Thinking ahead

‘Innovation is essential. . .’

According to Patheon’s Mike Mencer, innovation is essential to the pharmaceutical industry. “Advancements are made every day to ensure the products being delivered to patients are of the best quality and best suited to meet their medical needs. From softgel technologies to solubility enhancers to integrated supply chains, many innovations have evolved in recent years yet the pace of innovation is likely to only increase. The need for customised medications and greater speed to market is a principal component currently driving innovation in the industry. The recent global Ebola crisis speaks to the demand for making needed medications available quickly and how fast the pharmaceutical industry can respond to such outbreaks. Potential Ebola vaccines are currently undergoing clinical trials led by a joint Liberian-US clinical research partnership and sponsored by the National Institute of Allergy and Infectious Diseases (NIAID),” he says.  

Mencer adds that according to the National Institutes of Health (NIH), the average time to market for a new drug is 14 years, with six of those years dedicated to ensuring drug safety during clinical trials. However, research surrounding treatments and vaccines for the Ebola virus seem to be moving at a much faster pace in the last six to nine months.

“In order to continue this trend of reacting to crises in real time, there needs to be consistent focus on innovative solutions that improve speed to market, not only for vaccines, but also for new drugs and drug-device combinations.

“Patheon meets this need for maximised speed and innovation through the Patheon OneSource service solution. This offering links both drug substance (small and large molecules) supply with drug product manufacturing spanning a range of oral and injectable dosage forms for products in both development and commercial stages. With an integrated service, customers gain value in four areas – speed, simplification, harnessing global expertise and choice. This service gets product to clinic more quickly, so can lead to faster product to market,” he says. 

‘Driven by the need to improve efficiency. . .’

Natoli’s Dale Natoli believes that innovation in the pharmaceutical industry, where manufacturing is concerned, is almost always driven by the need to improve efficiency – to produce more, faster.

“We’ve seen it with inquiries about continuous manufacturing in facilities, and with the advent of functionality being added to the electronic components on tablet presses. However, a very simple way to improve efficiency during tablet manufacturing is to consider multiple tip punches and dies.

“Although multi-tip tooling has been available for years, this configuration has had a quiet adoption by the pharmaceutical industry. Multi-tip has become a popular option for manufacturers in the United States, and we have begun to see an uptick in interest from customers in other parts of the world.

“Multi-tip tools can provide a drastic increase in output and reduction in operating costs. Running a tablet press with multi-tip tooling produces more tablets per compression cycle, while reducing run time for the machine. There are clear advantages to receiving more tablets in less time, but multi-tip also provides the same production capacity using fewer presses – which increases usable space in the compression room, reduces set up and cleaning time and the amount of operators needed to run the equipment. Multi-tip punches and dies can be produced in the same shapes, with embossing, etc. as standard, single tip tooling.

“We believe the tabletting industry will increasingly adopt these simple tooling configuration enhancements, in addition to the technological enhancements that are becoming available.

“Improvements to efficiency will always be a goal for pharmaceutical manufacturers. Increased production can help consumers by getting the drug to market sooner, and manufacturers benefit by cutting costs and overhead. Multi-tip tooling can be one solution among a host of options to help the pharmaceutical industry innovate.”

‘Implications driven by regulations. . .”

Richard Nemesi, Videojet Technologies says that for suppliers of serialization equipment to the pharmaceutical industry, there are several trends driving innovation in technology.

He says: “Demand is increasing for coding technologies that can mark a wider range of substrates and handle more complex data management responsibilities, without compromising product safety or legislative compliance. Optimal coding solutions are part of a holistic approach to pharmaceutical manufacturing, with the printer playing a small but integral role in addressing industry regulations.

“One key trend is the heightened need for intelligent data management. One example of this is asynchronous communication, where the printer can decouple its print function from the data management activities going on simultaneously. This enables higher throughput which is required on some production lines. Another example is effective buffer management. Some track and trace solutions send many serialization codes to the printer at once, where they reside in a buffer until placed on the package. In the event of an unexpected line stoppage, codes can be left unused unless an intelligent coding device can communicate which numbers are still available for use. This is especially relevant in countries where manufacturers may have to purchase serial numbers, enabling manufacturers to reclaim unused codes and protect their investment.  

“New regulation also demands more information to be printed on a wider variety of substrates, including traditionally challenging materials. One example of a difficult substrate to code is high-density polyethylene (HDPE). Recent innovations in laser printing technologies leverage UV wavelengths to create crisp, indelible black marks on HDPE, including serial number and bar codes.

“Effectively addressing regulations is a collective effort for all production line technologies, with coding playing a central role. Innovative coding solutions will integrate with other technologies upstream on the production line and also convey information effectively throughout the supply chain ultimately protecting brand reputation, and the consumer from substandard products.”

‘Breakthrough technology for drug delivery needs. . . ‘

According to Jim Coward, Capsugel dosage form solutions, the functionality and flexibility of lipid multiparticulate (LMP) technology offers an attractive formulation option for pharmaceutical and nutraceutical products, including pediatric and geriatric treatments.

“The innovative, lipid-based drug delivery platform has multiple applications, including taste-masking, extended release, immediate release and improved bioavailability. Because LMPs are truly spherical, matrix multiparticulates, they bring the benefits of multiparticulate delivery, which include gut distribution, less intra- and inter-patient GI transit time variability and potential improvement in ease of swallowing with the functionality of lipid-based formulations. But unlike other multiparticulate formulation options, LMPs offer intrinsic taste-masking properties and have a smooth texture when taken, simple processing with no solvents and high drug loading capacity (up to 50-60%). LMP technology is also very flexible in terms of multiparticulate size (50-1000 microns) and finished dose representation (capsule, sachets or orally dissolving tablets).

“Recently, Capsugel Dosage Form Solutions announced the broad commercial availability of its proprietary LMP technology, adding to its bioavailability enhancement technologies, including LBF options in liquid-filled hard capsules (LFHC) and softgels (SGC) for oral delivery. The LMP technology brings additional flexibility vs. LFHC or SGC lipid options in terms of release profile, drug combination delivery and ability to coat for additional functionality, such as targeted release.”