Monica-Vialpando

Monica Vialpando, Ph.D.

Pharmaceutical Formulation Technologies Applicable to Cannabis

Technological advancements and improvements in high-throughput screening have result in new drug candidates becoming increasingly complex and difficult to formulate1. While the number of potent lipophilic/hydrophobic drug candidates increases, so does the number of poorly soluble compounds. Currently, 60% of new chemical entities are reported to be poorly soluble2. The response to this growing challenge is the emergence of new enabling technologies to circumvent poor aqueous solubility in efforts to improve oral absorption and efficacy. While some approaches such as spray dry particle engineering are incorporated in a number of marketed products, there are still other technologies like electrospun nanofibres not yet implemented in commercialized products. Despite promising academic results, the pharmaceutical industry has been slow to integrate many of these new drug delivery technologies due to the lack of in-house expertise, investment required along with increased regulatory hurdles necessary for commercialization.

Given that cannabinoids are poorly water-soluble compounds, the cannabis industry can also use these technologies to its advantage. The simultaneous development of these technologies paired with the growing products with understanding of cannabinoids and their formulation challenges can result in improved dosing accuracy, decreased variability, increased patient adherence and market distinction. This presentation will provide an overview of the most promising pharmaceutical formulation strategies for cannabis for product development with a focus on improving and controlling oral absorption.

References:

[1] G. Amidon, H. Lenernas, V. Shah, J. Crison, A theoretical basis for a biopharmaceutic drug classification: The correlation of in vitro drug product dissolution and in vivo bioavailability, Pharm Res 114 (1995) 413-420.

[2] L.Z. Benet, The role of BCS (Biopharmaceutics Classification System) and BDDCS (Biopharmaceutics Drug Disposition Classification System) in Drug Development, J Pharm Sci 102 (2013) 34-42.

Dr. Monica Vialpando is a pharmaceutical development scientist and principal at Vialpando LLC, a provider of outsourced innovation consulting for the cannabis industry. She has seven years of pharmaceutical industry experience, four years of vaping (nicotine) experience and two years of cannabis product development experience for a variety of US, UK, European and Asian-based companies. Her development portfolio includes immediate and modified release oral tablets, sublingual tablets, dry powders and nebulizer solution for inhalation, nicotine and cannabis vape products and topicals. She was awarded her Ph.D. in Pharmaceutical Sciences from the University of Leuven, Belgium.