The program investigates a nanoparticle API used as an adjuvant to enhance the efficacy of Atorvastatin.
Atorvastatin belongs to a group known as "statins" for preventing heart disease, strokes and attacks. Atorvastatin is commonly prescribed for the lowering of a patient's cholesterol.
Side effects are well documented, most serious of note are rhabdomyolysis and autoimmune myopathy. Evidence to date indicates that statins can cause either self-limited myotoxicity, presumably due to the direct effect of statins in the muscle, or an autoimmune myopathy associated with autoantibodies targeting HMGCR.
Source: Pinal-Fernandez I, Casal-Dominguez M, Mammen AL. Statins: pros and cons. Med Clin (Barc). 2018;150(10):398-402. doi:10.1016/j.medcli.2017.11.030.
Atorvastatin has a significant bioavailability problem cited at 12%.
This program looks at establishing a NanoCelle® Atorvastatin (named NanoStat™) with improved bioavailability without increasing the drug risk profile.