we are experts in formulations
Our highly experienced researchers and scientists are experts in the development of specialized technologies and formulation technologies.
Amzell's Topical and transdermal TECHNOLOGY
Amzell’s FDA- and EMA-approved technology is based on the passive transport of a drug through the skin. The diffusion is described by the Fick’s first law incorporating a push effect which increases the thermodynamic activity with a pull effect optimizing the diffusion of the formulation into the skin’s layers.
This process relies on an innovative combination of volatile and non-volatile solvents and permeation enhancers providing a synergistic action. As the volatile solvents evaporates, drug concentration increases (supersaturated solution in a state of heightened thermodynamic activity), forcing penetration. Non-volatile co-solvents prevent drug crystallization maintaining the driving force to permeate the skin and sustain drug release. The drug forms a reservoir in the skin reducing the number of daily applications.
This innovative permeation enhancing system increases skin permeability and the drug is “boosted” through the skin. The technology can be designed so that the pharmaceutical agent is delivered within the skin and adjacent soft tissues (“topical skin delivery”) where it will exert a local therapeutic effect. Alternatively, Amzell's Permeation Enhancing System can be fined-tuned to deliver the drug substance beyond the skin into the bloodstream where it will be taken up and transported through the body to its site of action (“transdermal skin delivery”). This technology reversibly loosens the skin structure to improve delivery whilst respecting skin integrity.
Key benefits of the technology include:
- Greater bioavailability which reduces frequency of dosing and/or the application of smaller volumes of gel formulations.
- Excellent skin tolerability due to passive drug delivery technology (no need for heat, microneedle, occlusion, or electrical current).
- A skin-friendly gel carrier with regard to physiological skin pH, it is odourless, transparent, and preservative-free.
- Customizable technology which is effective either topically or transdermally providing local or systemic action across a broad range of conditions.
Amzell's ability to precisely fine tune the solvents and permeation enhancers allows the development of either topical or transdermal delivery.
Mucosal & Transmucosal Technology
A deep understanding of biological mechanisms governing the permeability of drugs into mucosae (local action) or through mucosal membranes (systemic action) is required to develop safe and efficacious drug products.
The Amzell team leverages its recognized experience in design of permeation enhancing systems through in vitro and in vivo models, and formulation strategies to develop an alternative method of systemic drug delivery that offers numerous benefits over/parenteral and oral administration. Especially true for those drugs which are large, highly charged and/or poorly soluble like peptides and proteins. Transmucosal delivery of drugs through mucosal membranes particularly buccal, nasal, rectal and vaginal cavities, enables delivery of drugs directly into the circulatory system. This provides: fast onset of action and bypasses the gastrointestinal tract including first-pass metabolism in the liver (lower side-effects and/or greater bioavailability).
To increase the therapeutic efficacy of a pharmaceutical product, Amzell's injectable technology provides a sustained release of the active ingredient due to the presence of a natural polymer derivative. This polymer also protects the drug from environmental degradants leading to improved stability.
These enhancing and protecting effects are achieved using a minimal amount of the polymer. The low viscosity, comparable to the viscosity of blood, gives excellent syringeability and injectability properties for the injectable products. Clinical studies showed excellent local tolerability at the site of injection.