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Injectable presentations, syringes and compositions with sustained and/or controlled release of lanreotide

A technology of syringes, compositions, applied in the field of injectable dosage forms, capable of solving problems such as not satisfactorily resolved

Pending Publication Date: 2020-12-04
EDIX SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Since the development of extended-release compositions of lanreotide currently on the market began, to meet the need for higher doses of lanreotide, the selected compositions included bringing the timing of injections closer together or increasing the injections at the same time, but did not satisfactorily address these issues. Questions about injections

Method used

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  • Injectable presentations, syringes and compositions with sustained and/or controlled release of lanreotide
  • Injectable presentations, syringes and compositions with sustained and/or controlled release of lanreotide
  • Injectable presentations, syringes and compositions with sustained and/or controlled release of lanreotide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0189] Preparation of compositions with 18-21% or 22% or even 25% of lanreotide in the form of lanreotide acetate in two types of solvents: water and a 95:5% water / ethanol mixture

[0190] The preparation is carried out by a reciprocating technique between 2 reservoirs of the syringe type, closed on one side by a piston and on the other side by means connected to a valve to allow the regulation of lansel acetate optionally under vacuum Peptide powder, hydrate the powder with a solvent and reciprocate mix the product through the connection opening of the regulating valve, which optionally measures the force applied to control the type of mixture to be prepared.

[0191] By comparing the method of making these blends with the method of making a 25% lanreotide composition comparable to the commercially available product, we see that making these 18-22% formulations is easier and faster and requires less mixing force. Mixtures of this type can then also be extrapolated to much la...

Embodiment 2

[0195] Composition comprising 19.0% lanreotide in water

[0196] Batch prepared from 1.88 g of lanreotide acetate and purified water.

[0197] The formulation was prepared by the reciprocating technique described in Example 1 using 2 plastic syringes connected to a connector that allowed mixing after the lanreotide acetate powder was hydrated with water. The obtained compositions were dispensed in different injection systems to evaluate injection force and other parameters such as peptide content and chromatographic purity.

Embodiment 3

[0199] Composition comprising 19.5% lanreotide in water and ethanol

[0200] A batch prepared from 0.36 g of lanreotide acetate and a 95:5 mixture of purified water and ethanol. A 95:5 water-alcohol mixture was prepared by mixing 1.906 g of purified water with 0.103 g of 96% ethanol.

[0201] Preparation was performed by the reciprocating technique described in Example 1, using 2 plastic syringes connected to a connector allowing mixing after hydration of the lanreotide acetate powder with the water / ethanol mixture. The obtained compositions were dispensed in different injection systems to evaluate injection force and other parameters such as peptide content and chromatographic purity.

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Abstract

The present invention relates to novel injectable presentations, kits or syringes comprising a composition with sustained or controlled release of lanreotide or one of the salts thereof. The compositions of lanreotide or one of the salts thereof are packaged in a syringe having a diameter greater than 3.00 mm and provided with a needle having an outside diameter no greater than 1.00 mm.

Description

technical field [0001] The present invention relates to new injectable dosage forms of pharmaceutical compositions for sustained and / or controlled release of lanreotide. [0002] More particularly, the subject of the present invention is a new injectable dosage form, kit or syringe comprising a composition with sustained or controlled release of lanreotide or one of its salts. Background technique [0003] Commercially available lanreotide, usually in the acetate form, is an octapeptide analog of natural somatostatin. Like somatostatin, lanreotide is an inhibitor of multiple endocrine, neuroendocrine, exocrine, and paracrine functions. It exhibits high affinity for human somatostatin receptors (SSTR) 2 and 5 and low affinity for human somatostatin receptors SSTR 1, 3 and 4. The main reason for the inhibition of growth hormone is this activity on SSTR 2 and 5. Lanreotide is more active and lasts longer than natural somatostatin. Its remarkable selectivity for growth hormo...

Claims

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Application Information

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IPC IPC(8): A61K38/25A61M5/315
CPCA61K38/25A61M5/31596A61P5/08A61K9/0019A61K47/10A61K47/183A61K9/10A61K38/08A61P35/00A61P27/02A61M5/178A61M5/31511A61M5/31513A61M2005/3128A61M5/315
Inventor 玛利亚·伊莎贝尔·冈萨雷斯·加西亚若泽·玛利亚·罗卡·托雷利亚斯塔巴塔·布尔古瓦洛朗斯·拉尚弗雷德里克·拉孔布
Owner EDIX SA