Pharmaceutical packaging. Primary, secondary, transport packaging of medicines - presentation

Date of: 19.07.2019

Samvel Grigoriano on whether it is expedient to allow the "sharing" of packages of medicines

In the work of the first-timer, there are often situations when he would like to fulfill the request of the buyer, but he does not have the right. What can you do, pharmaceutical legislation, like other branches of law, is full of restrictions and prohibitions. Most of them are justified and do not raise doubts, disputes about their usefulness and necessity.

But there are also such legal norms that are assessed as ambiguous not only by practitioners and experts in the pharmaceutical industry, but sometimes by representatives of regulators. Recent example: in March current year it became known that the Ministry of Health of the Russian Federation is considering the possibility of allowing pharmacy organizations to dispense drugs not only in secondary packaging, if this is required by the course of treatment prescribed by the doctor (“ Russian newspaper”, Federal issue No. 6621/50). Secondary packaging, as you know, is also called consumer, or external (as opposed to primary, internal).

In exceptional cases - when it is possible to share secondary medical packaging

This topic is regulated by the order of the Ministry of Health and Social Development No. 785 of December 14, 2005 (“On the procedure for vacation medicines"). Paragraph 2.8 of this regulatory legal act establishes that violation of secondary packaging is allowed only "in exceptional cases, if the pharmacy institution (organization) is unable to fulfill the appointment of a doctor (paramedic)".

The wording, it must be said, is very vague. It can be assumed that the cited fragment is about a discrepancy between the course of treatment prescribed by a specialist and the number of tablets / capsules / ampoules, etc. (in a word, with “numero”) in the secondary packaging. But it is impossible to build work on assumptions, especially in the field of healthcare; each legal norm must be clear and unambiguous.

The same applies to the phrase "in exceptional cases". Here, health care practitioners and drug supply - v in particular, pharmacists and pharmacists are also required by law to provide clear, unambiguous explanations as to the circumstances under which such cases may occur. For example, if they occur every time the course of treatment prescribed to the patient does not match the “numero” of the secondary package, then such situations in everyday life pharmacy practice are not so rare as to be rated as "exceptional". Lack of clarity on these issues can be literally costly - judging by media reports, regulatory authorities periodically “fine” pharmacy organizations on the basis of non-compliance with the norms of clause 2.8 of order No. 785.

In addition to the above, this paragraph contains two more provisions. One of them explains that in those very exceptional cases when a violation of the secondary factory packaging is allowed, the medicinal product should be dispensed in a pharmacy package with the obligatory indication of the name, factory batch, expiration date, series and date according to the laboratory packing log and providing the patient with other necessary information, in particular instructions for medical use drug.

Another provision is more concise; it clearly and unequivocally establishes that the primary packaging of medicinal products is not allowed to be violated during dispensing. It is worth recalling this in connection with the fact that in March of this year headlines like “Pharmacists will be allowed to sell pills by the piece” multiplied in the media. First, the Ministry of Health has not yet decided anything; whether it will decide at all and in what form is still unknown. Secondly, depending on what is meant in this case by “thing”. If the blister is one thing; if one tablet, then this is impossible without the annulment of the provisions of clause 2.8 of order No. 785, since it would be a violation of the primary packaging.

In March, headlines such as "Pharmacists to be allowed to sell pills by the piece" multiplied in the media. First, the Ministry of Health has not yet decided anything; whether it will decide at all and in what form is still unknown. Secondly, depending on what is meant in this case by "thing"

Why now?

This regulation has been in effect for almost ten years now. Why did the Ministry of Health of the Russian Federation decide to consider the advisability of adjusting them right now? Two reasons can be suggested. The first follows from what we said above: the courses of treatment prescribed by doctors are not always a multiple of the number of tablets / capsules / ampoules in the secondary packaging. This discrepancy is by no means exceptional, although it cannot be said that it is very frequent, and requires an optimal solution, primarily in the legal and regulatory sphere. These circumstances were often pointed out by experts, practitioners (pharmacists, pharmacists, doctors); patients complained about them.

It is clear that introducing a rule obliging physicians to prescribe medicines only “by packaging” is a wrong decision. Firstly, the “numero” packages of not all drugs correspond to traditional courses of treatment. Secondly, therapeutic schemes are by no means something once and for all established, frozen - they are prone to change and variability. Pharmaceutical production is not always and not immediately able to fix, take into account these changes and make appropriate adjustments to the packaging process.

Thirdly, in addition to traditional therapeutic schemes, there are special cases. Each body is unique, each patient needs an individual approach. In some and very frequent cases, doctors prescribe to their patients courses of treatment that are somewhat different from the usual, standard ones. Such courses, as a rule, "do not match the packages." And it is clear that the packaging part of pharmaceutical production cannot provide for the whole variety of such individual cases.

The second reason for the current attention of the Ministry of Health to this topic also lies on the surface. The change in the situation in the economy and the industry raises questions about the advisability of maintaining certain restrictions and prohibitions. Initially in demand and necessary, over time they can lose their relevance and even become, to some extent, an obstacle in the provision of medicines to the population and the optimal service of pharmacy visitors.

In 2014–2015 the situation in the Russian economy and medicinal treatment has become more complicated. The factors that have a significant impact on the state of the domestic pharmaceutical industry are the trend towards higher prices for medicines and a decrease in real incomes of citizens. Under these conditions, in pharmacies, requests from customers to release this or that drug “not entirely”, that is, as part of a consumer (secondary) package, but “partially” - for example, one or two blisters, have become more frequent.

So the current attention of our main regulator to this topic can be explained by the fact that over the past year it has been updated. Probably, the Ministry of Health is thinking about the fact that in matters of dispensing drugs in various packages, more flexibility should be shown, taking into account the current situation and the variability of therapeutic schemes.

No more, no less

While the Ministry of Health is evaluating the feasibility of any changes on this issue, we will also try to consider them. Let us give examples from the daily practice of a pharmacist.

A patient suffering from bronchitis was prescribed antibiotic T. at a dosage of 500 mg, one tablet once a day for seven days. But there are practically no packages of this drug "No. 7" in the Russian pharmacy network, but there are packaged in five and ten. The drug is very expensive - the calculated price of one tablet fluctuates around a hundred rubles. One package "No. 5" is not enough for the patient; if he buys two (or one package of "No. 10"), he will overpay approximately three hundred rubles for three tablets, which he does not need at present and, perhaps, will never need again.

Let's take a "over-the-counter" example. The popular laxative F. is available as a powder for oral solution, in sachets. In production, they are packaged in large cardboard packages of ten, twenty or more pieces. In each such package, there is only one leaflet (instruction for the medical use of the medicinal product). But pharmacy visitors often ask for only two, three or five sachets.

Often, doctors prescribe their patients courses of treatment that differ from the standard ones. Such courses, as a rule, "do not match the packages." And it is clear that the packaging part of pharmaceutical production cannot provide for the whole variety of such individual cases.

It is clear that buyers are trying to reduce what they see as unnecessary spending on medicines so as not to devastate family or personal budgets that are already under strain. And naturally the following question arises. People, on the other hand, acquire medicine not on their own whim, but on medical necessity, in particular, on medical prescription. And if the patient needs not five, not ten, but exactly seven tablets, then why not make sure that he, the patient and the consumer, is given exactly seven - no more, no less?

There is such a Latin term in pharmacy - quantum satis (translated as “as much as needed”), meaning the required / required amount. It is mainly used in extemporaneous recipes, but in terms of meaning it also fits the situations we are considering.

People acquire medicine not on their own whim, but on medical necessity. And if the patient needs not five, not ten, but exactly seven tablets, then why not make sure that he is given exactly seven - no more, no less?

Division of drug packaging

Probably, it will seem to many that the answer to the above question is obvious, but not everything is so simple. Yes, there are arguments in favor of the possibility of a “blister release” - we have already identified them - but there are also arguments against. Let's start with the counterarguments. next question: if the dispensing of medicinal products not in secondary packaging is still allowed in cases specified by law - then what should be a signal for the primary distributor of the possibility of such dispensing?

Medicines are divided into prescription and over-the-counter drugs, and in the context of the topic at hand, these are two different stories. In the first case, the situation seems clearer - information about the non-multiplicity of the number of tablets / capsules / ampoules prescribed to the patient in the usual factory packaging is received by the first-timer from a prescription that comes to him from the hands of a pharmacy visitor (or, in the foreseeable future, electronically).

A lot has been said about how “willingly” treating specialists write out prescriptions, how often they are incorrectly formatted and unreadable. And nothing has changed. And this is not so much a “sin” of doctors as a consequence of shortcomings in the organization of healthcare. But now the conversation is not about this, but about the fact that many problems of drug supply and optimal pharmacy service simply rest on the fact that doctors do not write prescriptions properly.

And if the prescription is not written out and not presented to the first-timer, then there can be no account of the individual course of treatment of this particular patient, since this would be a double violation of the licensing requirements and conditions: “dispensing a prescription drug without a prescription” and “dispensing a drug in violation of the secondary packaging without sufficient grounds to do so." In a word, you first need to solve the problem of proper prescription writing, and then proceed to the one that we are considering in this article.

If, however, we are talking about any over-the-counter drug, then in this case the instruction to the pervostolnik to release it in a “non-standard quantity” will come not from a doctor, but from a citizen (buyer) self-medicating. And here, pharmacists and pharmacists will need clear and unambiguous instructions in which situations it is possible to “share” a package of medicines and release blisters, and in which not.

Frankly, in the case of over-the-counter drugs, the answer “none” especially suggests itself, otherwise there will be no end to the wishes of buyers to “split” this or that drug - because almost everyone always wants to “save”, regardless of whether the economy and personal income rise or crisis. However, a problem in this regard is created by preparations similar to the laxative F., which we talked about above: secondary packaging - - sometimes quite large in volume - - containing twenty, twenty-five, and sometimes more sachets or blisters. For example, in the secondary packaging of another well-known laxative C. contains twenty blisters and five hundred tablets. In most cases, one buyer does not need so much, even regardless of the price.

Questions and difficulties

If the Ministry of Health nevertheless expands the possibilities of "division" of secondary medicinal packages, then for pharmacy organizations this will create a lot of additional responsibilities and complexities. The release of the drug in this case does not mean at all that the pervostolnik gives the buyer one or two blisters, and that's it. Firstly, it is necessary to attach the instructions, which means that it must be duplicated, since the package inserts are usually delivered to pharmacies at the rate of “one secondary package - one insert”.

Secondly, the blisters will most likely need to be placed in a pharmacy package (mentioned in clause 2.8 of order No. 785), on which it is necessary to indicate the name, series of the drug, expiration date, etc. All this will take the first-timer a lot of time, especially if cases "Irregular holidays" will occur frequently. The consequence of this will be a slowdown in the first-table work; a slight decrease in the "throughput" of the pharmacy is also not excluded. It is likely that additional regulation of the concept of "pharmacy packaging" will be required.

With all obviousness, another problem will arise, which can be demonstrated by the above example of the above-mentioned antibiotic T., which is present in the assortment of Russian pharmacies in secondary packages containing five or ten tablets. If the patient is prescribed a course of seven tablets, then the blister will need to be divided. Is it possible to do this? Is this a violation of the primary packaging (which is unacceptable in any case)? Most likely it is. If the proposed change in drug dispensing legislation actually happens, it should answer these questions.

The example with the antibiotic T. allows us to identify another important problem of “fractional release” - what to do with the remaining blisters / tablets / ampoules. After all, they may not be in demand later. All subsequent purchasers of the drug in a particular pharmacy may have a medical prescription that is the same as or a multiple of the secondary packaging. As a result, the tablets of the drug remaining after the only “fractional” purchase will become a loss for the pharmacy organization.

Vacation in a container

In connection with the topic under consideration, specialists familiar with foreign dispensing practices may recall that in many countries of America and Asia, drugs of some forms - in particular, tablets and capsules - go to pharmacies "angro" (from the French "en gros") - i.e. "in in large numbers”, usually in the amount of a thousand pieces, in a large plastic container.

In such a system, the responsibility for filling the required number of tablets/capsules lies with the pharmacist, and the concept of “secondary packaging of the medicinal product” is absent in relation to this part of the drug assortment. Its role is essentially played by an individual (separate for each customer) container, where the pharmacist places the number of tablets counted according to the doctor's prescription. This container to a certain extent corresponds to the concept of "pharmacy packaging" of clause 2.8 of order No. 785. The pharmacist signs it, thereby transmitting to the buyer the necessary information about the drug prescribed to him, and also certifies it with his own signature.

In those states of America and Asia where a similar scheme of packaging, packaging and dispensing of medicines takes place, it has traditionally formed. In Russia, a different order has developed - with primary and secondary packaging - - one that is typical for European countries.

The first method seems convenient and flexible from the point of view of fulfilling any medical prescriptions to the pharmacist, including "non-standard" courses of treatment. However, it has a significant flaw in terms of pharmacy service - more precisely, the duration of service for each customer and the rate of "flow" of pharmacy visitors in general.

In order to carefully count and double-check the required number of tablets, place them in a container, properly arrange it, it takes time - as practice shows, in a queue sometimes up to fifteen or even twenty minutes. If the pharmacy is located in a large mall, often the buyer is given a signal device like a pager for this time, which notifies him that the order according to his prescription has been completed. And yet, complaints and lamentations about the fact that we had to wait too long for the medicine do happen. With the same method of packaging, packaging of medicines and their dispensing, which has developed in the pharmaceutical industry of European countries - in particular Russia - there is no such problem.

Without scissors

In a word, the problem of "division" or "week" of secondary medicinal packages is quite complex and very ambiguous. Before making any decision, it is worth studying the experience of some neighboring countries, where, due to the low solvency of the population, scissors for dividing a blister into parts have become one of the attributes of the first table. Drastic legislative changes - for example, the introduction of a binding norm to “divide” at the request of the buyer packages of over-the-counter drugs are hardly appropriate and productive. This can lead to a surge in irresponsible self-medication. It would probably be worth starting by clarifying the phrase "in exceptional cases" of paragraph 2.8 of Order No. 785. And, perhaps, this will be limited to this for now.

Medicine packaging technology In pharmaceutical production, containers and packaging play a special role, providing not only the possibility of convenient use of medicines, but also the preservation of their properties during storage. The problem of packaging finished medicines requires constant attention, because. its irrational choice leads to a decrease in quality and significant losses of medicines and packaging materials.

Basic concepts of containers and packaging Packaging is a set of tools designed to protect the drug from the effects of environment, damage and loss and facilitating the handling process. A container is an element of packaging and is a container designed to accommodate products. Packaging combines containers, medicines, closures and auxiliary elements that determine the consumer properties of the product. For example, an empty bottle is a container, and a bottle with a drug, a stopper or a dropper, a label or other auxiliary means is a package. In the production of FPP, packaging is classified into the following types: Primary packaging Individual or consumer packaging, the material of which is in direct contact with the drug. It is designed to create the necessary conditions to ensure the long-term preservation of the LF contained in it. Secondary packaging is a package designed to protect the integrity of primary packages and to provide more complete informative information (for example, about methods of administration and doses of drugs).

Secondary packaging provides the most simple and convenient accounting and product control. As secondary packaging, cardboard packs and boxes are used, where tablets, dragees, capsules, vials and ampoules with liquid and powdered drugs, metal and polymer test tubes with tablets, tubes with ointments, bags with powdered drugs are placed in the primary blister pack. In some cases, secondary packaging creates additional sealing and protection of primary packaging from the influence of external factors. Secondary packaging also belongs to consumer packaging, so it is important to ensure the necessary consumer properties packaging, such as: ease of wearing, the content of information about the storage and reception of the product, control of the first opening of the package, maintaining microbiological purity and attractive appearance. Group packaging (or block) is a group of primary or secondary packaging, which is formed when packaging products in shrink film, paper, cardboard boxes. Transport packaging packaging in a shipping container in which products are delivered to distribution and sale sites. It can be the same for each series of drugs.

Materials and methods of packaging manufacturing Special requirements are imposed on the container material approved for use in the pharmaceutical industry: gas and vapor tightness, chemical indifference to drugs, resistance to temperature effects, strength, opacity, barrier resistance to microorganisms, ensuring maximum shelf life. There are the following types of primary packaging for medicines (according to GOST) Rigid packaging 1. metal is used for primary packaging: jars, test tubes (for packaging tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments ); 2. glass is used for the production of jars, test tubes, vials, bottles (tablets, dragees, powders, granules, capsules, ointments, pastes, liniments are packed in them, eye drops), ampoules; 3. the polymer is used for the manufacture of test tubes, cups, jars (they are used for packaging tablets, dragees).

Semi-rigid packaging: 1. cardboard is used for the production of boxes, packs (for plasters, herbal medicines); 2. polymers are used for the production of syringe tubes (for dosage forms intended for injection); tube-droppers are used for packaging eye drops; contours used for packaging suppositories; 3. The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, herbal medicines. Soft packaging: 1. made of polymer is used as packaging in the form of bags for powders, granules, plasters; 2. paper packaging in the form of a bag, wrappers is used for packing dragees, tablets, herbal medicines. All types of primary packaging and closures for it should be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial articles. Materials used for the manufacture of primary containers and closures must be approved for use by the Ministry of Health Russian Federation.

Packaging should be the same for each series of packaged medicinal products and take into account their physiochemical properties 1. Light-sensitive medicinal products are packed in light-tight containers; 2. medicines containing volatile, weathering, hygroscopic or oxidizing substances are packed in jars or vials sealed with screw caps complete with stoppers or gaskets with sealing elements; plugs with sealing elements; rolled-in metal caps complete with plugs or gaskets with sealing elements, rolled-in metal caps; 3. Medicinal products containing highly volatile, weathering, hygroscopic and oxidizing substances intended for export are packed in containers sealed with roll-top lids or in other containers that ensure their safety; 4. each medicinal product containing a volatile substance or having an odor is packed separately from the others; 5. tablet medicines containing essential oils, wrapped in paraffin paper before packing into test tubes; 6. shock absorber seals when packing tablets, dragees or capsules in a container that does not have a stopper with shock absorbers. It is allowed to use medical absorbent cotton wool or carded viscose tape. Secondary packaging is designed to protect the inner packaging and promote sales.

The main types of secondary packaging used for medicines: 1. Cardboard is used to produce packs for jars, test tubes, vials with medicines for injection, bottles, aerosol cans, ampoules; boxes are used for packing ampoules, vials, syringe tubes; 2. Polymers are used to make contour packaging for ampoules, drug vials for injections, and syringe tubes. When packing ampoules, it is allowed to use medical lignin as a shock absorber. Each package with ampoules must contain a device for opening ampoules. Consumer packaging with medicines must be packed in a group container carton boxes or foot, followed by packing the foot in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes may be packed in shrink film. If the medicinal product does not have a secondary package, then instructions for use (or leaflets) should be enclosed in the group package in an amount equal to the number of primary packages. The dimensions of the container must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container). Group containers with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, sack paper. Each packing unit of any type of group container is supplied with a label. For tying group containers, materials are used that ensure the strength of the package. When gluing or tying group containers, the ends are sealed with a label that provides control of opening.

Group and transport packaging is used for transportation, warehousing, storage of goods and wholesale or small wholesale sales. It provides protection of the goods from mechanical impacts that may occur as a result of squeezing, bending, twisting, stretching, etc., and losses during transportation and storage. The transport packaging of medicines includes wooden, polymeric and cardboard boxes. Inner surface plank crates or crates made of wood-based panels are lined with wrapping paper, parchment, wrapping paper or plastic wrap. When packaging the medicinal product, the free space in the boxes is filled with soft packaging material, which excludes their movement. It is allowed to use packaging alignin as a sealing material; paper and cardboard waste paper; shavings from porous elastic polymeric materials. The gross weight of the package must not exceed 20 kg.

Pharmaceutical packaging

The hermetic sealing operation plays a key role in the production of medicinal products (MP), especially in the manufacture of sterile dosage forms (DF). High-quality capping ensures the safety of the medicinal product during its transportation, storage and use by consumers. It should be noted right away that there is a primary packaging, i.e. packaging in which the drug is directly placed, as well as secondary or outer packaging, i.e. cardboard or plastic boxes, boxes, flights, which provide ease of storage, transportation and use. The quality of the primary packaging is of fundamental importance for the medicinal product, which will be the focus of this article.

Modern LPs are distinguished by a huge number of various options and forms of packaging. Despite this diversity, it is possible to formulate the basic requirements that must be met regardless of the form of packaging used.

These requirements can be divided into four types:

1. Design requirements for primary packaging.

2. Requirements for materials.

3. Specific requirements depending on the type of drug, packaging design and manufacturing technology.

4. General requirements to the packaging.

1. The design of the primary packaging must ensure:

protection of LP from adverse effects external environment;

Protect from mechanical influences;

ensure tightness and stability;

Protection against microbial contamination

Dosed or piece extraction of medicinal products;

Aesthetic appearance and ease of use;

structural elements should be standardized, there should be no deviations from the geometric dimensions;

· elements of the primary packaging must be designed with the possibility of their automatic processing and hermetic connection on automatic equipment.

2. Primary packaging materials must not contain:

heavy metals, arsenic, other harmful impurities, in quantities exceeding the standards;

Dyes that are not approved for use;

carcinogenic and toxic components;

foreign odor;

microbial contamination above the established norms;

Not allowed:

damage to protective coatings;

the presence of mechanical impurities;

materials should not be brittle and must withstand thermal and mechanical treatment, treatment with disinfectant solutions;

Materials must be neutral and not interact with the components of the medicinal product.

3. Specific requirements for packaging are determined mainly by the type of medicinal product and technological process its manufacture. For example, when storing a number of preparations, exposure to direct sunlight is not allowed, so the packaging must be opaque or, for example, for glass vials, made of orange glass. For injection solutions, eye drops, on the contrary, the packaging should be as transparent as possible to control micro-contamination.

4. General requirements for packaging:

legibility of texts printed on the packaging;

a brief annotation or instructions for use;

color design;

Lack of aids for opening the package;

· if possible, the presence of control of the first opening;

Safe handling, no sharp corners or edges.

Most of the requirements listed above are obvious and, as a rule, are met in modern packaging. However, in connection with the transfer of production to GMP compliance, a number of specific conditions arise that must be taken into account when designing or choosing primary packaging. One of the main and fundamental requirements of GMP is the maximum reproducibility and repeatability of processes, as well as the minimum participation of a person in these processes. This means that all pharmaceutical production processes should be automated.

Packaging plays a key role in the automation of drug production. As mentioned above, all packaging elements must be standardized, have no deviations from the specified dimensions, and be processed in automatic lines. This means that the packaging elements must be automatically oriented in a certain unique way and connected together automatically.

Packing and packaging of finished dosage forms are made manually or semi-mechanized. With the manual method, the entire process of manufacturing the finished product is divided into several operations, each of which is performed by one worker. Usually several people sit at the work table, passing the product to the neighbor after completing their operation (for example, the first worker pours the liquid, the second corks the bottle, the third sticks the label, etc.). At the same time, mechanisms can be used for some operations, for example, for liquid medicines, filling machines, for loose powders, for tablets and dragees, a machine for counting them and placing them in convales, for ointments, ointment machines, etc. All these devices can have manual or mechanical control.

Currently, many enterprises are moving to a flow method of work, which means that the transfer of products from one operation to another is carried out using a moving conveyor belt. The rhythm of the movement of the conveyor is determined by the time required to complete each operation. With this way of working, the possibility of using various mechanisms increases.

The process of filling and packaging itself consists in measuring the required amount of medicines and filling them with the appropriate containers: tablets and dragees - in convales, tubes, paper bags; liquid medicines - in bottles or vials; ointments - in jars or tubes. After that, corking, gluing with cellophane, screwing lids with sheets of parchment paper lined, sticking labels, etc. is carried out. The final operation is boxing, paper wrapping, strapping, etc., after which the finished product is sent to the warehouse.

All operations of filling and packaging of finished dosage forms are light physical work. The only exception is the delivery of bottles, barrels and other capacious containers filled with products to be packaged to the workshop, as well as their transportation around the premises for loading bunkers and tanks of machines. This job is hard physical activity. In order to eliminate it, siphons and hand pumps are used for liquids, and in large enterprises, the mechanical supply of liquids through pipelines and various lifting devices.

Main harmful factor in the packing shop is the possibility of air pollution by various harmful substances. When packing many liquid dosage forms, vapors of both the medicinal substances themselves and their solvents can be released. For example, when packing ammonia, ammonia is released into the air, corn liquid and ether-valerian tincture - ether, wormwood tinctures - alcohol, etc. Many of these substances, in addition to general toxic properties, also have a pronounced irritant effect (iodine vapor , camphor). When packing bulk dosage forms, dust can be released, as well as vapors of strongly odorous substances (iodoform, xeroform). However, since when packing volatile liquids in most cases there are no large open surfaces (they are packed in small quantities), the concentration of their vapors in the air of working premises, as a rule, does not reach the regulated maximum permissible values.

When packing tablets or powders, the content of medicinal dust in the air is usually also low. But since many of the packaged powders are potent, small aerosol concentrations of these substances cause a toxic or allergic effect.

It is quite clear that the more mechanisms are used in filling and packaging, especially those that provide good sealing of the packaged product, the less the risk of contamination. air environment harmful gases, vapors or dust.

Under any production conditions (manual packing, in-line method, automated lines), it is necessary to equip the working rooms with artificial ventilation. In this case, both local devices (encapsulation, fume hoods, umbrellas, etc.) and a common supply and exhaust system should be used. When working with expensive dry medicines with a general exhaust system, it is advisable to use dust-setting plants to preserve valuable products and return them for processing.

In conclusion, it remains to be noted that when choosing or developing modern packaging, along with traditional requirements for materials, construction, design, etc. it is necessary to take into account the possibility of automated processing of all packaging elements. Of course, this article gives only some of the fundamental points that you should pay attention to.

In practice, in each case, already at the stage of development or selection of packaging, it is necessary to consult with the developers of packaging equipment. This is especially true now - at the stage of transition of Russian pharmaceutical enterprises to technologies and production that meet GMP requirements, where the main and fundamental requirements are the reproducibility and repeatability of technology, which can only be ensured by using automatic machines.

drug packaging

Bibliography

1. OST 64-803-01. Transport, group and consumer packaging for medicines

2. V.F. Stolepin, L.L. Gurary. "Starting materials for the production of medicines". M.: Medical Information Agency, 2003

3. "Pharmaceutical technology: technology of dosage forms", I.I. Krasnyuk and others. M .: Publishing Center "Academy", 2006

4. M.M. Gubin "The main problems of development and manufacture of packaging elements associated with their use in automatic packaging machines" Seminar "School of Pharmaceutical Packaging 2005" - Abstracts of the report, 2005, St. Petersburg, p. 13.

INTRODUCTION .................................................. ................................................. .3

CHAPTER 1

1.1 Types and functions of drug packages ............................................................... .............................five

1.2 Basic requirements for the packaging of medicinal products .............................................. ................10

CHAPTER 2. ANALYSIS OF CONSUMER PREFERENCES .................................14

2.1 Influence of packaging on consumer preferences....................................................14

2.1 Determination of consumer preferences in relation to medicines and their packaging .............................................................. ....................17

CONCLUSION................................................. ................................................. ..23

BIBLIOGRAPHY................................................ ................................................25

APPLICATIONS.................................................. ................................................. ..27

INTRODUCTION

Relevance of the topic. With the development of a market economy, the efficiency of domestic enterprises largely depends on whether their products are successful in the market. Therefore, more and more often there is a need to investigate the state of consumer preferences in relation to a particular product. Consumers during the acquisition or use of goods, including medicines, to meet their needs have the right to safety and proper quality of goods, to state protection of their rights and compensation for losses caused by goods of inadequate quality. Awareness of this information poses a challenge for pharmaceutical companies to conduct more in-depth scientific research in this direction.

Production of pharmaceutical packaging is an integral part of the pharmaceutical industry. Packaging has become a very important part of drug production as it innovations in the development of new drugs and new drug delivery systems in the body have reached a very high level. Pharmaceutical packaging must meet the increasing requirements for medicines.

Due to the unique requirements for pharmaceutical products, packaging for medicines must guarantee the preservation of the quality of medicines during transportation, which will increase their shelf life.

Objective- to study the features of modern packaging of medicines.

To achieve the goal, it is necessary to solve the following tasks:

1. To study the types and functions of drug packages;

2. Consider the basic requirements for the packaging of medicines;

3. Analyze and find out the impact of packaging on consumer preferences.

Object of study. Packaging and registration of medicines.

Subject of study. Requirements for the quality of packaging of medicinal products.

Research hypothesis. The material and appearance of drug packaging containers influence the preferences of buyers.

Work structure. Course work consists of an introduction, two chapters, a conclusion, a bibliography and an appendix.

CHAPTER 1. MODERN APPROACHES TO PACKAGING OF MEDICINES

Types and functions of drug packages

Packaging is understood as a complex consisting of containers, auxiliary means, packaging materials that determine the consumer and technological properties of the packaged product.

There are two types of drug packaging: primary packaging (individual) and secondary packaging (group or consumer).

Primary packaging- direct (individual) packaging, which contributes to the preservation of the goods during its sale; is part of the goods and, in general, is not subject to self-transportation;

secondary packaging- serves to protect individual packaging and surpasses it in terms of information content; performs protective function in relation to the product and primary packaging and creates conditions for their immunity to outside influences.

Primary packaging, depending on the materials used, their mechanical stability and strength, which determine the degree of preservation of goods, is divided into groups and types. For various dosage forms, GOST defines the types of primary packaging and closure material.

There are the following types of primary packaging for medicines (according to GOST 17768-90) (Appendix 1).

By material: hard, semi-hard, soft.

Rigid packing:

Metal is used for primary packaging: jars, test tubes (for packing tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments);

Glass is used for the production of jars, test tubes, vials, bottles (they pack tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops), ampoules;

The polymer is used to make test tubes, cups, jars (they are used to pack tablets, dragees).

Semi-rigid packaging:

Cardboard is used for the production of boxes, packs (for plasters, herbal medicines);

Polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used to pack eye drops; contours used for packaging suppositories;

The combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, herbal medicines.

Soft packing:

From polymer it is used as packaging in the form of bags for powders, granules, plasters;

Paper packaging in the form of a bag, wrappers is used for packaging dragees, tablets, herbal medicines.

All types of primary packaging and closures for it should be selected depending on the properties, purpose and quantity of medicines, in accordance with the requirements of state standards and pharmacopoeial articles.

The materials used for the manufacture of primary packaging and closures must be approved for use by the Ministry of Health of the Russian Federation.

Main types secondary packaging used for medicines:

Cardboard is used to produce packs for jars, test tubes, vials with medicines for injection, bottles, aerosol cans, ampoules; boxes are used for packing ampoules, vials, syringe tubes;

Polymers are used to make contour packaging for ampoules, vials with medicines for injection, and syringe tubes.

When packing ampoules, it is allowed to use medical alignin as a shock absorber. An ampoule opener must be included in each package of ampoules.

By appointment packaging is divided into: consumer, group and transport.

Consumer packaging with medicinal products should be packed in a group container - cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes may be packed in shrink film. If the medicinal product does not have a secondary package, then instructions for use (or leaflets) should be enclosed in the group package in an amount equal to the number of primary packages. The dimensions of the container must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container).

Group packaging with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines. For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, sack paper. Each packing unit of any type of group container is supplied with a label. For tying group containers, materials are used that ensure the strength of the package. When gluing or tying group containers, the ends are sealed with a label that provides control of opening.

TO transport packaging medicines include wooden, polymeric and cardboard boxes. The inner surface of board boxes or boxes made of wood-based materials is lined with wrapping paper, parchment, wrapping paper or polyethylene film. When packaging the medicinal product, the free space in the boxes is filled with soft packaging material, which excludes their movement. It is allowed to use packaging alignin as a sealing material; paper and cardboard waste paper; shavings from porous elastic polymeric materials. The gross weight of the package must not exceed 20 kg.

Liquid and viscous medicinal products require the use of packages that provide an accurate dose measurement. Basically, glass containers are used, for example: jars and bottles made of glass with a screw neck, oval jars and bottles with ground stoppers, jars and bottles made of dart, etc.

Medical ointments at present, they are produced mainly in aluminum tubes and glass containers (glass jars with a low screw neck are used, jars from drota). Aluminum tubes are made in two versions: regular and with an elongated spout. The inner surface of the tubes is covered with a protective layer of varnish, and the outer surface is coated with a decorative resistant enamel, which is marked. The serial number is embossed on the tail of the tube when it is sealed.

Solid dosage forms. Tablets account for approximately 70% of the total output of finished drugs, and their production tends to increase. Tablets are packaged in a variety of containers, including paper (non-currency), glass (jars and bottles), metal (test tubes, pencil cases), etc. The most promising is blister packaging (blisters).

Dosed packages powders are equipped with different design devices for dosed issuance. They are mainly issued foreign firms and represent a two-chamber system consisting of an external closed chamber communicating with the cavity of the container in which the drug is placed, and an internal dosing chamber.

Injection solutions most often packaged in ampoules, which are disposable packages, i.e. disposable packaging.

The glass ampoule is an ideal packaging in terms of its compatibility with pharmaceutical products, tightness and cost. However, at the same time, the fragility of glass is a serious drawback, so expensive secondary packaging is needed to prevent breakage, depressurization of ampoules, and cracking. IN last years ampoules made of polymeric materials are used, but there are problems associated with the compatibility of plastics with a solution of a medicinal substance and the expiration dates of these ampoules.

Some special types packages. For unstable drugs that lose activity in solutions or require preparation immediately before use, packages are being developed for separate storage of components. These are combined packs having two separate chambers with medicinal substances ready for mixing at the time of consumption (expensive but necessary packaging).

There are the following types of primary packaging for medicines (according to GOST 17768-90).

Rigid packing:

metal is used for primary packaging: jars, test tubes (for packing tablets, dragees, powders, granules, capsules), aerosol cans, tubes (for ointments, pastes, liniments);

glass is used for the production of jars, test tubes, vials, bottles (they pack tablets, dragees, powders, granules, capsules, ointments, pastes, liniments, eye drops), ampoules;

the polymer is used for the manufacture of test tubes, cups, jars (they are used for packaging tablets, dragees).

Semi-rigid packaging:

cardboard is used for the production of boxes, packs (for plasters, herbal medicines);

polymers are used for the production of syringe tubes (for dosage forms intended for injection); dropper tubes are used to pack eye drops; contours used for packaging suppositories;

the combined material is used for contour packaging of suppositories, tablets, dragees, capsules, powders, granules, herbal medicines.

Soft packing:

from polymer it is used as packaging in the form of bags for powders, granules, plasters;

paper packaging in the form of a bag, wrappers is used for packaging dragees, tablets, herbal medicines.

The materials used for the manufacture of primary packaging and closures must be approved for use by the Ministry of Health of the Russian Federation.

Packaging must be the same for each series of packaged medicinal products and take into account their physical and chemical properties:

medicines that are sensitive to light are packed in light-tight containers;

medicinal products containing volatile, weathering, hygroscopic or oxidizing substances are packed in jars or vials sealed with screw caps complete with stoppers or gaskets with sealing elements; plugs with sealing elements; rolled-in metal caps complete with plugs or gaskets with sealing elements, rolled-in metal caps;

medicinal products containing highly volatile, weathering, hygroscopic and oxidizing substances intended for export are packed in containers sealed with roll-top lids or in other containers that ensure their safety;

each medicinal product containing a volatile substance or having an odor is packed separately from the others;

tablet medicines containing essential oils are wrapped in paraffin paper before being packed in test tubes;

shock absorber seals when packing tablets, dragees or capsules in a container that does not have a stopper with shock absorbers.

It is allowed to use medical absorbent cotton wool or carded viscose tape.

Secondary packaging is designed to protect the inner packaging and promote sales.

The main types of secondary packaging used for medicines:

cardboard is used to produce packs for jars, test tubes, vials with medicines for injection, bottles, aerosol cans, ampoules; boxes are used for packing ampoules, vials, syringe tubes;

polymers are used to make contour packaging for ampoules, vials with medicines for injection, syringe tubes.

When packing ampoules, it is allowed to use medical alignin as a shock absorber. Each package with ampoules must contain a device for opening ampoules.

Consumer containers with medicines should be packed in group containers - cardboard boxes or stacks, followed by packing the stack in wrapping paper. Glass jars, test tubes, vials, bottles, aerosol cans, aluminum tubes may be packed in shrink film. If the medicinal product does not have a secondary package, then instructions for use (or leaflets) should be enclosed in the group package in an amount equal to the number of primary packages.

The dimensions of the container must be selected in accordance with the number of individual packages (no more than 200 pieces in a group container).

Group containers with medicines must be glued or tied. The requirements for gluing are specified in the regulatory and technical documentation for specific types of medicines.

For gluing group containers, it is allowed to use tape with a sticky layer, gummed adhesive tape, coated paper, wrapping paper, sack paper.

Each packing unit of any type of group container is supplied with a label.

For tying group containers, materials are used that ensure the strength of the package. When gluing or tying group containers, the ends are sealed with a label that provides control of opening.

The transport packaging of medicines includes wooden, polymeric and cardboard boxes. The inner surface of board boxes or boxes made of wood-based materials is lined with wrapping paper, parchment, wrapping paper or polyethylene film. When packaging the medicinal product, the free space in the boxes is filled with soft packaging material, which excludes their movement. It is allowed to use packaging alignin as a sealing material; paper and cardboard waste paper; shavings from porous elastic polymeric materials. The gross weight of the package must not exceed 20 kg.