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7Методы увеличения срока годности фармацевтических препаратов
Джалилова Айнурам,
коммерческий директор, ТОО ■ Казахстан
Юанте Групп», Республика
Сфера обращения лекарственных средств несет повышенный риск, в связи с чем в большинстве стран принимаются меры на государственном уровне по контролю качества и условий хранения лекарственных средств. Этот вопрос интересует всех в связи с тем, что в современной медицине оказание медицинской помощи населению посредством применения лекарственных средств является важным аспектом. Однако эффективность этих средств во многом зависит от их соответствия строгим стандартам качества. Данная тема становится особенно актуальной в свете статей 238 и 239 ТК РФ, которые предусматривают материальную ответственность работника, если это прямо предусмотрено трудовым договором или законодательством, при причинении прямого реального вреда. причинен работодателю. При этом, если в договоре прописаны условия ответственности, а работодатель претендует на материальный ущерб, то он должен доказать, что просрочка в аптеке возникла вследствие действий или бездействия материально ответственного лица. Случаи, когда финансово ответственное лицо заказало товар с ограниченным сроком годности в заведомо чрезмерном количестве или не были проведены работы по учету и выявлению товара с ограниченным сроком годности, могут расцениваться как вина работника [1,2].
Однако основной акцент следует сделать на продлении срока годности лекарственных средств, поскольку это важно для сохранения их качества и эффективности. Изучение изменений, которые могут происходить с лекарственными средствами при условиях длительного хранения, важно как с точки зрения терапевтической эффективности, так и экономической целесообразности. Даже при небольшом изменении активности препарата его можно отменить независимо от его стоимости. Это делает проблему стабильности лекарственных средств актуальной на государственном уровне. Оценка стабильности готовых лекарственных средств, методы исследования по ее улучшению в процессе производства, хранения и применения являются постоянными предметами изучения в научно-исследовательских институтах и кафедрах университетов. Основной целью автора при рассмотрении данной статьи было выявление и изучение возможных средств увеличения срока годности лекарственных средств.
Цель данной статьи - рассмотреть организацию правильного хранения лекарственных средств с учетом требований нормативных документов, а также предложить новые методы, направленные на увеличение сроков годности лекарственных средств.
Методика статьи основана на изучении нормативной базы, научных работ и специальной литературы.
Ключевые слова: срок годности лекарственных средств, фармацевтические препараты, методы увеличения срока годности лекарственных средств.
Introduction
The concept of "stability" for medicinal products covers the constancy of their physico-chemical, biopharmaceu-tical and pharmacotherapeutic properties. The "shelf life", in turn, determines the time period during which the drug (or its dosage form) retains its characteristics, subject to certain storage requirements. The duration of the shelf life is determined through the analysis of the results of stability studies. This creates an inextricable link between the concepts of stability and shelf life of medicines (forms).
Table 1. Processes affecting the stability and shelf life of pharmaceuticals
Processes Affecting the Decrease in Stability and Reduction of Shelf Life of Pharmaceutical Preparations Description
Chemical Processes Chemical transformations arise from chemical reactions such as hydrolysis, oxidation, demeth-ylation, racemization, photochemical, and enzymatic processes. Less common reactions include polymerization, isomerization, carboxy-lation, and others. Chemical alterations lead to changes in physical properties, and the influence of physical factors contributes to the occurrence of undesirable chemical reactions.
Physical Processes Among the physical processes most typical for pharmaceutical storage are evaporation, layer separation, sublimation, structural changes, enlargement of dispersed particle size, and others.
Biological Processes Biological phenomena, in turn, lead to alterations in both the chemical and physical properties of finished medicinal products. Biological processes bring about changes in medications due to the activity of microorganisms, and more often than not, these occurrences result in undesirable chemical transformations of components within the preparations, accompanied by changes in the physical characteristics of the medicinal form.
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Modern research in the field of stabilization of dosage forms, mainly in recent decades, has led to the development of various approaches that contribute to increasing the stability of pharmaceutical products and dosage forms at the stages of their creation, movement, storage and use. These methods, on the one hand, physical, on the other - chemical, complement each other, contributing to improving the shelf life of drugs [3].
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I. Legislative framework
When referring to legal acts, it is worth noting the existence of a regulatory document that regulates issues related to the storage of medicines. OFS.1.1.0010.18, which establishes common standards for the preservation of pharmaceutical substances, auxiliary components and medicines, covering all organizations involved in the storage of medicines, taking into account their functional activities.
Storage of medicinal plant materials and preparations is carried out in accordance with the provisions of the OFS "Storage of medicinal plant raw materials and medicinal plant preparations". The storage process is the preservation of medicines until they are used within the prescribed shelf life, and this stage is an integral part of the handling of medicines.
The general requirements for the premises for the storage of medicines and the organization of this process are the need to use special premises for this purpose. The design, dimensions, functional equipment of storage facilities, their regular maintenance should provide optimal conditions for the preservation of various categories of medicines.
The storage room system should include:
• The receiving area intended for unpacking and receiving supplies with medicines, as well as their preliminary inspection;
• Space for sampling medicines according to the requirements of the OFS "Sampling";
• A room for quarantine storage of medicines;
• Special rooms for storing medicines that require special storage conditions;
• A zone for the preservation of rejected, returned, recalled or expired medicines [4].
II. Methods of prolonging the shelf life of medicines
There are the following methods focused on achieving this goal:
1. Lyophilization is a method of soft drying of substances, in which the dried preparation is frozen, and then placed in a vacuum chamber, where the sublimation (sublimation) of the solvent takes place. As an effective practice used to stabilize and extend the shelf life of medicines, it carefully considers many influencing factors. In this connection, the following advantages of this method of increasing the shelf life of pharmaceuticals can be distinguished: the absence of exposure to high temperatures on the drug, the preservation of the dispersed phase of the drug, the possibility of using volatile solvents. [5] (fig. 1).
2. Stabilization of the formula is carried out by modifying the composition or structure of the drug in order to increase its resistance to environmental influences, moisture, light and other factors. The use of packages with a high barrier function is also applicable due to the fact that high-barrier packages help protect the drug from the effects of oxygen, moisture and light, which as a result contributes to an increase in the duration of its shelf life.
Liquid nitrogen (-196°C) Condensation
Fig. 1. The lyophilization process
3. Storage control consists in ensuring the necessary storage conditions, including temperature and humidity, has a strong effect on the shelf life of medicines.
Fig. 2. Microcapsulation of pharmaceutical products
4. The microcapsulation procedure involves packing an active or functional element, that is, a core, into a microcapsule shell. The uniqueness of microcap-sulated formulas is that the substance is preserved from the effects of external environmental factors that could cause their destruction. This method is used for a variety of groups of medicines, including antibiotics, nootropics, vitamins, probiotics, anticonvulsants and enzymes. Microencapsulation has even made it possible to create highly concentrated aqueous pseudo-solutions of furacilin, expanding their scope of application by increasing solubility in water. The microcapsulation procedure stabilizes unstable medications (vitamins, antibiotics, vaccines, serums, enzymes). One of the major advantages of microcapsulation is the ability to prolong the active effect of medications. Medications with a prolonged effect can most effectively achieve the desired therapeutic result, while reducing their tox-icity. This is of particular importance in the treatment of diseases caused by pathogenic microorganisms, since this type of medication provides a constant and powerful effect on microorganisms, unlike frequent doses of non-prolonged medications or drugs with repeated exposure that act discretely. As a result, microcapsulation is a promising way to create innovative forms of medicines with
a long-lasting effect, opening up new ways to increase the effectiveness of drug therapy, especially for the creation of vector medicines that can improve stability, bioavailability and prolong the therapeutic effect [6] (fig. 2).
Conclusion
Based on the above, it should be said that a variety of methods aimed at increasing the shelf life of pharmaceuticals are an important direction in modern medicine and pharmaceuticals. The development and application of these methods make it possible to ensure a longer and stable effectiveness of medicines, as well as to increase their safety and accessibility for patients.
Литература
1. "Labor Code of the Russian Federation" dated 30.12.2001 N 197-FZ (ed. dated 04.08.2023). [Electronic resource] Access mode: https://www.con-sultant.ru/document/cons_doc_LAW_34683 /. -(accessed 28.08.2023).
2. Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 N 706n "On approval of the Rules for the storage of medicines" (with amendments and additions). [Electronic resource] Access mode: https://base.garant.ru/12179278/53f89421bb-daf741eb2d1ecc4ddb4c33 /? ysclid=llou-w0nw50438388669. - (accessed 28.08.2023).
3. Decision of the Board of the Eurasian Economic Commission No. 69 dated 10.05.2018 "On approval of Requirements for the stability study of medicines and pharmaceutical substances". [Electronic resource] Access mode: https://pharmapharm. ru/dokumenty/reshenie-kollegii-eek-69-ot-100520 18/. - (accessed 28.08.2023).
4. ORDER No. 749 of October 31, 2018 On Approval of General Pharmacopoeia Articles and Pharmacopoeia Articles and Invalidation of Certain Orders of the Ministry of Health and Medical Industry of Russia, the Ministry of Health and Social Development of Russia and the Ministry of Health of Russia. [Electronic resource] Access mode: https://docs.cntd.ru/ document/551589636. - (accessed 28.08.2023).
5. Lyophilization as a way to stabilize drugs (review). [Electronic resource] Access mode: http://chem. folium.ru/index.php/chem/article/view/2171. - (accessed 28.08.2023).
6. Karnysheva N.G., Tetereva E.A., Konstanti-nov M.N. Microcapsulation of medicinal substances - new ways to increase the effectiveness of drugs // International Scientific Journal "Innovative science".2023. No. 4-2. pp.170-172.
METHODS OF INCREASING THE SHELF LIFE OF PHARMACEUTICALS
Jalilova Ainuram
Sante Group LLP
The sphere of circulation of medicines carries an increased risk, and therefore most countries take measures at the state level to control
the quality and storage conditions of medicines. Everyone is interested in this issue due to the fact that in modern medicine, providing medical care to the population through the use of medicines is an important aspect. However, the effectiveness of these funds largely depends on their compliance with strict quality standards. This topic becomes especially important in the light of articles 238 and 239 of the Labor Code of the Russian Federation, which provide for the financial liability of an employee, if this is directly provided for by an employment contract or legislation, when direct actual damage is caused to the employer. In this connection, if the conditions of liability are prescribed in the contract, and the employer claims material damage, then he must prove that the delay appeared in the pharmacy due to the actions or omissions of the financially responsible person. Cases when a financially responsible person has ordered goods with a limited shelf life in a deliberately excessive quantity or work is not being carried out on accounting and identification of goods with a limited shelf life can be regarded as the fault of an employee [1,2].
However, the main emphasis should be placed on extending the shelf life of pharmaceuticals, as this is important for maintaining their quality and effectiveness. The study of changes that can occur in medicines under long-term storage conditions is important from the standpoint of both therapeutic efficacy and economic feasibility. Even with a small change in the activity of the drug, it can be canceled, regardless of its cost. This makes the problem of drug stability relevant at the state level. Evaluation of the stability of finished drugs, research methods to improve it in the process of production, storage and use are constant subjects of study in research institutes and university departments.
The main purpose of the author when considering this article was to identify and study possible means to increase the shelf life of pharmaceuticals.
The purpose of this article is to consider the organization of proper storage of medicines based on the requirements of regulatory documents, as well as to propose new methods aimed at increasing the shelf life of pharmaceuticals.
The methodology of the article is based on the study of the regulatory framework, scientific papers and special literature.
Keywords: shelf life of pharmaceuticals, pharmaceuticals, methods of increasing the shelf life of pharmaceuticals.
References
1. "Labor Code of the Russian Federation" dated 30.12.2001 N 197-FZ (ed. dated 04.08.2023). [Electronic resource] Access mode: https://www.consultant.ru/document/cons_doc_ LAW_34683 /. - (accessed 28.08.2023).
2. Order of the Ministry of Health and Social Development of the Russian Federation dated August 23, 2010 N 706n "On approval of the Rules for the storage of medicines" (with amendments and additions). [Electronic resource] Access mode: https://base. garant.ru/12179278/53f89421bbdaf741eb2d1ecc4ddb4c33 /? ysclid=llouw0nw50438388669. - (accessed 28.08.2023).
3. Decision of the Board of the Eurasian Economic Commission No. 69 dated 10.05.2018 "On approval of Requirements for the stability study of medicines and pharmaceutical substances". [Electronic resource] Access mode: https://pharmapharm.ru/do-kumenty/reshenie-kollegii-eek-69-ot-100520 18/. - (accessed 28.08.2023).
4. ORDER No. 749 of October 31, 2018 On Approval of General Pharmacopoeia Articles and Pharmacopoeia Articles and Invalidation of Certain Orders of the Ministry of Health and Medical Industry of Russia, the Ministry of Health and Social Development of Russia and the Ministry of Health of Russia. [Electronic resource] Access mode: https://docs.cntd.ru/docu-ment/551589636. - (accessed 28.08.2023).
5. 5 Lyophilization as a way to stabilize drugs (review). [Electronic resource] Access mode: http://chem.folium.ru/index.php/chem/ article/view/2171. - (accessed 28.08.2023).
6. Karnysheva N.G., Tetereva E.A., Konstantinov M.N. Microcapsulation of medicinal substances - new ways to increase the effectiveness of drugs // International Scientific Journal "Innovative science".2023. No. 4-2. pp.170-172.
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