Method for preparing an injectable preparation and device for implementing same
First Claim
1. A process for preparing a liquid injectable preparation, comprising the steps of:
- providing an injection device from which the preparation can be ejected;
said injection device having a reservoir defining an internal volume;
said reservoir being an injection chamber of a syringe for injecting the liquid injectable preparation via an injection needle;
providing a dry form of an active principle under vacuum in the internal volume of the reservoir;
providing a liquid in which said dry form can be dissolved or suspended to form said liquid injectable preparation; and
extemporaneously introducing said liquid into said dry form by suction by virtue of the action of the vacuum in order to form said liquid injectable preparation in said reservoir, from which said preparation can be injected.
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Accused Products
Abstract
A method comprising the following steps: preparing in a vacuum a dry form (18) of an active principle, as well as a liquid (22), and drawing this liquid into the dry form, by the action of the vacuum to obtain an injectable preparation. The device comprises a gastight syringe (19) to condition under vacuum the dry form, a reservoir (12) containing the liquid (22) and a cap (29) forming a connector between the syringe and the liquid reservoir, the injection needle (25) of the syringe being driven into the septum (24) of the cap (29). The invention enables a preparation which is directly injectable by an automatic rehydration step to be obtained; indeed, after activation, the extemporaneous preparation is automatic since the device elements move by themselves under the action of the liquid which is drawn by suction into the volume under vacuum containing the solid formulation (18).
127 Citations
25 Claims
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1. A process for preparing a liquid injectable preparation, comprising the steps of:
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providing an injection device from which the preparation can be ejected;
said injection device having a reservoir defining an internal volume;
said reservoir being an injection chamber of a syringe for injecting the liquid injectable preparation via an injection needle;
providing a dry form of an active principle under vacuum in the internal volume of the reservoir;
providing a liquid in which said dry form can be dissolved or suspended to form said liquid injectable preparation; and
extemporaneously introducing said liquid into said dry form by suction by virtue of the action of the vacuum in order to form said liquid injectable preparation in said reservoir, from which said preparation can be injected. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 19)
9.The device according to claim 8, wherein the dry form occupies the entire volume of the reservoir after said extemporaneous rehydration. -
9. The device according to claim 8, wherein the connection means comprise either a septum and an injection needle, or a tap.
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10. The device according to claim 8, wherein the syringe is vacuum-packed in a flexible packaging and fixed to a connector in communication with the liquid reservoir.
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11. The device according to claim 8, wherein the syringe is provided with an injection needle engaged in a cap and adapted to slide therein in order to bring the syringe into communication with the liquid reservoir, and the entire unit being packed in a vacuum packaging.
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12. The device according to claim 8, wherein the liquid reservoir is a flexible bag linked by a stopper-septum to the vacuum-packed syringe.
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13. The device according to claim 8, wherein the syringe is packed in a vacuum packaging and provided with an injection needle forming a connector, introduced into the liquid reservoir through a stopper and joined to the syringe through the packaging.
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14. The device according to claim 8, wherein the syringe comprises two compartments delimited by a first piston integral with an active spindle and by independent pistons, optionally linked together.
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15. The device according to claim 8, wherein the syringe comprises two compartments separated by a central bypass and one of the two compartments, designed to contain the rehydration liquid, includes two independent pistons having a space therebetween for the liquid.
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16. The device according to claim 8, wherein the syringe contains a cartridge septum provided with a needle blocked off by insertion in an injection piston of the syringe, the cartridge septum adapted to contain the rehydration liquid and the syringe adapted to contain the dry form.
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18. The device according to claim 8, wherein the syringe is joined by a cap to a cartridge-septum containing the liquid, the syringe being fitted with an injection needle introduced and kept in place inside the cap, opposite the septum of the cartridge-septum, ready to be inserted in the septum in order to bring about rehydration of the solid of active principle contained in the syringe.
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19. A product obtained by implementing the process according to claim 1, comprising a dry form for parenteral administration and vacuum-packed inside a syringe for injecting the liquid injectable preparation and injection needle also containing a liquid volume ready to be mixed by suction with the dry form in order to reconstitute the injectable preparation.
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17. The device according to claim 17, wherein the cartridge-septum is fitted with a piston and a spindle of sufficient length to enable use of the cartridge-septum as a spindle of the injection piston, after insertion of the needle of the cartridge-septum in the injection piston in order to pass the liquid contained in the cartridge-septum into the reservoir of the syringe disposed between the injection piston and the injection needle, and containing a solid under vacuum, thereby making it possible to reconstitute the injectable preparation.
- 20. The product according to claim 20, wherein the dry form occupies the entire volume of the vacuum-packed reservoir.
Specification