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Immediate Release Tablets containing a Drug and processes to form tablets
专利权人:
INC.;GENENTECH
发明人:
申请号:
ARP160101961
公开号:
AR105184A1
申请日:
2016.06.29
申请国别(地区):
AR
年份:
2017
代理人:
摘要:
Requirement 1: the process of compressing the core per unit of pharmaceutical quantity includes: (1) mixing a drug active particle, an in particle filling, an in particle splitting and an in particle lubricant into a mixture, 1. The active substance d [V, 0.5] of drug granules is particle size, ranging from about 25 mm to about 65 mm, from about 25 mm to about 50 mm, or from about 30 mm to about 40 mm;(2) Use a compact unit of approximately 1 kiloton / cm to approximately 8 kiloton / cm, from approximately 2 kiloton / cm to approximately 5 kiloton / cm, or approximately 2 kiloton / cm to approximately 4 kiloton / cm; (3) chop and screen compact compressors to form particles; and (4) form particles. In the compression process, the compression force is used from about 5 kn to about 20 kn, from about 14 kn to about 19 kn, from about 14 kn to about 18 kn, or from about 8 kn to about 13 kn,Forming a compressed core of a drug dosage unit. Claim 17: a procedure consistent with any one of the above requirements, i.e. the active drug in granules is a polymorphous methylhydroxyacetylhydrazine hemispheres. Claim 25: a compression core of a drug dosage unit, which comprises: (1) about 5% by weight or (2) The content of lubricating oil calculated according to the weight of compressed core per unit of dosage varies from about 0.5% by weight to about 5% by weight; (2) the content of granular active agents in drugs.from about 0.5% by weight to about 3% by weight, from about 1% by weight to about 3% by weight, from about 1% by weight to about 2.5% by weight, or from about 1.5% by weight to about 2% by weight; (3) a disintegrant content, based on the weight of the pharmaceutical dose unit tablet core, ranging from about 2% by weight to about 7% by weight, from about 2% by weight to about 6% by weight, from about 2% by weight to about 5% by weight, from about 3% by weight to about 6% by weight or from about 3% by weight to about 5% by weight; (4) a filler content,based on the weight o
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