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Procedure for amending Training Drug modified Glass, Crystals and compositions containing same
专利权人:
NOVARTIS AG
发明人:
申请号:
ARP160100409
公开号:
AR103711A2
申请日:
2016.02.15
申请国别(地区):
AR
年份:
2017
代理人:
摘要:
We describe a procedure for modifying the Crystal habit of drug substances of acicular Crystals obtained through this procedure, and individual Crystal forms or modifications of mycophenolic acid or mycophenolate Sodium, as well as pharmaceutical compositions The treatment include Crystals, and methods and Uses Thereof.Claim 1: a procedure to change the habit of a drug substance of acicular Crystal, wherein the drug is a substance of acicular mycophenolate sodium salt, which comprises suspending such Crystalline Drug Substance in a Solvent System of methane L / water ratio in the range between 90 and 98: 2: 10 and,The suspension and subjected to a temperature Oscillation, where the habit of Crystal is modified and that the average aspect ratio of the Crystals is processed less than 10: 1 and the apparent Density is higher than 200 kg / m3.Claim 2: a procedure to recrystallize a drug substance wherein Crystalline acidify the acicular drug substance is a Salt of mycophenolate Sodium, which comprises suspending such Crystalline Drug Substance in a Solvent methanol / Water System A relationship in the range between 90 and 98: 2: 10 and,The suspension and subjected to a temperature Oscillation, where the Crystal habit is modified as the average aspect ratio of the Crystals is processed less than 10: 1 and the apparent Density is higher than 200 kg / m3.Se describe un procedimiento para modificar el hábito de cristal de sustancias de fármaco aciculares, cristales obtenidos a través de dicho procedimiento, y formas de cristal particulares o modificaciones de ácido micofenólico o micofenolato de sodio, así como composiciones farmacéuticas que comprenden los cristales, métodos y tratamiento y usos de los mismos. Reivindicación 1: Un procedimiento para modificar el hábito de cristal de una sustancia de fármaco acicular, caracterizada porque la sustancia de fármaco acicular es una sal de sodio de micofenolato, que comprende suspender dicha sustancia de fármaco cristalina e
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