April 28, 2023

Pharmacokinetics Study on Ion Gel ZCM-25® and ION-ZCM1

Ion Gel ZCM-25® in Breakthrough Study on Systemic Absorption and Oxidative Stress

Exploring New Drug Delivery Potential Through Injectable and Topical Routes

A breakthrough pharmacokinetic study is currently underway to assess the potential of Ion Gel ZCM-25® and its active pharmaceutical ingredient (ION-ZCM1) for both injectable and topical drug applications. This preclinical research, led by Dr. José Pérez of the University of San Luis Potosí and Scientific Director at Scientia Pharma S.A. de C.V., aims to provide comprehensive data on systemic absorption and biological effects, particularly its ability to reduce oxidative stress.

What Is Ion Gel ZCM-25®?

Ion Gel ZCM-25® is a topical antimicrobial gel, currently approved as a Class II Medical Device in Mexico. Its primary indications include:

  • Preventing skin infections caused by bacteria, viruses, and fungi
  • Promoting wound healing, especially in post-surgical and diabetic patients
  • Reducing oxidative stress, which is often elevated in chronic wounds

The product contains 25% of ION-ZCM1, a proprietary complex based on IBAL technology (Ion Biotechnology Aqueous Ligands). This complex includes zinc (Zn²⁺), copper (Cu²⁺), magnesium (Mg²⁺), hydrogen, sulfur, and ammonium ligands, designed to be biologically active and highly bioavailable.

Ion Gel ZCM-25

Study Design: Dual-Route Administration

This preclinical study explores both injectable and topical administration routes:

  • Injectable Phase: Multiple animal groups receive different dosing levels of ION-ZCM1 via injection. Blood samples are being analyzed for pharmacokinetics and systemic behavior.
  • Topical Phase: Ion Gel ZCM-25® is applied on the skin to evaluate dermal penetration, systemic absorption, and biological distribution.

This dual-path approach assesses how the ion-based formulation behaves when introduced into the body via different routes, and whether it maintains safety and efficacy profiles across applications.

Evaluating Oxidative Stress Reduction

One of the study's secondary endpoints is reducing oxidative stress, a key factor in wound chronicity, inflammation, and delayed healing.

Researchers are using a Maximum Use Test (MUST) protocol—an industry-standard in vivo study method—to evaluate the extent to which ION-ZCM1 penetrates the skin and whether it has systemic bioavailability when administered topically.

By collecting urine samples and analyzing them for oxidative stress biomarkers, the team can determine the antioxidant efficacy of Ion Gel ZCM-25® compared to control groups. This is especially relevant for its future potential in treating autoimmune skin conditions, radiation burns, and oncological wounds.

Why This Study Matters

The data from this study will play a vital role in:

  • Supporting regulatory submissions for Ion Gel ZCM-25® as a drug candidate for oncology and advanced wound care
  • Establishing safety thresholds for systemic exposure via dermal and injectable routes
  • Enhancing our understanding of ion-based antioxidant therapies
  • Validating IBAL technology as a reliable delivery system for multi-ion coordination complexes

If successful, this research could redefine topical drug formulations and pave the way for multi-functional therapeutics that heal and regenerate tissue at the cellular level.

Learn More About Ion Gel ZCM-25®

For more details on the science, clinical studies, and product availability of Ion Gel ZCM-25®, visit the official website: https://zcm25.com

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