Miniaturised device for automated manufacture of pharmaceutical compositions, and associated method

Patent metadata

Field	Value
Publication number	US-2021308642-A1
Application number	US-201917287802-A
Country	US
Kind code	A1
Filing date	Oct 25, 2019
Priority date	Oct 25, 2018
Publication date	Oct 7, 2021
Grant date	—

Abstract

The present invention relates to a device ( 60 ) for manufacturing pharmaceutical compositions, comprising: a support ( 62 ); a mixing container ( 16 ); a plurality of reservoirs ( 18, 20 ) containing starting materials for the composition of a medicament; at least one dispensing device ( 64, 66 ) that is designed to dispense an amount of a starting material into the mixing container, wherein the dispensing device is assembled, or is designed to be assembled, with a reservoir; a stirring device ( 68 ) that is able to stir the mixing container and/or the contents of the mixing container; and an electronic module ( 74 ) for controlling the at least one dispensing device.

First claim

1 . A device ( 100 ) for manufacturing pharmaceutical compositions, comprising a mixing assembly ( 102 ) including:
a first controlled atmosphere enclosure ( 103 ) and, in the latter, a mixing unit ( 10 , 60 ), wherein the mixing unit comprises:
a support ( 12 , 62 );
a mixing container ( 16 ) received on the support;
a plurality of reservoirs ( 18 , 20 ), wherein each of the reservoirs is able to contain a quantity of a starting product used in the composition of a medicament,
at least one dispensing device ( 22 , 44 , 64 , 66 ) that is designed to dispense an amount of a starting material into the mixing container, wherein the dispensing device is assembled, or is designed to be assembled, with a reservoir; and
a stirring device ( 24 , 68 ) that is able to stir the mixing container and/or the contents of the mixing container;
the manufacturing device further comprising an electronic module ( 28 , 74 ) to control the at least one dispensing device and the stirring device.

2 . The manufacturing device according to claim 1 , wherein the first enclosure ( 103 ) of the mixing assembly ( 202 ) defines a first chamber ( 107 ) in which the first enclosure is set to maintain a controlled atmosphere of the ISO 7 air class.

3 . The manufacturing device according to any previous claim, wherein the mixing unit ( 10 ) further comprises a mechanical arm ( 14 ) that is movable relative to the support, wherein an end of the mechanical arm comprises a coupling member ( 36 , 38 ), while the mechanical arm is designed to move at least one of the plurality of reservoirs ( 18 , 20 ) with respect to the mixing container ( 16 ).

4 . The manufacturing device according to claim 1 or 2 , wherein the mixing unit ( 60 ) comprises a device ( 68 ) for moving the mixing container, and is able to position the container in a dispensing position with respect to the at least one dispensing device ( 44 , 64 , 66 ).

5 . The manufacturing device according to one of the preceding claims, wherein the plurality of reservoirs comprises at least one solid reservoir ( 18 ) and/or at least one liquid reservoir ( 20 );
wherein the mixing unit further comprises: at least one solid dispensing device ( 44 ), assembled, or designed to be assembled, with the at least one solid reservoir ( 18 ), wherein the solid dispensing device is designed to dispense a quantity of powdery solid composition into the mixing container ( 16 ); and/or at least one liquid dispensing device ( 22 , 66 ) that is assembled, or is capable of being assembled, with the at least one liquid reservoir ( 20 ), wherein the liquid dispensing device is able to dispense a quantity of liquid composition into the mixing container.

6 . The manufacturing device according to one of the preceding claims, wherein the stirring device ( 24 , 68 ) is selected from among: a centrifugation device that is designed to receive the mixing container ( 16 ) to rotate the container; a magnetic stirring device and a mechanical stirring device.

7 . The manufacturing device according to one of the preceding claims, wherein the mixing unit further comprises a weighing device ( 23 ) designed to receive the mixing container ( 16 ), wherein the weighing device is electronically connected to the electronic control module ( 28 , 74 ).

8 . The manufacturing device according to one of the preceding claims, wherein the mixing unit further comprises at least one analysis device ( 25 , 26 , 70 , 72 ) that is able to analyze the contents of the mixing container ( 16 ).

9 . The manufacturing device according to one of the preceding claims, further comprising a processing unit ( 104 ), wherein the processing unit is able to process the contents of the mixing container ( 16 ), and comprises a filter ( 124 ).

10 . The manufacturing device according to one of the preceding claims, further comprising a packaging assembly ( 106 ) that is capable of packaging the contents of the mixing container ( 16 ) in at least one packaging container, the packaging assembly ( 106 ) comprising a second enclosure ( 138 ) with a controlled atmosphere in which a packaging unit ( 140 ) is included.

11 . The manufacturing device according to claim 10 , wherein the second enclosure ( 138 ) defines a second chamber ( 142 ) in which the second enclosure is able to maintain an ISO 5 or similar controlled atmosphere.

12 . The manufacturing device according to any of claims 2 to 11 , wherein the volume of the first chamber ( 107 ) is less than 1 m 3 .

13 . A method of manufacturing a medicament by means of a manufacturing device ( 100 ) according to one of the preceding claims, wherein the method comprises the following steps:
dispensing into the mixing container ( 16 ) an amount of a starting material contained in a first container ( 18 , 20 ); repeating the preceding step for at least one second reservoir ( 18 , 20 ); then stirring the contents of the mixing container ( 16 ).

14 . The method of manufacturing according to claim 13 , by means of a manufacturing device according to claim 7 , comprising:
receiving the mixing container on the weighing device ( 23 ); performing the dispensing step by moving a reservoir ( 18 , 20 ) above the mixing container ( 16 ) or by moving the mixing container below the reservoir, or at least one dispensing device ( 44 , 66 ); then, by actuating the at least one dispensing device ( 22 , 44 , 81 ), depositing by gravity into the mixing container, a predetermined mass of starting material contained in the first reservoir; and controlling the deposition of the predetermined mass by the weighing device.

15 . The method of manufacturing according to claim 13 or claim 14 by means of a manufacturing device according to claim 8 , comprising:
after the stirring step, analyzing the contents of the mixing container by the at least one analysis device ( 25 ); and
if a result of the analysis is different from an expected result, adding an amount of a starting material to the mixing container.

16 . The method of manufacturing according to one of the claims 13 to 15 by means of a manufacturing device according to claim 9 , comprising:
depositing at least one starting material in the mixing container ( 16 ) in the form of a liquid composition; and
after the stirring step, filtering the content of the mixing container.

17 . The method of manufacturing according to one of the claims 13 to 16 by means of a manufacturing device ( 100 ) according to claim 10 , comprising, after the stirring step, packaging the contents of the mixing container in at least one packaging container.

Assignees

• Ferring Bv

Inventors

• Rönnback Robert
• Saunier Josselin

Classifications

• B01F35/92

  for heating the outside of the receptacle, e.g. heated jackets or burners · CPC title

• B01F35/146

  Working under sterile conditions; Sterilizing the mixer or parts thereof · CPC title

• B01F33/452

  using independent floating stirring elements · CPC title

• B01F31/20

  Mixing the contents of independent containers, e.g. test tubes · CPC title

• B01F29/15

  Use of centrifuges for mixing · CPC title