Roundtable: The Future of Tabletting

Transcription

1 The tabletting industry is currently undergoing a seismic shift. The main contributing factors are the number of expiring blockbuster patents and subsequent growth of generic drug producers and contract manufacturers. Another key driver is of course the emergence of and competition from developing markets, with the majority of pharmaceutical companies also relocating their facilities in order to capitalise on these. So the pressure is on, now more than ever, for tabletting equipment manufacturers to supply their customers both pharmaceutical companies and their generic competitors with minimal investment equipment that increases productivity and reduces costs. EPM has consulted a number of tabletting equipment manufacturers on how the aforementioned issues and demands can be best addressed both now and in the future. Dale Natoli, President, Natoli Engineering Company The tabletting industry is currently undergoing a seismic shift. The main contributing factors are In 1966, Eng. Charles Swartz employed by Smith Kline French (SKF) in Philadelphia Pennsylvania, today known as Glaxo Smith Kline (GSK) realised the need to establish standards for tablet compression tooling used in the pharmaceutical industry. His main focus at that time was to engineer and make available tablet compression tool drawings, which could be used to source tooling from competent machine shops other than the OEM. At the time, they had unacceptable manufacturing lead times commonly exceeding six months. The other advantage of standardisation was to allow tooling to be interchanged between the most common tablet presses. There is no question that the pharmaceutical industry, tablet press manufacturers and tooling manufacturers continue to enjoy the benefits from the hard work and initial framework of Eng. Swartz s tablet tooling standardisation. With the support of the American Pharmaceutical Association, which acted as the organiser, publisher and distributor of the tooling standard known as the IPT manual, an industry guideline was established. It is known today as the Tableting Specification Manual, or TSM American standard, currently in its 7th edition. The TSM continues to be instrumental for tablet press and tooling manufacturers by providing a guideline for interchangeability of tablet compression tooling. Shortly after releasing the 3rd edition of the TSM, an English tooling manufacturer, I Holland Ltd, realised the importance of the American standard and established a guideline for the

2 European community known as the EU standard, which has recently been superseded by the published ISO international tablet tooling standard. Unfortunately, the TSM, EU and ISO tooling standards did not address the type or position of the upper punch key, which is required for pressing shaped tablets such as capsules and ovals. As there is not a standard for the upper punch key position, it allows tablet press manufactures to engineer and build presses, placing the key position in various radial locations. This eliminates the possibility of interchanging tooling between the most common tablet presses. As an example, tablet presses made by different manufacturers, while both adhering to the standard B tool format, may not be interchangeable. The problem arises at the ejection cycle of the tablet where it makes contact with the tablet take-off and is removed from the press. When tooling is interchanged between these presses, the tablet may not be properly orientated. With improper orientation, the tablet must rotate or spin at ejection, causing tablets to accumulate on the die table at the takeoff, resulting in damaged tablets and adversely affecting press output. This situation with random keyway locations results in extra expenses, as many companies are not aware that their tooling is not interchangeable between presses. Additional operating costs are incurred due to multiple sets of the same required tooling. In order to help rectify this problem and, in doing so, better serve the pharmaceutical industry, I believe that tabletting equipment manufacturers and also drug manufacturers themselves should be supporting the need to update ISO and make it complete with standardisation for key type and location. I would therefore like to invite readers to register their interest in supporting the cause by contacting either myself (dale@natoli.com) or ISO Secretariat Mme Elisabeth Guérin (e.guerin@unm.fr). Jens Torkel, Managing Director, IMA Kilian GmbH & Co. KG Of course maximum attention to costs containment is now also a priority for equipment manufacturers and one of the key drivers for innovation as well as the internal organisation of

3 the manufacturing process. However, capital assets expenditure is only a portion, and certainly not the largest portion, of overall production costs for pharmaceutical companies; equipment productivity and effectiveness and reductions in waste, time-to-market and cost of inventory assets must also be considered. As a global partner and not merely a supplier, IMA has a wider approach to the problem, considering the overall profitability of the process that the tabletting equipment is serving. Take, for example, our new CWC (Continuous Weight Control) system, which allows one tablet to be checked each turret revolution, with all stations being checked in sequence; the more frequent weight checking guarantees extremely precise feedback on machine working parameters, ensuring high quality production with the most difficult products. The HMI is also a crucial factor when talking of machine efficiency and the new Trending and Human RQ options enable easy and quick machine set-up. When considering the profitability of the whole pharmaceutical manufacturing process, the reduction in waste and the improvement of product quality achievable with these features have a far greater impact than the initial capital investment for purchasing the equipment. Or consider, for instance, minimisation of downtimes for machine cleaning and maintenance, which our customers have always considered to be key factors when deciding on a new machine, although they become even more crucial when looking to achieve inventory reduction and just-in-time manufacturing. This is why our customers appreciate the wellknown separation of the compression area from the lower machine compartment, which is the hallmark of the Synthesis series; besides minimising the area to clean (and thus cleaning times), the absence of powder in the mechanical area means less maintenance interventions and longer machine life. IMA s long-standing partnerships with the most diverse pharmaceutical companies (from small and medium sized to big multinationals, producing branded or generic drugs) has generated an exclusive expertise based on a deep knowledge of pharmaceutical production. This is why we believe that concepts like cost containment and minimal investment equipment should be integrated in a more holistic approach that considers the overall profitability of the drug manufacturing process. Jan Vogeleer, Managing Director, GEA Pharma Systems - Courtoy Our most powerful asset in successfully dealing with today s challenges is our advanced technology. We strongly focus on increasing the productivity of our tablet presses, which gives us on edge over our competitors. Two exclusive Courtoy machine features have enabled

4 us to greatly enhance productivity. The first is the air compensator, extending the dwell time and, thereby, allowing our tablet presses to run at higher RPM than other machines. A second major development, which has helped us to maximise machine productivity, is the patented ECM (Exchangeable Compression Module) concept. With the ECM, extremely fast product changeover can be achieved, contributing in turn to the overall productivity of the tablet press and tabletting line. The increasing success of our ECM-based MODUL range illustrates that a strategy of innovation is one way of effectively navigating the current shifts in the industry. While it is certainly true that the rise of contract-manufacturers and generic producers poses a major challenge, we also see a number of interesting opportunities in today s pharma landscape. We have followed the rapid growth of a number of speciality applications with great interest. These have proved to be both technically demanding and particularly suited to GEA Pharma Systems - Courtoy s advanced technology. One example is the high-containment processing of highly potent drugs, where GEA Pharma Systems - Courtoy has become market-leader in recent years thanks to its unique and patented WOL (Wash-Off-Line) concept. This demonstrates once again that innovation is key; by responding very quickly to budding trends in pharmaceutical manufacturing, we have managed to secure the lead position in several increasingly important markets. We are, of course, continually striving to cut the cost of manufacturing, so we can supply our technology at the best possible price. Being part of the GEA Group is of invaluable importance in this respect; a network of over 20,000 employees spanning more than 50 countries worldwide opens up many opportunities for low-cost sourcing around the globe. Access to such a wealth of resources, as well as the implementation of the design for assembly principle, allows us to manufacture and build our machines with maximum efficiency, resulting in short delivery times and competitive prices. Ryan D. Keefer, General Manager, The Elizabeth Companies Both multi-layer and core tabletting technologies have become hot topics in the recent decade due to the advancement of many high potency formulations; there is an ever-increasing demand for these types of innovative oral drug delivery systems by the pharmaceutical and nutraceutical industries. There are various factors that determine the need for the multi-layer tablet over the conventional single-layer tablet, perhaps the most prominent of which is the incompatibility of multiple

5 drug matrixes to be contained in the tablet in a multi-layer tablet, incompatible matrixes are separated by an inert barrier layer to prevent interaction. Then, of course, there are the distinct commercial and financial advantages of utilising the multilayer tablet such as: combining two or more different drugs in one solid dosage form; a unique tablet appearance for the marketing of new products to consumers; a marketing advantage over competitors by putting a new spin on an ordinary product; and ability to extend product patents by introducing established products in new forms. Accompanying the recent innovations in multi-layer tabletting, the manufacturing capabilities of new product concepts allow for creative solutions in formulation development. Tablets unheard of a few years ago, such as the Poly Pill, are being introduced. These enable modified-release formulations and multiple active ingredients to be kept separate from the ordinary single-layer tablet, allowing a single dose or pill as oppose to multiple doses to be administered ideal where there are concerns over elderly patients remembering to take prescribed amounts of tablets throughout the day. In addition, advancements in core tabletting technology and the more recent multi-layer core tablet technology are receiving increasing levels of interest. As many new high potency formulations that must be released in the lower stomach are being developed, a dependable, accurate delayed release delivery mechanism is being sought. New product possibilities with time-release, time-delayed and extended time-release drug delivery systems are being added to the physician s arsenal of weapons to fight various diseases and ailments. This type of flexible solid dosage form allows for a multitude of drug matrix combinations, creating a broader range of product possibilities. To accommodate the aforementioned increasing demand for high potency drug products, advanced core tabletting methods have achieved exact core placement versus the antiquated coreplacement methods of the past. The new developments in core placement enable the core to be positioned precisely in the tablet top, bottom, side-to-side or exact centre. This allows the tablet designer to anticipate the rate of dissolution of the core coating before activation of the active core. We, at The Elizabeth Companies, have patented a mechanical method to achieve precision core placement with the Hata Core-Tableting Press System. The Hata Core-Press is capable of singlelayer, bi-layer, multi-layer and custom core tabletting with a unique multi-layer core capability. This recent ability to provide precise core placement and flexibility of multi-layers has allowed tablet designers to expand their product development into exciting new areas with new solid dosage innovations.