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A polarographic method for the determination of nedocromil sodium in inhalation aerosols

A polarographic method for the determination of nedocromil sodium in inhalation aerosols. Hermening, P.; Hoffmann, H. (Inst. Pharmaceutical Chem., Johann Wolfgang Goethe-Univ., Frankfurt/Main D-60439, Germany). Pharmazie, 51(11), 854-856 (English) 1996 Govi-Verlag Pharmazeutischer Verlag. CODEN: PHARAT. ISSN: 0031-7144. DOCUMENT TYPE: Journal CA Section: 64 (Pharmaceutical Analysis) Based on the investigations concerning the electrochem. behavior of nedocromil sodium a polarog. method for the detn. of nedocromil sodium in metered dose inhalers (Tilade, Halamid) was developed and validated. There are some commonly used reagents like 69049-74-7 in this article. The results of the detn. were confirmed by HPLC and UV-spectroscopy. Validation and the following comparison of the anal. methods showed their equivalence. .

A placebo-controlled comparison of ketotifen fumarate and nedocromil sodium ophthalmic solutions for the prevention of ocular itching with the conjunctival allergen challenge model

A placebo-controlled comparison of ketotifen fumarate and nedocromil sodium ophthalmic solutions for the prevention of ocular itching with the conjunctival allergen challenge model. Greiner, Jack V.; Minno, George (Schepens Eye Research Institute, Department of Ophthalmology, Harvard Medical School, Boston, MA, USA). Clinical Therapeutics, 25(7), 1988-2005 (English) 2003 Excerpta Medica, Inc. CODEN: CLTHDG. ISSN: 0149-2918. DOCUMENT TYPE: Journal CA Section: 1 (Pharmacology) Section cross-reference(s): 63 Background: Ketotifen fumarate 0.025% ophthalmic soln. and nedocromil sodium 2.0% ophthalmic soln. are 2 topical antiallergic medications with different modes of action and efficacy profiles. Both solns. are indicated for ocular itching assocd. with allergic conjunctivitis. Objective: This study compared the efficacy, safety, and comfort of ketotifen fumarate 0.025% ophthalmic soln. and nedocromil sodium 2.0% ophthalmic soln. for the prevention of ocular itching, using the conjunctival allergen challenge (CAC) model. Methods: This was a single-center, double-masked, contralateral, randomized, placebo- and active-controlled CAC clin. trial. Subjects aged >10 yr with a history of allergic hypersensitivity who responded to the CAC at screening visits 1 and 2 qualified for randomization at visit 3. At visit 3 (day 21) and visit 4 (day 35), subjects received 1 of 3 treatments: ketotifen, nedocromil, or placebo (artificial tears), randomized by eye. Allergen challenges were conducted at 5 min posttreatment dose (visit 3) and 12 h posttreatment dose (visit 4). At each visit, subjects evaluated their ocular itching every 30 s for 20 min. At visit 4, subjects evaluated the comfort of the medication immediately after instillation, at 30 s after instillation, and at 1, 2, 5, and 10 min after instillation. The subjects were also queried about overall eyedrop comfort by choosing from descriptive terms and about overall eyedrop preference based on comfort and perceived efficacy. Results: Eighty-five subjects were screened for this study. Fifty-nine (28 males, 31 females; mean age, 38.7 yr) qualified and were randomized to receive study medications. Ketotifen-treated eyes experienced significantly less ocular itching induced by CAC than nedocromil-treated eyes and those that received placebo at both the 5-min and 12-h posttreatment allergen challenges (all P < 0.05). Nedocromil-treated eyes showed no statistical or clin. differences from placebo at any time point. Ketotifen-treated eyes showed no differences in comfort from those that received placebo but were significantly more comfortable than nedocromil-treated eyes at 1, 2, 5, and 10 min after instillation (all P < 0. 34580-14-8 and 69049-74-7 are just another two chemicals used in this study.05). On the basis of comfort and subjective efficacy, 60% of subjects preferred ketotifen, 21% preferred nedocromil, and 19% preferred placebo. Conclusion: Ketotifen was significantly more effective and comfortable than nedocromil at both 5 min and 12 h after administration in this CAC model. .