The secret quality assurance that the original research lenvatinib (Levima) cannot be imitated guarantees the efficacy and safety

Some people say that when people start to pursue quality rather than price, life is getting better
.
At the time when the material life is gradually abundance, people gradually have the ability to pursue their own "poems and distant places".
The pursuit of quality in the heart is awakened, and they yearn for an extraordinary high-quality experience in their precious lives
.
For a cup of coffee, some people will travel far and wide to find the richest bean fragrance; in order to eat classic cuisine, people will spend hours waiting in line.
.
.
People are beginning to pay more attention to quality, or more willing to pay for quality
.
If people begin to pay attention to quality in life, then high quality is the most important and indispensable in life
.
Today, we come to reveal a small capsule, and experience the high quality that is related to life
.
The capsule we are talking about is the original research lenvatinib (Levima), a targeted drug developed and produced by Japanese pharmaceutical company Eisai Co.
, Ltd.
for the treatment of advanced liver cancer
.
When it comes to medicines, it is inevitable to talk about the efficacy.
The original research lenvatinib has benefited nearly 110,000 Chinese liver cancer patients in the three years since it entered the Chinese market.
Liver cancer is widely circulated in the circle
.
But today we will not talk about the curative effect, and talk about the craftsmanship of this small capsule in the preparation process
.
As we all know, the process of drug preparation is quite complicated, and the uncertain factors of any process will bring unknown risks.
Therefore, it is necessary to ensure that each process is perfect or even perfect
.
Next, the editor will reveal the three high-quality ingenuity keys that the original lenvatinib cannot replicate from three aspects: the proportion of excipients, equipment cleaning, and the control of harmful impurities. .
Ingenuity Key 1 Gold compatible pharmaceutical preparations are composed of active ingredients and auxiliary materials.
Excipients are an indispensable part of drug preparation.
They not only give the drug a certain dosage form, but also good and safe excipients can not only synergize with the main ingredients.
It can improve the curative effect of the medicine, improve the effect of the medicine, and at the same time, it can reduce the toxic and side effects under the condition of precise proportioning [1]
.
The term excipient has been regarded as a treasure as early as ancient times.
In the "seven emotions" of drug compatibility, there is the feeling of "adjuvant", which refers to excipients
.
It is reported that in the process of preparing the original lenvatinib, researchers have gone through tens of thousands of attempts, and it took two and a half years to explore the most suitable ratio of excipients and the best particle diameter
.
The gold ratio and particle diameter of the excipients can be called the top secret weapon of the original research drug, because the detailed information of the excipients is the part of the original research drug that is not disclosed to the public.
It is difficult for imitation products to be exactly the same as the original research, and these seem to be subtle The difference may lead to a difference in efficacy
.
It is the excelsior exploration in excipients that has created high-quality original research drugs
.
Ingenuity Key 2 Safe solvent for cleaning equipment Ethanol is the solvent of choice for cleaning equipment in the pharmaceutical process because it can dissolve most organic matter
.
However, in the process of producing the original lenvatinib, the solvent used to clean the equipment is not ethanol, but water
.
Why choose water? The answer is simple, because water is the safest and does not produce harmful substances
.
However, we all know that water has the effect of diluting.
The seemingly simple replacement actually "touches the whole body".
The factory needs to face huge challenges.
According to relevant people familiar with the matter, in order to avoid small risks, R&D personnel need to avoid small risks.
It took a long time to develop a set of cleaning process that is most suitable for the production of lenvatinib after comprehensive considerations such as dosage, quality, and the number of replacements. .
Ingenuity Key 3 Ultra-low harmful intermediate compound content In the production and preparation of all drugs, harmful intermediate compounds will inevitably be produced.
According to the Chinese Pharmacopoeia (2020 edition), the content of harmful impurities in lenvatinib should not exceed the limit.
The value is 0.
0417%[2], while the intermediate product content of the original research lenvatinib is only 0.
02%, which is far lower than the industry standard
.
It is not easy to reach the standard of 0.
02%.
Every production link of the original research lenvatinib has an extremely strict supervision process
.
Repeated inspections and inspections are indispensable before, during and after pharmaceuticals.
Drugs in the manufacturing process need to undergo "intermediate process control" test inspections and strict quality management; raw materials and manufactured drugs will be controlled by the quality management department Carry out analysis to ensure the effectiveness and safety of the drug; after the product is shipped, the factory will save the samples and conduct regular quality inspections to ensure that the quality gap between batches is controlled within a strict range
.
Do not underestimate the quality control between batches.
If the quality control is not done well or the supervision is not strict, there will be differences in the quality of medicines between different batches.
The phenomenon that the effect of approved drugs is not enough" is an extremely serious drug quality problem
.
In the production process of the original lenvatinib, multiple procedures are inspected by cameras, from feeding to filling medicine to packing, etc.
, to ensure that there is nothing wrong
.
Such strict quality control is not possible in all factories.
Quality problems such as different sizes of tablets and improper packaging occur frequently in many medicines
.
Medicines are about lives, and we all hope that the medicines we take are of the highest standard
.
The original research lenvatinib's preparation process focuses on details, strictly disciplines itself, and interprets the spirit of ingenuity to the fullest
.
When people start to pursue quality rather than price, life is getting better
.
We have experienced the era of lack of resources.
At that time, the word "quality" did not seem to have appeared in our lives; we were helpless with high prices for beauty and quality, and quality seemed to be beyond the reach of most people at that time. .
The pursuit of quality is actually the pursuit of "better".
The more advanced the society, the stronger this demand will become
.
Ingenuity is the foundation of quality, and quality is the interpretation of ingenuity
.
Medicines are about life.
Scientific clinical data and strict preparation techniques are the reliable guarantee for the efficacy of medicines.
This is our reliable ingenuity
.
Reference materials [1] The effect of pharmaceutical excipients on drug safety; Yang Rui, Sun Huimin*, Yu Lina, Yuan Song (China Food and Drug Control Institute, Beijing 100050), Chin J Pharm Anal 2012, 32(7) ) [2] Chinese Pharmacopoeia (2020 edition)