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What is Copaxone?
What is Copaxone?
Copaxone, also known as glatiramer acetate injection, is a prescribed medicine that is used to treat relapsing forms of MS. [10] For patients prescribed with 40mg dosages, injections must occur 3 times a week and must be at least 48 hours apart. For prescriptions of 20mg, injections are done on a daily basis.
Copaxone, also known as glatiramer acetate injection, is a prescribed medicine that is used to treat relapsing forms of MS. [10] For patients prescribed with 40mg dosages, injections must occur 3 times a week and must be at least 48 hours apart. For prescriptions of 20mg, injections are done on a daily basis.
The Issue...
The Issue...
Some of the side effects for Copaxone occur at the injection site. Due to multiple injections over time, skin irritation, pain, swelling, redness, or itching is common. In other circumstances, severe rashes have been known to develop. Patients can also experience shortness of breath or flushing (redness to your cheeks and other body parts) and are instructed to contact their physician. [10]
More Severe Side Effects...
More Severe Side Effects...
In other circumstances, patients have been known to experience more severe side effects when using Copaxone. One example is angina or major chest pains. Angina can occur either immediately post-injection or a part of the symptom by itself. These occasions of chest pains vary after 1 minute or approximately 30 days after Copaxone injections have begun. Moreover, another severe side effect includes skin damage or lipoatrophy. This refers to the loss of tissue of the underneath the epidermis due to multiple subcutaneous injections. As a result, necrosis or death of the skin cells occurs. Also, damage to the fatty layer can result in a "dent" at the injection area that won't fade away. [10]
The Improvement
The Improvement
The existing side effects of Copaxone and its delivery method motivated our creative solution design. Currently, patients that are prescribed with Copaxone are instructed to inject dosages of glatiramer acetate, either by themselves or by their caregiver. A 20mg prescription needs to be injected once every day and the 40 mg prescriptions are injected 3 times per week, separated by at least 48 hours. [11] In order to prevent skin irritation, rashes, or even tissue death, patients are also instructed to change the site of injection every so often. This distributes the effect of glatiramer acetate throughout the body and helps reduce the amount of times an area of skin needs to be punctured by a needle. Since multiple sclerosis has no cure, all of these disease-modifying drugs and symptom management methods will last a lifetime. After a while, these treatments can be overwhelming, confusing and, with the numerous drug side effects, reaps more drawbacks than there are benefits. And so, our solution aims to improve upon the side effects relating to the injection site and the way that Copaxone is administered.
Monitoring System
Monitoring System
Our creative solution combines two separate inventions. The first component of our solution is called the SweatSenser. This sensor was developed by Dr. Prasad’s research lab earlier this year. Currently, this sensor is being commercialized by a company called EnLiSense and put into wearables for daily activity. The SweatSenser is capable of analyzing a person’s sweat level for an increase in cytokine levels. This drastic change in cytokine levels, called a “cytokine storm”, can be used to indicate when the body is triggering a proinflammatory response. [8]
In detail, the device uses an electrochemical biosensor strip equipped with multiple probes that can detect target biomarkers. Also attached to the device will be a reader in order to showcase real-time and continuous measurements of cytokines in the patient’s sweat levels. Depicted in the image above is the composition of the sensor strip and its mechanism in response to skin contact. The top layer is the area where the analyzed or old sweat can be released. This will also prevent any external moisture from entering this specific area of skin being monitored. While in direct contact of the skin, an absorbent patch captures the passive sweat from the user. The sweat will then diffuse through a porous sieve. This will allow for the biomolecules to properly diffuse. Following this layer, the biomolecules enter a region of antibodies that can trap target biomarkers by using a semiconducting nanofilm. The semiconducting nanofilm is made from zinc oxide (ZnO) and ranges between 100 to 200 nm in thickness. The metallized layer transduces electrochemical binding interactions. The sweat diffuses into the next layer to be released and more passive sweat is collected. Although a majority of people do not sweat an exorbitant amount throughout the day, the increased sensitivity of the sensor itself is able to pick up and absorb the smallest amount of sweat from the eccrine glands and analyze its contents. The antibodies present fight against numerous pro-inflammatory proteins such as interleukin-6 (IL-6), IL-8, tumor-necrosis-factor-α (TNF-α),etc. [8] The binding between the antibodies and the proteins present in sweat molecules have the ability to change the electrical current, resulting in the uptake of the person's minimal amount of sweat.
The device itself has been designed to detect and track levels of the target biomarkers in a multiplexed way combined with the user's vitals to establish the progression of the disease and before the manifestation of a pro-inflammatory response in the body. The SweatSenser is also able to simultaneously measure temperature of the skin and perspiration in order to assess the user's vitals. The device is able to distinguish healthy individuals from individuals with a fever or viral infections (like the common flu). The development of this device demonstrates how cytokine levels can be utilized for creating future wearables capable of monitoring infections. [8] For many viral diseases or conditions that help manage autoimmune symptoms, this is a huge advantage towards preventing symptoms from manifesting. In the case of multiple sclerosis, we know that an inflammatory response is a common symptom. Whether in regards to progressive or relapsing forms of multiple sclerosis, most treatment methods attack or alter the functions of T cells or B cells. While these methods provide certain advantages in treating MS, the results often includes a weakened immune system overall. Using a sensor device to monitor the levels of cytokine through the absorption of the user's passive sweat and administering specified dosages of glatiramer acetate will still prevent inflammation in the nerves with a lower impact on the immune system as a whole.
Also...
Also...
We wanted to improve the delivery method. For a patient who is suffering from cognitive dysfunctions and additional physical ailments, constantly needing to track injection treatments can cause confusion and further stress. This is especially true for those who have to administer their Copaxone injections by themselves. So, we took inspiration from the insulin pump. Our device mimics the insulin pump which will be a small device that is about the size of a cellphone, can be carried with the patients whether place it in the pocket or attached it to an undershirt and so easily to see by others. Also, there will be an Infusion Set which is a small tube that will attached to the body of the patients. Therefore, the mechanism of Copaxone pump will be more precise. [9]
Delivery Method:
Basal Rate: A small amount of Copaxone that consistently pump into the body. Depends on the body’s need of medications, the drug delivery rate can be pre-programmed first and health care professional can adjust the program based on the patient’s needs (discreet mechanism). [9]
Bolus Dose: Another advantage of this pump is it can match up with the cytokine levels in the patients to deliver an additional drug amount. The pump itself was pre-installed with a bolus calculator in which it will determined the bolus amount of drug according to the predetermine settings by the health care providers to better assist the patients. [9]
A reservoir is a container that filled with Copaxone. This is a compartment of the Copaxone pump. Copaxone will flow from the pump’s reservoir through a small tube and infuse into the body. The infuse set will be placed under the skin. The whole set if infusion tube comprised of a thin cannula right beneath the skin. Depending on what patient wants, the small tube and the pump itself can be detached and reattach to the body easily. This will be applied in a situation when the patient needs to take a bath or participates in any outdoor activities like sport or running. [9]
The 3 Main Compartments:
1) Copaxone Pump
A system to pump dosages of glatiramer acetate is needed. This pump will be a hand-held sized electronic device. Similar to the insulin pump design, the device will have pushable buttons in order to customize the settings and guide through the selection menu. It will also include an LCD color monitor screen to display the user's vitals and skin temperature recorded from the SweatSenser. The pump will also require a single AA alkaline battery as its power source, that can be easily replaced. The last main aspect of the pump itself will be the reservoir compartment.
2) Reservoir
A reservoir is needed to contain the dosages of glatiramer acetate for the patient. This container is filled with the drug and then secured into the pump's reservoir compartment. The reservoir can be replaced every three days. An adjustment from the standard insulin pump will be the size of the reservoir. In the diagram above, the reservoir holds up to 18mL of insulin. To sufficiently treat MS patients for an extended period of time, the reservoir will need to hold up to 240mg of glatiramer acetate. This mechanism will preserve the quantity from contamination and attempt to deliver a fresh dose of medicine for a case by case need. [9]
3) Infusion Set
A set of small tube that travels from the reservoir into the patient’s body. It will be normally placed in the abdominal area subcutaneously. Then, it will be replaced by a new set in every two to three days.. [9]
The other clinical benefit of Copaxone pump is to assist the patients to keep track with the daily doses especially elderly. Also, a bolus calculator inside the pump will be helpful to compute the exact boluses precisely, and be able to customize the setting up to different basal patterns for daily works or holidays. [9]
Ideally this method would be suitable for people who are afraid of needles, looking for a convenient and easier way to deliver the drug, better management of doses, or those who are concerned about complications caused by repeated self-administered injections over an extended period of time. All in all, we believe this solution would decrease the amount of effort for the patient, and provide a simpler way to administer the dosages Copaxone by monitoring cytokine levels in the body.
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