DK200900595A

DK200900595A - Tablet production module and method for continuous production of tablets

Info

Publication number: DK200900595A
Application number: DK200900595A
Authority: DK
Inventors: Page Trevor Gordon; Waldron Michel Simon; Boeckx Jurgen
Original assignee: Gea Pharma Systems Ltd
Priority date: 2009-05-07
Filing date: 2009-05-07
Publication date: 2009-05-07

Claims

1. A module for production of tablets, the module comprising: at least one inlet for an active pharmaceutical ingredient (API); at least one inlet for an excipient; at least one mixing unit; at least one analytical sensor; a tablet press; and at least one outlet for tablets; characterized in that said inlets are in fluid communication with an inlet of the at least one mixing unit, an outlet of the at least one mixing unit is in fluid communication with an inlet of the tablet press, and an outlet of the tablet press is in fluid communication with the-outlet for tablets; that the module is contained; and that said at least one analytical sensor is positioned to analyse the contents or properties upstream of the tablet press.

2. A contained module according to claim 1, wherein said inlet comprises a releasable inlet conduit (2; 21) for an active pharmaceutical ingredient (API) and a releasable inlet conduit (3; 31; 31a, 31b) for an excipient, and said outlet a releasable outlet port (7; 71)) for tablets, the releasable inlet conduits being in fluid communication with the inlet of the mixing unit (4;41,42,43,44,45,46,47), and the outlet of the tablet press (6) is in fluid communication with the releasable outlet port for tablets.

3. A contained module according to claim l or 2, wherein the module has a level of containment below 100 mcg/m3, preferably below 10 mcg/m3.

4. A contained module according to any one of the preceding claims, further comprising a control unit (8), which control unit is capable of receiving data from the at least one analytical sensor (51, 52, 53).

5. A contained module according to claim 4, wherein the control unit (8) is adapted to send commands to the inlets for API and/or excipi-ent{s) and/or to the mixing unit (4; 41,42,43,44,45,46,47) and/or to the tablet press (6).

6. A contained module according to claim 5, wherein the control unit is adapted to control the speed of the tablet press.

7. A contained module according to any one of the preceding claims, wherein the analytical sensor is a spectroscopic analytical sensor.

8. A contained module according to any one of the preceding claims, further comprising an additional mixing unit (41,42,43, 44,45,46,47).

9. A contained module according to any one of the preceding claims, further comprising a drying unit (5).

10. A contained module according to any one of the preceding claims, wherein said at least one analytical sensor Is positioned at the inlets to the contained module and/or at the inlet of the mixing unit or mixing units, and/or at the outlet of the mixing unit or mixing units, and/or at the inlet of the tablet press.

11. A contained module according to any one of the preceding claims, wherein the contained module is designed as a single piece of equipment, preferably including a physical confinement of the interfaces of the contained module.

12. A method for continuous production of tablets, including the following steps: providing a contained module comprising at least two inlets, at least one mixing unit, at least one analytical sensor, a tablet press, and at least one outlet for tablets; feeding an active pharmaceutical ingredient (API) to one of said at least two inlets; feeding an excipient to the other of said at least two inlets; mixing the material stream comprising the API and the excipient in said at least one mixing unit; measuring parameters of the contents of the material stream with said at least one analytical sensor upstream of the tablet press; controlling said two inlets and/or said mixing unit in response to the parameters measured; continuously supplying the tablet press with the material stream; controlling the speed of the tablet press in response to the parameters measured upstream of the tablet press, and discharging tablets at said at least one outlet.

13. The method of claim 12, whereby a further mixing step is carried out, In which a further excipient is fed into the existing material stream.

14. The method of claim 12 or 13, whereby a drying step is carried out before supplying the material stream to the tablet press.

15. The method of any of claims 12 to 14, whereby contents or properties of the tablets are measured by at least one analytical sensor downstream of the tablet press.