Can topical administration of amino acids be effective at managing conditions, such as erectile dysfunction?

Durham, North Carolina
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About This Project

The use of amino acids in medicine today continues to be explored using clinical research. Many of the therapeutic effects provided by the amino acids can be beneficial to treat a number of topical conditions. Nevertheless, amino acids have been predominantly administrated orally, with limited success. The present research is focused on understanding whether amino acids can be applied directly on the skin to achieve efficacious amounts locally, at the target site.

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What is the context of this research?

Amino acids are known to be generally safe and can offer therapeutic effects, including vasodilation, anti-aging, wound healing, etc. These effects could be fully exploited if amino acids were to be applied topically. However, amino acids are often taken orally, despite the drawbacks associated with this route of administration. For example, approximately 40% of oral l-arginine is metabolized by arginase on the first pass metabolism, which can then result in sub-therapeutic effects. The present research is focused on investigating whether amino acids can be administrated topically, such to overcome the issues associated with the oral route.

What is the significance of this project?

There are several scientific publications in support of the therapeutic effects provided by amino acids. For example, arginine seems to be one of the most promising amino acids for boosting levels of a substance called nitric oxide, which can in turn relax blood vessels. Such an effect is highly sought for example, when treating topical conditions such as, erectile dysfunction and/or peripheral arterial disease. Amino acids can also be beneficial to treat topical conditions such as, cold sores.

This study is especially important as with this information, we can prove that the application of amino acids topically, can help with bypassing first-pass metabolism and improve targeting of these compounds for a local effect.

What are the goals of the project?

The aim of the project is demonstrate whether therapeutic amounts of amino acids can be delivered across and into the skin.

We will test up to 5 prototype formulations for topical delivery of amino acids. The prototype formulations will be manufactured at a pharmacy by Tommaso Renzi (who is a compounding pharmacist). Then we will conduct an in vitro skin permeation experiment. During this experiment, we will be monitoring (using an analytical method, such as HPLC) the amount of each amino acids that will be delivered across the skin and into skin layers (such as epidermis and dermis). At completion of the experiment, we will assess whether therapeutically effective amounts of amino acids are achieved at the target site.


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This budget will be used to buy consumables for the preparation and analysis of topical formulations including amino acids. We are planning to manufacture up to 5 formulations. The formulations will be then evaluated in vitro for their ability to provide efficacious amounts of the selected compounds across the skin, to the target site. The costs associated with the in vitro testing include: purchase of the skin, development of suitable conditions to extract amino acids from the skin, and use of vertical diffusion cells.

Endorsed by

Dr. Caserta and Renzi have been studying the beneficial effects of amino acids for several years and they are positioned to make great strides in developing new treatments for conditions such as, erectile dysfunction. The experimental plan is adequate and the timelines are feasible. I support this fund raising effort to speed their research efforts.

Project Timeline

We do plan to have all experiments completed by end of March 2022, with data being published by end of June 2022.

Nov 11, 2021

Project Launched

Jan 21, 2022

Manufacturing Prototype formulations

Mar 25, 2022

In vitro skin permeation experiment

Jun 24, 2022

Data analysis and manuscript preparation

Meet the Team

Francesco Caserta
Francesco Caserta
Tommaso Renzi
Tommaso Renzi

Francesco Caserta

I have received a master in Pharmaceutical Chemistry from Sapienza University of Rome and a Ph.D. in Pharmaceutics from the University of Hertfordshire. I have published 10+ peer-reviewed articles and 2 book chapters. My research interests lie mainly in designing novel drug delivery systems. During my 10 years at MedPharm, a world-renowned contract research organisation specialized in designing products for dermatological, nail, eye, mucosal membrane and transdermal application, I have been involved in the pharmaceutical development of several products that are now on the market in Europe and America.

I have a patent for a novel formulation (, that is currently being tested in clinical trials.

I have founded IInKos with Tommaso Renzi, a company focused on enhancing the benefits of nutraceuticals and botanicals by developing formulations optimized to deliver these compounds safely and efficaciously.

In collaboration with Tommaso Renzi, we have recently decided to concentrate efforts on developing child-friendly formulations with antibiotics. Few things in life are as frustrating and worrisome as watching my child spit out the medicine we gave him to make him better and we want to identify new dosage forms to address these issues.

Tommaso Renzi

I have received a master in Pharmaceutical Chemistry from the School of Pharmacy at Sapienza University of Rome. I have been a practising pharmacist for over 10 years. I have specialized in compounding customized medications for women, men and children including suspensions, ointments, capsules, gels and creams that are not otherwise commercially manufactured or available. I consult with patients regarding their symptoms and review bloodwork to determine appropriate dosages.
I have co-founded IInKos with Francesco Caserta, where I oversee the development of novel delivery systems for nutraceuticals and botanicals.

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