PREFILLED SYRINGE CONTAINING A GLATIRAMER ACETATE PRODUCT

The patent provides a prefilled syringe for use in treating a patient suffering from a relapsing form of multiple sclerosis, containing 1ml of an aqueous pharmaceutical solution, which has a pH in the range of 5.5-7.0, comprising 40mg/ml of glatiramer acetate and 40 mg/ml of mannitol, the prefilled...

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Bibliographische Detailangaben
Hauptverfasser:	COHEN, Rakefet, SAFADI, Muhammad, HABBAH, Sasson
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Beschreibung
Zusammenfassung:	The patent provides a prefilled syringe for use in treating a patient suffering from a relapsing form of multiple sclerosis, containing 1ml of an aqueous pharmaceutical solution, which has a pH in the range of 5.5-7.0, comprising 40mg/ml of glatiramer acetate and 40 mg/ml of mannitol, the prefilled syringe prepared by the process comprising the steps of: (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol; (ii) filtering the aqueous pharmaceutical solution at a temperature from above 0°C up to 17.5°C to produce a filtrate; and (iii) filling a syringe with the filtrate obtained after performing step (ii), so as to thereby prepare a prefilled syringe for use in treating a patient suffering from a relapsing form of multiple sclerosis, containing 1ml of an aqueous pharmaceutical solution, which has a pH in the range of 5.5-7.0, comprising 40mg/ml of glatiramer acetate and 40 mg/ml of mannitol.