Drug Development

In response to new regulation, funding, and scientific understanding in a variety of indications, the development of cannabinoid-based medicines represents a meaningful therapeutic category in the drug development industry. However, like majority of drug substances, cannabinoids are not water soluble and have been shown to be poorly absorbed when orally administered in a variety of non-human and human models. Thus, in order to prioritize achieving proof of concept data in animal and humans, drug development teams must be ready to identify effective and straightforward formulations solutions that will overcome these challenges to successfully and quickly transition to first in man studies. Sante Laboratories has in-depth and cannabinoid-relevant expertise in successfully addressing a variety of formulation challenges that are experienced during development and formulation optimization.

Recognizing that cannabinoids exhibit poor aqueous solubility

that leads to inadequate and inconsistent absorption after oral administration, the use of solubility and bioavailability enhancement technologies are obvious. At Sante Laboratories, a lipid-based delivery system that is aqueous based was developed and shown to overcome solubility challenges with cannabinoids and a variety of other hydrophobic compounds. This approach enables Sante Laboratories and its partners to expedite the formulation optimization process to overcome intrinsic physicochemical properties of cannabinoids and therefore improve oral bioavailability. Formulating with only FDA approved and GRAS excipients, lipid-based delivery solutions such as the one developed by Sante Laboratories are considered practical solutions to improve oral bioavailability of difficult to absorb drugs.

Regardless of phase of development and borrowing from relevant expertise in cannabinoid sciences, Sante Laboratories can work with you to overcome formulation challenges and provide commercially viable drug delivery solutions to quickly enter the clinic. Leveraging the lipid-based drug delivery technology, Sante Laboratories can work with you to provide the following formulation services:

  • Drug substance and formulation characterization
  • Formulation development, optimization, and screening to identify lead formulation candidates
  • Evaluate chemical and physical stability of cannabinoid formulations
  • Evaluate and select appropriate formulation strategies to overcome chemical, physical, and microbiological instabilities such as use of saturated medium chain triglycerides and antioxidants
  • Evaluate drug release kinetics of cannabinoids

In addition,

Sante Laboratories understands there are other well-established technologies to address solubility concerns with compounds like cannabinoids, therefore Sante can work with you to identify alternative drug delivery approaches that are robust and commercially viable to accelerate success in early development and first in man studies. Proven alternative formulation strategies with varying degree of complexities are available to address cannabinoid formulation challenges such as:

  • Liposomal delivery systems
  • Various lipid systems such as nanoemulsions and solid lipid nanoparticles
  • Self-Emulsifying Drug Delivery Systems (SEDDS)
  • Co-Solvent-based formulations
  • Surfactants-based formulations
  • Cyclodextrin complex formulations
  • Spray dried formulations – Spray drying has been shown to improve solubility of cannabinoids in combination of various excipients. Sante Laboratories has experience in developing aqueous and solvent-based formulations that can be spray dried to overcome solubility and drug delivery challenges.

Sante Laboratories and its lipid-based technology can work with cannabinoids from traditional and non-traditional sources such as:

Synthetic Cannabinoids – Currently multiple active drug master files (DMF) available for synthetic cannabidiol
Plant-extracted Cannabinoids – Isolated and ratios thereof
Semi-synthetic cannabinoids – Isolated and ratios thereof

Sante Laboratories will work with you to rapidly and successfully advance your cannabinoid formulation from benchtop to clinic using its lipid-based formulation technology.

Specialty Drug Delivery Company

Developing room-temperature stable and bioavailable formulations for Consumer Goods and Pharmaceuticals.