Types of packages. Classification and basic requirements for packaging Secondary consumer packaging of medicines

Gubin M. M.,
Gene. director of VIPS-MED,
cand. tech. Sciences

I Introduction

The hermetic sealing operation in the manufacturing process of medicinal products (MP) plays a key role, 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.

II. Packing Requirements

Modern drugs are distinguished by a huge number of different 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:

Design requirements for primary packaging.
material requirements.
Specific requirements depending on the type of product, packaging design and manufacturing technology.
General requirements for packaging.

1. The design of the primary packaging should ensure:

protection of LP from the effects of adverse environmental influences;
protect from mechanical influences;
ensure tightness and stability;
protection against microbial contamination;
dosed or piece extraction of medicinal product;
aesthetic appearance and ease of use;
structural elements must 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 not allowed for use;
carcinogenic and toxic components;
foreign smell;
microbial contamination is higher than the established norms;

Not allowed:

damage to protective coatings;
the presence of mechanical impurities;
materials should not be brittle and must withstand heat and mechanical treatment, treatment with disinfectant solutions;
materials must be neutral and not interact with the components of the medicinal product.

3. Specific packaging requirements are determined mainly by the type of medicinal product and the technological process of 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 packaging requirements:

clarity 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.

III. Additional requirements for closures when used in automatic machines

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.

As a rule, in the manufacture of LP, the main problem is the orientation and connection of the closure elements, i.e. droppers, caps, stoppers, caps, etc.

A classic example of an optimal vial-cork-cap design, standardized throughout the world, is a penicillin vial with a neck diameter of D=20 mm, a rubber stopper and an aluminum cap. They are well oriented and processed automatically, the connection is tight and reliable. Now, with the development of the drug market, plastic packaging is increasingly used, especially for eye and nasal drugs and for non-sterile drugs. There are no standards for packaging elements for plastic, so LP developers tend to use their own packaging designs. At the same time, the possibility of their automatic orientation and feeding is often not taken into account.

Consider the main criteria that should be used when choosing packaging elements using the example of a dropper and a cap; Fig.1a, b.

To ensure non-stop operation of the automatic machine, the capping elements must:

a) easy to navigate, i.e. to be located in the bunker in a strictly defined, single position,

b) it is easy to move along the guides in the hopper and along the conveyor to the capping point,

c) easy to insert and / or twist on the neck of the vial.

Rice. 1. Packing elements: dropper (a); cover (b); metal cap (c); rubber stopper (g).

In order to provide a certain orientation in the case of an elongated design, such as a dripper (Fig.1a), it is necessary that the center of gravity is pronounced (D) and offset with respect to the dripper shoulder (F), i.e. Lv? 0.8 Ln. In this case, the fulcrum of the dripper will always be the dripper shoulder (F) and the dripper extension (B). To facilitate the orientation of the dropper, it is desirable that d 1< d 2 .

To ensure efficient feeding, the elements must have a smooth surface without roughness and rounded shapes.

When feeding lids, caps, another problem arises - they can fit into each other and collect several pieces, while it is very difficult to separate them. To avoid this, the lid should not be cone-shaped. For lids having a stepped shape (the most common), the following conditions must be met: d 2 ? 0.8d3,d1? 0.8d2.

This means that the larger diameter d 1 in principle cannot enter the inner hole with the diameter d 3 , and the smallest diameter d 2 easily exits d 3 (does not jam).

For the same reason, the lid should not be in the shape of a cone, because. the cone easily enters the internal threaded hole and jamming can occur, which is very difficult to eliminate automatically. Several elements are assembled in chains, and the equipment stops. This rule is also very important to observe for metal caps, Dн > Dв, where Dн is the outer diameter of the cap, Dв is the inner one.

Until recently, this condition was not taken into account. On the contrary, some manufacturers of caps make them with a small taper, which greatly simplifies the stamping process, but leads to constant malfunctions of automatic equipment.

Finally, the last stage of the process is the installation or dressing of the dropper, cap, cap on the bottle. Here, too, certain rules must be observed when designing closures.

Stoppers and droppers should easily and accurately enter the inside of the bottle, for this:

a) they must have a chamfer or rounding (Fig.1a, d; chamfer C) in the part that enters the vial. Its length must satisfy the conditions Lk< 0,3Lв;

b) the rest of the surface must be strictly smooth, cylindrical, without roughness. This is also a very important condition. If the surface entering the inside of the bottle is cone-shaped, then there are big problems when putting on the cork, it cannot be tightly installed on the bottle. An example of an unsuccessful design is the 4C rubber stopper, which was developed in the Soviet era, without taking into account the possibility of automatic processing. Its inner part has the shape of a cone. At present, we have developed a special 4C capping method using expensive manipulators. Stoppers made in accordance with Western standards do not have such problems.

If we consider plastic bottles from the point of view of their processing in automatic machines, then the main requirement for them is to ensure the rigidity of the bottle design. If the vial does not have sufficient rigidity, it can “jump” during sorting and orientation, when feeding on automatic lines and when fitting closures on it. This usually happens with enough effort.

IV. The main types of vials, containers and closures

The manufacture of vials and containers for liquid and bulk drugs is mainly made of glass, usually for sterile drugs and plastic, mainly polyethylene, polystyrene, polypropylene, etc.

According to the methods of capping and the materials used for these purposes, they can be divided into the following groups:

1. Glass (rarely plastic) bottle with a smooth neck, a rubber stopper and a metal cap; Fig.2. This type of packaging is mainly used for the production of sterile drugs that are administered intravenously or intramuscularly. At the same time, after the selection of the medicinal product from the vial through the cork, the tightness and sterility are not violated.

Rice. 2. Packaging elements for the production of sterile drugs.

2. Plastic (or glass) bottle with a screw neck, dropper cap, plastic cap (usually with first opening control); Rice. 3. Most often, this type of packaging is used for sterile nasal, eye drops, where an accurate dosage is required, while during the first opening, the sterility of the drug is violated. For non-sterile drugs, there is another way of hermetic packaging, more often used for sealing loose substances or tablets. This method uses a combined metal-plastic membrane, which is welded (welded) onto the neck of the vial (jar).

Rice. 3. Packaging elements for sterile and non-sterile drugs for nasal and oral administration.

3. Glass or plastic bottle with a screw neck and a metal cap with a sealing gasket; Rice. 4. Usually used in the production of non-sterile preparations: tinctures, medical nutrition, syrups, etc.

Rice. 4. Packaging for non-sterile liquid drugs.

4. Sterile containers with drugs, which are sealed and sealed during the manufacturing process of drugs; Rice. 5. For glass, these are ampoules, for plastic, containers with drugs, which are often manufactured in the same technological cycle with dosing and sealing of drugs (bottelpack technology). The author and leader of this technology is the German company Rommelag.

Rice. 5. Packing of sterile drugs produced using the “bottelpack” technology.

5. Packing of drugs in the form of sprays or aerosols; Rice. 6. A glass or plastic bottle is used with a mechanical microdoser in the case of a spray and with a valve-spray head in the case of an aerosol. At the same time, different types of nozzles are used to output different LPs.

Rice. 6. Packing elements for drugs in the form of sprays and aerosols.

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.

Bibliography

OST 64-803-01. Transport, group and consumer packaging for medicines
V.F. Stolepin, L.L. Gurary. "Starting materials for the production of medicines". M.: Medical Information Agency, 2003
"Pharmaceutical technology: technology of dosage forms", I.I. Krasnyuk and others. M .: Publishing Center "Academy", 2006
MM. Gubin "The main problems in the 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.

Packaging plays an important role in the production and distribution of medicines. It must fully comply with all regulatory requirements for this type of product. Pharmaceutical packaging falls into three main categories:

Primary packaging

Primary is in direct contact with the medicinal product and is designed to create conditions that will ensure long-term preservation of products. It includes: glass ampoules, vials, jars and bottles, polymer containers, aerosol cans, blisters, capsules, aluminum tubes, syringes and more.

secondary packaging

It does not come into direct contact with the drug and is designed to protect and preserve the primary packaging, as well as to account for and control stored products. There are certain requirements for packaging for medicines:

legibility of information printed on it;
brief instructions for use;
safe handling;
control of the first opening (if possible);
lack of aids for opening.

For the manufacture of secondary packaging, various materials are used:

Cardboard. Packs and boxes are made from it, in which blisters with tablets, capsules, aerosol cans, vials, bottles, polymer containers and so on are packed.
Polymers. They are used for the manufacture of contour packaging for ampoules, vials, syringe tubes. In most cases, the medicine is already in polymer packaging, everything is packed in cardboard.
Shrink. It packs jars, vials, bottles. Often in this form, drugs are transported.

Another important function secondary packaging performs is to provide useful information about the contents of the box. On pharmaceutical packaging indicate the name, concentration of the active substance, the number of tablets or capsules, the warranty (limit) period of use. This information is placed on at least two opposite sides of the box. It is also very important to note that if the primary packaging needs to be opened using any means, then they must be included in the medicine box.

Tertiary packaging

Tertiary or transport packaging is designed to deliver products to the point of sale. The main task of transport packaging is to protect medicines from external physical influences and mechanical damage. As a tertiary container, wooden boxes, containers, as well as bags can be used: fabric, paper and polymer materials. Very often, for long-distance transportation, boxes and boxes are placed on pallets, wrapped with stretch film or glued with adhesive tape, which allows both to optimize the loading process and additionally protect medicines from mechanical influences.

Requirements for transport packaging:

safety - is the absence of contamination of products with packaging components, including those harmful to humans;
reliability - the safety of drugs in the proper form for a long time;
environmental friendliness - the possibility of recycling after use;
interchangeability - the possibility of replacement, while not changing the functional purpose;
The aesthetic appeal of the packaging also plays an important role.

If you need quality pharmaceutical packaging, then you should take this very seriously, because not every company can fulfill the high requirements that apply to such products.

Contents

Recommendations for indicating the dosage (quantitative content of active substances) in the name of medicinal products

The medicinal product is labeled as “(trade) name + dosage + dosage form”. Such an indication is considered as the full name of the drug, and therefore the concept of “name” in these Recommendations should be understood as the full name of the medicinal product containing these 3 elements. The active substance must be indicated directly under the full name of the medicinal product.

In accordance with paragraph 1 of Section III of the Requirements for the instructions for the medical use of a medicinal product and the general characteristics of a medicinal product for medical use, the dosage in the name of a medicinal product is understood as the amount (content) of the active substance in a dosage form unit, as well as in a mass or volume unit of a medicinal product, significant for the correct identification and use of the medicinal product. The dosage in the name of the medicinal product must correspond to the information specified in sections 2 and 4.2 of the general characteristics of the medicinal product for medical use (hereinafter - SmPC).

For some types of dosage forms, the dosage is expressed as the amount of active substance released from the dosage form per unit of time.

The purpose of indicating the dosage in the name of the drug is to provide the most significant information about the amount of the drug in use, easy identification and distinction from other forms of release, as well as prescription by a doctor, taking into account other aspects of the process of prescribing and using drugs. Dosage indication should be based on convenience criteria for the consumer (prescriber) and not on quality criteria (analytical criteria).

The level of detail between Sections 1 and 2 of the SmPC may vary, so when specifying the dosage in Section 1 of the SmPC, it is often not necessary to include redundant information that is contained in other sections of the SmPC and the labeling of the medicinal product. If the dosage in the name of the medicinal product reflects only the total amount of the active substance in the primary packaging, in other sections of the SmPC and labeling of the medicinal product, a clear indication of the total volume and concentration per volume unit should be given. Similarly, if the dosage in the 3 name of the medicinal product is indicated as a concentration per unit volume, in other sections of the SmPC and labeling of the medicinal product, the total amount of the active substance and the total volume of the medicinal product must be clearly indicated. The precise indication of these key elements in the proposed marking and on the packaging material by the applicant is a key aspect in the examination of mock-ups and samples, aimed at reducing the risk of dosing errors. The design used by a pharmaceutical company should ensure that key information is conspicuous and unambiguous for the correct use of the medicinal product.

The dosage (concentration) is indicated, as a rule, for one-, two- and three-component drugs. In some cases, it is allowed to indicate the dosage (concentration) for four- and five-component drugs.

The dosage (concentration) of medicinal products is indicated on the primary and secondary packaging and is included in the information about the medicinal product provided to patients and healthcare professionals in the instructions for the medical use of medicinal products, in official and reference publications, electronic information retrieval systems.

These Recommendations are aimed not only at achieving harmonization between similar medicinal products and dosage forms, but also at improving the labeling of medicinal products to ensure the correct and safe use of medicinal products and to minimize dosing errors.

The recommendations apply exclusively to the indication of the dosage in the name of medicinal products and do not automatically affect other regulatory procedures (for example, the rules for assigning marketing authorization numbers, calculating fees, choosing between a change requiring and not requiring a new registration, etc.).

2. Recommendations for indicating the dosage in the name of medicinal products

The most appropriate indication of "dosage" in the name of the medicinal product is determined on an individual basis.

In addition to the factors identified in Section 1 of these Requirements, there are factors that need to be taken into account to correctly determine the most appropriate indication of “strength”, for example, dosage in the labeling of medicinal products under investigation in clinical trials (ideally, the same approach to expressing dosage should be used when labeling investigational medicinal products), or in the presence of a dosing device. If a suitable dosing product is included in the package and one or more fixed doses will be administered by means of it, its influence on the indication of the dosage should be taken into account.

2.1. To indicate the dosage (concentration), the following abbreviations for units of measurement are used:

g - gram
mg - milligram
mcg - microgram
ml - milliliter

To indicate the dosage, the activities indicated in subparagraph 1.1 are also used. Section III of the Requirements for the instructions for the medical use of the medicinal product and the general characteristics of the medicinal product for medical use.

When indicating the dosage, the name of the unit of the dosage form is not given. For example, 200 mg rather than 200 mg/tablet, 20 IU rather than 20 IU/vial.

2.2. Quantitative indication of dosage (concentration)

2.2.1. When specifying a dosage (concentration), its numerical value must be expressed in a rational form, which is achieved by choosing the appropriate units of measurement or appropriate prefixes to form decimal multiples and submultiples of measurement.

2.2.2. When specifying the dosage (concentration), units of measurement are chosen that allow the use of integers, not fractional numbers, or integers with a fractional digit of the 1st and 2nd order. For example, 50 mcg, not 0.05 mg, 200 mg, not 0.2 g, 1.5 mg, not 0.0015 g.

2.2.3. When specifying the dosage (concentration), units of measurement are chosen to avoid numbers containing more than three digits (1000 or more). For example, 1.5 g, not 1500 mg, 5 mg, not 5000 mcg.

In cases where the dosage is not expressed in units of mass, in particular in IU or other units, the abbreviations “million”, “billion”, for example 5 million IU, are allowed on the package, but they should not be used in the SmPC and PL.

2.2.4. If a manufacturer produces a drug of the same name in the same dosage form with different amounts of the active substance, the dosages are indicated in the same units for the entire line of the drug. 6 For example, 0.75 g, 1 g and 1.5 g rather than 750 mg, 1 g and 1.5 g, 250 mg, 500 mg and 1000 mg rather than 250 mg, 500 mg and 1 g.

2.2.5. In the case of using esters, salts, solvates as active substances, the content of the active substance is indicated in terms of the active part of the molecule (acid, base, anhydrous or dry substance). For example, when using ketotifen fumarate as the active substance, the content of the active substance is indicated in terms of ketotifen.

If the salts and esters used differ in pharmacological action, it is allowed to indicate the dosage in terms of the entire molecule of the active substance (for example, benzylpenicillin sodium salt).

2.2.6. For two-component medicinal products, the content of each of the two active substances is indicated using the sign and the same units of measurement, for example, "25 mg / 50 mg".

For multicomponent medicinal products, the content of each of the active substances is indicated sequentially in the order corresponding to the grouping (generally accepted) name, using the “+” or “/” sign.

For example:

"Amlodipine + Valsartan + Hydrochlorothiazide" - "5 mg + 160 mg + 12.5 mg", where 5 mg is the content of amlodipine, 160 mg is the content of valsartan, 12.5 mg is the content of hydrochlorothiazide;

"Amlodipine / Valsartan / Hydrochlorothiazide" - "5 mg / 160 mg / 12.5 mg", where 5 mg is the content of amlodipine, 160 mg is the content of valsartan, 12.5 mg is the content of hydrochlorothiazide.

In this case, the same units of measurement are used to indicate the content of each of the active substances (in the case of using mass units of expression).

2.3. Indication of concentration for medicinal products

2.3.1. To indicate the concentration, a combination of the ratios of the units of measurement given in subparagraph 2.1 of these Recommendations is used:

g/ml grams per milliliter
mg/mL milligram per milliliter
μg/ml micrograms per milliliter
mg/g milligram per gram
µg/g micrograms per gram
mcg/mg microgram per milligram
IU/ml international unit of biological activity per milliliter
IU/g international unit of biological activity per gram
IU/mg international unit of biological activity per milligram.

2.3.2. Dosage indication as a percentage is not allowed, with the exception of registered medicinal products (or new dosages of such drugs), the dosages of which have traditionally been expressed in this way (in particular infusion and injection solutions: isotonic sodium chloride solution, glucose and albumin solutions). In this case, it is allowed to use the percentage "%" in the values:

mass percentage expressing the number of grams of active substance in 100 grams of the medicinal product;
mass-volume percentage, expressing the number of grams of active substance in 100 milliliters of the medicinal product;
volume percentage, the number of milliliters of the active substance in 100 milliliters of the medicinal product.

2.3.3. When indicating the concentration of the active substance in a unit of mass or volume of the medicinal product, the number "1" is not indicated. For example, 200 IU/ml, not 200 IU/1 ml.

2.3.4. It is allowed to indicate the content of the active substance in a different amount of mass or volume of the medicinal product, while giving this amount of the drug, for example, 200 IU / 0.5 ml.

2.3.5. For multicomponent medicinal products, the concentration is indicated taking into account subparagraph 2.2.6 of these Recommendations, for example, (25 mg / 50 mg) / 5 ml or (25 mg + 50 mg) / 5 ml.

Indication of the dosage (concentration) for various dosage forms is given in the table, where the following conventions are used: x mg / ml = concentration; z mg = total content of the active substance; y ml = total volume; z mg/y ml = total content of the active substance in the total volume.

Dosage form	Type of primary packaging 1	Preferred dosage designation 2	Way of expressing dosage (concentration) 3
Medications for oral administration
Solid single dose dosage forms (eg tablets, capsules)	single-dose		z mg
Solid dosage forms (eg granules)	multidose	quantity per unit mass	x mg/g
Soft dosage forms (eg, paste, oral gel)	single-dose		z mg
	multidose	quantity per unit mass	x mg/g
Liquid dosage forms (e.g. ampoules, sachets)	single-dose	total quantity in primary packaging	z mg
	multidose	quantity per unit volume	x mg/ml
Powders (granules) for the preparation of liquid dosage forms	single-dose	total quantity in primary packaging	z mg
	multidose		x mg/ml
Medicinal products for parenteral administration
Liquid dosage forms	single-dose (with a single administration of 4)	total quantity in primary packaging	z mg5
		quantity per unit volume	x mg/ml5
	multidose	quantity per unit volume	x mg/ml
Powders for the preparation of liquid dosage forms6	single-dose	total quantity in primary packaging	z mg
	multidose	quantity per unit volume after dissolution	x mg/ml
concentrates	single-dose (with a single administration4)	total quantity in primary packaging	z mg5
	single-dose (with partial administration 4)		x mg/ml5
	single-dose (with partial administration4)	amount per unit volume before dilution	x mg/ml5
concentrates	multidose	amount per unit volume before dilution	x mg/ml
Implants
Implants		total amount in the implant	z mg
Medicinal preparations for external, transdermal, rectal, vaginal administration, application to the mucous membrane of the oral cavity, gums
Solid dosage forms (eg, suppository, tablet, capsule)	single-dose	quantity per dosing unit	z mg
Solid dosage forms (eg powder)	multidose	quantity per unit mass	x mg/g
Transdermal preparations for systemic use (eg, transdermal patch)	single-dose	nominal amount released per unit of time	x mg/y h
Topical transdermal preparations (eg, transdermal patch)	single-dose	total amount in patch	z mg
Soft dosage forms (eg, cream, gel, ointment)	single-dose multi-dose	quantity per unit mass	x mg/g
Liquid dosage forms	single-dose	total quantity in primary packaging	z mg
	multidose	quantity per unit volume	x mg/ml
Medications for inhalation
Inhalation dosage forms (eg, hard capsules, aerosols, gases)	single-dose multi-dose	amount in delivered dose	x mg/dose
	single-dose	total quantity in primary packaging	z mg
Solution (suspension, emulsion) for nebulizer	multidose	quantity per unit volume	x mg/ml
Ophthalmic, ear and nasal medicines
Liquid dosage forms	single-dose multi-dose	quantity per unit volume	x mg/ml
Soft dosage forms (for example, ointment)	single-dose multi-dose	quantity per unit mass	x mg/g

1 Single-dose primary packaging contains the amount of the drug intended for full or partial use in 1 dose. Multi-dose primary packaging contains the amount of the drug, suitable for dosing twice or more.

2 The amount of pharmaceutical substance or active substance, respectively.

3 In addition to the ways of expressing dosage (concentration) indicated in the table, other acceptable units of measurement for expressing dosage (concentration) can be used.

4 Single administration: the use of the entire amount of the active substance contained in the primary packaging at a time within one administration. Partial administration: the administered dose is calculated on an individual basis (in mg/kg of body weight, in mg/m2), and the unused part of the medicinal product is destroyed.

5 If the concentration is indicated in the name of the medicinal product in the form of “dosage”, the total content in the total volume must be clearly indicated on the package. If the name of the medicinal product indicates the total amount of the active substance in the primary packaging in the form of “dosage”, the total volume or total content in the total volume and concentration must also be indicated on the package. If the name of the medicinal product indicates the total amount in the total volume in the form of “dosage”, the concentration should also be indicated on the package.

2.4. Special cases of indication of dosage (concentration)

2.4.1. For medicinal products for oral administration in multi-dose packaging, the form of application of which differs from the original form (requires conversion by dissolution, dilution), the dosage is indicated for the form of application. For example, "powder for suspension for oral administration 4 mg/ml" - in the absence of a dosing device, "powder for suspension for oral administration 20 mg/5 ml" - when equipped with a dosing device.

2.4.2. For radiopharmaceutical medicinal products, the total radioactivity expressed as the radioactivity of the nuclide in becquerels (GBq, MBq, kBq) per dose unit (for dosed medicinal products) or the radioactive concentration expressed as the radioactivity of the nuclide in becquerels (GBq, MBq, kBq) in the primary packaging unit (for non-dosed medicinal products) is indicated.

2.4.3. Dosage (concentration) is not indicated for the following drugs:

in the dosage form "medical gas", "oil", "liquid"; in the form of packaged medicinal raw materials and intended for the preparation of aqueous extracts;
complex saline solutions for infusion administration;
homeopathic preparations;
multivitamin preparations and preparations containing multivitamins in combination with mineral components and others.

2.4.5. On the packaging (label) of liquid medicinal products for injection, in addition to the dosage, the concentration of the active substance in 1 ml may be indicated. For the contents of a package with a volume of less than 1 ml, it is allowed to indicate the content of the active substance in the total volume of the package, for example, 12.5 mg / 0.625 ml. If the purpose of the medicinal product depends on its concentration in percent, it is allowed to indicate the content of the active substance in the total volume of the package along with it, for example, 1% (100 mg / 10 ml).

1. Introduction………………………………………………………….page 3

2. Types of drug packaging, their functions………….page 3-6

3. Separate types of packaging dosage forms………………page 6-8

4. Basic requirements for the packaging of medicines………………………..…page 8-9

5. Modern approaches to drug packaging…………………………page 9-10

6. Conclusion………………………………………………………..page 11

7. References……………………………………………….page 12

Introduction

Production of pharmaceutical packaging is an integral part of the pharmaceutical industry. Packaging has become a very important part of drug production as it innovation in the development of new drugs and new systems for delivering drugs to the body has reached a very high level. Pharmaceutical packaging must meet the increasing requirements for medicines. Packaging for pharmaceutical products and traditional packaging for other products are incomparable things. The production of pharmaceutical packaging should be based on scientific research, while traditional packaging is more consumer-oriented.

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.

Types of drug packaging, their functions

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 that 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 a 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).

Material: rigid, semi-rigid, soft.

Rigid packing:

The metal is used for primary packaging: jars, test tubes (for packaging

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.

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;

Tableted medicines containing essential oils are wrapped in paraffin paper before being packed into 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.

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, and 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.

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

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.

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. 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.

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