of Aquacoat CPD in drug products. Aquacoat CPD is manufactured in accordance with Current Good Manufacturing Practice and is in compliance with the Federal Food, Drug and Cosmetic Act, as amended and applicable regulations.

Shelf Life/Strorage Conditions for Aquacoat CPD
Aquacoat CPD should be stored refrigerated at 5°C (40°F) and is stable for 18 months at those conditions. At ambient temperature Aquacoat CPD latex is stable for 9 months. It is available in 3kg, 15 kg, 50 kg and 190 kg containers, for your convenient handling, dispensing and storage.

Kosher Status
Aquacoat CPD is certified as Kosher. For certificates, please contact your nearest representative

Product Brochure

For a copy of a product brochure, please click here.

MSDS
For a copy of the MSDS, please click here.