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Pharmaceutical dosage forms for oral administration
专利权人:
NOVARTIS AG
发明人:
申请号:
ARP150102160
公开号:
AR101116A1
申请日:
2015.07.06
申请国别(地区):
AR
年份:
2016
代理人:
摘要:
Claim 1: a pharmaceutical dosage form for oral administration comprising (a) The Drug 4 - [(5R) - 6.7 - dihydro - 5h pyrrolo [1,2-c] imidazole - 5 - yl] - 3 - fluorobenzonitrilo as defined by the formula [1] or a pharmaceutically acceptable Salt thereof, and (b) at least 30% Microcrystalline Cellulose by weight based on the total weight of the pharmaceutical dosage form.Claim 3: the pharmaceutical dosage form according to any of the preceding Claims, wherein Said Agent is present AS phosphate Salt, preferably as a Salt of mono - phosphate.Claim 1: the pharmaceutical dosage form according to any of the preceding claims comprising: (a) 4 (1%), which is calculated based on the weight of the Drug Free Base, 4 - [(5R) - 6.7 - dihydro - 5h pyrrolo [1,2-c] imidazole il] - 3 - 5 - - fluorobenzonitrilo present as a Salt of monofo Sfato (b), 77 (7% by weight of microcrystalline Cellulose, (c) 0.6 (0.2% by weight of Colloidal SILICON DIOXIDE (b), 10 (2% by weight of mannitol, and optionally further comprising: (e) 2 + 0.5% by weight, preferably a disaggregating Agent, croscarmellose Sodium, and (f) 1.5 (0.5% by weight of a Lubricant, preferably stearate Magnesium base The total weight of the pharmaceutical dosage form.The process according to claim 15: 12 to 14 claims is additionally characterized by the following process Steps: (1) mixing the drug with microcrystalline Cellulose and Optionally additional Ingredients such as a Slip Agent, a disintegrating Agent.And a LUBRICANT Agent, to obtain a mixture compactable by Compacting Machine, (2) mixing Machine through compactable Dry granulation, preferably by Roller Compaction, to obtain a Compacted material, (3) Mix Compacted material with Silic dioxide The Colloidal, and optionally with additional Ingredients such as microcrystalline Cellulose, mannitol,A disaggregating Agent and a Lubricant, to obtain a mixture Machine understandable, (4) compressing the mixture Machine understandable through the use of a machine to obtain Tra
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