Tablets & Capsules

TC1017

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I Tablets & Capsules October 2017 33 product identification The evolution of on-dose product identification Edward S. Novit Freund-Vector On-dose identification enhances patient safety and differentiates your product. This article reviews traditional methods of adding identifiers to tablets and capsules and discusses new technologies that will increase safety, protect the supply chain, and meet manufacturers' business needs. Imagine a world where all tablets and capsules are imprinted, allowing every tablet and capsule in a pre- scription to be digitally verified as they're dispensed to patients. With a smart phone, patients anywhere in the world could instantly and at any time confirm they have the correct medicine and dose. A phone app could also help patients manage their regimen, ensuring each medi- cine is taken at the right time of day and reducing dose duplication. For pharmaceutical manufacturers, digital printing holds the promise of better brand protection and another layer of deterrence against counterfeiting. In fact, this is all happening right now as new thermal inkjet cartridge systems allow on-demand digital printing of codes onto tablets and capsules that can identify the manufacturing lot, expiration date, and country of origin. On-dose markings can show—alone or in combina- tion—trademarks, product names, dose strengths, manu- facturer name, and data matrix codes. This information helps prevent patients from taking the wrong medication. It also helps prevent dispensing errors at the pharmacy or by caregivers and could reveal counterfeit and expired drug products. Background Since the early 20th century, rotary tablet presses have enabled manufacturers to identify their products with debossing. This wasn't possible with hard shell capsules, and the only option for differentiating them was to use different color combinations for the bodies and caps. My research indicates that the first use of imprinting to identify a tablet occurred in the early 1950s, even though the technique of printing with pads and rolls was widely used in other industries. Just after World War II, for instance, Ford Gum began using inked rubber rolls to print its name on candy-coated chewing gum to distin- guish it from inferior products. Soon, many pharmaceutical manufacturers began branding their coated tablets with ink. At the time, tablets were coated in pans like those used for candy. In that process, heavy syrup and powder are layered on the tablets to build up a thick, elegant coating. The coating made any tablet debossing illegible or invisible. Printing on the surface of coated tablets thus became a new means of identifying tablets. Imprinted capsules soon followed. Regulations Today, it's hard to imagine that manufacturers of solid oral dosage forms (SODFs) could operate without identi- fying their products with unique markings. But prior to 1995, there were no regulations. In fact, it was only in 1986 that the FDA began gathering identification data from manufacturers, which they provided voluntarily. FDA's CDER then made the data available to pharma- cists. In that pre-internet age, inquiries were time- consuming, and for some drug products no data could be found. By 2006, more than 30,000 imprints were avail- able online in CDER's searchable database. In 1995, the FDA implemented the regulations in 21 CFR Part 206, "Imprinting of solid oral dosage form drug products for human use." Section 206.10 states, in part, that: [N]o drug product in solid oral dosage form may be introduced or delivered for introduction into interstate commerce unless it is clearly marked or imprinted with a code imprint that, in conjunction with the product's size, shape, and color, permits the unique identification of the drug product and the manufacturer or distributor of the product. Only a few exemptions were allowed, and those are described in Section 206.7. The FDA allows manufactur- ers some latitude in what imprinting technology they use, and defines imprinted as "marked with an identification code by means of embossing, debossing, engraving, or

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