Pharmaceutical industry

The pharmaceutical industry requires the utmost care, precision and quality in every aspect of the production and sale of medicines. Starting from restrictive requirements regarding raw materials, to the storage conditions of ready-made medicines and supplements sold later to patients.

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The PCC Group manufactures a number of chemicals dedicated to the pharmaceutical industry. They meet the highest international quality standards for the production of medicines and other pharmaceutical products. The offer of the PCC Group for pharmacy includes chlorine and chlorinated products as well as other chemical substances, for example, macrogols or ethoxylated oleyl alcohols.

Published: 21-04-2017

The pharmaceutical industry is a branch of the economy dealing with the design, production and distribution of medicines. Technological progress, innovations in the area of R&D and growing demand for pharmaceutical products and dietary supplements make pharmaceuticals one of the fastest growing market sectors. This industry has many restrictions on the quality and legal requirements and because of that it operates differently to the other industries.

The global COVID-19 pandemic has seriously affected many industries. Nevertheless, pharmaceutical companies are reporting only a slight reduction in profits for 2020, compared to the preceding year. It is believed that 2021 should see an increase in the sales of over-the-counter drugs, exceeding the achievements from 2019. The most popular pharmaceutical substances include cold and cough medications. The number of medicinal substances exported to the EU countries is also growing. The largest recipients of therapeutic or prophylactic drugs are Germany, Russia, the Czech Republic and Great Britain

Pharmacy is a very broad field, dealing with both synthetic, biological and natural medicines as well as cosmetics and food ingredients. The pharmaceutical industry is one of the fastest growing economic sectors both in Poland and in the world. Its development is determined not only by technology and R&D, but also by many socio-economic factors, such as: aging of the population, wealth, economic situation, but above all, legislative issues. The pharmaceutical market is very dynamic and the huge potential of this industry can be observed. Demand for medicines and other pharmaceutical products shows a constant upward trend, as well as the need for chemical raw materials used in their production.

Composition of pharmaceuticals

Drugs are pharmaceutical products containing a substance or a mixture of medicinal substances that are in a form suitable for direct use in therapy. The origin of the drug can be mineral, plant, animal, synthetic or semi-synthetic. Raw materials for the production of medicines can be divided into three groups:

a) API (Active Pharmaceutical Ingredients) – active pharmaceutical ingredients. These are chemical compounds that are isolated from pharmaceutical raw materials or obtained by means of synthesis. They act as the active substance of the drug and usually constitute about 30% of its composition. Hydrochloric acid with very high purity (37%) can be used in chemical synthesis of active drug components (API). Another product that is widely used in the pharmaceutical industry is monochloroacetic acid (MCAA). It is one of the most important semi-finished products in the chemical industry and is widely used in many organic synthesis processes. It can be used to produce ibuprofen, caffeine, vitamins (eg B6), glycine and many more. Monochloroacetic acid chloride (derived from MCAA) is a precursor of adrenaline (epinephrine).

b) Excipients – otherwise known as drug carriers. Excipients are natural or synthetic chemical compounds that are devoid of pharmacological properties. They serve mainly as carriers of active substances, solubilizers or emulsifiers. Usually, these are various types of solvents, capable of transferring the actual drug and not affecting its characteristics. They constitute about 50% of the composition.

The PCC Group offers POLIkol products of pharmaceutical quality, that can be used as excipients. They belong to the group of polyoxyethylene glycols (PEGs, polyethylene glycols, macrogols) and are characterized by a very wide spectrum of application properties. Their physicochemical characteristics and action depend on the molecular weight specified by the number included in the product name.

Macrogols (the pharmacopoeial name of ethylene oxide polymers) can be used as components of drugs, ointments, syrups, tablets, capsules, make-up removers, as well as dermocosmetics. All POLIkol products meet the stringent quality requirements set out in the latest edition of the European Pharmacopoeia, thus they can be components of modern, non-toxic medicines. PEGs have anti-electrostatic and moisturizing properties, therefore, they can be used as ingredients of emollients – skin lubricating agents. They also have solubilizing and rheological properties, thanks to which they provide liquidity to all pharmaceutical preparations and ointments.

In addition, POLIkol products are characterized by very good dispersing properties and good solubility in water. Therefore, they can be used to combine many active substances with each other. All macrogols in the form of wax are perfectly suitable for mixing with liquid, low-molecular polyethylene glycols, as a result of which are obtained unctuous blends, that are excellent binders in cosmetics.

Apart from basic macrogol functions, PEGs can also act as humectants, i.e. agents that bind the water that is part of the formulation. They ensure an even distribution of ingredients, which is crucial in products such as shampoos.

Another group of surfactants with a wide range of applications in the pharmaceutical industry are pharmaceutical quality products from the ROKAnol series. These include macrogols of cetostearyl ether (ROKAnols T) and macrogols of oleyl ether (ROKAnols O). These products are characterized by stabilizing and dispersing properties, thanks to which they ensure the creation of stable formulations in which the active substance is in a solid form. For this reason, they are widely used, for example, for the production of ointments or spray dressings. They also have very good emulsifying properties, thanks to which they enable the preparation of emulsions at room temperature, which is of particular importance when using active substances sensitive to high temperature.

c) Drug forms – forms given to medicinal preparations. Typically, plastics or polymers are used for their production. Drugs may take various forms: solid (e.g. powders, tablets, granules), liquid (e.g. solutions, suspensions, syrups) and semi-solid (e.g. ointments, gels, creams).

Chlorine and other products dedicated to the pharmaceutical industry

One of the basic chemical raw materials used in pharmacy is chlorine. It is used as an intermediate for the synthesis of drugs. It can also be embedded in their molecules. There are different groups of drugs that can be produced using chlorine. These include diuretics, anesthetics, cardiological, psychotropic or antineoplastic drugs. Their chemical structure, application in treatment and mechanisms of action are diverse.

Caustic soda and sodium lye produced by PCC Group, like chlorine, are raw materials used in pharmacy as intermediates in drug synthesis processes.

The PCC Group’s offer also includes hydrochloric acid produced in many different concentrations (from 28% to 37%). It also occurs in various degrees of purity: from purified, through synthetic used for food industry, to pure high-grade hydrochloric acid. Its high purity makes it applicable in highly demanding processes, such as the synthesis of chemical active ingredients of API drugs. Other products used in pharmacy are monochlorobenzene and orthodichlorobenzen, which also are raw materials used in the synthesis of drugs.

PCC Group products dedicated to the pharmaceutical industry meet, among others, restrictive standards such as the European Pharmacopoeia. They are produced on installations covered by the GMP (Good Manufacturing Practices) certification, ISO 9001, ISO 14001, as well as the OHSAS system. Thanks to the highest quality and cleanliness, the company supplies its products to the largest pharmaceutical companies in Poland and in the world.

Chemical reagents for the analysis of pharmaceutical substances

Apart from the above pharmaceutical ingredients, equally important for the pharmaceutical industry are the chemical reagents used in qualitative and quantitative analysis. These tests allow the determination of the chemical composition and the content of individual ingredients in pharmaceutical products, expressed either as a numerical value or percentage. They can also establish whether substances have been adversely affected by physicochemical or biological factors (light, solution pH, temperature or enzymes).

In qualitative analysis, the choice of the chemical reagent is dictated by the target element. In assays for nitrogen content, saturated solutions of iron (II) sulphate and diluted sulphuric acid are used. Sulphur can be detected using reactions with lead acetate or sodium nitroprusside. To detect halogens, assays with silver nitrate (V) are utilised, whereas to identify them chlorine water and chloroform are often used.

Qualitative analysis can involve various methods, including acid-base, precipitation, redoxymetric, fluorometric, spectrophotometric and colorimetric titration. Most of them require chemical reagents, necessary to conduct the titration process, such as potassium permanganate, iron (II) sulphate and iodine or thiosulphate solutions.

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