ВЛИЯНИЕ КИСЛЫХ И ЩЕЛОЧНЫХ СРЕД НА ВРЕМЯ ПЛАВЛЕНИЯ ГИДРОФИЛЬНЫХ И ЛИПОФИЛЬНЫХ СУППОЗИТОРИЕВ

Abstract

Abstract. In the pharmaceutical industry, disintegration testing is one of the most important methods for the development and quality control of drugs in the form of suppositories. Once inserted into a natural body cavity, the suppositories melt, soften, or dissolve in the rectal fluid and produce localized or systemic effects. The results of the active development of the excipients industry and the dynamics of the pharmaceutical ingredients market, the success of pharmaceutical technology, new principles of quality regulation dictate the need to analyze and generalize the current trends in the production of this dosage form. The purpose of this study is to show the effect of acidic (pH=4) and basic (pH=6) solvents on the melting time of both hydrophilic and lipophilic bases. Eleven formulas of different mixing concentrations of hydrophilic bases (polyethylene glycols) and one formula of a lipophilic base (Witepsol W37) were obtained by fusion. As a result of the experiment, it was found that the melting time of lipophilic bases (W37) was longer compared to hydrophilic bases in both acidic and basic environments. Among the hydrophilic suppositories, the formula containing PEG 4000 demonstrated a longer melting time compared to other formulas in both media. In addition, during the experiment, it was found that lipophilic bases (W37) are harder than hydrophilic ones in terms of characteristics, which may be due to including those with a higher melting point of fat-soluble than hydrosoluble suppositories. The results obtained led to the conclusion that suppositories based on hydrophilic bases (polyethylene glycol) have a shorter melting time in both acidic and basic solutions than lipophilic ones (Witepsol W37). Due to this, soluble drug compounds are more easily delivered to the site of action. That is, hydrophilic bases are more effective for the manufacture of vaginal suppositories.