CapsCanada, a Lyfe Group company and leader in capsule technology for over three decades, is pleased to announce the launch of a new liquid-filled hard capsule manufacturing service. CapsCanada’s objective is to support the entire manufacturing process, from formulation and development through full-scale production.
In creating this service CapsCanada partnered with one of the leading manufacturers of generic and branded drugs in Canada. Production will be done at a dedicated Health Canada approved facility in Canada 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 US FDA approved and cGMP compliant for the manufacture and testing of injectables and is currently awaiting US 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,” there is an urgent need to bring pharmaceutical and over-the-counter (OTC) drug manufacturing back to North America. This new service was launched to help address this issue.
“We are excited,” says Jonathan Gilinski, CapsCanada’s Executive Director, “to help solve ongoing outsourcing and supply chain issues in the OTC and pharmaceutical markets.”
CapsCanada has perfected the technology for developing and manufacturing liquid-filled hard capsules (LFHCs). With this technology, liquids, suspensions, semi-solids, pastes and waxy substances can all be filled into gelatin or HPMC vegetarian two-piece capsules. This North America-based manufacturing option based on CapsCanada’s LFHC technology offers pharmaceutical companies a number of distinct advantages in product development, speed to market and cost savings.
For example, CapsCanada’s LFHC technology can address a variety of complex formulation challenges. These include common issues 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 itself 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 feasible for pharmaceutical makers to pursue niche therapies.
“LFHCs also support brands’ marketing efforts,” Mr. Gilinski notes. “LFHCs are available in an endless combination of colors and imprints, allowing companies to create a unique branding for their products.”