Monday, 19 November 2018

A Articles

Pharmaceutical Packaging

The Importance of Packaging

Packing is an extremely vital part of the pharmaceutical industry. Drugs and medicines are sensitive to the environment and require more sufficient packaging than other products. A product packaging is the chief element to hold onto the sanctity and quality of the product for which the consumers can lean on their trust. Some of the key performance functions of packaging, in general, are to provide presentation, protection, identification and information, and convenience (Kulkarni 239).

The presentation of the packaging is a strong marketing tool. The colors and designs of the packaging attract the customer to purchase the product and can convey a certain expectation or level of confidence for the product. For instance, an ethical product (a prescribed medicine) usually has a high standard of packaging which is relatively simple, elegant, but not over-dressed. On the other hand, an OTC (over-the-counter) package, which would sell through more rigorous advertising, may be designed with more decoration or detail (Dean 4).

The containment and protection of the product is the most fundamental function of a package. It creates a physical barrier between the product and ambient air to maintain integrity of the product through transit and usage. Certain testing is done on the packaging to ensure its capability to perform for the product. This testing includes shock, puncture, climate (temperature and humidity), and pressure testing to name a few (Dean 6). Other forms of protection lie within the materials that are used. For instance, a medicine that degrades in sunlight would require a dark glass bottle to protect it during transit and use.

Identification and information is also an important feature of a pharmaceutical package. All information needs to be readily available for the consumer. This information includes the name of the product, ingredients, usage instructions, warnings, etc. Companies are now exploring a variety of packaging solutions that can increase compliance. Some different methods used by package designers are color coding to help identify dosages clearly and technologies that remind the patient to take the right dosage at the right time (Kulkarni 231-232). Because there is so much information that must be placed on medicine containers to ensure compliance, they oftentimes use folded pamphlets that keep all the information in small text attached to the bottle or folded sheets of information within the secondary container.

Convenience is also important to the packaging because it makes it easier for the consumer to use the product. Some factors of convenience are the opening/closing of a package, size of package, storage, and transporting. These conveniences are not just for the consumer but extend to the shipping, warehousing, and production of the product (Dean 5).

The packaging of pharmaceuticals can be classified in many ways based on the classification of the product inside. Some influences on packaging style and functions include dosage form, administration, and type/material. It is important to note that these influences oftentimes have interchangeable and connecting effects on the overall package.

The number of doses and form of a dosage strongly influences what type of material, shape, size, etc. a package should be (Dean 2). For instance, a medicine that is in liquid form intended for a single dosage would be placed in a glass container or an ampoule. A medicine in solid form as tablets intended as a multi-dosage would be placed in a blister package where each pill is in a separate space. A semi-solid medicine like a cream or ointment may be placed in a metallic collapsible tube (Kunal 1282-1283).

Packaging design is also influenced by the administration method of the medicine. In some cases, the package may be required to act as a dispensing aid like an aerosol, or have accessories that can either be made part of the package or used as a separate unit like a dropper assembly. In addition, the package can become part of a device, like a cartridge tube, which can be used with a reusable or disposable syringe (Dean 3).

Dosage and administration methods also dictate the materials for the packaging (glass, plastic, foil, etc.) and/or the style of the package such as a bottle, tube, blister, etc. to produce the most effective usage and performance for consumers. For instance, a multi-use medicine that is in powder form would require a container that is re-closable like a pouch which is also highly convenient for the user.

Tamper-Resistant Packaging

Tamper-resistant packaging is one of the most important topics for the FDA (Food and Drug Administration) concerning pharmaceuticals. Tamper-resistant packaging, according to FDA definition, is one having an indicator or barrier to entry, which, if breached or trussing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred. This sort of packaging can involve immediate container systems (the container that contains the actual product), secondary container systems (the container that holds the immediate container), and a variety of mixtures of both systems. FDA identified the packaging configurations that meet the requires of a tamper-resistance packaging: Film wrappers; blister package; strip package, bubble pack; shrink seal and bands; foil, paper, or plastic pouches; bottle seals; tape seals; sealed tubes; aerosol containers; and carton.

Interestingly, the FDA does not have specific standards and regulations for the creation of the packaging. This is left to the manufacturer to make sure that the packaging ensures the safety and integrity of the product for usage. The FDA only regulates the materials of the packaging, which is listed in the GRAS (Generally Recognized As Safe) (Kunal 1285).

The Advancement of the Pharmaceutical Packaging Industry

The pharmaceutical industry is continuously expanding and making advancements, specifically in the form of dosage and administration and availability to the consumer population. Traditionally, 51% of medicine is taken orally in capsule or tablet form. However, there has been a rise in other forms of dosage and administration, such as intravenous, inhalation, and transdermal, which require alternative packaging that is different in shape, material, convenience, compliance, safety, etc. (Kunal 1287). This goes to say that the advancement of modern medicine requires the advancement and innovation of the packaging to ensure the product’s integrity until shelf life. For example, many new biotechnology-derived drug therapies are unstable in liquid form and, as a result, are introduced as lyophilized or dry powder dosage forms. Lyophilized drugs need special stoppers for optimal performance in lyophilization chambers. The stoppers must also not stick to the lyophilization shelf after the cycle is completed. In addition, lyophilized drugs typically are reconstituted at the point of care, thus requiring patient-friendly administration systems (Kulkarni 234).

Future of Pharmaceutical Packaging

As the pharmaceutical industry continues to grow, the demands for more efficient packaging techniques grow as well. This will be a challenge for the pharmaceutical packaging industry but there is confidence that these demands can be met. Some of the specific demands of the pharmaceutical industry are driven by cost because pharmaceutical manufacturers face increased pressure to produce more for the least cost. As a result, packaging machines must become more efficient and user friendly by offering flexibility, easy operation, robustness, intelligence and protection from interference. It can be challenging to meet these requirements at once. Another growing issue is that the constant globalization trend with extended competition in the pharmaceutical industry will lead to smaller batch sizes. This means that existing packaging equipment will have to be replaced because older machines are often not designed for quick changeovers and flexibility. Aside from the many challenges that must be met, there are good things to look forward to for the pharmaceutical packaging industry. The growth of the global market in countries like India and China will result in increased demand for packaging machinery. Additionally, the global packaging industry understands where it needs to move forward in the next few years. Their top priorities are improving operational efficiency, new products and services, and expanding in the current market (Kunal 1287-1288).

References

C, Mehta Kunal, D. Akhilesh, and B. Shyam Kumar. "Recent Trends in Pharmaceutical Packaging: A Review." International Journal of Pharmaceutical and Chemical Sciences, 1.3 (2012): 1282-292. Print.

Dean, D. A., E. R. Evans, and I. H. Hall. Pharmaceutical Packaging Technology. N.p.: Taylor & Francis, 2000. Print.

Kulkarni, Sunisha, Anisha Agrawal, Shyam Bihari Sharma, and Suman Jain. "Creative Innovations in Pharmaceutical Packaging." Indian Journal of Pharmacy and Pharmacology, 2.4 (2015): 230. Web.

Packcon.org

Packaging Connections
[PACKCON.ORG]

A Division of Cloud Publications
Email: Info@packcon.org
Tel: (+91)- 1202648076

Powered By

TAPPI Student Chapter 
Gadomski School of Engineering, Christian Brothers University (Memphis, TN, USA)