发明名称 ORAL DOSAGE FORM OF DICLOFENAC PROVIDING FAST ABSORPTION OF DRUG
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.
申请公布号 NZ579972(A) 申请公布日期 2012.03.30
申请号 NZ20080579972 申请日期 2008.04.24
申请人 NOVARTIS AG 发明人 SHAW, LANCE;KIENZLER, JEAN-LUC;RAULT, ISABELLE
分类号 A61K9/48;A61K31/196 主分类号 A61K9/48
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