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ORAL DOSAGE FORM OF DICLOFENAC PROVIDING FAST ABSORPTION OF DRUG
专利权人:
NOVARTIS AG
发明人:
SHAW, LANCE,KIENZLER, JEAN-LUC,RAULT, ISABELLE
申请号:
NZ57997208
公开号:
NZ579972A
申请日:
2008.04.24
申请国别(地区):
NZ
年份:
2012
代理人:
摘要:
Disclosed is the use of a pharmaceutically acceptable diclofenac salt for the manufacture of a soft gelatin capsule for the ultrafast oral treatment of pain, wherein said pharmaceutically acceptable diclofenac salt (preferably diclofenac potassium) is present in said soft gelatin capsule in solution and wherein said ultrafast treatment of pain is defined by an AUCtmaxref value (area under curve until median tmax for the reference formulation) which is statistically significantly numerically higher than for an oral dosage form tablet comprising diclofenac potassium at the same dosage [statistical method applied: two one-sided tests procedure (average bioequivalence): analysis of variance of log-transformed AUCtmaxref including terms for sequence, treatment, and period as fixed effects and subject nested within sequence as a random effect], wherein said ultrafast treatment of pain is particularly defined by an AUCtmaxref value (area under curve until median tmax for the reference formulation) of at least 175 ng × hour/mL derived from a pharmacokinetic graph diclofenac concentration (in the blood) versus time.
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