Drug Labeling Solutions

Part of the relevant laws and the characteristics of the drugs themselves make the labeling of pharmaceutical products very challenging, and suppliers have already proposed solutions to this challenge.

Compared with ordinary packaging, pharmaceutical packaging needs to meet some special requirements. Accuracy is the absolute premise of pharmaceutical packaging. The amount of information that comes with pharmaceuticals is much larger than that of other industrial products. Some products have a unique form of packaging and a particularly small size, especially after the implementation of unit dose packaging, it also presents many challenges for pharmaceutical packaging.

Child protection is a permanent topic in the packaging of medicines, and in some countries there are special legislation requiring the use of explanatory labels that describe medical reimbursement schemes.

In addition, the need for a small amount of test drugs in each batch of clinical medical tests also makes the production cost of such packaging high and complex; because drugs generally have a high unit value, resulting in the emergence of many fake and shoddy drugs, etc. Pharmaceutical packaging presents great challenges.

The solution to these problems is the demand for cutting-edge and innovative packaging production processes. Fortunately, experts in the packaging field have responded to these problems, especially in terms of labels, and have solved many similar problems.

Illustrative drug labels first appeared in the early 1970s. All pharmaceutical companies must fulfill the requirement that product information must be added to the packaging. However, due to the peculiarities of the drug, the amount of information that needs to be described is large and is called "information overload." The illustrative drug label became a widely accepted solution at the time.

Recently, Inprint has proposed two new developments in this product area. The first is a blister seal—it can be attached directly to the blister pack, which simplifies the packaging process and enhances protection for children.

The blister inner seal is mainly applied to the flat aluminum foil surface of a blister pack, which is attached to the package by a sticky base. "This creates a more secure barrier that makes the package strong enough that children can't tear it." The substrate has tiny holes or small transverse cuts that can be easily accessed when the user tears open the blister pack label. Extrude the tablets.

An illustrative drug tag with multiple pages can carry a large number of product descriptions expressed in different languages, eliminating the need for additional loose-leaf descriptive tags. Similarly, in some cases, blister packs may not need carton packs, which reduces costs—especially for small batches of clinical trials.

In addition, because of its increased safety, blister closures are considered ideal tools for OTC drugs such as paracetamol that can be sold through vending machines because it is both safe and economical. Inprint Company stated that this way of selling OTC drugs has already existed in the United States, and is also increasingly popular in Europe.

Inprint is currently working on the next phase of development for blister-packed explanatory labels, combining a special label substrate to test new standards for child protection.

The company has also developed a "reverse separation" tag, which was developed based on traditional extended text labels designed to accurately record pharmaceutical information.

The reverse separation tag contains a subtag on the parent tag substrate. Sub-labels can be overprinted with some product details. As the name implies, the child tags of the reverse separation tag can be separated and transferred to a supplemental document to provide a copy of the drug's detailed information.

Specifically, the reverse separation of tags is to meet two key market requirements.

First, in the field of clinical trials, it can allow certain critical drug information to be transferred from the packaging to the case report form without any transcription errors. In addition, it also allows the inclusion of multiple languages, which eliminates the need to label different languages ​​for different countries participating in the same experiment.

Secondly, for the special problems in Europe, that is, the compensation system used for prescription drugs, the reverse separation label also provides a good solution.

This compensation system requires that the label be removed from the package in order to be used as a record for purchasing medicines for compensation purposes. Reversely detach the tag, and the detachable tag can be printed with more information. This eliminates errors and provides a simpler compensation plan.

Large amount of information
As an intensive information specialist with a long history, Denny Bros offers pharmaceutical companies a variety of solutions, including the original Fix-a-Form format and the recently launched PackXtra and Informaxx formats.

A recent application for GR Lane Health Products in Gloucester, United Kingdom, highlighted the issue of how much information can be printed on a leaflet label. GR Lane selected the 10-page Fix-a-Form as the packaging label for the new drug Detoxplan, and packaging purchaser Zo Johnson explained: “When designing the packaging for this nutritional supplement tablet, we want to ensure that the packaging is portable and It's best to fit in a handbag or a make-up box. We also have a lot of text that needs to be printed on the package, which is why we need Fix-a-Form help.

We printed a 10-page Fix-a-Form as a main package in monochrome to illustrate our Detox system. In addition, according to the relevant laws, we must list the complete ingredients and nutritional information related to this pill. It is important to use information that always accompanies the use of the product. Fix-a-Form ensures that it is quickly placed on the packaging. This organ-like page can be neatly folded and repackaged, ideal from a reusable perspective.

This artwork-like description tag was provided by the design company to Denny Bros' prepress production department, so we didn't need to do any extra work. ”

At the same time, Clinical Print Finishers launched a very unique miniature folded Outsert label specifically designed for medical applications.

This multi-folded label has a size of 50 x 30mm and contains 160 pages for a total of 80 sheets. By using a reusable sticking point to glue adjacent pages together, this tag can be prevented from popping.

Management manager Alvin Brown said: “For Tiny Print Finishers, any tiny things are critical. We use the latest H&H machine and then combine two special glue guns, which can produce two Sticky points, this is actually a great improvement."

“In the past 18 months, several of our customers have asked if it is really feasible. We have carefully studied the current market situation in the United States, and we are convinced that we are the first to successfully launch this kind of combination. Folding gluing system."

According to Clinical Print Finishers, the Outsert label folds a large-size label into the smallest label on the market today, and its superiority is very significant. It can complete the packaging of medicines or make-up products faster so that production tasks can be completed before the tight deadline.

With regard to available space, the PrisyMedica labeling software provided by MAP80 Systems complies with the FDA 21 CFR Part 11 standard and now includes symbolic barcodes (RSS barcodes) that can reduce space occupied. The FDA recommended this RSS code, belonging to the UCC/EAN family, in its most recent guidelines, primarily to include key information on the packaging of unit-dose drugs, biopharmaceuticals, and blood products.

The use of RSS barcodes allows drug manufacturers and distributors to attach information such as the unit dose, the validity period, and even the national pharmacopoeial code to any form of packaging, even if the packaging space is limited.

MAP80 stated that because the RSS barcode can be scanned for reading without having to go through the naked eye, the problematic product can be identified more quickly and accurately.

Clinical Print Company Related Products

Security issues
The problem of counterfeit drugs in developing countries is particularly acute. U.S. CCL Label Company and Orbid Company, which is specially developed to identify and protect the product's security tracking system, form a strategic partnership. In this way, Orbid’s patented 2DMI coding system will be embedded in CCL’s newly developed security package. “With this innovative labeling and packaging, it is possible to verify the authenticity of medicines throughout the entire supply chain (from manufacturers, wholesalers, pharmacies, and consumers),” said Kevin T. Simmons, Orbid’s sales manager. Say.

The company said that the label will provide manufacturers and pharmacies with a tool to identify the authenticity and legality of the drug, even if the drug is the smallest transport unit. In the past, when large quantities of medicines were left in warehouses and distributed to pharmacies, there was no way to track and verify whether drugs were forged or stolen. The security tag used by this 2DMI system can be easily embedded in any CCL packaging and label design. Each 2DMI tag is unique and can be printed on virtually any surface in any color, any size, while still ensuring that it is easily read by standard commercial scanning equipment. Pills, labels, individual tablets, or capsules printed with or engraved with 2DMI markers can be cross-checked against a database that is unique to the manufacturer to identify authenticity. 2DMI is a closed system, and its mark itself looks like encrypted data that cannot be read. Only the manufacturer of drugs has the unique algorithm for interpreting the true meaning of these marks, which makes it impossible to falsify such marks on a large scale.