[Development of inhalation powder formulation of gentamicin sulphate].

Aminoglycosides, including gentamicin, are considered among the most useful classes of antibiotics for treating Pseudomonas aeruginosa infections. The major drawback of aminoglycosides is the need for their relatively high-dose intravenous administration, which carries the potential for systemic toxicity. Granulometry analysis of gentamicin sulfate powder (substance) has shown, that generally it consists of large particles, and thus is not suitable for inhalation. Six different inhalation composition containing gentamicin sulfate has been developed, one of which showed the best inhalation properties. Technological chart and pilot Master formula for inhalation gentamicin sulfate composition delivered via Handi Haler have been developed.

[Dissolution study of the gentin tablets].

To establish individual dissolution test for the tablets gentin, which have a marked influence on the secretory function of the stomach (increase the free acidity of the gastric juice and stimulate enzymoproduction function of the stomach), and gastroprotective functioning, the conditions for the test realization were studied and specified, using apparatus "Rotating Basket" (Dissolution test, apparatus 1, p.1791, USP XXIII, 1995). For the quantification of the active ingredients in buffer solutions chromatospectrophotometric method was used. The same conditions were used for the accomplishment of the dissolution test using apparatus "Rotating Paddle" (Dissolution test, apparatus 2, p.1791, USP XXIII, 1995). Metrologic characteristics were compared for the evaluation of the reproducibility of the results. Obtained data showed better reproducibility of the results for the apparatus "Rotating Paddle" compare to the apparatus "Rotating Basket". Estimated conditions are useful for the routine control of the tablets "Gentin" in the case of manufacturing.