Process for reconstitution of a solid form of a pharmaceutical composition
OwnerXavier Payet-Burininventor
Life of this patent
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Abstract
The invention relates to a process for reconstitution of a solid form of a pharmaceutical composition, comprising the following successive steps: (i) providing the solid form of the pharmaceutical composition in a sealed container, the pressure within the container being an initial pressure (pi,) comprised between 0.5 Pa and 1.2×105 Pa; (ii) at a first time point (t0) introducing the solvent into said sealed container and maintaining the resulting pressure (pr) within the container during a controlled time Δt1; and (iii) at a second time point (t2) increasing the pressure within the container to a controlled pressure (p2) higher than said resulting pressure (pr) until complete reconstitution.
Claims19
A process for reconstitution of a solid form of a pharmaceutical composition, comprising the following in succession:
- (i) providing the solid form of the pharmaceutical composition in a sealed container, the pressure within the container being an initial pressure comprised between 0.5 Pa and 1.2×105 Pa;
- (ii) at a first time point, introducing a solvent into said sealed container and maintaining the resulting pressure pr within the container for a controlled time;
- and
- (iii) at a second time point, before reconstitution is complete, increasing the pressure within the container to a controlled pressure higher than pr until complete reconstitution.
A process for minimizing a reconstitution time of a solid form of a pharmaceutical composition, wherein:
- the solid form of the pharmaceutical composition is provided in a sealed container, the pressure within the container being an initial pressure comprised between 0.5 Pa and 1.2×105 Pa;
- at a first time point, a solvent is introduced into said sealed container so that the pressure within the container increases from the initial pressure to a resulting pressure and the resulting pressure is maintained within the container during a non-null controlled time, wherein said controlled time is chosen based on a U-shaped curve representing a total reconstitution time of the pharmaceutical composition as a function of the time during which the resulting pressure is maintained in the container after introduction of the solvent;
- and
- once said non-null controlled time has elapsed, the pressure is increased within the container to a controlled pressure higher than said resulting pressure.
Dependencies are inferred from the claim text.