Case Study - GEA Courtoy’s PERFORMA™ P tablet press at Sanico, Belgium
GEA Courtoy and Sanico have developed a close collaboration to evaluate and fine-tune GEA Courtoy’s latest compression technology, which is available on the PERFORMA P and the MODUL P tablet presses, in real-life daily tablet production. To this end, a PERFORMA™ P was installed in Sanico’s tablet production department, which produces ca. 5 billion tablets per year.
Sanico is a privately owned pharmaceutical third-party manufacturing company, employing approximately 250 people, situated in Turnhout, Belgium. Sanico offers the full range of non-sterile galenic forms for (non-) pharmaceutical products and clinical trials, taking care of all aspects of the production process: analysis, development, validation, stability testing etc. To read more about the company and the services it offers, we invite you to visit their website at www.sanico.eu.
For tablet compression, Sanico uses a large number of rotary tablet presses, supplied by a well-known European manufacturer other than GEA Courtoy. These machines are conventional tablet presses in the sense that tablet weight control is based on compression force measurement and the machines do not have extended dwell time capability. The MODUL™ P and the PERFORMA™ P, on the other hand, allow for both equal thickness (ETC) and equal force compression (EFC), and consequently offer the feature of extended and freely adjustable dwell time at pre-compression and main compression. We refer to GEA Courtoy’s publication “Ultimate Process Flexibility and Robustness” for a detailed technical description of these ground-breaking compression methods. The only way to extend the dwell time on a conventional machine is reducing the rotation speed of the turret, which will inevitably lead to a lower machine output.
The purpose of the collaboration between Sanico and GEA Courtoy was mainly to investigate and qualify (and, whenever possible, to quantify) the advantages of Courtoy’s innovative compression modes, in comparison with conventional tablet presses. The conventional type of tablet press described above is referred to as “Press Q” in the remainder of this article. The presses of this type used by Sanico are medium scale machines with 24 to 47 punch stations, depending on the exact configuration.
During a six-month period, over 20 different formulations were tested on the PERFORMA™ P and its performance in terms of machine speed and tablet quality was compared to that of the conventional presses. The results were quite sensational, as can be seen in the following overview.
Survey of production runs on the GEA Courtoy PERFORMA™ P
Difficult formulations on conventional presses
| Ibuprofen - 400 mg |
| Formulation: |
ibuprofen 80%; starch 10% |
| Process: |
wet granulation with starch in fluid bed (top spray) |
| Press Q: |
dry granulation step required prior to compression;
maximum speed 50.000 tab/h |
| PERFORMA™ P: |
compression mode 3 – equal porosity tableting |
|
Compression possible without dry granulation;
maximum speed 90.000 tab/h – nearly 2 x faster. |
| Paracetamol - 500 mg |
| Formulation: |
paracetamol 77%; starch |
| Process: |
wet granulation with starch in high shear mixer –
drying in fluid bed |
| Press Q: |
dry granulation step and addition of purified water
in external phase required prior to compression;
maximum speed 25.000 tab/h. |
| PERFORMA™ P: |
compression mode 3 – equal porosity tableting |
|
Blend compressible without dry granulation or
external water addition; maximum
speed 110.000 tab/h – more than 4 x faster. |
| Formulation A - 5 mg and 10 mg |
| Formulation: |
API 3%; lactose 80 75%; avicel 18% |
| Process: |
dry blend |
| Press Q: |
not faster than 100.000 tab/h due to risk of
capping and sticking.
Problems occur during packing.
Maximum hardness 70 N, decreases significantly
during stability testing. |
| PERFORMA™ P: |
compression mode 3 – equal porosity tableting |
|
Problem free compression at 200.000 tab/h – 2 x faster.
Hardness 100 N. No capping or sticking detected.
Hardness does not decrease during stability testing. |
| Formulation B - 40 mg and 80 mg |
| Formulation: |
API 20%; tablettose 80 40%; avicel 35%; starch |
| Process: |
dry blend |
| Press Q: |
problems (capping) occur during coating, due to
inconsistent tablet compression quality. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Problem free compression at 150.000 tab/h.
No problems detected at coating stage. |
| Formulation C |
| Formulation: |
API 55%; lactose 200; starch |
| Process: |
wet granulation with povidone in conical screw mixer |
| Press Q: |
hardness too low; maximum speed
achieved 45.000 tab/h. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Harder tablets produced at 175.000 tab/h –
nearly 4 x faster. |
| Formulation D |
| Formulation: |
disulfiram 71%; lactose 200; starch |
| Process: |
wet granulation with starch in
high shear mixer / drying in fluid bed |
| Press Q: |
maximum speed limited to
50.000 tab/h to prevent capping. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Problem free compression at 150.000 tab/h –
3 x faster. Higher speed may be possible,
but was not tested due to batch size. |
| Formulation E |
| Formulation: |
API 70%; lactose 200; starch |
| Process: |
wet granulation with starch in
high shear mixer / drying in fluid bed |
| Press Q: |
dry granulation step and addition of purified water in
external phase required prior to compression;
maximum speed 50.000 tab/h. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Blend can be compressed without dry granulation
or external water addition; speed 120.000 tab/h –
more than 2 x faster. |
| Formulation F - 1 mg and 2 mg |
| Formulation: |
API 1%; lactose 200 81%; starch 13% |
| Process: |
lactose is moistened with solution of
active ingredient in chloroform |
| Press Q: |
tablets are too soft; friability is too high.
Dry granulation step required prior to compression. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Compression possible without dry granulation step. |
Formulations not presenting compression problems on conventional presses
| Formulation G - 2,5 mg |
| Formulation: |
API 1%; lactose 200 88%; starch 1500 10% |
| Process: |
lactose is coloured with aqueous solution and
dried / active ingredient added dry |
| Press Q: |
problem free. Slight sticking, but acceptable. |
| PERFORMA™ P: |
compression mode 3 – equal porosity tableting |
|
Problem free, without sticking. |
| Formulation H - 1 mg |
| Formulation: |
API 1%; lactose 80 44%; acivel 25%;
starch 1500 20% |
| Process: |
dry blend |
| Press Q: |
problem free. Speed 120.000 tab/h. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Problem free up to speed 150.000 tab/h –
25% faster. |
| Formulation I |
| Formulation: |
API 20%; mannitol 70% |
| Process: |
wet granulation with gelatin in high shear mixer /
drying in tray dryer |
| Press Q: |
problem free. Speed 85.000 tab/h. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Problem free. Speed 140.000 tab/h –
nearly 70% faster. |
| Ibuprofen - 400 mg |
| Formulation: |
ibuprofen 67%; klucel 2,5%; avicel 11% |
| Process: |
wet granulation with water in high shear mixer /
drying in fluid bed |
| Press Q: |
problem free. Occasionally,
slight sticking is observed (acceptable). |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Problem free. |
| Formulation J |
| Formulation: |
dimenhydrinate 35%; lactose 200 42%; starch 15% |
| Process: |
wet granulation with povidone in water in
high shear mixer / drying in tray dryer |
| Press Q: |
problem free. |
| PERFORMA™ P: |
compression mode 1 – default Courtoy mode:
compression with extended dwell time |
|
Problem free. |
Conclusion
The main difference between any conventional type tablet press and the GEA Courtoy PERFORMA™ P and MODUL™ P tablet presses is the extended dwell time at pre- compression and main compression, along with the ability to freely adjust this dwell time independently of machine speed.
Extensive comparative production runs with multiple formulations under real production conditions have turned up amazing results for quite a few formulations, known as “difficult” formulations for conventional tablet presses.
The results observed can be summarized as follows:
- The additional dry granulation step required to enable compression of several formulations on the conventional machines is no longer required to achieve the desired tablet quality (thanks to the extended dwell time).
- Machine speeds of two to four times the speed of conventional machines can be reached.
- In some cases, an important increase in tablet hardness is achieved. In many cases, the occurrence of capping is observed to decrease significantly or disappear completely.
The above process improvements enable substantial savings in production cost and a sizable reduction in product lead time.
For non-problematic formulations also, GEA Courtoy’s innovative compression technology is able to make a considerable difference: speed increases from 25% to 70% have been achieved for these formulations.
The introduction of the PERFORMA™ P with GEA Courtoy’s novel compression technology at Sanico has proved very successful, as it has enabled the company to increase their productivity and tablet quality significantly, as well as reducing product lead times.
Contact Sanico
Email: info@sanico.eu
Web: www.sanico.eu
Contact GEA Courtoy
Email: courtoy@geagroup.com