Can a Microneedle Patch Delivering Nanoparticles of Drugs Revolutionize Body Sculpting?

Given the number of food-related articles we’ve published in recent months, you may be forgiven for thinking we are somewhat obsessed. While researching topics like activated charcoal in ice cream to wine-infused coffee beans to last month’s unveiling of the all-new ruby chocolate, we at Berkshire have enjoyed feasting our eyes on some exciting new developments at the intersection of nutrition and science.

But we will admit, there has been a price to pay for our albeit purely academic and altruistic efforts. In order to bring these topics of interest to our contamination control community, we have perhaps enjoyed the fruits of our research a little too much. We’re noticing the needle on the scales creeping upward and the necessity of loosening off our belts a notch or two. Dare we say it: we just might be getting chubby.

So, taking ourselves in hand, we called a halt to this insidious weight creep, examined the latest developments in weight loss and fat removal, and were surprised to see how far the landscape has shifted since we were last on the market for a body sculpting regimen. Gone are the days of healthy and moderate eating, lowering caloric intake, and increasing energy expenditure to smooth out those voluptuous curves. Banished is the brutal, sledgehammer approach of the caloric deficit, achieved by hours of earnest effort on the elliptical or treadmill at the gym. And in their place are myriad 21^st century therapies that blast away fat in a controlled and highly targeted way. From liposuction to patches, lasers to freezing, let’s burn off a few calories by running through a new terrain: body sculpting for the modern day.

Before we pack a snack for our journey into this brave new world of weight loss, let’s just take a moment to look at fat. What is it and why is it so persistent in our bodies? Fat cells – or adipocytes as they are scientifically known – are an integral part of our anatomy and fall into one of two distinct categories: brown fat and white fat. The former cells are our main source of heat as babies and are considered ‘good fat.’ Brown cells tend to be found around the neck and upper back – those delightfully chubby areas that are so softly sweet on newborns and infants. The brown adipocytes are a cluster of lipid droplets containing iron-rich mitochondria, and are lost as we develop from infants to adults. White fat cells, by contrast, are made up of a single lipid droplet with a lower density of mitochondria, resulting in a white – or yellowish – appearance. White fat accumulates around the hips, thighs, and buttocks in women, and in the abdominal area in men. It’s a thermal insulator, protective cushion, and an endocrine organ that produces estrogen, adrenaline, cortisol, and leptin. So, although adipose tissue is a part of us we all love to hate when we’re pouring ourselves into those ‘skinny jeans,’ it’s actually vital to our physiological make up.

But there’s a limit to how thick a layer of fat we actually require. And when we exceed that limit, it’s time to take action. One of the best known and perhaps most invasive of our options is liposuction, a surgical procedure in which long, tubular needles – cannulas – are inserted into the body via small incisions. Tumescent liposuction uses only a local anesthetic as the tubes enter the patient’s subcutaneous fat layer and remove adipocytes from the body via vacuum suction. General anesthesia or very heavy IV sedation is not considered to be as safe a procedure as tumescent liposuction as the temptation exists to remove too much fat or to package a number of cosmetic treatments together, resulting in greater trauma to the body.

And from a contamination control perspective either of these types of procedure could present cause for concern.

Cannulas may be disposable or non-disposable, the latter type being not inexpensive. As we discussed in our previous article, Examining the Scope of the Problem, fully sterilizing medical devices that enter the body is a critical but challenging process. While the SOPs for cleaning inter-patient devices like duodenoscopes, endoscopes, or cannulas for that matter may be comprehensive, the reality is that the correct pre-cleaning and reprocessing of equipment may in practice fall short. In 2013/14 European hospitals received warnings from Olympus Corporation regarding the potential of the Olympus Video Duodenoscope to retain ‘residual residue at the distal end.’ In short: blood and other biological matter from one patient could remain in the device even after sterilization and carried the risk of cross-contamination of a subsequent patient. Although liposuction cannulas are very much less complex devices, the potential for problems clearly exists.

So if the thought of cannulas sucking fat out of your body is about as enticing as that lo-cal kale and brown rice salad you reluctantly bought for dinner – you know, the one where the packaging actually has more taste to it – you’ll be glad to hear that other options exist. Take for instance the patch…

When applied to a problem area, a grid of microneedles on the patch pierce the skin and deliver a dose of nanoparticles containing an as yet unspecified drug to the fat cells.

Successful body sculpting, the art and science of targeting specific areas for fat reduction, is one of the holy grail outcomes for the weight loss industry. And according to an article just published in MedGadget.com, reporting on medical technology around the world, researchers based at Columbia University Medical Center and the University of North Carolina have developed a microneedle patch that uses nanoparticles to convert white fat to its more friendly brown counterpart.(1) When applied to a problem area, a grid of microneedles on the patch pierce the skin and deliver a dose of nanoparticles containing an as yet unspecified drug to the fat cells. As the nanoparticles break down, the drug is released turning the white adipocytes into brown-like ones.(2) To date, research has been confined to lab mice but the results look promising. The fat cells targeted by the patch shrank by 20% within one week and a decrease in blood glucose levels was a helpful side effect. Clinical trials have yet to be conducted on human volunteers but researchers are celebrating the potential of the patch to treat not only obesity but also diabetes and other metabolic conditions.

Given that the microneedles puncture the skin, it will be critical that manufacturers and care providers adhere to strict codes of conduct in their supply and usage, as anything less will bring in its wake a very real threat in terms of contamination control.

And part of the approval process for use in human patients must include the development of cGMPs and SOPs to regulate the conduct of those preparing and performing the treatments. Given that the microneedles puncture the skin, it will be critical that manufacturers and care providers adhere to strict codes of conduct in their supply and usage, as anything less will bring in its wake a very real threat in terms of contamination control.

So if liposuction and lipolysis via microneedle patch are not for you, are there other options? You are in luck – this is not the only fat-melting game in town. SculpSure, a proprietary laser-based treatment, has been approved by the federal Food and Drug Administration (FDA) for targeted fat removal in patients with a BMI of up to 43.(3) Non-surgical, this alternative to liposuction is suitable for areas such as the thighs, back, and abdomen, and involves the use of a 1060nm wavelength laser that raises the temperature of the sub-cutaneous adipocytes to between 42°C and 47°C. Although this heat exchange destroys the structural integrity of the cells it does not burn the outer layers of skin and results only in mild and temporary side-effects.

Although approved by the FDA, hot laser sculpting and its $1500 per session price tag is not for everyone.(4)

So if it’s too ‘James Bond/Austin Powers’ for you, it might be time to consider CoolSculpting. In observing that children eating popsicles got small dimples in their cheeks, doctors Dieter Manstein and R. Rox Anderson of Harvard University theorized that freezing pockets of fat would destroy adipose tissue without broader damage to the skin. Pioneering a process termed Cryolipolysis® to actively reduce the number of fat cells, the researchers developed a non-invasive technique to kill fat cells by the application of intensely cold gel-packs. And this point is critical: weight loss is not the same as fat loss. In the former, fat cells become smaller but their relative abundance remains the same. With CoolSculpting, treated areas see an actual reduction in the number of fat cells (between 20% and 25%) as they are eliminated from the body within the 4 to 12 weeks of treatment. And what is especially interesting from a contamination control perspective is that, like SculpSure, the procedure is non-surgical and avoids those troublesome issues with re-usable cannulas.

Approved by the FDA in 2015, Kybella is a series of injections of a synthetic deoxycholic acid – a salt in human bile that aids digestions – to encourage the dissolution of dietary fat

So when you’ve dieted and exercised and laser-blasted and frozen your adipose tissue into submission, there’s always one place it will lurk. Where it will persist, a deeply unwelcome reminder of our chubby past. And it’s an area that is impervious to exercise. No amount of deadlifts, squats, lunges, or isometric exercises are going to tackle this: submental fullness, also known as the dreaded double chin. Enter Kybella. Approved by the FDA in 2015, Kybella is a series of injections of a synthetic deoxycholic acid – a salt in human bile that aids digestions – to encourage the dissolution of dietary fat. When destroyed, the fat cells are cleaned up by immunologic cells, swept into the circulatory and lymphatic systems, and expelled from the body. Allergen’s research builds upon earlier trials in which phosphatidylcholine was used to dissolve fat that had migrated into the blood stream in patients suffering physical trauma such as a bone break or fracture. The competitive world of body-building quickly embraced phosphatidylcholine along with deoxycholic acid in a formulation termed PC/DA, in order to get rid of spots of fat. Upon closer analysis, it was observed that the active ingredient was the ‘DA’ component and the cosmetic industry seized upon the idea.

Today, Kybella is available by prescription only to permanently transform adipocytes over the course of up to six months, with treatments administered one month apart. It requires receiving approximately 20 injections at a time, given using a grid to map specific sites for each shot. And interestingly it need not be done at a medical facility. In fact, according to an article by Lindsey Hunter Lopez writing for The Atlantic, many treatments are performed in ‘the kind of chic place you’d imagine one would visit for such a procedure, with futuristic light fixtures, high-end products on display, and luxe gold accents. It feels less like a medical environment and more like an upscale boutique, complete with a velvet couch.’(5) Most patients report little recovery time between sessions with localized swelling and bruising being the major after-effects, and as consumers we have to hope that best practices are followed by aestheticians and others delivering the injections.

So, in terms of battling the bulge, we now have more options available than ever. Whether we are looking to lose a lot of weight (hello gym and healthy eating routine!) or targeted pockets of ourselves, thanks to research and cleanroom science we can get the results we’re looking for relatively quickly and safely. Assuming all protocols are followed and that we have the necessary budget of course. And if all else fails, there is always one last solution: instead of blasting them into submission, perhaps we could try radical and complete acceptance of our bodies for the incredible, but imperfect, organisms they already are.

Have you ever opted for fat loss treatments? Would you prefer surgery or out-patient treatments like those described here? We’d love to know your thoughts!

References:

1. https://www.medgadget.com/2017/09/microneedle-patch-can-burn-fat.html
2. http://abcnews.go.com/Health/sculpsure-surgical-procedure-melt-body-fat/story?id=42685223
3. In adults 20 years and older, a BMI value of 30 or over is considered medically obese.
4. http://abcnews.go.com/Health/sculpsure-surgical-procedure-melt-body-fat/story?id=42685223
5. https://www.theatlantic.com/health/archive/2017/06/kybella-the-injection-that-melts-a-double-chin/529893/