SPIREAS SPIRIDON,PIYA ISHARI,GROVER RAKESH,SAGI SUNIL,KALLUR RAM K.
申请号：
NZ61143811
公开号：
NZ611438A
申请日:
2011.12.09
申请国别(地区):
NZ
年份:
2015
代理人:
摘要：
Disclosed is a pharmaceutical composition comprising one or more pharmaceutically acceptable inactive ingredients and an amorphous solid solution consisting of an orally active nucleotide analogue or an orally active nucleotide analogue prodrug and a pharmaceutically acceptable inactive polymer, wherein the pharmaceutical composition is a solid dosage form, wherein the orally active nucleotide analogue or the orally active nucleotide analogue prodrug degrades to provide a pharmaceutical composition containing no more than (a) 0.8% by weight of a less bioavailable impurity, relative to the original amount of the orally active nucleotide analogue or the orally active nucleotide analogue prodrug, when the pharmaceutical composition is maintained at a temperature of 25°C and at a relative humidity (RH) of 60% for a period of 1 month (b) 1.2% by weight of a less bioavailable impurity, relative to the original amount of the orally active nucleotide analogue or the orally active nucleotide analogue prodrug, when the pharmaceutical composition is maintained at a temperature of 25°C and at 60% RH for a period of 12 months (c) 1.5% by weight of a less bioavailable impurity, relative to the original amount of the orally active nucleotide analogue or the orally active nucleotide analogue prodrug, when the pharmaceutical composition is maintained at a temperature of 25°C and at 60% RH for a period of 24 months (d) 2.0% by weight of a less bioavailable impurity, relative to the original amount of the orally active nucleotide analogue or the orally active nucleotide analogue prodrug, when the pharmaceutical composition is maintained at a temperature of 40°C and at 75% RH for a period of 3 months (e) 1.75% by weight of a less bioavailable impurity, relative to the original amount of the orally active nucleotide analogue or the orally active nucleotide analogue prodrug, when the pharmaceutical composition is maintained at a temperature of 40°C and at 75% RH for a period of 2 months
