Manufacturing of pharmaceutical compositions
AssigneeFerring International Center S.A.
InventorsRobert RÖNNBACK, Josselin SAUNIER
Life of this patent
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Abstract
The present disclosure discloses a process for the continuous manufacture of a liquid pharmaceutical composition, the process comprising providing a mixing unit, feeding a therapeutic agent and a liquid vehicle to the mixing unit, operating the latter thereby mixing the agent and the vehicle into a liquid pharmaceutical composition, discharging the composition into a holding unit.
Claims23
A process for the continuous manufacture of a liquid pharmaceutical composition, the process comprising the steps of:
- providing a supply of a therapeutic agent and a supply of a liquid vehicle,
- dispensing the therapeutic agent and the liquid vehicle from the corresponding supplies and feeding them into a mixing unit (1), said dispensing and feeding being performed according to a predetermined, timely-steady rate, the rate of the agent and the rate of the liquid vehicle being each independently adjustable,
- operating the mixing unit (1) thereby obtaining a liquid composition having a therapeutic agent concentration,
- discharging the liquid composition from the mixing unit (1) into a holding unit (2), the holding unit (2) being configured so that the unit residence time of the liquid composition is at least sufficient to normalize the therapeutic agent concentration,
- discharging the liquid composition from the holding unit (2) and processing the same.
The process according to any one or more of the preceding claims, wherein the liquid composition is in the form of a solution or a suspension.
The process according to any one or more of the preceding claims, wherein the liquid pharmaceutical compositions contains more than about 0.05 mg/mL of a therapeutic agent per volume unit of the composition.
The process according to any one or more of the preceding claims, wherein the dispensing and feeding of the agent and the vehicle is made according to a steady flow.
The process according to any one or more of the preceding claims, wherein the dispensing of the therapeutic agent includes microdosing the same.
The process according to any one or more of the preceding claims, wherein the dispensing and feeding of the therapeutic agent includes in-line weighing the same.
The process according to any one or more of the preceding claims, further including a step of discharging the composition from the holding unit (2) and controlling the therapeutic agent's concentration in the discharged liquid pharmaceutical composition, wherein said controlling includes quantifying the agent's concentration in the composition, outputting data representing the measured concentration, processing the data thereby generating a corresponding signal and using this signal to dynamically adjust the dispensing and feeding rates of either the therapeutic agent or the liquid vehicle in order to keep the ratio between therapeutic agent and liquid vehicle fed to the mixing unit (1) stable over time.
The process according to any one or more of the preceding claims which is an automated process.
An apparatus for the continuous manufacture of a liquid pharmaceutical composition, the apparatus comprising:
- at least two dedicated dispensing units (3,4), containing a supply of a therapeutic agent and a liquid vehicle, respectively, each dispensing unit (3,4) including a release actuator configured to trigger the dispense of the liquid vehicle and the agent at a predetermined, timely-steady rate, the rate of the agent and the rate of the liquid vehicle being each independently adjustable,
- downstream to the dispensing units (3,4), a mixing unit (1) fluidly connected with the dispensing units (3,4), the mixing unit (1) including a mixing chamber having proximal and distal ends, a feeding inlet at a proximal end of the chamber and a discharging outlet (12) at a distal, opposite end of the chamber, the chamber being configured to receive the therapeutic agent and the liquid vehicle through said inlet, the mixing unit being configured to obtain a liquid composition having a therapeutic agent concentration,
- downstream to the mixing unit (1), a holding unit (2) fluidly connected with the discharging outlet (12) of the mixing unit (1), said holding unit having an inlet (13) and an outlet (14), and said unit (2) being configured to have a residence time of the liquid composition which is at least sufficient to normalize the therapeutic agent concentration, and
- conveying elements (5,6,22) arranged to fluidly connect the dispensing units (3,4) with the feeding inlet of the mixing unit (1) and the discharging outlet (12) of the mixing unit (1) with the inlet (13) of the holding unit (2).
The apparatus according to anyone or ore of the preceding claims, further including elements (23) conveying the liquid pharmaceutical composition away from the holding unit (2) towards further processing units, these conveying elements (23) including a concentration control arrangement (15) arranged to control therapeutic agent's concentration in the liquid pharmaceutical composition.
The apparatus according to anyone or more of the preceding claims, wherein the holding unit (2) further includes an arrangement configured to monitor the pH of the liquid pharmaceutical composition and optionally correct the same in case of divergences with respect to a predetermined target pH.
Use of an assembly including:
- a microdosing device (8),
- downstream to the microdosing device (8), an in-line weighing device (9), and
- downstream to the in-line weighing device (9), a holding unit (2),
- for maintaining a steady concentration of a therapeutic agent during a continuous manufacturing of a liquid pharmaceutical composition, the composition containing said agent and a liquid vehicle.
An assembly including:
- a microdosing device 8,
- downstream to the microdosing device 8, an in-line weighing device 9, and
- downstream to the in-line weighing device 9, a holding unit 2,
- the assembly being configured for maintaining a steady concentration of a therapeutic agent during a continuous manufacturing of a liquid pharmaceutical composition, the composition containing said agent and a liquid vehicle.
Dependencies are inferred from the claim text.