Questions
What is the overall focus of your research?
Mostly I look at ways to deliver drugs to the skin more quickly, so we’re looking at either modifying the compound to make it through the skin more quickly and then we look at different formulations like gels and creams and patches.
Why is the skin important as a drug-delivery avenue? Most people think of taking a pill or drinking something or receiving an injection. What is it about the skin?
The skin is a good alternate route of delivery for chronic types of therapies. So something you wear multiple days.
One of the most popular products was the fentanyl patch for chronic cancer pain, for example. It’s something that a patient doesn’t have to take orally if they have nausea and vomiting. And so drugs like that, as well as nicotine patches for smoking cessation treatment, are very popular over the counter and pain patches as well, like lidocaine and diclofenac for back pain and muscle pain.
Is there something about the skin that makes it a good vehicle for delivering medication or is it more about convenience?
It’s more of a convenience issue, and that way you could actually have a once-a-week patch.
Some people are working on just a twice-a-month patch, so you can wear it for a long time and not have to worry about taking drugs, which is ideal for some patients like Parkinson’s patients or Alzheimer’s patients as well. Caregivers can put on the patch, and that can last for a week at a time, for example.
Let’s talk about your hormone compounding study. Can you tell us why people need hormones and need them to be working well in their bodies?
So hormones are things like estrogen and testosterone that you need to be healthy. And so we were working on estrogen supplement products primarily for menopause treatment and relief of symptoms like hot flashes and night sweats and things like that. And what we’re interested in mostly is compounded products. So compounded products are an area where you have a prescription from your physician for a specific product that you can’t get in the pharmacy, so like a standard prescription product.
You take it to a compounding pharmacy, and the compounding pharmacist will make up whatever type of sort of niche products that you need from your condition. The concern potentially is that you might get too much absorption of estrogen, which can cause cardiovascular issues or other things in sensitive populations.
The other side could be you’re not getting any absorption at all from some of these products. There’s a reason why we have the drug development process and it takes a very long time to deliver, to develop a drug so that it delivers a reproducible amount of compound from the product over time.
And so that’s why there’s a long drug development research process. And so the compounded products don’t have to go through all that testing. There are certain limitations of the amounts of things they can put into the products. And they’re mainly compounded for people maybe who have allergies or sensitivities to some of the things in the products that are available and there’s some compelling reason why they would need the products.
There’s been some controversy about hormone replacement therapy over the years. Will you talk in general about menopause and perimenopausal hormone replacement therapy for women and the importance of that topic and treatment for women?
There’s been kind of a large change over multiple decades about the thought process on when do we treat perimenopause and menopausal symptoms and when do we not?
There were studies that were done that showed there were too many adverse events associated with the hormone therapies and then there were other studies showing, well, maybe if you don’t use them in the sensitive populations, then they are so much more beneficial than not being treated with the hormone replacement therapy, and I think women have really demanded that they would like to feel better. You know, the estrogen replacement is responsible for all sorts of things, from brain fog to the night sweats and the hot flashes.
What might happen if your research isn’t done? What could be the potential negative outcome?
I think the negative outcome here would, if we, you know, can no longer do this type of research is that we don’t know about some of the products that are on the market now.
We also did a similar project with sunscreens a few years ago, looking at the absorption of compounds from those, and sunscreens are being reformulated to be better now and have less drug absorption of different chemicals. And this is similar for the hormone products now and so we’re interested also after looking at some of the estrogen products to go on and look at some of the compounded testosterone products as well that are on the market. So besides the research results that we get from this project for the FDA, what this funding allows us to do is to train the next generation of scientists.
So if we didn’t have the funding for the trainees, there wouldn’t be the opportunity for them to learn how to do clinical research and clinical trials done by lots of companies, there wouldn’t be good trained people in the future available to work on the new products that we need later on.
