BME100 s2018:Group10 W0800 L1

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BME 100 Spring 2018 Home
Lab Write-Up 1 | Lab Write-Up 2 | Lab Write-Up 3
Lab Write-Up 4 | Lab Write-Up 5 | Lab Write-Up 6
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Name: Alison Dewald
Name: Taylor Miller
Name: Liana Soto
Name: Darius Williams
Name: Dylan Mitchell


Section 1

Sub-section 1-1
We are going to prevent opioid addiction by suppressing the dopamine receptor upon use of the drug thereby eliminating the effects of the drug on the brain. In 2016, 116 people died everyday from an opioid related drug overdose, and 42, 249 people died by the end of the year. 11.5 million people misused opioid drugs and 2.1 million people reported having an opioid drug use disorder. Deaths from opioid drugs have more than quadrupled since 1999. The opioid epidemic is something Americans need to become more aware of and needs to be controlled. By creating a product targeting the prevention of opioid addiction, we can reduce the number of people addicted to opioids, reduce the cost burden of opioids on our country, and most importantly, reduce the number of deaths related to opioid use.

This device will work by first detecting the presence of morphine-3,6-diglucuronide;the chemical that all opiates convert to once they inside of the body. Once morphine-3,6-diglucuronide2 is detected,the device would release gamma-Aminobutyric acid or GABBA into the brain in order to bind to the mu-receptor;which is the primary receptor that dopamine,first.While gamma-Aminobutyric acid is present in the ventral tegmental areaof the brain,this device will allow GABBA to be released more efficiently so this chemical can get to the receptors first rather than the morphine-3,6-diglucuronide1. After GABBA is binded to the receptors, the opiate will have no area to bind and thus preventing the dopamine receptors from flooding the brain and suppressing the“vacuum cleaner” from drawing in the excess dopamine and keeping the brain in chemical balance.


Sub-section 1-2
There are many different types of customers that our device can target. Some organizations consist of the National Institutes on Health, National Institute on Drug Abuse, Substance Abuse and Mental Health Administration, American Academy of Pain Medication, Drug Enforcement Administration, and the Prevention for States. Some health centers that would have interest in our product would be hospitals, retirement homes, rehab centers, and insurance companies. The people that would be using or distributing our product would be physicians, psychotherapists, clinicians, patients, parents of patients, psychiatrists, detox specialists, surgeons, and plastic surgeons.

Section 2

Sub-section 2

There are a handful of current solutions related to the prevention and treatment of opioid addiction. While our product is aiming towards the prevention of addiction, noting current solutions towards the treatment of opioid addiction could help us better develop our own product. Solutions for the treatment of opioid addiction consist mostly of medications that reduce withdrawal symptoms in the patient. The first solution is a combination of saffron, which is expensive due to it being a labor-extensive crop, and methadone, a drug commonly used to treat addiction already in place. The cost of methadone annually per patient is $4,700, and once paired with saffron, this cost will increase. Although this drug will be able to reduce withdrawal symptoms in patients, there is no guarantee the patient will become fully addiction free before relapsing. Another method, similar to methadone, is buprenorphine, a drug used to induce and relieve opioid withdrawal symptoms. Comparable to methadone, buprenorphine does not ensure the patient will completely recover and refrain from further drug use and the cost is very similar per patient per year. An additional method for the treatment of opioid addiction is injectable, extended-release naltrexone, which averages about $1,100 per injection. Advantages to this drug include help in achieving remission in drug addiction patients, and the ability to get treatment as an outpatient. Disadvantages, besides the costly price per injection, are the lack of knowledge on when is best to begin injections and the commitment required to remain drug free. This method has been found to be most successful when done in patients already drug free, as an aid to remain on the path to long-term remission. How our product differs from the solutions already stated is the time at which the drug is given. Our product is going to be used in the prevention of opioid addiction, whereas these drugs are used in the treatment of addiction. Furthermore, our product is going to be an implant that releases the drug directly into the bloodstream, making it more reliable to prevent addiction. Present solutions for the prevention of opioid addiction are prescription monitoring programs, abuse deterrent forms of opioid drugs, state prescription drug laws, and educational programs about the effects of opioids. Prescription monitoring programs collect information on the prescriber, pharmacy, product name, concentration, dose, and amount of medicine dispensed. This method has been found to limit “pharmacy-shoppers”, but are not effective in eliminated the problem entirely. These monitoring programs are also only operational in 33 states, restricting the use across the country as a whole. Likewise, educational programs and state prescription drug laws have been found to be somewhat effective, but only in certain cases where patients are not likely to become addicted. A final solution, that could actually be very beneficial if a product is created, is the abuse deterrent formula of opioid drugs. There have been three specific forms created targeting different areas of addiction prevention. The first is the “fortress approach,” in which the formulation maintains its extended-release characteristics despite attempts to crush or dissolve it. The second is the “neutralizing approach,” in which the formulation is relatively easy to alter, but tampering with the formulation results in the release of a neutralizing antagonist. And the final is the “aversive approach,” in which the opioid is formulated with an aversive agent that results in unpleasant side effects when a large quantity of the opioid is ingested. Overall, these drugs could be effective in preventing drug addiction; however, our product aims to block the effects of the drug on the brain, thereby preventing addiction in a different way.


Section 3

Sub-section 3-1
I. Abuse-deterrent pharmaceutical compositions of opioids (Collegium Pharmaceutical Inc.) (2002-06-05)(US8557291) This patent was filed with the sole purpose of stopping the misuse of opioid drugs. The goal of the company is to create a new type of drug that is resistant to the ways that drug abusers administer drugs. Many drug abusers in the U.S. today choose to snort, or break the pills and dissolve them in water or insert them intravenously. In this way the drugs can be immediately broken down in the blood, or the mucus tract and more of the drug is able to enter the brain very quickly giving the users a “high”. This new drug aims to increase the lipophilicity of opioid drugs to increase the insolubility in an affect to limit the amount of the drug being released into the system at one time. This would deter the users because the body would not be hit with a lot of the drug at once and the “high” would not be achieved.

II. Individualized addiction cessation therapy (Leon Lewandowski) (2001-06-29)(US20030003113A1)

This patent aims to use a pre-existing algorithm to slowly decrease the doses being administered to the abusers. This algorithm gives each patient a certain concentration of the drug to begin with, and then slowly decreases the concentration over time according to the algorithm. In this way, the users are not immediately taken away from the drug which can have long term side effects, but instead are slowly weaned off with the treatment. The graphs below represent the doses administered to patients over time, and represent the concentration being cut in half first, then into fourths, than eighths, until the patients no longer are dependent on the drug. This method is special in a way because the inventor aims to make each treatment individualized based on existing history of the abusers. This new computer data processing software will work with health officials to give the patients the best personal care possible.

III. Pharmaceutical formulation containing dye (Thomas Gruber) (2008-08-06)(US7214385B2)

This patent also aims to prevent the abuse of opioid drugs and painkillers prescribed by doctors. The goal of the invention is to stop abusers from tampering with the drugs given to them. Many of the people addicted to drugs snort or take the pills in ways that were not meant to be administered in order to achieve the overdose of the drug into the system. The patent describes a new formula for opioid drugs that will dye the mixture a certain color after being tampered with. In this way, users can visually see that they are doing something wrong, and others witnessing can see as well. The direction the creator wants this new drug to take is to make abusers see that they are not doing something right and deter them from using the drug in this way.

Sub-section 3-2

Customer Validation: 1

Competitors: 3

IP Position: 2