It takes several years for a drug to reach pharmacies. During this time, it is carefully developed, researched and tested to be safe, effective and meet all the requirements of institutions that allow it to be on the market. Only in the case of the most dangerous diseases, such as cancer, the time of introducing the drug to pharmacies can be shortened by several months, provided that the first tests show its high effectiveness.

In the past, drugs were created by nature or by accident - this is how, for example, the first antibiotic, penicillin, was created. Its discoverer Alexander Fleming did not wash the dishes in the laboratory and went on vacation. Upon his return, he found mold had developed in one of the dishes, but the bacteria around it had died. That's how he discovered penicillin. Initially, drugs were generally manufactured by small producers and their production was not strictly regulated. Today, the entire production process is based on cooperation between research teams and pharmaceutical companies. Up to a thousand scientists are involved in the work on the development of one drug. Pharmaceutical companies are investing heavily in researching and researching new substances.

- The modern pharmaceutical industry comes from local pharmacies that used to distribute herbal medicines such as morphine and quinine, and over time, in the mid-19th century, began to produce them in bulk. The development of the first pharmaceutical companies was also influenced by discoveries resulting from applied research. The beginning of the targeted use of plants as a source of drugs was the isolation of morphine, an analgesic, in 1803-1805. The German assistant pharmacist, Friedrich Wilhelm Sertürner, by isolating morphine from opium, initiated research experiments to confirm the properties of active substances, says Dr. Małgorzata Kęsik-Brodacka, advisor to the director of scientific affairs at the Institute of Biotechnology and Antibiotics. Merck is the oldest operating company in the pharmaceutical industry. In 1827 it was transformed from a pharmacy into an industrial enterprise based on scientific research.

Concept starts in the library

Today, drug development work is well thought out, planned and subject to specific legal regulations. Scientists have at their disposal modern apparatus, laboratories and equipment, which greatly facilitates the production of drugs. - Thanks to the creationresearch databases, there has been tremendous progress in drug research. Quick access to this data allows scientists to find much necessary information at the stage of planning experiments. A significant facilitation is also the access to reagents, new tools, devices and systems that support the experimental work, as well as the analysis of the obtained results. The automation of routine laboratory procedures is also helpful, as well as access to specialized software - says Małgorzata Kęsik-Brodacka.

Modern, innovative technologies also make it very easy to find an idea for a given drug. Drug recipes are developed by interdisciplinary research teams combining specialists from many fields. Biologists from pharmaceutical companies search the world's professional literature, read available studies, looking for a suitable disease for which a cure can be invented. Then, often in cooperation with academic research centers, a molecule is created based on the knowledge about the nature of the disease and cells, and then it is comprehensively checked.

Animal and human research

- The developed active substances in the first stage are subjected to in vitro tests. For this purpose, animal and human cells and tissues grown in the laboratory are used. This allows the effectiveness of the test substance to be assessed. At this stage, a large pool of test compounds is eliminated. This has the effect of limiting the number of experiments that are carried out in the next phase with animals - says Dr. Kęsik-Brodacka.

Preclinical studies in animals, mainly in rats, last 3-4 years. At this stage, from the initial pool of tested compounds, no more than 0.5% remains.

- Scientists observe how a given substance behaves in a living organism, toxicological studies and pharmacological safety studies of a drug candidate are carried out. Safe maximum concentrations are established and potential side effects of the drug under development are determined. In addition, work is underway to develop a production technology. Drug forms are also tested, including mixing medicinal substances with appropriate excipients and giving them the form required for a given drug, says Kęsik-Brodacka.

Even if a substance appears to have very promising therapeutic effects in animal tests, it doesn't mean that it will work the same for humans. Ultimately, confirmation of effect is obtained in human clinical trials. This research covers four phases. Their scope is contained in a carefully observed code. This is the most expensive stage duringdrug formation.

- If the test substance is sufficiently effective and safe for the pre-clinical evaluation, the drug regulatory authorities should be asked for permission to start clinical trials. During clinical trials, the efficacy, safety, toxicity, changes in the concentration of the drug in the body as well as the mechanisms and effects of the test substance on the body are determined. During the successive phases of clinical trials, data is collected and documented containing a comprehensive description of the adverse events that occurred during the conduct of the study, he says. If the investigational drug passes the final phase of clinical trials, the pharmaceutical company may seek approval from regulatory authorities to allow the drug to be sold in certain countries or regions. For a new drug, the registration office determines the method of its use and the group of patients to whom it may be prescribed. When specifying these ranges, the regulatory office is guided by the scientific evidence gathered in clinical and preclinical studies.

Research on conventional drugs is usually financed by organizations or individuals, foundations, NGOs or pharmaceutical companies.

Types of drugs: chemical, generic, biological

There are different types of drugs on the market.Chemical drugs , developed and approved for the first time are the so-calledoriginal drugs . They arise as a result of chemical synthesis. Another chemical drug containing the same active ingredient is known asgeneric drug . From a chemical point of view, there is no difference between the original drug and the generic drug. Unlike chemical drugs,biological drugsare medicinal products containing a biological active substance that is produced or isolated from a biological source.

- Biological drugs are one of the most important innovations in modern medicine. Biological treatment is most often used in the case of diseases having an immune basis and the treatment of type I diabetes, Crohn's disease, ulcerative colitis, and also in some neoplastic diseases - says Dr. Małgorzata Kęsik-Brodacka. On the other hand,biosimilar biological drugis a drug showing biosimilarity to the reference biological drug, already available on the market. It is not called a generic, as is the case with chemical drugs, because it is not an identical substance. The biosimilarity of biosimilar medicines to the reference medicine is demonstrated on the basis of scientific research.

Only three molecules have been designed in Polanddrugs

The process of developing new drugs is lengthy and very costly. Since the end of World War II, only three drug molecules designed in Poland have reached the stage of human research. - Drug development is a high-risk investment with a high probability of failure. Most of the new substances are still disqualified at the stages preceding clinical trials. After entering the clinical trial phase, only 13.8 percent. of the investigated drugs go to pharmacies. Hence, it is estimated that of many substances that were started to be tested at the very beginning of the drug development process, only a small fraction will meet all the restrictive requirements and can be administered to the patient - says Dr. Małgorzata Kęsik-Brodacka.

Manufacturing drugs is very expensive. - All this has an impact on the possibility of developing the technology for the production of new drugs in the native environment - he adds. Currently, Polish laboratories are working on technologically advanced therapeutic substances. - This group includes biological drugs. Modern preparations are subject to very high safety requirements. Cancer, Alzheimer's disease and diabetes are most certainly areas where intense drug research continues. Innovative substances are also urgently needed to deal with drug-resistant bacterial infections emerging all over the world - adds the expert.

Billion dollar drugs

The high costs of drug production are associated with many years of complex and expensive research. - The development of an innovative biological drug takes about 12 years, and the total cost may be as high as USD 2.5 billion. On the other hand, the total cost of developing a biosimilar biological drug that meets the formal approval requirements, along with the cost of production, is already lower, amounting to approximately USD 75-250 million. The time needed to develop the entire procedure is also shorter. This usually takes 7-8 years.

The development of a generic chemical drug is even cheaper and takes 3-5 years and costs 1-5 million dollars, says Dr. Małgorzata Kęsik-Brodacka.

The price of a drug that ends up in pharmacies is driven by the long and costly process of drug development, including the cost of clinical trials and the cost of introducing the drug to the market. - Usually, a new, innovative, patent-protected drug introduced to the market will be expensive. When a patent for a given drug expires (patent protection lasts 20 years) and competition appears, and then generic products are launched on the market, drug prices usually drop sharply, often by up to 90%. - says the expert.

Tablets, dragees, syrups,suppositories - various forms of drugs

A drug is a substance or a mixture of substances that is given the property of preventing or treating disease in humans or animals, or administered to a human or animal for the purpose of making a diagnosis or restoring, correcting or modifying physiological functions of the body.

Medicinal products authorized by the President of the Office of Medicinal Products, Medical Devices and Biocidal Products may be authorized for marketing. Drug manufacturers are obliged to present detailed characteristics of medicinal preparations and tests that will prove that the product is safe and effective in use.

Supervision over the quality of medicinal products is carried out by the State Pharmaceutical Inspection.

This task is carried out both at the voivodeship level by pharmaceutical inspectors from 16 Voivodeship Pharmaceutical Inspectors, and at the national level by the services of the Chief Pharmaceutical Inspector (GIF.webp). These institutions control, among others: the conditions of transport and storage of medicines, check pharmacies and other points selling medicines, check whether medicines are properly labeled and advertised.

Elżbieta Piotrowska-Rutkowska, president of the Supreme Pharmaceutical Council:

"If, during the inspection and research, it turns out that a medicinal product does not meet the established quality requirements, the State Pharmaceutical Inspection authorities may suspend the sale of a given batch or the whole batch in their area of ​​operation or the entire country, or withdraw it completely."

Medicines come in various forms. They can be purchased in solid, semi-solid and liquid form. The first group includes, among others: powders, granules, tablets, capsules, pellets, pellets, suppositories and rods. The second group includes: ointments, creams, gels, and the last one includes: solutions, suspensions, tinctures, drops, mixtures, syrups, infusions, decoctions, emulsions.

Elżbieta Piotrowska-Rutkowska, president of the Supreme Pharmaceutical Council:

"Each form of the drug provides adequate release and absorption of the drug substance in strictly defined situations. Tablets are the most popular form of the drug, but not everyone can take them, because they may contain auxiliary substances that are a source of allergies, such as lactose. rectal forms work faster than tablets. This form works well in infants, in the unconscious, vomiting, and people who have trouble swallowing. In turn, the liquid form of the drug ensures a high absorption rate of the drug substance. risk of choking Medicines in the form of ointments, creams orgels reduce the risk of systemic side effects. "

Turmeric, lactose, cellulose, so what's in the drug?

Apart from the active substance, there are auxiliary substances in medicines. The role of the excipient differs depending on the drug form produced (ointments, suppositories, eye drops, etc.). The use of excipients in medicinal products facilitates the drug production process, supports the availability of the drug (active) substance, facilitates the identification of the finished product and, above all, ensures the safety and effectiveness of drugs during use.

Excipients used in solid oral forms of drugs, i.e. tablets, capsules are divided into:

  • dyes and fragrances - improve the appearance (turmeric, sunset yellow)
  • fillers - added to obtain the appropriate weight and volume of the drug unit (lactose, cellulose, starch);
  • coating substances - forming a tablet coating that can modify the time and place of the release of the drug substance, e.g. in the intestine, protect against external factors such as gastric juice, give an aesthetic appearance (beeswax), facilitate swallowing (sucrose)
  • fillers (e.g. lactose, microcrystalline cellulose),
  • binding (e.g. starch, povidone),
  • slip (e.g. magnesium stearate),
  • binders - they allow you to obtain the appropriate form of the drug,
  • disintegrants - accelerate the disintegration process, directly affecting the availability of the drug substance (sodium croscarmellose).

Read also: ABC of taking medications, or how to take medications correctly

How are the names of drugs determined?

Medicinal substances contained in drugs have their names:

- Chemical name(systematic name): typically only used in scientific and specialized studies, publications. Created according to strictly defined nomenclature rules developed by the international chemical association (IUPAC), it defines the exact structure of the molecule of a given substance.

- Commonly used name(international nonproprietary name -INN; international non-proprietary name; the term "international name" is also used in various publications and statements). The name of the drug substance appears on the drug packaging, information leaflet, advertising materials and in official publications, registered documents for a given product, as well as in publications and studies intended for specialists and patients.

- Common name ,fixed in social consciousness. These names rarely appear in publications or information materials, but they are known to patients, pharmacists and doctors and used in communication between them, e.g. polopyrin, saline

- Proper names , otherwisetrade names , given to a specific medicinal product by its manufacturer.

example:

Chemical name (systematic): 2-acetoxybenzoic acid

International name (commonly used): acetylsalicylic acid

Common names for substances: aspirin, polopyrin

Examples of trade names: Aspirin (Bayer), Polopiryna (Polpharma)

Prescription or generally available

Authorized medicinal products are classified according to the assigned availability category. This is of great importance in the drug approval process. It also affects the trade in a medicinal product, especially the possibility of reimbursement, determines the type of prescription on which the drug can be prescribed, it also affects the availability of the drug in non-pharmacy outlets (e.g. gas stations) and the possibility of mail order sale.

The Pharmaceutical Law Act distinguishes five categories of the availability of medicinal products intended for people. So they are:

  • over-the-counter drug (OTC),
  • on prescription (Rp),
  • prescribed by a doctor for restricted use (Rpz),
  • Prescription, Containing Narcotic Drugs or Psychotropic Substances (Rpw) and
  • used only in inpatient treatment (Lz).

- In accordance with the regulations on the criteria for classifying a drug into each availability category, a given medicinal product is classified as dispensed under a prescription when it may pose a direct or indirect threat to life or he alth, even when used correctly, without medical supervision. Also when it may be used incorrectly, resulting in direct or indirect he alth hazards, or if it contains substances whose therapeutic effects or side effects require further study. Also, drugs intended for parenteral administration, in accordance with the provisions of the regulation, can be classified as "Rp" - explains the president of the Supreme Pharmaceutical Council.

The Ministry of He alth decides whether a given drug will be reimbursed. After receiving the necessary documentation, he applies for a recommendation to the Agency for He alth Technology Assessment and Tariff System. The Agency's recommendation is one factor it takes into accountthe ministry of he alth when making the final reimbursement decision.

Dietary supplement is not a drug

Apart from drugs, there are also supplements on the market. These are foods that supplement your daily diet. They are a concentrated source of vitamins or minerals or other substances with a nutritional or physiological effect.Dietary supplements are not drugs . They do not cure or prevent disease.

They are sold in the form of: capsules, tablets, dragées, powder sachets, liquid ampoules or dropper bottles. The content of vitamins, minerals and other substances is selected in such a way that the use of the supplement in accordance with the information provided in the labeling is safe for human he alth and life.

According to the regulations, the packaging of supplements must include: the term "dietary supplement" , the name of the category of nutrients or substances characterizing the product or an indication of the nature of these substances, the recommended portion of the product consumption during the day, a warning regarding not exceeding the recommended daily dose, a statement that dietary supplements cannot be used as a substitute (replacement) for a varied diet and that they should be stored out of the reach of small children.

- Dietary supplements are controlled by the State Sanitary Inspection (GIS). In the current legal situation, it is quite easy to introduce the supplement to the market, declaring only its composition to sanitary authorities by the so-called notification. The current notification system allows the dietary supplement to be placed on the market immediately after the notification is submitted. The notification verification procedure and the possible initiation of an investigation do not stop its distribution. During the pending proceedings, the unverified product may be on sale. However, such a condition poses a risk to the he alth and even life of the consumer - says Elżbieta Piotrowska-Rutkowska.

It is also worth knowing that in the case of supplements, you do not need to conduct expensive tests confirming the effectiveness or safety of use, because dietary supplements are food. Unlike drugs, they are not subject to such rigorous control at every stage of production, storage and sale. It is also simpler to advertise them, due to the lack of many restrictions in the case of drugs.

Category:

He alth