March 27, 2013 in a solemn ceremony was laid the first cubic meter of concrete in the foundation of a new production unit "Stirolbiofarm" — of the production of hard gelatin capsules. This event is, without exaggeration, be called historic. In fact, this was the start of a fundamentally new for the Ukrainian pharmaceutical production, and the event itself opened up a new era in the Ukrainian pharmaceutical industry.
According to the number of units of output gelatin capsules in the last 5 years out of all drug products in second place after pills and according to some scholars, the next 20 years may even oust the last in the world market.
The largest manufacturers of encapsulated drugs today are the company of the "Big Seven", as well as Belgium, South Korea, Switzerland and Mexico. In Ukraine, this production is in its infancy and its development — an urgent task of the domestic pharmaceutical science and industry.
Such a high popularity of the dosage form from the producers, consumers and physicians due to a variety of benefits and positive characteristics, such as:
Dosing accuracy — modern equipment provides high precision filling of capsules filled (with a tolerance of no more than ± 3%) and minimum loss, high performance — depending on the equipment used, methods of filling characteristics of the filler and its dosage modern machines can produce up to 120,000 capsules per h;
High Bioavailability — studies conducted by a number of scientists (Eckert, et al Lindvald) showed that the capsules often disintegrate faster than pills or dragees, and their liquid or solid uncompressed content quickly and easily absorbed in the human body;
Expansion indications for — in some cases capsule as the dosage form preparations help to identify new kinds of pharmacological activities that are not exhibited by the same dose in other dosage forms (e.g., a group of scientists scientific laboratory Italian firm «Pharmagel» found that tablets temazepam 20 mg exhibit anxiolytic properties, while this same dose capsules provides a hypnotic effect allows its use as a sedative);
High stability — the shell capsules ensures a sufficiently high air tightness and insulation labile components of content from a variety of environmental factors (oxygen, air, direct sunlight, extremes of humidity, etc.), so you can often avoid the need for the use of antioxidants or stabilizers, or to reduce their number ;
Correcting capability — the shell capsules also helps to hide the unpleasant taste, which have many medicinal substances. This is especially important in pediatric use such as in the popular medicine dosage forms as syrups always rational (for example due to inaccurate dosage of insufficient stability of certain drugs, etc.);
Minimize the potential for production errors — to apply different colorations and labeling helps reduce the risk of errors and change agents in the production process;
High aesthetics — is also achieved through the use of different colors in the preparation of the capsule shell. In this connection, noteworthy observation made by Dr. Max Luscher of Switzerland, a long time has been analyzing the color values for the drugs. He states that although color is not an objective selection factor medication, it nonetheless is a psychological factor of choice of drug. At this osnovano use of additional therapeutic effects of color. Today, leading pharmaceutical companies applied to 1000 different colors and shades to color the shell capsules;
Ability to specify the Medicines certain characteristics — it can be most clearly demonstrated by creating a so-called enteric capsules (resistant to gastric juices but readily disintegrate in the environment of the small intestine) and capsules retard (prolonged release drug), which may achieved by various technological methods;
Gentle technological modes — processing methods avoid encapsulation of many undesirable effects of moisture labile substances (e.g. by wet granulation), pressure (for example when pressing tablets);
Currently, the needs of Ukrainian pharmaceutical industry are covered by imports. On the territory of the former Soviet Union today there are two companies that profile, in the Russian Federation and Belarus. Tomsk Ltd. "Artlayf" in 2007 commissioned the first Russian factory hard gelatin capsules designed capacity of 1.3 billion capsules per year, which is almost equal to the annual volume of the Russian market of hard gelatin capsules. She is currently working first production line with capacity of 680 million capsules per year, which covers about 50% of the Russian market.
In 2009, the adjusted production of hard gelatin capsules in the pharmaceutical enterprise "Minskinterkaps" (Belarus). This is the only Belarusian company, which produces such products. In Ukraine, no enterprise gelatin capsules for the pharmaceutical industry does not produce.
A few words about the technology
One of the most common materials for the manufacture of forming capsules is gelatin — proteinaceous macromolecular compound. It is a product of partial hydrolysis of collagen, which forms the main part of the connective tissue of vertebrates (bone, cartilage, horns, hooves, skin, tendons, cattle and pig skin). The basis of the protein molecule is gelatin polypeptide chain formed by 19 amino acids, most of which are essential for the human organism. The main ones are: Glycine (30%), proline, hydroxyproline, glutamic acid, arginine and lysine. Collagen bones and skins of animals subjected to maceration (softening and loosening due to prolonged exposure to liquid) and cleaning acids or alkalis that break it digested by almost linear amino acid chains of varying lengths, ie, gelatin.
Gelatin is easily and quickly absorbed by the human body, even for serious violations of the gastro-intestinal tract, non-toxic and has no side effects. The characteristic property of gelatin (from Lat. Gelare — freeze) is the ability of its solutions jel on cooling to form a solid gel. This property of gelatin based manufacturing gelatin capsules.
Position requires an innovative enterprise
Today was founded 1st cubic meter of concrete manufacturing business gelatin capsules for medicines. Built on "Stirolbiofarm" plant will be the 4th in the whole of Europe. The development strategy of "Stirolbiofarm" coincides with the state’s development strategy pharmaceuticals and aims that we have done a maximum of medicines in Ukraine — said Advisor to the President of Ukraine, Hero of Ukraine N.A.Yankovsky, speaking at the ceremony of laying the first concrete cube.
The efforts of th
e President of Ukraine Viktor Yanukovych, the program of development of the Ukrainian pharmaceutical industry provides for provision of quality drugs, the increase in the market share of the available drugs Ukrainian, a gradual weakening of import for the industry. Opening of the new capsule production in Gorlovka is a real step towards the realization of this strategy. After all produced in Gorlovka capsules to be consumed not only its own production of "Stirolbiofarm", but will be supplied to pharmaceutical companies in Ukraine. Ukrainian pharmaceutical company will buy gelatin semi-finished products in Ukraine, without investing the foreign producers.
Future production capacity in Gorlovka-half billion capsules per year with the possibility of doubling its increase.
To ensure the quality of all the indicators in the production of gelatin capsules will run all of the special requirements for carrying out the process, clean production facilities, work process equipment, ventilation and air purity, the system of training of the main raw materials and auxiliary materials.
Event March 27 once again confirmed the status of the innovative "Stirolbiofarm", which in many areas has been a pioneer.