Pharmaceutical packaging serves multiple functions, including protecting the medicine, facilitating use, and conveying information. It includes inner packaging, outer packaging, labeling, and usage instructions. Inner packaging maintains product quality and reduces spoilage. Outer packaging and labeling facilitate transportation, storage, and sales, enhance product appearance, and improve the quality of use and service.
Inner Packaging
Inner packaging refers to the packaging that comes into direct contact with the medicine, such as aluminum foil and PVC in blister packs. Inner packaging should ensure the quality of the medicine during production, transportation, storage, and use, and be easy to use. Changes to inner packaging materials or containers should be based on the selected materials, and stability tests should be conducted to assess compatibility between the packaging materials/containers and the medicine.
Outer Packaging and Labeling
Outer packaging refers to packaging that is not part of the inner packaging, such as cartoning and case packers. Outer packaging should be selected based on the characteristics of the medicine to ensure its quality during transportation, storage, and use.
Labeling refers to the requirement that each smallest unit of a pharmaceutical product’s packaging must be printed or affixed with a label containing the required information, as stipulated.
For the outer packaging and labeling of pharmaceutical products, the packaging container must be sealed, sealed with a tamper-evident seal, or use an anti-theft cap. Labels must be affixed and securely attached correctly. Any packaging with damaged seals, labels, or containers must not be shipped or sold.
Pharmaceutical instructions include the drug’s name, shape, pharmacology and toxicology, pharmacokinetics, indications, dosage, and contraindications.
Inner packaging, outer packaging, labeling, and instructions for use must comply with regulations and be approved.
Common types of inner packaging:
1. Strip packaging:
This refers to tablets, capsules, and other sealed products, enclosed between two layers of packaging material and heat-sealed to form a unit. Each unit of strip packaging can be individually torn or cut for sale or use. Besides tablets and capsules, strip packaging can also be used to package small quantities of liquids, powders, or granules.
The packaging material used for strip packaging is a variety of composite films. Composite films need to meet the following requirements:
(1) Hygiene: Must meet hygiene requirements.
(2) Protection: Must ensure the medicine retains its medicinal value within its shelf life. To achieve this, it must have sufficient physical strength and barrier properties.
(3) Workability: Must have good adaptability to filling and sealing requirements, and good heat-sealing properties.
(4) Simplicity, safety, and portability.
(5) Commercial viability and good printability.
(6) Economy, ease of transportation, and storage.
2. Blister Packaging
Compared to bottled tablets, the most significant advantage of blister packaging for pharmaceuticals is its enhanced portability and reduced risk of contamination during transport and administration. However, for patients taking medication long-term with large single-dose doses, the unit cost of blister packaging is significantly higher than that of bottled medicines. Pharmaceutical companies typically choose blister packaging for high-value-added drugs.
The primary materials used in blister packaging are PTP aluminum foil and plastic film. Pharmaceutical aluminum foil is made from aluminum as its base material and is characterized by being non-toxic, corrosion-resistant, impermeable, moisture-proof, and light-blocking. Plastic film materials are typically PVC or PVDC.
3. Pharmaceutical Glass Bottle Packaging
Glass has good chemical stability and is also transparent, aesthetically pleasing, inexpensive, and recyclable. Pharmaceutical glass bottles can be used for:
Packaging products such as plasma, albumin, and globulin, typically in sizes ranging from 20 mL to 100 mL.
Packaging products such as freeze-dried biological agents, powder injections, vaccines, and genetically engineered drugs, typically in sizes ranging from 3 mL to 12 mL.
Pre-filled syringes are primarily used for packaging biological drugs, such as vaccines and interferon, which are single-use, drug-containing injections.
4. Composite Flexible Packaging
Composite flexible packaging facilitates sales and use. The production process for pharmaceutical flexible packaging requires high precision, naturally demanding high-quality adhesives. Besides traditional pharmaceuticals and food, composite flexible packaging bags are also widely used in the pesticides, electronics, and cosmetics industries. In the food packaging field, composite flexible packaging has various applications, including pasteurization, boiling, and vacuum packaging.
5. Co-extruded Film (Infusion Containers) Glass and plastic infusion bottles share a common weakness. During use, an air loop is required, allowing outside air to enter the bottle and cause the medication to drip out. This increases the risk of secondary contamination, especially in hospitals with high levels of bacteria and poor hygiene. To address this issue, polyvinyl chloride (PVC) flexible bags for infusion packaging were developed. PVC flexible bags allow the medication to drip out under its own tension, eliminating the need for an air loop and reducing the risk of secondary contamination. However, PVC flexible bags contain PVC monomers, which are known to be harmful to human health. Furthermore, plasticizers (DEHP) are added during the production of PVC flexible bags to alter their properties. Studies have found that DEHP may leach from PVC flexible bags during use; DEHP is a harmful substance.
6. Plastic Bottles
Pharmaceutical plastic bottles are plastic containers used to package medicines, liquids, solvents, and chemical reagents. Pharmaceutical plastic bottles are typically made of PET material, which offers several advantages, including being lightweight, high-strength, resistant to breakage, exhibiting good sealing performance, being moisture-proof, and promoting hygiene. They are an excellent pharmaceutical packaging container, widely used for packaging oral solid medicines (such as tablets, capsules, granules, etc.) and oral liquid medicines.
7. Aluminum Tubes
Pharmaceutical aluminum tubes can be divided into two types: soft aluminum tubes and rigid aluminum tubes. Soft aluminum tubes are used for packaging creams, ointments, eye ointments, and other dosage forms. Rigid aluminum cans are unsoftened and used for packaging dosage forms such as effervescent tablets, pills, capsules, and sprays. Both types of containers are made of pure aluminum. Aluminum has good light-shielding and airtight properties, meeting the requirements of pharmaceutical packaging. It is also easy to recycle and does not pollute the environment, conforming to environmental protection principles. Among various pharmaceutical packaging materials, it has a wide range of applications and promising development prospects.
The quality evaluation of pharmaceutical inner packaging, outer packaging, and labeling typically involves packaging testing, which encompasses various tests to assess the packaging’s protective effect on the drug, its impact on drug stability during long-term storage under different environmental conditions, and other relevant factors.
With technological advancements, increased human understanding, and abundant resources, people have increasingly higher demands for packaging materials, and more new, safe, and environmentally friendly materials will be developed and introduced in the future.