“Our LIPIDEX technology platform provides tailored solutions for the manychallenges our customers face, whether it’s development of low solubility drugs in their pipeline, repositioning existing drugs for better therapeutic performance or rebranding them using innovative dosage forms,” said Amit Patel, president, Capsugel DFS. “Through Capsugel’s historical investments and our recent acquisition of Encap Drug Delivery, the LIPIDEX platform represents the industry’s most comprehensive and vertically integrated offering in the lipid, liquid and semi-solid arena. It spans polymer science and process engineering at the capsule level, as well as API handling, dosage formulation development using expert systems, clinical trial quantity supply and commercial manufacturing.”
Capsugel DFS can encapsulate formulations using several lipid, liquid and semi-solid fill dosage forms including its established Licaps liquid-filled and SGcaps soft gelatin capsules, which currently account for several billion capsules produced annually. And DFS continues to innovate and expand its dosage form options — a new solid lipid pellet dosage form is being utilized for select internal and customer projects and will be formally launched to the market later this year. These multiple dosage forms provide customers with options and flexibility to meet their target product profile, according to the company.
The LIPIDEX technology platform centers on Capsugel DFS’ clinical fast-track development program that utilizes its exclusive Lipid Expert System developed by its formulation scientists over the past decade to streamline various aspects of the development process. The company’s formulation scientists have extensive background in simple to complex lipid systems in solution, suspension or SEDDS/SMEDDS formulations. Small-scale liquid fill manufacturing technology, also unique in the industry, is available at Capsugel’s global research and development (R&D) locations.
“Customers are increasingly coming to us early in the R&D process to quickly solve their formulation challenges. Our Lipid Expert System can model ternary phase diagrams based on solubility in individual lipid-based excipients, so identifying the optimum formulation space for an API can happen much faster than by conventional matrix solubility screening experiments,” said Keith Hutchison, PhD, senior vice president of R&D, Capsugel. “The combination of our formulation and encapsulation expertise is being leveraged for unparalleled speed and precision in product development, scale-up and manufacturing.”
Rounding out the LIPIDEX platform is the company’s network of dedicated small-scale and commercial manufacturing sites in the U.S., Europe and Japan.This global manufacturing footprint assures business continuity planning and includes FDA and MHRA accreditation, and specialty capability in high potency actives, controlled substances and hormones.
For more information: www.capsugel.com