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Clinical pharmacological equivalence of a novel FCH-free GTN spray with low ethanol content vs a FCH-containing GTN spray (1995)

Mey, C. ; Erb, K. ; Mutschler, H. ; [et al.]

Springer

European journal of clinical pharmacology 47 (1995), S. 437-443

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ISSN: 1432-1041

Keywords: Nitroglycerin ; Glyceryl trinitrate ; Fluorochlorohydrocarbons ; Bioequivalence ; digital plethysmography

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Abstract The overall therapeutic equivalence of a fluorochlorohydrocarbon (FCH)-free glyceryl trinitrate (GTN) pump spray with a low ethanol content (TL) was investigated relative to an FCH-containing GTN spray (Nitrolingual; R), in terms of: (1) pharmacokinetic bioavailability, (2) pharmacodynamic responses as assessed by digital plethysmography (DPG), and (3) clinical perception upon application. Pharmacokinetically, the time courses of the plasma concentrations of GTN and its dinitrate metabolites, 1,2- and 1,3-GDN, subsequent to the sublingual administration of 0.8 mg GTN showed somewhat lower bioavailability of GTN and its metabolites than to the reference. Pharmacodynamically, the changes in the DPG signals after the application of 0.8 mg GTN with TL were biostatistically euivalent with R (estimated ratio TL/R for the maximum decrease of the ratio between the systolic a wave and c incisure: 0.98; 90% CI: 0.84–1.14; and for the average decrease of the c: a ratio: 0.97; 90% CI: 0.80–1.16). The time of occurrence of the maximum effect of TL was not significantly different from that of R (estimated difference TL-R: -2.25 min; 95% CI:-9.5 min to 2 min). In contrast, after the administration of an FCH-free GTN spray with a higher ethanol content (TH, active control), the effect had a slightly earlier onset (TH-R:-6 min, 95% CI: -9.5 to -2 min) and there was a higher average response (TH/R: 1.12: 90% CI: 0.95 to 1.34). However, TH was consistently judged to cause an extremely unpleasant burning sensation in the mouth and thus was perceived as distinctly different from R. In contrast, TL was well tolerated and could not be distinguished from R. Therefore only TL met the criteria of overall therapeutic equivalence to R.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF00196858

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Koordinationsverbindungen des 2-Hydroxy-4,6-diphenyl-thiobenzophenons. Chelat-Komplexe des Cobalts und Nickels, Röntgenkristallstrukturanalyse der Nickelverbindung (1993)

Lorenz, B. ; Zimmermann, T. ; Hübener, R. ; [et al.]

Weinheim : Wiley-Blackwell

Zeitschrift für anorganische Chemie 619 (1993), S. 1905-1908

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ISSN: 0044-2313

Keywords: Cobalt complexes ; Nickel complexes ; X-ray diffraction ; Monothio-β-diketonato chelates ; Chemistry ; Inorganic Chemistry

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Chemistry and Pharmacology

Description / Table of Contents: Coordination Compounds of 2-Hydroxy-4,6-diphenyl-thiobenzophenone. Chelate Complexes of Cobalt and Nickel, X-ray Structure of the Nickel Compound2-Hydroxy-4,6-diphenyl-thiobenzophenone (HL) reacts under deprotonation with metal salts to chelate complexes. The reactions with nickel acetate or cobalt acetate yield neutral complexes of the composition NiL2 and CoL3, respectively. The nickel compound crystallizes monoclinic in the space group P21/c (No. 14), a = 17.55(6), b = 26.69(4), c = 8.49(9) Å, β = 102.7(2)°, Z = 4. The nickel atom has a distorted squareplanar coordination sphere. The ligands are cis coordinated.

Notes: 2-Hydroxy-4,6-diphenyl-thiobenzophenon (HL) reagiert unter Deprotonierung mit Metallsalzen zu Chelatkomplexen. Die Umsetzung mit Ni— bzw. Co-Acetat führt zu neutralen Komplexen der Zusammensetzung NiL2 bzw. CoL3. NiL2 kristallisiert monoklin in der Raumgruppe P21/c (Nr. 14); a = 17,55(6); b = 26,69(4); c = 8,49(9) Å; β = 102,7(2)°; Z = 4. Das Nickelatom befindet sich in einer verzerrt quadratisch-planaren Koordinationssphäre. Die Liganden nehmen die cis-Konfiguration ein.

Additional Material: 1 Ill.