Drug packaging

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Tablets in a blister pack in folding carton Risperdal tablets.jpg
Tablets in a blister pack in folding carton

Drug packaging (or pharmaceutical packaging) is process of packing pharmaceutical preparations for distribution, and the physical packaging in which they are stored. It involves all of the operations from production through drug distribution channels to the end consumer.

Contents

Pharmaceutical packaging is highly regulated but with some variation in the details, depending on the country of origin or the region. Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, [1] uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation of the drug by oxygen, moisture, heat, light exposure etc., prevention of microbial contamination, sterility, etc. Packaging is often involved in dispensing, dosing, and use of the pharmaceutical product. Communication of proper use and cautionary labels are also regulated. Packaging is an integral part of pharmaceutical product. [2] [3]

Segments of usage

Pharmaceutical packaging can often be thought of by the segment in the distribution system being encountered and by the functions needed by the user of the package. Packaging requirements are different. [4]

Bulk drugs in fiber drums Examining Bulk Drug Containers (FDA 100) (8250838700).jpg
Bulk drugs in fiber drums

Bulk pharmaceuticals can be shipped to another pharmaceutical company for further processing, to a contract packager for forming unit packs, to international customers, etc. Bulk shipments might be in fiber drums (with plastic liners), bulk boxes, corrugated boxes with liners, intermediate bulk containers, and other shipping containers.

Smaller bulk packs can be shipped to pharmacies, particularly compounding pharmacies. The liquids or powders can be measured and put into primary packages.

Shipments to medical professionals could be at hospitals, nursing homes, veterinarians, dentists, etc. These packaged pharmaceuticals are intended to be dispensed and administered by professionally trained and certified personnel.

Preparing consumer packaging of prescription drugs at pharmacy Drugstore Ancillary Personal at work 19.JPG
Preparing consumer packaging of prescription drugs at pharmacy

Drugs under prescription control are sent to pharmacies in multi-packs of unit packs or in bottles containing many hundreds of capsules. Typically a pharmacist prepares the final form of the unit pack or places a lower count of capsules in a small bottle for the customer. In a pharmacy, pharmacists are available to answer questions and to ensure that proper documentation is provided. Internet pharmacies mail the prescribed drugs to the customer; boxes or mailing envelopes are used. Child resistant packaging is often required on the unit packs; if requested, a pharmacist is allowed put drugs in a bottle with easy open features.

Over-the-counter drugs are sold in drug stores, grocery stores, and diverse retail outlets. Usually the package needs to have all the usage information available. Packages often need to have tamper resistant features and child-resistant packaging.

Usually the packaging and labeling of dietary supplements, homeopathic drugs, and folk medicines are not regulated. Some producers voluntarily follow the regulations for over-the-counter drugs or regional Pharmacopoeias.

Package forms

The wide variety of pharmaceutical solids, liquids, and gasses are packaged in a wide variety of packages. Some of the common primary packages are:

Blister packs

Birth control pills in blister packs Plaquettes de pilule.jpg
Birth control pills in blister packs

Formed solid unit doses of pharmaceuticals (capsules, suppositories, tablets, etc.) are commonly packed in blister packs. In Europe about 85% of solid unit doses are packed in blister packs with only about 20% in North America. [5]

Blister packs are pre-formed plastic/paper/foil packaging used for formed solid drugs. The primary component of a blister pack is a cavity or pocket made from a thermoformed plastic. This usually has a backing of paperboard or a lidding seal of aluminum foil or plastic film. Blister packs are useful for protecting drugs against external factors, such as humidity and contamination for extended periods of time.

Blister packing machinery is readily available and is suited to validation processes. [6]

Bottles

A foil innerseal on a bottle Induction sealed bottle.jpg
A foil innerseal on a bottle

Bottles are commonly used for liquid pharmaceuticals as well as formed tablets and capsules. Glass is most common for liquids because it is inert and has excellent barrier properties. Various types of plastic bottles are used both by drug producers as well as by pharmacists in a pharmacy.

Prescription bottles have been around since the 19th century. [7] Throughout the 19th and 20th centuries, prescription medication bottles were called medicinal bottles. [7] There are many styles and shapes of prescription bottles. [7] Bottles would often include cotton to cushion powdery, breakable pills. In modern times, pills are coated, and thus the inclusion of a cotton ball is no longer necessary. The U.S. National Institute of Health recommends consumers remove any cotton balls from opened pill bottles, as cotton balls may attract moisture into the bottle. [8]

Prescription bottles come in several different colors, the most common of which being orange or light brown due to its ability to prevent ultraviolet light from degrading the potentially photosensitive contents through photochemical reactions, while still letting enough visible light through for the contents to be easily visible. Other common colors include: Clear (for compounds that don't degrade in light), blue, dark brown, green, and various opaque hues. [9]

Temperature

Shipment of vaccine: PU insulated box, gel packs, temp monitor, etc. Cold control packaging.jpg
Shipment of vaccine: PU insulated box, gel packs, temp monitor, etc.

Many pharmaceutical products are sensitive to heat or cold. Controlled distribution systems and sometimes cold chains are required.

A mail order or online pharmacy usually ships orders by mail services or by small parcel carrier. The shipment is not temperature-controlled and it may sit in a mail box upon delivery. Conditions can include high or low temperatures outside of the recommended storage conditions for certain products. For example, the USFDA found that the temperature in a steel mailbox painted black could reach 136 °F (58 °C) in full sun while the ambient air temperature was 101 °F (38 °C). [10] Insulated mailing envelopes are sometimes used.

Larger shipments are sent in insulated shipping containers with dry ice or gel packs. A digital temperature data logger or a time temperature indicator is often enclosed to monitor the temperature inside the container for its entire shipment.

Moisture

Many dry pharmaceuticals are sensitive to moisture. Tablets may become unstable and the drug may degrade. High barrier packaging (including seals) is necessary but, by itself, is often not enough. Shelf life of a moisture-sensitive drug can be extended by means of desiccants. [11] Several types of dessicants are available; the type and quantity need to be matched to the particular drug and package. One common method is to include a small packet of dessicant in a bottle. Other methods of including desiccants attached to the inner surface or in the material have recently been developed. [12] [13]

Counterfeiting

CD-3- Fighting Counterfeit Drugs (8675484534).jpg
Two drug packages appear to be identical in normal light
CD-3- Fighting Counterfeit Drugs (8674379559).jpg
Selective UV wavelength identifies counterfeit package on left

Counterfeit drugs are a serious problem. People can potentially ingest useless or dangerous drugs without their knowledge. Custom package seals, authentication labels, holograms, and security printing can be valued parts of an entire security system. [14] They help verify that enclosed drugs are what the package says they are. Drug counterfeiters, however, often work with package counterfeiters, some of whom can be sophisticated. No packaging system is completely secure.

Prescription labels

Medication packaging includes a document that provides information about that drug and its use. In the US, this information is overseen by the Center for Drug Research and Evaluation (CDER), a branch of the Food and Drug Administration (FDA). For prescription medications, the insert is technical, and provides information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user -- the person who will take the drug or administer the drug to another person. Inserts for over-the-counter medications are also written plainly. [15] [16] [17] [18]

In the US the document is called "prescribing information" or the "package insert" (PI) and layperson's document is called the "patient package insert" (PPI). [15] In Europe the technical document is called the "summary of product characteristics" and the document for end-users is called the "package leaflet". [19]

The bottle or box also has information printed on it, intended for the person taking the medication. [18]

Packaging production

Example pharmaceutical packaging line Laboratoires Arkopharma - Chaine de conditionnement remplissage piluliers.JPG
Example pharmaceutical packaging line

All aspects of pharmaceutical production, including packaging, are tightly controlled and have regulatory requirements. Uniformity, cleanliness (washdown), sterility, and other requirements are needed to maintain Good Manufacturing Practices.

Product safety management is vital. A complete Quality Management System must be in place. Validation involves collecting documentary evidence of all aspects of compliance. [20] Hazard analysis and critical control points is a methodology which has been proven useful. [21] Quality assurance extends beyond the packaging operations through distribution and cold chain management; Good distribution practice is often a regulatory requirement. Track and trace systems are usually required.

With a large portion of pharmaceutical packaging being outsourced to contract packagers, additional demand is being placed on specialty areas, i.e. specialty dosage forms. [22]

Examples

See also

Related Research Articles

<span class="mw-page-title-main">Over-the-counter drug</span> Medication available without a prescription

Over-the-counter (OTC) drugs are medicines sold directly to a consumer without a requirement for a prescription from a healthcare professional, as opposed to prescription drugs, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they contain ingredients that are safe and effective when used without a physician's care. OTC drugs are usually regulated according to their active pharmaceutical ingredient (API) and strengths of final products.

<span class="mw-page-title-main">Packaging</span> Enclosure or protection of products for distribution, storage, and sale

Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Packaging also refers to the process of designing, evaluating, and producing packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Packaging contains, protects, preserves, transports, informs, and sells. In many countries it is fully integrated into government, business, institutional, industrial, and for personal use.

<span class="mw-page-title-main">Shelf life</span> Length of time that a commodity may be stored before it degrades

Shelf life is the length of time that a commodity may be stored without becoming unfit for use, consumption, or sale. In other words, it might refer to whether a commodity should no longer be on a pantry shelf, or no longer on a supermarket shelf. It applies to cosmetics, foods and beverages, medical devices, medicines, explosives, pharmaceutical drugs, chemicals, tyres, batteries, and many other perishable items. In some regions, an advisory best before, mandatory use by or freshness date is required on packaged perishable foods. The concept of expiration date is related but legally distinct in some jurisdictions.

<span class="mw-page-title-main">Closure (container)</span> Devices and techniques used to close or seal a bottle, jug, jar, tube, can, etc.

A closure is a device used to close or seal a container such as a bottle, jug, jar, tube, or can. A closure may be a cap, cover, lid, plug, liner, or the like. The part of the container to which the closure is applied is called the finish.

Moisture vapor transmission rate (MVTR), also water vapor transmission rate (WVTR), is a measure of the passage of water vapor through a substance. It is a measure of the permeability for vapor barriers.

<span class="mw-page-title-main">Blister pack</span> Type of packaging

A blister pack is any of several types of pre-formed plastic packaging used for small consumer goods, foods, and for pharmaceuticals.

A contract packager, or co-packer, is a company that packages products for their clients. The packaging and labeling services can be used for many types of products including foods, pharmaceuticals, household products, and industrial products.

An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.

<span class="mw-page-title-main">Induction sealing</span> Process of bonding thermoplastic materials by induction heating

Induction sealing is the process of bonding thermoplastic materials by induction heating. This involves controlled heating an electrically conducting object by electromagnetic induction, through heat generated in the object by eddy currents.

Dosage forms are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration, and apportioned into a particular dose. For example, two products may both be amoxicillin, but one is in 500 mg capsules and another is in 250 mg chewable tablets. The term unit dose can also sometimes encompass non-reusable packaging as well, although the FDA distinguishes that by unit-dose "packaging" or "dispensing". Depending on the context, multi(ple) unit dose can refer to distinct drug products packaged together, or to a single drug product containing multiple drugs and/or doses. The term dosage form can also sometimes refer only to the pharmaceutical formulation of a drug product's constituent drug substance(s) and any blends involved, without considering matters beyond that. Because of the somewhat vague boundaries and unclear overlap of these terms and certain variants and qualifiers within the pharmaceutical industry, caution is often advisable when conversing with someone who may be unfamiliar with another person's use of the term.

<span class="mw-page-title-main">Compounding</span> Preparation of a custom medication

In the field of pharmacy, compounding is preparation of custom medications to fit unique needs of patients that cannot be met with mass-produced products. This may be done, for example, to provide medication in a form easier for a given patient to ingest, or to avoid a non-active ingredient a patient is allergic to, or to provide an exact dose that isn't otherwise available. This kind of patient-specific compounding, according to a prescriber's specifications, is referred to as "traditional" compounding. The nature of patient need for such customization can range from absolute necessity to individual optimality to even preference.

<span class="mw-page-title-main">Food packaging</span> Enclosure and protection of nutritional substances for distribution and sale

Food packaging is a packaging system specifically designed for food and represents one of the most important aspects among the processes involved in the food industry, as it provides protection from chemical, biological and physical alterations. The main goal of food packaging is to provide a practical means of protecting and delivering food goods at a reasonable cost while meeting the needs and expectations of both consumers and industries. Additionally, current trends like sustainability, environmental impact reduction, and shelf-life extension have gradually become among the most important aspects in designing a packaging system.

Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical substances, including the active drug, are combined to produce a final medicinal product. The word formulation is often used in a way that includes dosage form.

<span class="mw-page-title-main">Epedigree</span> Electronic document which provides data on the history of a particular batch of a drug

An epedigree is an electronic document which provides data on the history of a particular batch of a drug. It satisfies the requirement for a drug pedigree while using a convenient electronic form.

Insulated shipping containers are a type of packaging used to ship temperature sensitive products such as foods, pharmaceuticals, organs, blood, biologic materials, vaccines and chemicals. They are used as part of a cold chain to help maintain product freshness and efficacy. The term can also refer to insulated intermodal containers or insulated swap bodies.

<span class="mw-page-title-main">Child-resistant packaging</span>

Child-resistant packaging or CR packaging is special packaging used to reduce the risk of children ingesting hazardous materials. This is often accomplished by the use of a special safety cap. It is required by regulation for prescription drugs, over-the-counter medications, Nicotine Containing Electronic Cigarette devices or Refill containers that can contain Nicotine EUTPD 36.7 pesticides, and household chemicals. In some jurisdictions, unit packaging such as blister packs is also regulated for child safety.

The terms active packaging, intelligent packaging, and smart packaging refer to amplified packaging systems used with foods, pharmaceuticals, and several other types of products. They help extend shelf life, monitor freshness, display information on quality, improve safety, and improve convenience.

Pharmacy automation involves the mechanical processes of handling and distributing medications. Any pharmacy task may be involved, including counting small objects ; measuring and mixing powders and liquids for compounding; tracking and updating customer information in databases ; and inventory management. This article focuses on the changes that have taken place in the local, or community pharmacy since the 1960s.

<span class="mw-page-title-main">Package testing</span>

Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components, primary packages, shipping containers, and unit loads, as well as the associated processes.

<span class="mw-page-title-main">Poison Prevention Packaging Act of 1970</span> US law

The Poison Prevention Packaging Act of 1970 (PPPA); was signed into law by U.S. President Richard Nixon on December 30, 1970. It was enacted by the 91st United States Congress. This law required the use of child-resistant packaging for prescription drugs, over-the-counter (OTC) drugs, household chemicals, and other hazardous materials that could be considered dangerous for children.

References

  1. ↑ Forcinio, Hallie (2 October 2018). "Protecting Solid-Dose Shelf Life". Pharmaceutical Technology. Vol. 42, no. 10. UBM . Retrieved 8 November 2018.
  2. ↑ Santoro, MIRM (2009). "Pharmaceutical Packaging". In Yam, K L (ed.). Encyclopedia of Packaging Technology . Wiley. pp.  205–216. ISBN   978-0-470-08704-6.
  3. ↑ Kunal, Mehta (July 2012). "Recent Trends in Pharmaceutical Packaging: A Review" (PDF). International Journal of Pharmaceutical and Chemical Sciences. 1 (3): 1282–1292. Archived from the original (PDF) on 14 February 2019. Retrieved 24 June 2017.
  4. ↑ Dean, D A (2000). Pharmaceutical Packaging Technology. Taylor and Francis. ISBN   978-0-7484-0440-7.
  5. ↑ Pilchik, R (November 2000), "Pharmaceutical Blister Packaging, Part 1, Rationale and Materials" (PDF), Pharmaceutical Technology: 68–77, retrieved 26 June 2017
  6. ↑ Pilchik, R (December 2000), "Pharmaceutical Blister Packaging, Part 2, Machinery and Assembly" (PDF), Pharmaceutical Technology: 56–60, retrieved 26 June 2017
  7. 1 2 3 Lindsey, Bill (20 November 2016). "Medicinal/Chemical/Druggist Bottles". sha.org. Society for Historical Archaeology.
  8. ↑ Berger, Arielle (2017). "Here's why that huge cotton ball comes in pill bottles". Business Insider. Retrieved 3 July 2020.
  9. ↑ "Why are Many Bottles Brown?" . Retrieved 1 January 2014.
  10. ↑ Black, J. C.; Layoff, T. "Summer of 1995 – Mailbox Temperature Excurions of St Louis" (PDF). US FDA Division of Drug Analysis. Retrieved 1 July 2017.
  11. ↑ Carstensen, J T (24 October 1997), "Stability of Drugs and Drug Products in Clinical Packaging", in Monkhouse, D C (ed.), Drug Products for Clinical Trials, Marcel Decker (published 1998), pp. 231–2, ISBN   0-8247-9852-X
  12. ↑ USapplication 2020016034,Voellmicke, Craig,"Blister packages containing active material and methods of making and using same",published 2020-01-16, assigned to CSP Technologies Inc.
  13. ↑ US 6112888,Sauro, Raymond J.; Pryor, James Neil& Chu, Jia-Ni,"Non-reclosable packages containing desiccant matrix",published 2000-09-05, assigned to W. R. Grace & Co.
  14. ↑ Dallas, Martin (1 October 2014), "Anticounterfeiting Packaging 101", PharmTech, retrieved 21 January 2018
  15. 1 2 Nathan, Joseph P.; Vider, Etty (2015). "The Package Insert". US Pharm. 40 (5): 8–10.
  16. ↑ Nadine Vanlaer (31 August 2006). "Drug Package Inserts: the Letter of the Law - Packaging Gateway". Packaging Gateway.
  17. ↑ Consumer Reports (January 2012). "Drug Safety: Reading Labels and Patient Information" (PDF). consumerreports.org.
  18. 1 2 Consumer Reports (January 2012). "Drug Safety: Taking Drugs as Directed" (PDF). consumerreports.org.
  19. ↑ "Marketing authorisation - Product-information requirements". European Medicines Agency. Retrieved 18 August 2018.
  20. ↑ Jatto, E; Okhamafe, A O (December 2002), "An Overview of Pharmaceutical Validation and Process Controls in Drug Development", Tropical Journal of Pharmaceutical Research, 1 (2): 115–122, doi: 10.4314/tjpr.v1i2.14592 , retrieved 26 June 2017
  21. ↑ Dahija, S; Kar, Chhikara (April 2009), "Opportunities, challenges and benefits of using HACCP as a quality risk management tool in the pharmaceutical industry", The Quality Assurance Journal, 12 (2): 95–104, doi: 10.1002/qaj.446
  22. ↑ "Two-thirds of pharmaceutical manufacturing is outsourced; preferred providers pick up largest share". Pharmaceutical Processing. 16 November 2016. Retrieved 16 November 2016.
  23. ↑ Cheng, Y S (2001), "Characterization of Nasal Spray Pumps and Deposition Pattern in a Replica of the Human Nasal Airway", Journal of Aerosol Medicine, 14 (2): 267–280, doi:10.1089/08942680152484199, PMID   11681658

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