1. The 24-h progression of menstrual pain in women with primary dysmenorrhea when given diclofenac potassium: a randomized, double-blinded, placebo-controlled crossover study
Stella Iacovides • Fiona C. Baker • Ingrid Avidon. Arch Gynecol Obstet (2014) 289:993–1002
The progression of dysmenorrheic pain intensity, expressed as the average VAS scores, throughout the day when the women were taking diclofenac potassium compared with placebo (including the six women who took rescue medications) is displayed in Fig. 2. A two-way RMANOVA revealed signiﬁcant treatment [F(5,115) = 31.27, P<0.0001], time [F(1,23) = 32.60, P<0.0001] and treatment-time interaction [F(5,115) = 8.47, P<0.0001] effects. As demonstrated by the starting points of the two curves in Fig. 2 (Time ‘‘0’’), the women’s intensity of dysmenorrheic pain before any treatment was not signiﬁcantly different between the two trials (diclofenac versus placebo; P = 0.90). The progression of pain intensity throughout the day, as shown in Fig. 2, followed two distinct patterns, depending on the treatment received (diclofenac or placebo). As conﬁrmed by post hoc analyses, the pain intensity of the women taking diclofenac potassium was signiﬁcantly reduced after taking capsule 1 and remained at a signiﬁcantly lower intensity at all the time points compared with the initial (Time ‘‘0’’) pain intensity (SNK: P<0.0001 between Time ‘‘0’’ and all subsequent time-points; Fig. 2). In addition, women rated their pain intensity as signiﬁcantly lower when taking diclofenac potassium compared with placebo at each time point after commencing treatment (after Time ‘‘0’’) (P<0.0001; Fig. 2). When the women were taking placebo, pain intensity was signiﬁcantly lower at 7 h (after capsule 2; SNK: P = 0.001) and in the morning (SNK: P = 0.0007) compared with Time ‘‘0’’.
2. Design of Biorelevant Test Setups for the Prediction of Diclofenac In Vivo Features After Oral Administration
Marie Guhmann & Markus Thommes. Pharm Res (2013) 30:1483–1501
The particle size distribution of diclofenac potassium (Fig. 1c) extends from about 0.6 to 60 μm. The particle size is markedly influenced by the acidic media contact resulting in a distribution pattern from 2 to 100 μm and a high proportion of particles in the 100–400 μmrange.After dispersion in acidic media, an increased mean particle size of 26 μm is observed in comparison to a mean diameter of 14 μm measured for the dry dispersion. Kinetic measurements show a rapid decrease of the proportion of fines and large particles with similar mean particle size around 25 μm, but particles in the 250–600 μm size group can be observed.