A preclinical pharmacokinetic study of ION-ZCM1 as an API substance having potential uses in multiple administration methods of finished drug products is being evaluated. Dr. Jose Perez at the University of San Luis Potosí is the principal investigator and Scientific Director at Scientia Pharma S.A de C.V.
The study design is over multiple injectable dosing groups evaluating blood samples to determine how the subject animals handle the substance. In addition, a secondary evaluation is being done on the Ion Gel ZCM-25® to decide on its biological distribution through the skin.
The product Ion Gel ZCM-25® currently has sanitary registration as a class II medical device, with indications for use as a topical gel to prevent infections (bacteria, fungi, and viruses) and promote the healing of skin wounds.
Ion Gel ZCM-25® contains 25% of ION-ZCM1 - a cationic solution of ammine, zinc, copper, magnesium, sulfur, and hydrogen in a hexaqua ligand system formulated in a topical pharmaceutical transport mechanism of Sepineo Derm, sodium hyaluronate and glycerin.
This exact formulation using ION-ZCM1 will be further investigated for specific topical indications in oncology and presented to the regulatory as a drug candidate. A critical safety consideration for topical drugs is whether the application to the skin results in dermal penetration and systemic exposure of the active ingredient and, if so, to what extent.
This information helps identify potential safety issues and aids in determining whether an adequate margin of safety exists. A maximum use test (MUST) is a standard approach for assessing in vivo bioavailability of a topical drug substance.
Elements and considerations of a MUST study include study population, number of subjects, the amount applied, the surface area treated, dosing frequency, application method, active ingredient combinations, formulation considerations, sample collection, sensitive and validated analytical method, safety data, and data analysis.
In this study, the subject animal groups' urine will be collected and evaluated with common antioxidant studies to determine the reduction of oxidative stress over the control groups.
These critical evaluations will help support the further drug development of the Ion Biotechnology Aqueous Ligands “IBAL” delivery system and its components.