[Development of formulations of desmopressin intranasal drops].
ABSTRACT In recent years synthetic vasopressin analogues (particularly desmopressin) emerged as safe and effective representatives of this class of drugs for same clinical indications as natural hormone. It was imperative to create intranasal drug form using synthetic desmopressin compound. The purpose of this work was to develop formulations of intranasal desmopressin drug using synthetic active compound with optimal composition. Aquatic desmopressin intranasal solution was prepared in 0.05 mg/ml concentration using phosphate buffer (pH 4.5-5.5) and following preservatives: nipagin-nipazol 7:3--0.1% or benzalkonium chloride 0.01%. Sterility is the main condition for intranasal drops and hormones as a raw material are thermolabile so it is not possible to apply a thermic sterilisation. Polymeric membrane filters of 0.22 micron pore size were employed as sterilizing filters. In order to control the quality, to determine the stability of desmopressin intranasal drops at long-lasting storage (24 months) and to evaluate the influence of the technological factors we have developed the analytical methods of quality control. According to our quality control data, desmopressin intranasal drops are stable for two years and remain sterile during storage and administration of the drug.