FIELD: pharmaceuticals.
SUBSTANCE: present invention relates to the pharmaceutical industry, namely to a liquid storage-stable ophthalmologic composition with a low atropine dosage (variants), to a method of manufacture of a storage-stable liquid ophthalmologic composition with a low atropine dosage and a method of increasing stability thereof, to a kit for treatment of myopia. The liquid storage-stable ophthalmologic composition with a low atropine dosage contains a water solution containing a buffer at a concentration equal to or less than 75 mM, a tonicity regulator, a viscosity modifier, a chelator and atropine or a pharmaceutically acceptable salt thereof at a low dosage, wherein the ophthalmologic composition of atropine has a pH of 5.0 to 6.0; wherein the ophthalmologic composition of atropine is essentially free of preservatives (variants).
EFFECT: described invention allows producing liquid storage-stable ophthalmologic composition with a low atropine dosage with improved stability and a physiologically acceptable pH, wherein the compositions contain a low level of tropaic acid from degradation of atropine (less than 0.35%) and are also essentially devoid of preservatives.
109 cl, 1 dwg, 28 tbl
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Authors
Dates
2021-03-29—Published
2018-05-10—Filed