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R＆D

Drug Delivery System Created with Effort and Passion – Adhesive Patch Formulation

Chapter 1: Development Technology of Patch Formulation Leading the World

Nitto’s adhesive technology is also used in the medical field. As one of them, we have been developing the patch formulation (transdermal pharmaceuticals) ahead of the world. Patch formulation is a formulation with drug in the adhesive and when the patch is applied to the body, the drug is absorbed from the skin and goes into the blood stream through the capillaries to flow throughout the body. As a result, the drug expresses effect.
Medicines are typically dosed orally, via nasal or oral inhalation, or via injection. However, patch formulation has benefits over them, such as the ease of supplying stable amount of drug into the body, the ability to visually confirm dosing, and the ability to remove the patch immediately if side effects occur. Furthermore, replacing oral medication with patch medication can reduce burdens for patients who must take numerous medications orally. These points delight countless patients and those around them, but development of this technology was not simple; it required long years of repeated challenges with effort and passion.

Chapter 2: Difficulty of Delivering Required Amount of Drugs When Needed

The mechanism whereby drugs applied to the skin are delivered into the body

Just including drugs in the adhesive of patch formulation is not enough, and past development of transdermal medication focused on sustained absorption of drugs over a long time. Nitto specializes in blending various compounds into adhesives, but our developers sought to produce formulation that go a step beyond and serve patients better. In other words, we resolved not only to achieve sustained administration but also to develop a product that could deliver the required amount of drugs when needed, as a more evolved transdermal medication.
However, in order to do so, the release rate of the drug from the formulation has to be controlled precisely. This proved to be extremely difficult.

Chapter 3: Amount and Concentration of Drug Found with Tenacity

Drug release rate is determined by the complex relationships among the type of adhesive used, the thickness of the adhesive, and the amount and concentration of drug contained.
Moreover, the type of adhesive which can be used in medical use is limited and there are not many options. This means inevitably that it is necessary to control release rate by drug amount and concentration.
In the absence of any revolutionary way of solving this problem, it was a matter of making samples with various combinations in a repeated process of trial and error. Although computer simulations can be used now for parts of this process, there was nothing so convenient at that time. Combinations were tried without missing any possibility and never giving up.
As a result of painstaking hard work, this goal was finally achieved by maintaining the drug in the crystalline state and the drug in the dissolved state to be present in a certain rate in the adhesive. This result was truly the product of our tenacity to development. This technology was subsequently applied in the development of other patch formulations as Nitto’s original technology.
Furthermore, we cannot miss the existence of the advanced processing technology that specifically enabled commercialization using the results of this tenacity.
For example, the adhesive layer of one of the patch formulation products is designed with only 20 μm (0.02 mm) in thickness. For it is used in medical applications, there could be no variation in quality and the adhesive layer is controlled with high accuracy of ±2 µm (0.002 mm) when manufacturing.
It is no exaggeration to say that precise coating technology is the real secret behind the successful commercialization of this product.

A scene of an experiment that was repeatedly carried out

Chapter 4: You'll Never Know Unless You Try

To achieve goals, it is necessary to think carefully and to implement the ideas into action, and to repeat this process over and over. Basically, “manufacturing” is tough work that requires much effort and there is nothing stylish about it at all. Because it is so, the pleasure when completed is very special.
At times you may face big hurdles, but you just have to take the initiative and try something else when you get lost. Nothing gets solved sitting at a desk.
“Products leading the world” do not necessarily appear suddenly from some revolutionary idea. This development success teaches developers about the importance of always having a mindset of “you'll never know unless you try.”

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