Product Description
Aquacoat ECD is a 30 percent by weight aqueous dispersion of ethylcellulose polymer. Ethylcellulose is a hydrophobic coating material used in a variety of coatings applications to achieve:

• Sustained release
• Taste masking
• Moisture barrier/sealant

Applications
Aquacoat ECD has been used in a wide variety of applications as listed below.

Sustained Release Beads for Capsules
Aquacoat ECD offers excellent dissolution rate control, stability and reproducibility that are pH independent. Aquacoat ECD is typically used on drug layered nonpareils, microcrystalline cellulose beads and beads prepared by extrusion/spheronization for sustained release applications. These applications are typically delivered using gelatin capsules. Aquacoat ECD has been demonstrated in many sustained release applications including phenylpropanolamine HCL (PPA), conjugated estrogen, diltiazem, ibuprofen, chlorpheniramine maleate and theophylline. To request literature on this application please contact us for more information.

Moisture Barrier/Sealant for Powders, Granules, Tablets and Capsules
Aquacoat ECD forms a superior barrier to seal out moisture and heat and will prevent bleed through and assist color adherence for hard-to-coat compounds like multivitamins. A 50/50 mix of HPMC and Aquacoat ECD gives a high level of protection with an immediate release profile.

Tastemasking for Powders, Granules and Tablets
Aquacoat ECD is an effective tastemasking agent for many applications.

Wet Granulation
Aquacoat ECD can also be used in wet granulation where granulation and sustained release need to be achieved.

Benefits

• Completely water-based system, allows solvent-free coating.
• Low viscosity and non-tacky features.
• Coat with a 30 percent solids level for a faster coating rate and lower overall production time.
• Stable and reproducible release rates. Zero order release achievable.
• No logo bridging.
• Worldwide acceptance.
• Easy to use. Easy cleanup. No talc needed.
• Odorless and tasteless. No ammonia used.
• Acceptable for food use in the U.S.
• FMC considers Aquacoat ECD to be "Generally Recognized as Safe" (GRAS) for use in food.

Specifications for Aquacoat ECD
Aquacoat ECD is sold as a 30 percent by weight dispersion.
Total Solids	29 - 32 %
Ethylcellulose	24.5 - 29.5 %
Sodium lauryl sulfate	0.9 - 1.7 %
Cetyl alcohol	1.7 - 3.3 %
Hydrogen peroxide	< 50 ppm
Heavy metals	< 10 ppm
Total aerobic microbial count	< 100 cfu/g
Total yeast and mold count	< 20 cfu/g
pH	4.0 - 7.0 pH
Viscosity	< 150 cps

Detailed Product Information

Formulation, Processing Conditions and Equipment for Aquacoat ECD
For sustained release applications, with Aquacoat ECD you can tailor your release profile to suit your specific application. Adjustment of release profiles can be acheived by adjusting the coating level, the plasticizer type, the level of plasticizer and by adding soluble polymers like hydroxypropyl methyl cellulose (HPMC) or polyethylene glycol (PEG). Figure 1 shows the effect of increasing coating levels, and Figure 2 shows the effect of adding HPMC.

Figure 1 - Increasing the Coating Level Slows the Drug Release Rate

PPA loaded non-pareils coated with Aquacoat ECD™ and using DBS as a plasticizer.

Coating Appearance
Aquacoat ECD coated on a tablet looks like a solvent based ethylcellulose providing a smooth tablet surface which can be printed on. Logo definition for even hard to coat logos can be retained.

Color Addition
Aquacoat ECD is compatible with most alcohol and propylene glycol based color dispersions. It is recommended that the plasticizer be added first and mixed for 30 minutes before adding the color. Color can also be added as a separate coating on top of the Aquacoat ECD.

Equipment
Aquacoat ECD is typically coated onto beads for sustained release applications and the preferred equipment is a bottom spray fluid bed coater with Wurster insert. However, top spray and tangential spray fluid beds and modified coating pans can also be used for bead coating. Side-vented and conventional coating pans can be used for tablet coating when using Aquacoat ECD for taste masking or as a moisture barrier.

Coating Conditions
For most sustained release applications, a 30 percent weight dispersion of Aquacoat ECD and plasticizer can be used as the coating dispersion. Aquacoat ECD's low viscosity will give excellent coating results. The high solids content will mean quicker coating times and lower energy costs for water evaporation. For low weight addition coatings, a 15 weight percent dispersion is recommended.

Stirring Aquacoat ECD upon opening is recommended because minor settling may occur during storage. Plasticizer should be added and allowed to mix for 30 minutes before adding any other materials such as HPMC or colors. Use only moderate mixing speeds to avoid air inclusion. A propeller blade will give the best results.

Aquacoat ECD is normally applied at 5 to 10 percent of the tablet weight or 8 to 15 percent of the bead weight for sustained release applications and 1 to 2 percent for a barrier coat. For sustained release, adjustments to the weight percent are made to modify the release rate and to obtain the desired release rate.

After spraying, allow the beads or tablets to rotate in the coater and maintain the bed temperature for an additional 15 minutes to assure the beads or tablets are dry in order to avoid bead or tablet sticking problems.

Curing
For sustained release applications, a two hour curing time at 60ºC using a tray dryer is necessary after coating to insure reproducible release profiles. Curing in a fluid bed column can also be done for some applications.

Formulation Using Aquacoat ECD
The following describes conditions and equipment used for a sustained release coating of Aquacoat ECD on 1 mm drug-loaded beads. The example will give you a general idea of conditions.

Formulation

		Suspension (grams)	Solids (grams)	Percent (%)
	Aquacoat ECD	425.0	131.8	80.6
	Plasticizer (24% DBS NF)	31.6	31.6	19.4
	Water	88.0	-	-
		544.6	163.4	100.0

Equipment
Coater	Fluid bed coater with Wurster insert
Column	100 mm bottom/150 mm top
Insert	50 mm
Partition setting	10 mm
Nozzle Orifice	1 mm
Pump	peristaltic pump

Coating
Product charge	1 kg of 16/20 mesh size drug-loaded beads
Application rate	8 - 10 mL/min*
Atomizing air pressure	25 psi
Temperature, inlet	60ºC
Temperature, outlet	39 - 41ºC
Bed temperature	32 - 35ºC
Relative humidity of inlet air	40%
Coating level (theoretical)	10%
Spray time	42 min.
Drying time post coating	15 min.
Oven Curing (needed for sustained release applications)	2 hours at 60ºC

*Use 4-5 mL/min at start for highly water soluble substrates. Apply a 2% coating by weight at this rate, then proceed with a 8-10 mL/min rate to complete the coating run.

Regulatory Status of Aqucoat ECD

Aquacoat ECD has been approved in many applications around the world including the U.S., Canada, Europe and Japan. Aquacoat ECD meets the standards set forth in the United States Pharmacopeia/National Formulary for ethylcellulose aqueous dispersion. Ethylcellulose, a component of Aquacoat ECD, meets the standards of the current Japanese Pharmaceutical Excipients book and is used in approved formulations in Europe. Sodium lauryl sulfate, a component of Aquacoat ECD, meets the standards set forth in the European Pharmacopoeia and the Japanese Pharmacopoeia. Cetyl alcohol, a component of Aquacoat ECD, meets the standards set forth in the European Pharmacopoeia and is used in approved formulations in Japan. FMC BioPolymer has characterized Aquacoat ECD 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 ECD in drug products. Aquacoat ECD is manufactured in accordance with Current Good Manufacturing Practice and is in compliance with the Federal Food, Drug and Cosmetic Act, as amended.

Shelf Life/Storage Conditions for Aquacoat ECD
Aquacoat ECD should be stored at room temperature (20ºC to 25ºC) and is stable for two years at those conditions. It is available in 3 kg, 15 kg, 50 kg and 190 kg containers, for your convenient handling, dispensing and storage.

Kosher Status
Aquacoat ECD is certified as Kosher. For certificates, please contact FMC BioPolymer

Product Brochure

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