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​Where Tableting Technology Is Heading:

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6 September 2016 No comments

The industry has been undergoing revolution lately with the increase in the number of patents expiring and the growth of generic producers as well as increase in contract manufacturers. Another force is the increase in the competition with developing markets and other companies that are relocating their facilities to take advantage of these.

That said, these factors put pressure to the tableting manufacturers to provide their clients both pharmaceutical companies and those who manufacture generic tablets with equipment that increases production volume and at the same time lowers operation cost.

The industry has being undergoing significant changes in the past few years, most significantly in 1966 when Eng. Swarz (employed by then Smith Kline French or presently known as Glaxo Smith Kline) realized the need for a standard tooling equipment for tablet compression in the pharmaceutical world. He was determined at the time to develop a compression tool that can be sourced from other shops other than the OEM. During that time, the company had problems one of which is longer lead times that exceed half a year. The standardization of the tooling compression allows manufacturers to use the tooling equipment for various tablet presses.

Up until today, the industry, the tablet press manufacturers and tooling vendors continue to experience the benefits of Eng. Swarz tooling standardization. The American Pharmaceutical Association supported this endeavor by publishing the standard guideline manual called as the IPT manual. Known today as Tableting Specification Manual or the TSM American Standard, it is now on its 7th edition. The manual continues to be the guideline for tablet press and tooling manufacturers in determining the specification for the interchangeability of tablet compression tooling equipment.

After the release of the third edition of the TSM, one company – I Holland Ltd. realized the need for a European version of the TSM guideline for the European community --he EU standard so far superseded by the ISO 18084 international tablet-tooling standard.

That said, the manuals failed to address the position of the upper punch key, which is needed for shaped tablets such as ovals and capsules. As there are, no standards for the upper punch key, manufacturers would build presses in different positions. This prevents the possibility of interchanging the tooling for common presses.

One example of this dilemma is when two different manufacturers are manufacturing the same tooling equipment. Although both are following the “B” format standard, the tooling may not be interchangeable. The problem is clearly seen during the ejection cycle of the tablet when it makes contact with the take off and removed from the press. If the tooling is interchangeable, the tablet may not be properly aligned. With improper orientation, the tablet needs to rotate or spin during ejection, which causes tablets to accumulate on the die table. This can result to damaged tablets and affects the output.

The random keyway results to high operation costs as many tablet manufacturers are unaware of this problem. Added cost may be needed to supplement purchasing additional sets of the same tooling equipment.

In order to fix this problem, the industry, including the tooling vendor should support the update to ISO 18084 and help complete the standardization for the key type and location.

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Increasing cost and addressing this problem is one of the driving forces for the constant innovation in the industry not to mention the internal organization of the complete manufacturing process. That said, the capital asset is just a part of the overall operating cost for pharmaceutical companies. Equipment efficiency, waste reduction, time to market and the inventory cost of assets should also be taken into consideration.

An example is for the new Continuous Weight Control System, which allows a tablet to be checked for every turret revolution. As all the stations are checked at the same time, it allows continuous checking of the tablets ensuring a precise collection of data for the said equipment thus ensuring that quality is monitored even with tablets that have different configurations. When discussing efficiency, one cannot help but mention the importance of HMI, Trending and Human RQ, which makes it easy to set up a machine. When one considers profit for the company, ensuring the reduction of waste as well as improving the tablet, quality has a greater impact than the initial capital that one shells out to purchase the equipment.

Another thing to consider is the reduction of downtimes for maintenance and cleaning of the equipment. Many customers consider this and it especially becomes more relevant for customers that need to reduce their inventory or are interested in a just-in time manufacturing process. This is the reason why many customers appreciate the Synthesis series, which is the trademark for equipment that separates the compression area from the lower compartment. With the machine, maintenance is reduced as it minimizes the area to be cleaned and the reduction of powder in the area means longer equipment life and less intervention.

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One of the most powerful assets that one can have is innovation and advancement in technology. In increasing the productivity of the equipment, one would be able to get ahead of their competitors. The company has two Courtoy machines that has shown their capability and allow the company to enhance productivity; one of the machines is the air compensator. The air compensator extends the dwell time thus allowing the presses to run at a higher RPM. The ECM or Exchangeable Compression Module concept increases the overall productivity of the presses and the tableting line. The success of the ECM-based MODULE shows the power of innovation and its effectiveness in navigating the shift in the industry.

Although the rise of contract manufacturers and generic suppliers poses a threat to the industry, one can only see some opportunities opening up in the industry.

the resources and implementation of the design principle allow the companies to build the machine with efficiency and results to short delivery times and reasonable prices.

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In recent years, the multi-layer and core tableting technology has come a long way due to the advancement in the science particularly needed for tablets that have high potencies. The increase in demand for this type of technology is more so for companies in the oral drug manufacturers.

Several factors determine the need for multi-layer instead of conventional single layer tablet, which is most noticeable when it comes to incompatibility of different drug matrices that are contained in the tablet. In multi-layer tablets, a barrier separates the incompatible matrices in order to prevent the drugs from mixing.

There are several advantages of using multi-layer tablets in that a.) It combines different drugs in one form, b.) New image for marketing purposes of new product to different consumers, c.) Advantage over competitors and d.) Ability to extend the patent of the drug.

Accompanying the revolution in the multi-layer tableting, the capabilities of innovative products allow for the inventive solutions in the development of formulation. Tablets that were unnoticed before are now being introduced, enabling modified release tablets, those with active ingredients to be kept separated allowing single dose, or multiple dose to be administered which is ideal for elderly patients.

In addition, the advancements in the core tablet technology and recently the multi-layer core tablet technology are also gaining interest from the public. As there is an increase in the high potency formulation that should be released in the lower stomach area, new technology must be met. With the different new products being introduced in the market today, the flexibility of the solid dosage form is needed to ensure that different drug matrix combinations can be catered.

To accommodate the increase in the demand, recent developments in core tableting allow machines to do precise tablet core placement, which has been a problem in past years. The new development allowed the tablet to be precisely placed and helps tablet designers to determine the dissolution rate before the core is activated. The Elizabeth Companies has designed and patented the Hata Core Tableting Press system, which allows precision core placement and can be used for single, bi-layer, multi-layer and custom core tableting.

This feature allows the tablet designer to expand and discover new ways of product development while ensuring solid dosage improvements.