STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS

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专利权人:

EFFRX PHARMACEUTICALS SA

发明人:

MARSHALL A. HAYWARD, PH.D.,TIMO SCHMIDT, PH.D.

申请号：

MYPI 2013002085

公开号：

MY166971A

申请日:

2011.12.05

申请国别(地区):

MY

年份:

2018

代理人:

摘要：

A STABLE EFFERVESCENT TABLET, GRANULE OR POWDER COMPOSITION FREE FROM EXCIPIENTS THAT MAY REACT WITH AN EFFERVESCING ORGANIC ACID COMPONENT, COMPRISING: AN EFFECTIVE AMOUNT OF A BISPHOSPHONATE BONE RESORPTION INHIBITOR, AN EFFERVESCING ORGANIC ACID COMPONENT, AN EFFERVESCING BASE COMPONENT； WHEREIN SAID COMPOSITION IS FREE OF POLYOL BINDERS AND TABLETING LUBRICANTS； HAS A LOSS ON DRYING OF 0.25% (M/M) OR LESS； HAS A COMPLETE DISINTEGRATION TIME OF NO MORE THAN 180 SECONDS WHEN PLACED IN 3 TO 8 FLUID OUNCES OF WATER AT BETWEEN 5-20 °C； AND SAID BISPHOSPHONATE IS INCORPORATED AS A MICRONIZED PARTICLE OR BY SPRAY DRYING AND IS COMPLETELY SOLUBILIZED IN WATER WITHIN 2 MINUTES WITHOUT STIRRING. FIGURE 3

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