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Formulation of an injectable paracetamol solution, process for preparing and packaging such a solution, and device for packaging such a solution
专利权人:
MOLY PHARMA
发明人:
DOULEAU, DIDIER
申请号:
DK09152160
公开号:
DK2087909T3
申请日:
2009.02.05
申请国别(地区):
DK
年份:
2013
代理人:
摘要:
Formulation of a ready to use injectable paracetamol solution, comprises paracetamol, bi-distilled water and buffering agent, where the formulation has a maximum concentration of paracetamol (1 g/100 ml), a pH of 5.5-6.5, and an oxygen content of less than 0.2 ppm, is claimed. Independent claims are included for: (1) a process for preparing and conditioning of a paracetamol solution using a sealed reactor, where the reactor is composed of a tank (7) and tightly linked to a distribution circuit of bi-distilled water, a circuit of white steam injection of bi-distilled water, and a dissolution circuit of paracetamol, sodium acetate and a solution transfer circuit, comprising (a) introducing a volume of bi-distilled water in the tank by the distribution circuit of bi-distilled water, where the tank is previously cleaned by white steam of bi-distilled water, (b) cooling the volume of water to a temperature of 30-35[deg] C, (c) controlling the oxygen content dissolved in the water volume and deoxygenating by white vapor of bi-distilled water if the oxygen content is greater than 0.2 ppm, (d) introducing the paracetamol and sodium acetate by aspiration in the form of powder in the dissolution circuit, where the paracetamol and sodium acetate is then dissolved in the dissolution circuit by an ultra-disperser, (e) returning the mixture obtained at the dissolution circuit outlet in the tank through the transfer circuit, (f) adjusting the pH of the solution by glacial acetic acid and completing the final volume of the mixture with bi-distilled water, (g) controlling the oxygen content of the solution and deoxygenating using white steam if the oxygen content is greater than 0.2 ppm, (h) passing the paracetamol solution through a first filter of 0.45 mu m and a second filter of 0.22 mu m, (i) conditioning step (consisting of filling the filtered paracetamol solution in step (h) in a soft pouch (3), and sealing the pouch in an over-packaging (2) with an oxygen absorbent (4)) and
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