Encap will manufacture batches for Phase III clinical trials from its high-potency suite at its facility in Livingston, Scotland, following several months of transferring the manufacturing process and validation of test methods for Lipocine’s twice-daily oral testosterone drug, LPCN 1021.
Lipocine developed the LPCN 1021 in-house, Dr. Stephen Brown, Managing Director at Encap Drug Delivery told this publication, but during the course of its development Encap has had numerous discussions with the firm, adding “Encap is an industry-recognized leader in the development, scale-up and commercial manufacturing of this particular oral dosage form.”
Brown also spoke to us about the increasing demand for formulation services using highly potent active pharmaceutical ingredients (HPAPIs) which are increasing in customers’ pipelines
“High throughput screening has resulted in an increased percentage of highly potent APIs in the pharmaceutical development pipeline,” he told us, adding: “We expect this sector to continue to grow.”
He also spoke of the necessity of the ability to safely formulate, scale up and manufacture finished dosage forms to OEB 4/5:
“When manufacturing HPAPIs, a key requirement is to ensure dosage consistency and minimal exposure of the HPAPI to facilities and operators through engineering controls.”
Liquid-filled hard and soft gelatin capsules are perfectly suited for such compounds due to the initial stage of the manufacturing process incorporating the API into a liquid formulation, he added and “beyond this initial step, the hazard of API exposure to the manufacturing environment is significantly reduced compared with other dosage forms such as tablets.”
Investment and Capsugel
However, Capsugel/Encap has also invested in HPAPI manufacturing at the facility, Brown said, “due to the inherent suitability of the liquid-fill manufacturing process.
“At the Livingston site alone, we currently have five LFHC development client projects with highly potent APIs in late Phase 3 or submission phases that are scheduled to become commercial products in the near term.”
Furthermore, he told us further expansions are planned at the site over the next 12-18 months.