CapsCanada, a Lyfe Group company and provider of capsule technology, has launched a new liquid-filled hard capsule manufacturing service. CapsCanada aims to support the entire manufacturing process, from formulation and development through full-scale production. In creating this service CapsCanada partnered with a leading manufacturer of generic and branded drugs in Canada.
 
Production will take place at a dedicated Health Canada-approved facility that has a full analytical lab, licensing for controlled drugs and substances including narcotics, and a choice of blister or bottle packaging. The facility is also U.S. FDA approved and cGMP compliant for the manufacture and testing of injectables and is currently awaiting FDA approval for the manufacture and testing of solid oral dosage forms.
 
As CapsCanada discusses in its white paper, “Deglobalization of APIs and Pharmaceutical Manufacturing: Addressing a Significant National Security Risk,” the new service aims to return pharmaceutical and over-the-counter (OTC) drug manufacturing back to North America.
 
With CapsCanada’s technology for liquid-filled hard capsules (LFHCs), liquids, suspensions, semi-solids, pastes and waxy substances can all be filled into gelatin or HPMC vegetarian two-piece capsules. Also, the LFHC technology can address various complex formulation challenges associated with low-dose products, nano-sized or highly-potent active pharmaceutical ingredients (APIs) and formulations made with excipients that are not compatible with softgels. In addition, product development can be accelerated because LFHCs can be made with fewer excipients than other solid dosage forms.
 
The liquid-filled hard capsule manufacturing process is less complex and capital-intensive than manufacturing softgels, with filling equipment available in all scales, from benchtop to production. This makes scaleup from demonstration and clinical batches linear, resulting in faster product launches. The ability to do small production runs also makes it suitable for niche therapies.