Extension of the company’s intrinsically enteric capsule portfolio can accelerate product development and reduce costs by eliminating the need for functional coating
Morristown, N.J., October 7, 2016 – Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions, recently announced the launch of its Vcaps® Enteric capsules, a new functional capsule technology that achieves enteric protection and delayed release without the need for functional coating. The new capsules provide Capsugel’s customers with another solution for intrinsically enteric delivery, complementing the company’s enTRinsic™ Drug Delivery Technology launched in late 2015.
Incorporating enteric polymers to form the primary capsule structure is a breakthrough in drug product development that can accelerate speed to market while reducing costs. Intrinsically enteric capsule technologies allow formulators to avoid coating preparation, application and validation, which greatly simplifies preclinical and clinical studies for compounds requiring enteric protection or delayed release.
At the CPhI Pharma Awards 2016 in Barcelona this week, Capsugel won the “Excellence in Formulation and Excipients” award for the technology used in its Vcaps® Enteric capsules.
“Finding better ways to deliver drugs to the small intestine, formulate acid-sensitive active ingredients and protect the stomach are significant challenges for the biopharmaceutical industry. Capsugel’s new Vcaps Enteric capsules provide a novel and highly accessible solution to address these challenges,” said Keith Hutchison, PhD, Senior Vice President of Research and Development, Capsugel. “Our leadership in polymer science and capsule engineering continues to generate technologies that may help reduce the variability, complexity and risk associated with drug product development. In this case, we are standardizing the enteric barrier and bypassing the need for film coat development and the process scale-up steps that can be involved with enteric coating.”
Intrinsically enteric capsule technology can reduce development time by up to six months through Phase I and by more than 12 months through Phase III for acid-sensitive or gastric-irritating compounds. With the recent launch, Capsugel now offers two distinct yet complementary intrinsically enteric capsule technologies. Vcaps Enteric capsules are suited for delivery of a wide range of active pharmaceutical ingredients (APIs), while the enTRinsic Drug Delivery Technology is an ideal solution for APIs with high acid or enzyme sensitivity, such as certain peptides, proteins, vaccines and microbiomes. Both solutions are composed of approved pharmaceutical grades of cellulose-based derivatives with extensive market precedence of providing enteric protection.
“At Capsugel, we strive to provide fit-for-purpose technologies and formulation approaches tailored to API specifics and target product profiles,” added Hutchison. “We look forward to working with our customers on ways to apply our encapsulation technology to existing and new products in their portfolios and pipelines.”
Vcaps Enteric capsules have been evaluated in-vitro and in-vivo across a number of compounds – demonstrating full compliance with relevant European, Japanese and U.S. Pharmacopeia monographs.
Capsugel designs, develops and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health and nutrition industries. Our unique combination of science, engineering, formulation and capsule expertise enables our customers to optimize the bioavailability, targeted delivery and overall performance of their products. We partner with more than 4,000 customers in over 100 countries to create novel, high-quality and customized solutions that align with our customers’ evolving needs and benefit patients and consumers. For more information, visit www.capsugel.com and follow us on Twitter and LinkedIn.