Why is curing of Aquacoat ECD or Aquacoat CPD important?
Answer: Proper curing of Aquacoat ECD and Aquacoat CPD are important to ensure that the film coating is fully coalesced. Films that are not properly formed could result in release profiles that change upon storage or exhibit pH dependence.
What are the recommended plasticizers?
Answer: A wide variety of plasticizers can be used with Aquacoat ECD. Aquacoat ECD has been successfully used with diethyl phthalate, triethyl citrate, dibutyl sebecate, acetyl tributyl citrate and more. TEC is most often chosen by our customers for its global regulatory acceptance.
What pore formers do you recommend?
Answer: After extensive characterizations of over 30 polymers, salts, and sugars, we have determined that a PVA-PEG graft copolymer blend is the most suitable for pH independent coatings. Carrageenan is also an acceptable poreformers which results in pH independent release coatings. Protanal alginates are most suitable when some pH dependence is desired in the final product coating.
What are the recommended storage conditions and expiration date for Aquacoat CPD?
Answer: Aquacoat CPD should be stored at 5° C (40°F). Under these conditions, the expiration date is eighteen months from the date of manufacture.
Can I coat Aquacoat ECD or Aquacoat CPD at a higher concentration than 15% solids in the coating suspension?
Answer: Yes, process conditions can be modified to increase the total solids used. This is more common and more easily accomplished with Aquacoat CPD.
What curing conditions do you recommend?
Answer: We recommend holding coated pellets or tablets at a temperature 10 degrees above the glass transition temperature for 48 hours to assume that a stable endpoint is reached. During the storage time, samples should be taken and tested for release profile in order to determine the time required at condition to reach the ultimate release profile. This process allows curing time to be shortened dramatically.
How can release profile be modified?
Answer: The release profile of a given drug can be modified through the choice of plasticizer, choice of a pore former, amount of pore former used, and coating thickness.
What are your guidelines for coating suspension preparation?
Answer: Begin with Aquacoat ECD or CPD. Add plasticizer at a ratio of 1 part plasticizer to 4 parts of Aquacoat solids (20% of Aquacoat solids). Mix with plasticizer for 20 minutes. Add water to attain a 15% solids suspension.
You are welcome to contact us for more information.