Will manufacture Phase III batches of oral testosterone product in high potency suite at Livingston, Scotland
Encap Drug Delivery, part of Capsugel’s Dosage Form Solutions (DFS) business unit and a specialist in liquid-fill hard capsule development and manufacturing, is to manufacture Phase III clinical trial and ICH stability registration batches of Lipocine’s oral testosterone product, LPCN 1021. The product will be manufactured in the company’s high-potency suite at Livingston, Scotland.
Lipocine is a specialist pharmaceutical company developing products for use in men’s and women’s health using its proprietary drug delivery techniques. LPCN 1021 is under development as a testosterone product to treat symptoms related to currently marketed testosterone replacement products. The investigational drug is for twice-daily oral dosing.
'This collaboration highlights our long-standing and significant expertise in commercial-scale manufacturing and our ability to handle high-potent active pharmaceutical ingredients,' said Stephen Brown, Managing Director at Encap Drug Delivery.
Encap has completed the transfer of the manufacturing process and validation of all related test methods (in-process and finished product) for LPCN 1021 to Livingston. The firm has also manufactured all the Investigational New Drug (IND) registration batches for the upcoming Phase III clinical supply and stability registration at this facility, which opened in 2008.
Capsugel’s DFS business unit is working on a broad array of client projects ranging from the earlier stages of formulation and clinical development to late-stage clinical studies, as well as several products that are already approved for commercial sale. Encap’s Livingston site alone has five development client projects in late Phase III or submission phases that are scheduled to become commercial products in the near future.