Abstract
Aim. Analysis of osmolality and isohydricity of eye drops of extemporaneous manufacture for compliance with the requirements of the normative documents. Materials and Methods. The object of study was eye drops of extemporaneous manufacture according to formulations and technologies of the normative documents. To control determination of the permissible limits of osmolality, model eye drops with sodium chloride at concentration of 0.6%, 0.9%, 2.0% were manufactured. Osmolality of the eye drops was determined by a pharmacopeian method using МТ-5 thermoelectric milliosmometracryoscope. pH was measured by a method of ionometry using HANNA microprocessor pH/C meter. The results were statistically processed. Results. It was found that eye drops 2%, 3% collargol and 1% sodium thiosulfate solution do not comply with the normative parameters by osmolality. Such drops as 0.2% ascorbic acid; combined eye drops containing riboflavin, ascorbic acid and boric acid; riboflavin, ascorbic acid and glucose did not comply with the normative parameters by pH value. These drops have a strong shift of pH towards acidity. The value of pH was below 3.5. On the contrary, eye drops containing sodium hydrocarbonate, sodium tetraborate have an exceeding shift towards alkalinity with pH more than 8.5. Thus, the conducted study showed the necessity of introduction of certain changes to the composition of the above mentioned eye drops after consultation with ophthalmologists. Conclusion. In the work, technological and analytical study of osmolality and isohydricity of some official compositions of eye drops encountered in extemporaneous manufacture, was conducted. Using modern pharmacopeian methods, the mentioned parameters of eye drops were determined and compared with the normative parameters recommended by the governmental quality standards of General Pharmacopeia Monograph (GPM) «Ophthalmic Dosage Forms», and the necessity for correction of certain formulations of eye drops is shown.
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