Tip top: C-up of tips from I Holland
Know-how: Expertise from I Holland includes drip cups and bellows
I Holland explains why innovation is key to ensuring tablet production is fast, precise and accurate
The manufacture of oral solid dosage forms has come a long way since the procedure of hand rolling pills used in previous centuries. Innovations introduced by leading tablet tooling and pharmaceutical manufacturers have advanced in order to keep pace with the ever growing demand driven by developing markets in order to produce tablets for the masses.
Originally a pill would be rolled into a ball, then into a long pipe shape which was divided into lengths to roughly calculate dosage. This later progressed into using tiles with graduations so that the pipe could be rolled to a specific length equal to a more accurate dose.
One of the first innovations the industry could truly call a ‘machine’ was the pill machine. This allowed for the pipe to be measured and cut into accurate pieces. With careful manipulation it could produce quite rounded portions which were then put under a pill rounder to make the cut portions spherical. [1]
From these early days, tablet production has advanced thanks to the research and development undertaken by companies like I Holland, one of the world’s foremost tablet tooling manufacturers.
The vision of I Holland has always been, "to be the customer's preferred choice as the market leading provider of innovative tablet tooling and complimentary equipment, underpinned by our understanding of tabletting science.”
Pharmaceutical manufacturing is an ever-changing environment and to produce tablets cost-effectively, investment in new technologies and processes must be developed,
I Holland has introduced a number of innovative product developments and studies that continue to transform the way pharmaceutical manufacture is undertaken, making it a process that is fast, precise, reliable and a far cry from the days of the hand-rolled tablet.
Early innovations
One of the first notable punch and die innovations to have had an impact on tablet manufacture in the last 70 years, was the introduction of ‘hobbed tips’ which I Holland pioneered in 1964. This process uses an extremely high precision metal master of the desired tablet design to cold form the punch tip detail. I Holland led the way in the precision cold forming of tablet punch heads, resulting in the company patenting the process for tablet tooling manufacture. This method has now become the standard for quality punch manufacture and is used by leading tablet tooling producers across the world[AB1] . This unique technique ensures the production process is accurate, quicker, cheaper, and most importantly repeatable.
It was also during this period, and into the 70s, that I Holland began using Computer Numerical Controlled machines, again increasing precision and repeatability, all of which have helped to establish the company as one of the leading authorities in tablet compression tooling as it is today.
Changing manufacturing performance
With the increase in strict regulations and standards during the manufacture of tablets, the adoption of tried and tested protocols are important. It was the introduction of these exacting procedures that bought in the next step in I Holland’s history.
The I Holland Eurostandard technical document (in existence since 1992) advises tablet manufacturers on tablet tooling terminology, configuration and procurement and includes the latest technical specification compatible with ISO 18084:2005(E) – ‘Press Tools for Tablets’. There are also a number of guides including tablet design, troubleshooting and treatments and coatings. Used world-wide for many different type of tablet press, it has helped customers to accurately specify tablet punches and dies, answering commonly occurring questions found during tablet production. All the information included is a result of research and findings that have been documented over the years.
Another technological advancement in tooling which must be observed are multi-tipped punches. Although it is not a new technology (I Holland has been producing multi tip tooling for over 30 years) it has only been adopted fully in the pharmaceutical industry during more recent years. Multi tip tooling has transformed the quantity of tablets produced and it is now considered the most productive form of tablet manufacture where it can be applied.
Successful implementation of multi tipped tooling can reduce the need to invest in expensive tablet presses, therefore reducing the overall capital spend. The number of tool set-ups required per production batch can also be reduced and product batches are completed quickly decreasing the overall production time. It also benefits tablets which need to be compressed within a very short time of the formulation being prepared.
The modern tabletting process is an exacting one, and wherever possible tooling materials need to be optimised for the task. To this end, I Holland first developed Rotahead punches which allow the head to rotate independently to the punch body, providing a 'bearing' between the punch head and cams. This enables the head and body to be manufactured from different optimised materials, resulting in an extended tool life
Another notable process and innovative addition to the company’s portfolio is the PharmaCare 7-Step Process, a program of professionally planned maintenance which has been adopted as a SOP by companies world-wide.
The key factors required in tablet manufacturing include the need to increase production and accuracy, with the requirement to do it cost-effectively and quickly. This has always been a challenge since mass tablet production was introduced, but processes have been developed to help, including the PharmaCare 7-Step Process.
Tablet manufacturing problems and tablet tooling failures are generally the result of one, or a combination things including;
- Difficult product/granule
- Inappropriate tablet design
- Incorrect tablet press set up and operation
- Inadequate tablet press maintenance
- Poor condition of tablet tooling
The ’7 step’ process helps to reduce these problems through seven simple procedures.
Step 1 – Clean –Ensure tooling is free from contamination.
Step 2 – Assess – Following cleaning, punches and dies must be inspected for general condition.
Step 3 – Repair – Rectify any damage to the tooling i.e. light corrosion.
Step 4 – Measure –Essential after polishing and repair to ensure critical tooling dimension have stayed within tolerance.
Step 5 – Polish – Automated polishing is recommended for an even polish and consistent finish.
Step 6 – Lubricate –It is important to protect, preserve and aid the smooth operation of tooling.
Step 7 – Store – The final step is important to protect and minimise damage of tooling.
Application of the 7 Step Process will usually have a direct impact on the reduction of many common tablet and tooling problems, resulting in a better quality end product, and provide direct cost saving for the tablet manufacturer.
The latest innovation from I Holland, is TSAR-Predict, which has helped in reducing time consuming and expensive field trials by offering a solution to stop tablet tooling sticking problems.
An important advancement in tabletting history is the implementation of continuous tablet production. This form of manufacture made an impact on the way tablets were produced, with significant benefits from increased productivity to quality. Large pharma companies have seen the benefit in this method compared to the batch process technique, and innovation in continuous tablet production is still ongoing today. Even with this innovation the problem of ‘sticking’ still remained, and it was because of this that I Holland focused on finding an answer. After eight years of tablet tooling coating development I Holland has built up a range of anti-stick coatings. It’s due to the depth of this range and its many different anti-stick properties that the company embarked on the project that was later to become known as TSAR (Tabletting Science Anti-Stick Research).
Investigation into the cause of formulation sticking to punch tip faces was undertaken with a predictive tool developed to recognise the correct punch or die coating solution for sticky formulations without carrying out the long and expensive process of in-the-field testing.
It is not just research and standards that really make a difference in tablet production, it is also the tooling and technology behind it that makes a huge impact.
For any tablet tooling manufacturer it is important to always move forward in the design of tooling that leads to a better end product. There have been developments from a number of manufacturers over the years, which has seen tablet tooling progress to meet the demands of modern medicine. Most recently the implementation of metallised bellows and drip cups to help prevent tablet and punch guide contamination during the tablet compression process have been introduced. This pioneering advancement ensures that tiny fragments of material will not reach the end user, another insurance of a quality end product.
This innovative thought-process continues in 2015 with major product developments to be announced by I Holland at ACHEMA in Germany later this year.
The company will showcase its latest innovative products using the show as a platform to introduce new and ground-breaking developments to help customers run the best possible tablet manufacturing processes.
Capturing new technologies and adding to them through pioneering and novel introductions, I Holland sees itself as an innovator in its field, and with the continuation of constantly developing, improving and collaborating with its customers, this innovation will continue.
Reference
- Royal Pharmaceutical Society
- http://knowledge.insead.edu/innovation/the-dna-of-the-worlds-most-innovative-companies-1020#oTf0zripyvsoRPgS.99
the word!) Manufacturers of lesser ‘quality’ do NOT use this process but not sure how to word that.