Critical Pharmaceuticals and The University of Nottingham announced a collaboration to develop a nano-enabled intranasal formulation of teriparatide for the treatment of osteoporosis. The Technology Strategy Board and the Engineering and Physical Sciences Research Council (EPSRC) are supporting this project with £545,000 in grant funding as part of their investment in nanoscale technology-enabled solutions in healthcare.
Teriparatide currently needs to be injected every day. The consortium will exploit a recent discovery in nanotechnology to develop a nasal spray formulation of teriparatide that is easy to administer by patients and provides optimal drug plasma levels to enhance efficacy.
Critical Pharmaceuticals’ CriticalSorb™ nanotechnology is an absorption promoter designed to enable the nasal delivery of biological and small molecule drugs. Using conventional manufacturing technologies and delivery devices, possible formulation presentations include liquid nasal sprays or powders for nasal administration. The partnership will leverage this platform along with The University of Nottingham’s leading capabilities in clinical and basic research in osteoporosis, including expertise in imaging drug deposition and clearance.
CriticalSorb is a pharmaceutically acceptable excipient approved by the FDA as generally regarded as safe (GRAS). It is used in currently marketed products as a solubility enhancer for intravenous and oral administration. In preclinical toxicology studies, CriticalSorb has been found to be nontoxic and not irritating to the skin or eyes and was well tolerated by the nasal mucosa in acute, 14-day, and 6-month repeated-dose chronic toxicity studies, the company reports. Furthermore it is not mutagenic to bacteria, mammalian cells, and mammals, and no developmental toxicity or teratogenicity has been found, Critical Pharmaceuticals adds.
Critical Pharmaceuticals has used the technology to develop CP024, a nasal growth hormone product in Phase I development, and also with insulin and two partner programs that involve peptide drugs. The bioavailability of intranasal insulin using CriticalSorb is approximately 100% relative to subcutaneous injection and compared to <1% without CriticalSorb, according to Critical Pharmaceuticals.
Clinical proof of concept has been established for CP024 and the CriticalSorb technology. In a Phase I trial CP024 was shown to be well tolerated and able to induce insulin-like growth factor 1 (IGF-1) to the same levels as a subcutaneous injection of the marketed product.