StarCap 1500® Co-Processed Starch Excipient Receives Pharmaceutical Precedence of Use in the European Union
HARLEYSVILLE, Pa., April 30, 2012 /PRNewswire/ — Colorcon Inc., announces StarCap 1500® a co-processed excipient has recently gained precedence of use within the European Union (EU) in an approved drug product.
StarCap 1500 is comprised of both corn starch and pregelatinized starch and is designed specifically for use in pharmaceutical applications, such as tablets and capsules. Corn starch and partially pregelatinized starch are commonly used excipients in oral solid dosage forms. These components of StarCap 1500 meet the applicable compendial and regulatory requirements for the intended pharmaceutical uses in the United States, Europe, Japan and a number of other countries.
With precedence of use in the EU, StarCap 1500 is now established as an approved excipient and can be used in drug products to be marketed within the EU. StarCap 1500 has also been used in approved drug products in a number of countries, in Latin America and Asia. Pharmaceutical formulators can confidently use StarCap 1500 in their formulation development, taking advantage of its unique functionality including excellent flow, compressibility and pH independent release.
Colorcon is a world leader in the development, supply and support of formulated products for the pharmaceutical and nutritional industries. Its core businesses include film coatings, modified release technologies, functional excipients and tablet design services. Colorcon has 18 technical service laboratories globally and more than 1200 employees exclusively dedicated to its customer base.
SOURCE Colorcon Inc.