Rubicon Research Canada offers comprehensive drug product formulation and process development, as well as wide-ranging analytical testing services to the pharmaceutical industry, specializing in nasal and pulmonary drug products.
Rubicon Research Canada is well-positioned and experienced to support virtual, mid-size, and multinational companies by providing reverse engineering and novel formulation development solutions, manufacturing and packaging solutions, and associated analytical and stability support services.
Reverse Engineering of Products
Formulation, Process Development, and Pilot Scale-up
Management of CMO (Technology Transfer and Submission Batch Manufacturing)
Full Release Testing, Stability Studies, and Temperature Cycling Studies
Characterization and In-use Studies
In vitro Bioequivalence Studies
Proof of Concept Studies
"Lungs diagram with internal details" by Patrick J. Lynch, used under CC BY 2.5. .
Patrick J. Lynch, medical illustrator
Creative Commons Attribution 2.5 License 2006
Developed seven Rx FDA-approved products, including four generic CFC pMDI products for the U.S. market
Partnered with top U.S. and Canadian pharmaceutical companies to develop nasal sprays (solutions and suspensions) for both markets
Met the in-vitro bioequivalence criteria for all products developed to date
Developed products for United Nations development program to help transfer the pMDI products from CFC propellant to HFA for the developing nations
Successfully developed generic nebule and ophthalmic products
Pressurized Metered Dose Inhalers (pMDIs)
Metered Nasal Sprays
Small Volume Nasal Sprays (e.g. unit dose)