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Different methods of photostabilization are presented for the very light sensitive molsidomine tablets. The incorporation of photostabilizers such as light absorber or pigments into the tablets considerably improved the photostability. Nevertheless, photodegradation was still detected after 12 h of intense light stress. Pigments are superior to colorants or ultraviolet absorbers. The use of titanium dioxide needs to be considered carefully. Preblending the pigment with the drug substance is very helpful for taking full advantage of its photostabilizing properties. Surface-treated titanium dioxide with reduced photocatalytic activity was less suitable than untreated. That was due to a change of particle agglomeration and adhesion behavior, which was demonstrated by scanning electron microscopy pictures. However, only the protection of the tablets by a cover, either by blistering or film coating, gave a photostable drug product.
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http://dx.doi.org/10.1002/jps.20033 | DOI Listing |
Arch Pharm (Weinheim)
February 2023
Department of Biology, Chemistry and Pharmacy, Institute of Pharmacy, Freie Universität Berlin, Berlin, Germany.
Various drug samples (N = 249; drug substances, tablets, capsules, solutions, crèmes, and more) from the European pharmaceutical market were collected since 2019 and analyzed for 16 nitrosamines (NAs). In 2.0% of the cases, NAs were detected.
View Article and Find Full Text PDFAdv Ther
January 2014
Therabel Pharma S.A., Rue Egide Van Ophem 108, 1180, Brussels, Belgium,
Introduction: The direct nitric oxide donor molsidomine is commonly used to relieve symptoms in chronic angina thanks to its vasodilatory properties that induce both a reduction in myocardial oxygen demand and an increase in coronary blood flow. The objective of this study was to compare the short-term effect of molsidomine 16 mg once daily (Coruno(®), Therabel Pharmaceuticals Ltd, Dublin, Ireland) in patients with stable angina previously on molsidomine 8 mg twice daily, in care of general practitioners (GPs) versus cardiologists.
Methods: A total of 53 and 80 patients treated by GPs and cardiologists, respectively, took part in this multicenter, open-label clinical trial.
Adv Ther
November 2008
Therabel Pharma S.A./N.V., B-1180 Brussels, Belgium.
Introduction: Molsidomine, a direct nitric oxide donor, is frequently used in several European countries for the treatment of stable angina. The aim of this study was to compare the effects of a new once-daily 16-mg dose formulation, Coruno (Therabel Pharmaceuticals, Loughrea, Ireland), in patients with stable angina belonging to two distinct European ethnicities.
Methods: A total of 261 Hungarian and 267 Polish patients took part in this multicenter, randomized, double-blind, placebo-controlled clinical trial.
Adv Ther
June 2006
Therabel Pharma S.A./N.V., Brussels, Belgium.
Molsidomine, a sydnonimine acting as a heterocyclic direct nitric oxide donor, has been used for many years in several European countries for the treatment of patients with stable angina pectoris. The efficacy and tolerability of a novel once-daily 16-mg formulation of molsidomine (M16) were compared with those of the currently used twice-daily 8-mg molsidomine tablet (M8) in 666 patients. Study 1, a multicenter, randomized, double-blind, placebo-controlled, twin crossover study, involved 533 patients given acute and 2-week treatment with each drug formulation.
View Article and Find Full Text PDFAtherosclerosis
June 2005
University of Antwerp, Division of Pharmacology, Universiteitsplein 1, B-2610 Wilrijk, Belgium.
Recent clinical evidence has indicated that the severity of atherosclerosis is correlated with the level of soluble ICAM-1 (sICAM-1). Nitric oxide (NO) donors are used to treat patients with stable angina pectoris, and the aim of this study was to investigate the short- and long-term effect of molsidomine on the level of this circulating biochemical marker of endothelial function. We included 172 patients and examined the effect of the NO donor treatment on angina related parameters and on sICAM-1 levels after a 4-week- and a 1-year treatment period.
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