Tablet Press Meeting the Standards of Tomorrow's Pharmaceutical Production

Author / Editor: Stefania Barzanti / Dominik Stephan

In the pharmaceutical sector, there is a constant need for innovation through R&D. New medicines are being developed that require absolute isolation to ensure its purity. IMA Active has brought out the Prexima series for tablet manufactures.

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Prexima, IMA Active’s new series of tablet press machines.
Prexima, IMA Active’s new series of tablet press machines.
(Picture: IMA Active)

IMA Active’s experience and expertise in the pharmaceutical industry have been carefully channeled into Prexima, the new series of tablet press machines brought out by the company. Powered by IMA’s knowledge of the sector, designed with unique Italian style, built to deliver toplevel performance, the Prexima series is the best solution to handle all production volumes.

A key feature of Prexima is the complete isolation of the processing area. The machine ensures complete separation between processing and mechanical areas thanks to the use of seals and protections designed on purpose. Limited surfaces in contact with the product reduce cleaning times as well as avoid cross contamination. In addition to extending the duration of cams, tooling and compression rollers, the machine lifecycle is longer.

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Benefits Galore

Prexima has also been designed for accessibility to enable straightforward operations, easy inspection and cleaning. The processing area is fully accessible once the external doors are opened. Cam, rollers, and other components in the mechanical area are immediately visible when the side protections in the processing area are removed. Except for maintenance purposes, access to the machine basement is not required for machine set up, changeover, or cleaning operations.

Additional Information
Tablet Press
A Task Force for Tablets – The Developer's Statement

IMA Active Vice-President, Andrea Semprini Cesari states, “We have invested a lot in this new range of tablet press machines, by creating a department inside the IMA Active division specifically dedicated to this sector of solid dose processing. The so-called ‘Tablet Academy’ has been created to consolidate the important investments made in the tableting sector and to better serve the needs of our customers all over the world. We are happy to announce that 10 Prexima have already been sold in different countries.

IMA Active Vice-President, Andrea Semprini Cesari: “Our aim for the next three years is to increase our market share in tablet press machines, while consolidating our wide range of products aimed at driving our customers’ productivity to a higher level of efficiency.”
IMA Active Vice-President, Andrea Semprini Cesari: “Our aim for the next three years is to increase our market share in tablet press machines, while consolidating our wide range of products aimed at driving our customers’ productivity to a higher level of efficiency.”
( Picture: IMA Active )

Everything that we have gained over years of experience and expertise in this field has been carefully channeled into this new range of tablet presses, confirming our ability to anticipate all future challenges and our firm commitment to developing new solutions that incorporate the most advanced technology. Our aim for the next three years is to increase our market share in tablet press machines, while consolidating our wide range of products aimed at driving our customers’ productivity to a higher level of efficiency.”

The extraction of the turret is quick and easy thanks to a rotating arm completely housed in the mechanical compartment. The turret can be removed completely with dies and lower punches, thus preventing the powder from falling into the mechanical area through lower punch bores. The Human Machine Interface (HMI) guides the operator step by step during each phase of turret dismounting.

Positioned in the machine basement, the lubrication system is automated and works with only one type of oil. The lubricant oil does not go into the processing area, hence can be recovered into an apposite container and recirculated. As a result, the machine is clean and requires less maintenance, with no oil dripping from punches and no black spots on the tablets.

The machine’s compression support is based on robust columns linked together by strong cast iron structures. Upper and lower precompression and main compression rollers are housed within this robust frame and fixed on both sides. Both rollers have the same diameter, thus allowing flexible adjustment and optimal performance with a wide range of products. This exceptionally sturdy structure—an essential requisite for the production of quality tablets— guarantees compression forces up to 100 kN with maximum reliability.

To keep noise level at a minimum, Prexima has been fitted with sealing on its machine doors, sound-proof panels in the basement and anti-vibration feet. Prexima has been tested at the anechoic chamber at the University of Ferrara (Italy), which has offered IMA recommendations for the choice of the best technical solutions and sound-proof materials. The result is a very quiet machine with minimum vibrations.

Quality Software

Prexima is fitted with the new XIMA HMI, which was awarded the 2015 A’ Design Award for its strategic role in improving the operators’ efficiency. The control system is features linearity, intuitiveness, iconicity and scalability. XIMA follows the principle of linear navigation, in that each action of the user on the HMI corresponds to only one control signal. In addition XIMA is based on the principle of natural mapping: the synoptic uses spatial correspondence between the layout of the controls and the devices being controlled, thus reproducing the main machine workflow.

The icons of XIMA serve as perceivable indicators that suggest appropriate functions to the user. The principle of scalability, in the end, enables XIMA to be scaled to multiple devices and multiple machines.

Studies & Tests

Tests have been a key role in the development of Prexima right from the start. The most difficult-tomanage products have been tested, allowing a timely feedback on the machine design. IMA Active is still performing trials with several formulations: here are two of the most meaningful.

Additional Information
Tablet Press
From Food to Antbiotic: case Studies for tablet Presses

1. Poorly Flowing Nutraceutical roduct Requiring High Compression Forces

The study was carried out on a customer formulation based on Berberisaristata extract and vitamin B1 and B6. The mean particle size distribution of the blend is around 41.37 micron, with bulk and tapped density of respectively 0.39 and 0.56 g/cm3. The powder, as results from the Carr Index value of 30, has a poor flowability.

Target of the study:

Obtain oblong shape tablets of 20.5 mm x 9.5 mm with an average weight of 1,100 mg with percent deviation related to the average less than 10 per cent and hardness within 140–160 N range (customer requirements).

Process parameters:

Process description:

The product has an extremely low mean particle size and low bulk density. Already at low speeds, the requested main compression force approaches 85–90 kN, and also in pre compression it is necessary to apply almost 60 kN. This is an example of a poorly compactable product that requires very high force to be applied in both the main compression and in pre-compression in order to form solid bridges between the particles. The production speed of 61,560 tablets/hour on Prexima 300 tablet press is equal to 22 ms of dwell time, with Euro D punches. Owing to the product’s intrinsic characteristics, lower dwell time is deleterious from the point of view of product hardness: the force has to be applied for a determined extent of time, in this case not less than 22–25 ms.

The higher mass uniformity was achieved by using the round profile paddles with reversed rotation (outward counter-rotating): the round profile is useful when it is necessary to avoid powder compaction (in this case the powder is cohesive and tends to compact), whereas the reversed sense of paddle rotation helps to fill the dies better. In fact the left paddle moves in the opposite direction with respect to the turret and this may be helpful in some cases. Despite the product’s level of difficulty, the tablets obtained were compliant with the customer requirements.

2. Antibiotic Based Formulation With Highly Elastic Properties Under Compression

The study was carried out on a formulation based on amoxicillin trihydrate. The composition is shown in the table below.

The mean particle size distribution of the blend is around 650 micron, with bulk and tapped density of respectively 0.63 and 0.75 g/cm3.The powder, as results from the Carr Index value of 23, has a good flowability.

Target of the study:

Obtain oblong shape tablets of 17 mm x 7 mm with average weight of 600 mg (API content circa 525 mg) with percent deviation related to the average less than 5 per cent. Parameters such as hardness uniformity, friability and disaggregation time were evaluated as well.

Process parameters:

Process description:

The amoxicillin exhibits highly elastic properties that cause variations in the hardness value of single tablets. The same diameter of the pre-compression and of the main compression roller enables to transform the tableting process in two identical compression steps, rather than discriminating between the pre-compression and main compression steps.

In this case, the pre-compression force was kept at 15 kN, whereas the main compression was slightly higher, between 18 and 20 kN. This seems to improve the hardness uniformity, as can be seen from the table below. All the other parameters comply with the requirements of the European Pharmacopoeia:

* The author is Marketing manager at IMA Active

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