How a medicine is made?

 

We are all used to having the different treatments we need at the pharmacy. But what is behind them?

Before reaching our hands, medicines require a complex development, manufacturing, and packaging process, which implies an even greater level of difficulty in the case, for example, of certain highly specialized medicines such as those used in areas of oncology and transplants.

What are highly specialized drugs?

In addition to the generic drugs that we can all have on hand in our usual medicine cabinets, such as ibuprofen or paracetamol, there are also highly specialized generic drugs, which are those intended for areas such as oncology, transplants, or endocrinology. The large-scale manufacture of this type of drug has a great social relevance since it makes treatments accessible to the population that, otherwise, would have a very high cost for the citizen.

Its pharmaceutical and clinical development requires advanced technologies that allow controlling all the parameters of the production process. In addition, this type of medicine requires that the active principles be worked in a closed circuit and by highly qualified professionals. To work in optimal conditions, professionals have individual protection equipment such as autonomous breathing systems and specially adapted divers.

This specialized personnel controls the production process from the moment manufacturing begins until the last case is manufactured.

In what type of facilities are these drugs manufactured?

Highly specialized drugs are manufactured in special facilities, which have state-of-the-art technology and the latest systems in air conditioning, quality, and safety, to ensure that the product has optimal conditions for handling and maintenance and that professionals are fully protected.

At its Highly Specialized Generics unit (GAE), in Olloki (Navarra), Cinfa manufactures 60 million tablets and capsules of drugs each year indicated for the treatment of breast and prostate cancer or to prevent rejection after transplants of liver or kidney. Thus, the plant is divided into different rooms where a single product is manufactured at a time, with very demanding cleaning protocols and an automated air conditioning system that purifies the air through high-efficiency filters. In this way, practically all the air particles are retained, ensuring that both the air entering and leaving the plant makes it totally clean. 

Likewise, by controlling the pressures, the air flows are redirected, which allows isolating the rooms where the different phases of the process take place, in addition to controlling their temperature and humidity.

Finally, each room has a computer-controlled manufacturing team that manages each phase, both manufacturing, and automatic cleaning.

Phases of the manufacturing process

The manufacturing process of medicine is divided into seven phases:

1. Weighing.
In the first place, the active principles and excipients necessary for the manufacture of a batch of drugs are fractionated and weighed with extreme precision, in all cases following the amounts indicated in the formula for each specialty.

2. Granulation.
In this phase, the active ingredient and the excipients are mixed with a solution to form the wet granulate. To achieve a perfect mix, the equipment has two agitators that can rotate at a speed greater than 200 revolutions per minute.

3. Drying.
During drying, this solution is extracted to obtain a granulate with the appropriate degree of humidity. Drying is carried out with hot and filtered air, for which up to 800 cubic meters of air are used every hour.

4. Sifting.
The objective of this phase is to always obtain the correct granule size for each drug.

5. Mixed.
To the granulate, the excipients necessary for its compression are added, and then it is mixed until it is perfectly homogeneous. In this process, two specific parameters are controlled for each specialty: the speed and the turning time of the tank.

6. Compression.
The granulate obtained after mixing is subjected to pressure to obtain tablets. In this phase, one hundred percent of the tablets manufactured are controlled in real-time, and statistical control of their weight, hardness, and dimension is also carried out. The equipment with which it works has a speed of 8,000 tablets per hour.

7. Coating.
In some cases, the tablets are coated with a polymer film, which is applied by a spray gun system. This coating constitutes a barrier between the tablet and the environment. It is the most delicate part of the process and its functions can be to isolate it from light, modulate its release at the intestinal or gastric level, or simply give the tablet the desired color.

Once manufactured, the drugs go to the conditioning process, where they are placed in a blister to protect them from the environment and are packed, together with the package insert, in their corresponding case. Later, they will arrive at the pharmacies, where they will be available to all citizens.