Device for local administration of solid or semi-solid formulations and delayed-release formulations for proposal parental administration and preparation process
First Claim
1. Use, for the implantation or insertion of a solid (1, 9) or semi-solid (18) formulation, intended to be placed in a precise depot site (T) of a body, containing at least one active principle, the said formulation being of solid or semi-solid consistency such that it is able to persist for a certain period in the site, and containing a limited dose of active principle for a treatment in a targeted zone of the body, of a device comprising a part placed inside the body of the patient with means of packaging of the solid or semi-solid form, means of positioning allowing these means of packaging to be led to the site of deposition, means of injection or of insertion at this depot site, and means of withdrawal after injection or insertion, and a part left outside with means of operation of the functions of the device.
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Abstract
A method for implanting or inserting a solid or semisolid formulation containing at least one active principle uses a device comprising one part set inside the body of the patient and which conditions the solid or semisolid form, brings these conditioning action to the deposit site, injects or inserts in this deposit site, and withdraws after injection or insertion, with one part remaining outside and activating the functions of the device. The invention also concerns a sustained-release solid formulation for parenteral administration comprising a homogeneous mixture of an active principle in non-dispersed state and of a biologically compatible and biodegradable excipient, in which the amount of active principle is at least 50% by weight.
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Citations
72 Claims
- 1. Use, for the implantation or insertion of a solid (1, 9) or semi-solid (18) formulation, intended to be placed in a precise depot site (T) of a body, containing at least one active principle, the said formulation being of solid or semi-solid consistency such that it is able to persist for a certain period in the site, and containing a limited dose of active principle for a treatment in a targeted zone of the body, of a device comprising a part placed inside the body of the patient with means of packaging of the solid or semi-solid form, means of positioning allowing these means of packaging to be led to the site of deposition, means of injection or of insertion at this depot site, and means of withdrawal after injection or insertion, and a part left outside with means of operation of the functions of the device.
- 44. Solid delayed-release formulation, intended to be placed in a body, containing at least one active principle and a biodegradable excipient, characterized in that the excipient is a polylactide-glycolide (PLGA) copolymer, and in that the concentration of active principle is between 40 and 100%.
- 57. Solid delayed-release formulation for parenteral administration comprising a homogeneous mixture of an active principle in the non-dispersed state forming a continuous phase of which at least one part is in direct contact with the exchange surface of the formulation and of the exterior biological medium, and of a biodegradable biocompatible excipient, in which the quantity of active principle is at least 50% by weight with respect to the total weight of the formulation, and having a release profile which is independent of the composition of the excipient, of the molecular weight of the excipient or of the active principle/excipient weight ratio, the release profile being essentially exclusively dependent on the total quantity of active principle present in the formulation.
Specification