Pharmaceutical Technology Europe - June 2010 - (Page 10)

Coding technologies: breaking down the barriers Tablet coding or identification is based either on the detection system being overt or covert. The coding of tablets is obvious at an overt level because of size, shape, colour and logo design. These attributes are a function of the manufacturing process, such as the punch and die used to compress the tablet and, where appropriate, the coating material. However, the challenge with any overt technology is that it may be copied by any counterfeiter with access to a tablet press or coater. More recently, covert coding technologies have been introduced in the manufacture of certain tablets. These can be divided into invasive technologies, which include chemical or physical markers that are applied to the tablet or tablet coat, and non-invasive technologies based on lasers, which create codes on each individual tablet without adding to the tablet composition itself. tablet coding. However, our research indicates that commercial applications will be forthcoming as regulatory and technical barriers are overcome. be compromised by the addition of an extra step to incorporate a code. Although big pharma companies are pursuing anti-counterfeiting technologies regardless, it is uncertain whether the same can be said for other manufacturers. This situation is a time bomb that will only be resolved by a major incident unless action is mandated — regulatory authorities should recommend all companies to actively pursue an anti-counterfeit policy and should audit on this point. PTE The barriers to coding Unfortunately, there are barriers hindering the uptake of coding technologies. The production and distribution of tablets is complex, and when an extra material is added to a tablet it creates regulatory uncertainty that necessitates the submission of extra safety data. In this regard, the FDA Guideline to the Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anti counterfeiting has been a major step forward (July 2009) because it will at least encourage pharmaceutical manufacturers to evaluate anti-counterfeiting technologies. Cost is also an issue, especially where production efficiency may Dipankar Dey, OYSTAR Manesty Commercial applications of nanotechnology in coding tablets are coming to the market gradually, but the usefulness of nanotechnology for authentication and track and trace applications started only around 4 years ago. Most applications for nanotechnology in the anti-counterfeiting field are still in the laboratory stage — particularly for Based on a contribution by Dipankar Dey, Head of Process and Validation at OYSTAR Manesty. To read the full version of this article, go to www.pharmtech.com/dey www.oystar.manesty.com 1 CONTENTS 7 CONTINUOUS PROCESSES 3 CHANGING TRENDS 8 COATING CHALLENGES 4 EQUIPMENT PROBLEMS 10 CODING TECHNOLOGIES 5 GRANULATION 12 TOP TECHNOLOGIES http://www.pharmtech.com/dey http://www.oystar.manesty.com

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - June 2010

Pharmaceutical Technology Europe - June 2010
Contents
Find Out What PTE Readers Feel Are the Most Common Problems Encountered with Their Tabletting Equipment.
Tablet Compression: Changing Trends, More Demands
Tabletting Equipment: Common Problems and How to Avoid Them
Granulation: Evolving Slowly But Surely
Drying: Moving from Batch to Continuous Processes
Challenges in Coating
Flexible Blending
Coding Technologies: Breaking Down the Barriers
Inspection Technologies Update
Twelve Latest Technologies Showcased

Pharmaceutical Technology Europe - June 2010