FIELD: medicine; pharmaceuticals.
SUBSTANCE: present invention relates to a stable, fixed-dose aqueous pharmaceutical suspension composition for nasal administration in humans. Composition contains mometasone furoate in the form of particles, olopatadine hydrochloride in dissolved form, a hydrocolloid selected from sodium carboxymethylcellulose and xanthan gum, water and auxiliary ingredients. Invention also relates to a method of treating rhinitis in humans by administering as a nasal spray or nasal drops. Kit for treating rhinitis and a method for delivering a pharmaceutical aqueous suspension composition using a nebulizer to a person’s nasal passages is also described, with a spray pattern such that the largest axis is 15–75 mm, the smallest axis is 10–65 mm, and ellipticity is 1–2.
EFFECT: suspension composition according to the invention is stable and is characterized by the absence of phase separation for at least 24 hours of storage at 25 ± 2 °C and relative humidity of 60 ± 5 %.
46 cl, 4 ex
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Authors
Dates
2019-05-15—Published
2014-09-04—Filed