STUDY FOR SOLUBILITY OF HEMANTANE EXCIPIENT TO PRODUCE TOPICAL DOSAGE FORMS

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Purpose of the work was to study the solubility of himantane excipient. Materials and methods of the study: himantane excipient, solvents, water, ethanol, chloroform, ether, dimethyl sulphoxide, ethyl acetate, hexane, isopropanol, polyethylene glycol, polyethylene oxide, benzyl benzoate, glycerine. The study for the solubility of himantane excipients was conducted in accordance with SP XIII requirements. Results: himantane is an original excipient synthesized in V.V. Zakusov State Foundation Institute of Pharmacology. By chemical structure himantane is N-(2-adamntyl) hexamethylenimine hydrochloride salt. The himantane excipient is easy soluble in water (1:7), ethanol (1:8), chloroform (1:4), propylene glycol (1:8), low-soluble in isopropanol (1:200), in benzyl benzoate (1:200), very low-soluble in dimethyl sulphoxide (1:2000), practically insoluble in ether (more than 1:10000), practically insoluble in hexane (more than 1:10000), and in glycerine (1:10000). As we can see from the study conducted, himantane is well soluble in water, ethanol, chloroform, and propylene glycol. However, it is practically insoluble or extremely low-soluble in different ethers, ethyl acetate, hexane, PEO-400, benzyl benzoate, glycerine. There are solvents among those under study, which are widely used in the production of topical dosage forms. Isopropyl alcohol is used as a disinfectant and (co)soluble; propylene glycol is used as a humidity stabilizer, resorption intensifier; glycerin is used as an effective humidor and smoothing component. Dimethyl sulphoxide carries the function of adsorption activator for the intensification of transdermal transport of medical substances. Low-molecular polyethylene oxides are good solvents for drug substances. Together with high-molecular PEO they are widely used as the bases for the production of ointments. Conclusions: considering the results of the studies conducted we have determined the solubility of himantane excipient in different solvents. We have made a conclusion about the fact that himantane has hydrophilous properties. This conditions the production of gel compositions with a high content of hydrophilous solvents. Synthetic and semi-synthetic polymers, gels of non-organic polymers, proteins, polysaccharides etc are able to be used as gelation agents. We have revealed the insolubility of himantane in polyethylene oxide-400. This shows the impossibility of PEO application as a base.