Clinic Ready Formulations
The development of cannabinoid therapeutics will be an exciting class of pharmaceuticals in the world.
Flexible CMC and Solubility Enhancement for Investigational Cannabinoid Formulations
Drugs like cannabinoids are poorly water-soluble and exhibit low and erratic bioavailability when orally administered, and therefore, conventional formulation strategies may not be appropriate for long-term commercialization. Addressing solubility challenges remains one of the greatest and most common barriers to successful drug development programs and will likely constrain the development of cannabinoid drugs unless they can be quickly resolved. Scientists at Santé Laboratories developed a proven method of improving the solubility of cannabinoids and bioavailability using a proprietary lipid-based formulation technology. The lipid-based formulation technology and it’s manufacturing process were developed to dramatically speed up the investigation and commercialization of cannabinoid formulations by improving bioavailability and room-temperature stability.
Santé Laboratories understands first-in-man clinical investigation is a critical milestone in the drug development process especially for an emerging class of therapeutics like cannabinoids. We will partner with you to overcome formulation challenges leveraging a lipid-based nanoparticle formulation technology and provide manufacturing solutions suitable from benchtop to clinical scale-up.
With flexibility, speed, and exceptional science at the center of everything we do, Santé Laboratories can provide the following development and clinical manufacturing services:
- Develop and optimize clinical cannabinoid formulations leveraging Santé Labs lipid-based drug delivery system to solubilize cannabinoids at room-temperature and provide meaningful exposure during first in man clinical studies for multiple routes of administration
- Provide flexible GMP manufacturing solutions of cannabinoid formulations for first in man studies
- Straightforward and transparent chemistry manufacturing and controls (CMC)
- Execute and manage necessary stability studies following ICH requirements
- Collaborate for successful regulatory IND filings
- Applicable knowledge formulating and testing cannabinoids