Packaging is a complex or one product that ensures the safety and protection of the drug from losses, damage, as well as various environmental pollution during sale, transportation or storage. There are different types of it, depending on direct contact with the medicine. The inner or primary packaging of medicines is one that has direct contact with the medication. Its cost is included in the price of the drug and is fully paid by the consumer.
Forms of Medicines
Each medicine is given a specific look for ease of use. In addition, using various excipients, they improve the taste of the medication, increase the time of its action, using the technology of gradual release of the active component, etc. Capsules, solutions, ointments, tablets, suppositories, plasters that are rational from the medical point of view, are called medicinal forms. They are divided into several groups:
- Liquid - suspensions, drops, syrups, elixirs, infusions, extracts.
- Soft - pastes, ointments, candles, liniment, gels.
- Gaseous - aerosols and sprays.
- Solid - powders, dragees, capsules, pellets, granules, briquettes, tablets.
general information
Dosage forms have packaging, it happens:
- primary, or it is also called internal, individual;
- secondary, or external.
The drug can have either one or several types of packaging. The primary packaging of medicines is one that is in direct contact with the medication. For example, dragees are packed in glass containers or blisters, suppositories - in contour, solutions - in bottles or ampoules, herbal preparations - in bags. Packaging should protect the contents from the penetration of substances from the outside, as well as losses during transportation, storage or sale.
Each individual packaging is corked. Closures are different in appearance and type. The main ones are caps, caps, corks, bushons. In order to protect the primary packaging from damage, it is placed in an external, for example, cardboard box.
State Register of Medicines
This registry is a list of medicines of both domestic and foreign manufacturers, as well as drugs used for diagnostic and medical and preventive purposes, registered in our country by the Ministry of Health. The registry contains all the necessary information about the drugs:
- international nonproprietary and trade names;
- packaging;
- pharmacological group;
- dosage;
- dosage form.
The above information serves as the basis for the formation of various lists, for example, vital and necessary drugs or over-the-counter products. The register is kept in electronic form.
The State Register of Medicines is a publication that provides practical assistance not only to state authorities, but also to all health workers.
Classification
Inner packaging is classified according to the following characteristics:
- By degree of protection. The components of the packaging physically come into contact with the medicine and protect it from the negative effects of the external environment. In other cases, the primary packaging is an entire drug delivery system, for example, an aerosol.
- On protection against opening. Such packages provide for control of the first opening, which makes it possible to track any violation of its integrity. Violation of the primary packaging of the drug in a pharmacy is not allowed.
- For protection against environmental factors. Quality packaging provides protection against loss of contents and from ingress of foreign substances.
- By the number of uses and the number of doses. A single-dose package contains a preparation intended for use immediately after opening, and a multi-dose package is intended to be used in parts, that is, repeatedly.
- By type and type. Primary packaging: ampoules, cylinders, bottles, cans, bottles, cartridges, tube droppers and others.
- By mechanical properties. There are several types of packaging. Rigid - when filling or deleting content, the size and shape do not change. Fragile - sensitive to dynamic loads. Flexible - soft materials (foil, cardboard, paper, polymers) are used for its manufacture. Soft - shape and size change when you remove or fill content.
Marking
In the Russian Federation, there are uniform requirements for the design and labeling of drugs. They are listed in federal law and are binding on all drug manufacturers. Primary packaging labeling contains information written in Russian in clear print:
- shelf life;
- the brand name of the drug, as well as the international generic or chemical;
- number of doses in a package, as well as concentration and dosage;
- production date (for vaccines) and serial number;
- volume.
The radiation safety sign must be affixed to the individual packaging of radiopharmaceutical medicines. Other information is on the secondary packaging.
Labels (in other words, marking) are applied directly to the package or to the label that is attached to it. The chosen method should retain the label until the expiration date of the drug.
Types of inner packaging
There are several types of primary drug packages:
- Soft - made of paper, used in the form of a wrapper, bag for dragees, herbal remedies, tablets. Packages for powders, adhesives and granules are made from polymer.
- Semi-rigid - a tube dropper for eye drops and contours for packing candles are made from polymeric materials. Cardboard containers are suitable for herbal medicines and plasters. Combined materials are used for contour packaging intended for powders, granules, tablets, capsules, dragees.
- Rigid - these are bottles, ampoules, bottles, test tubes, as well as cans made of glass. They are filled with such forms as pastes, capsules, ointments, tablets, powders, liniments, granules, eye drops. Test tubes and cans are made of metal material; tablets, dragees, powders, granules, capsules are packaged in them. In addition, cylinders for sprays and tubes for liniment, ointments and pastes are made from this material. For the production of cups, test tubes and cans, polymer materials are needed. Such containers are filled with pills and tablets.
All types of primary packaging used by the pharmaceutical industry must be approved for use in our country.
Features of the packaging of solid dosage forms
For solid dosage forms (dragees, powders, capsules, granules, tablets), the primary packaging is multi-dose. It is represented by bottles, test tubes, jars made of metal, a polymeric material that is colorless and does not transmit light, as well as glass. Corks are used corks, caps, caps, equipped with special seals and having a shock absorber. Blisters are considered the primary multi-dose package equipped with cells or perforations for filling in individual doses of them, mainly solid forms of drugs.
They are made from component parts using paper and foil or using only aluminum foil or polymers. Corked by heat sealing. For granules and powders, sachets or sachets are best suited. Such primary single-dose packaging is made from composite materials. Often, foil, polymers and paper are taken as the basis. Capping them is similar to blisters.
Requirements for individual packaging of solid dosage forms
Requirements for the primary packaging of medicines in solid forms:
- Protect from atmospheric phenomena and microbiological effects.
- Be well corked.
- Moisture sensitive - packaged in a tight container that protects against its penetration. The presence of moisture-absorbing substances in the package is allowed.
- If volatile substances are present, the packaging must ensure air tightness.
- The presence of essential oils implies packaging in test tubes wrapped in parchment or paraffin paper.
- Capsules require protection against excessive moisture, drying and light.
Primary Packaging Materials
The materials used for the manufacture of inner packaging must comply with the following requirements:
- strength;
- chemical neutrality;
- aesthetics;
- gas tightness;
- mobility;
- transportability;
- ease of use;
- resistance to mechanical and negative influences of external factors.
The type of raw material for the production of primary packaging is selected depending on which specific medicinal substance will be packaged in it. Used materials such as:
- glass;
- polymer;
- metal;
- cardboard and others.
Special requirements for individual packaging material
Special requirements for inner packaging are:
- vapor, light and gas impermeability;
- barrier resistance to bacteria;
- strength;
- chemical neutrality to the drug;
- nice outlines;
- ease of use, such as wearing, moving or transporting;
- data on storage, as well as medication;
- appropriate sizes;
- the placement of the drug, allowing it to be used repeatedly and without violating sterility and impermeability;
- control of the first opening of containers.
Thus, the choice of packaging depends on the properties of the drug. They determine the type of materials based on the interests of the manufacturer, as well as the maximum satisfaction of user preferences.
Inner packing
Primary packaging of medicines is a type of packaging, the purpose of which is to create conditions that guarantee the safety of the substances packaged in it. Another name for such packaging is individual, this includes:
- tubes;
- large bottles;
- ampoules;
- capsules;
- bottles and more.
Individual packaging must guarantee:
- Piece or dosed drug recovery.
- The convenience of use.
- Protect from mechanical influences.
- Tightness.
- Standard sizes, deviations from them are not allowed.
Special requirements for inner packaging
For some drugs, special requirements for individual packaging are presented:
- Medicines that are sensitive to the effects of light are placed in containers that do not allow light to pass through.
- A medicinal product having an odor or containing a volatile component is packaged separately from the others.
- Preparations containing substances that cause combustion, volatile, absorbing water vapor from the air and bulk, intended for export, are placed in containers, which are sealed with special rolling caps to ensure their safety.
- Medicines containing weathering, oxidizing, volatile and hygroscopic components are placed in bottles or jars with screw caps, provided with gaskets or caps with special sealing elements. Then they are subject to rolling with metal caps.
- When filling a container that does not have a stopper with a sealant, capsules, dragees or tablets, it is allowed to use clean cotton wool.
- Tablets with essential oils are wrapped in paraffin paper, and then placed in test tubes.
For each series of drugs, the packaging must take into account their physical and chemical characteristics and be one.
Conclusion
On the basis of use, packaging is divided into group, transport and primary. Packaging of medicines is a kind of protection and safety of the substances contained in it. It includes glass jars and bottles, syringe tubes for single use, bottles for blood substitutes, etc. Special requirements are imposed on the material for individual packaging. The choice of different types of packaging devices depends on the properties of the drug that will be in it. In this case, one must adhere to the interests of both the manufacturer and the consumer. The decision of the EEC Board (Eurasian Economic Commission) approved the classifier of types of primary packaging of medicines. The classifier is a list of the types and materials of primary packaging of medicines, systematized in accordance with their type and the material from which they are made.