and contamination. This fact may be explained by some reasons. Firstly, the emulsion
base includes 20 % of glycerol and has appropriate consistency. Moreover, the
presence of 5 % of DMSO may be considered as an additional factor which maintains
microbiological purity of the pharmaceutical composition. Both those components
limit growing of microorganisms, that is why, introduction of the antimicrobial
preservatives into SAD based soft composition isn't required.
The analytical methods of quality control of Sad based soft composition have been
developed. These methods will be included to the draft of the analytical papers “Quality
control methods of medicines”. The specific colour reaction of the detection of amines
for SAD identification has been proposed. The spectrophotometry method for SAD
assays determination and gas chromatography for glycerol and dimethylsulfoxide have
been developed.
CONCLUSION
The formulation of the soft pharmaceutical dosage form based on succinic acid
derivate has been developed. The types of auxiliary substances have been grounded.
The paraffin oil as an oil phase of emulsion and glycerol as a hydrophilic solvent,
moisturizer and softening substance have been chosen. Dimethylsulfoxide as SAD's
solvent and emulsifier Lanette® SX 60 have been proposed. The anionic surface active
agent– sodium lauryl sulfate has been used as co-emulsifier and promoter. The
laboratory manufacturing technology of soft pharmaceutical dosage form based on w/o
emulsion has been developed. The obtained soft topical form may be considered as
hydrophilic crème according to its rheological indices. The required amount of
pharmaco-technological researches (measurement of oil phase particles's size, osmotic
activity, thermal stability, rheological behaviour) has been carried out. It has been
shown, that elaborated soft composition was homogenous at different temperatures,
has demonstrated sparingly osmotic activity and homogenous oil phase particles's size,
had good consistency and rheological indices. The microbiological research has shown
that soft composition based on SAD hasn’t had antimicrobial activity and is
microbiologically pure. The verified data of microbiological purity of the
pharmaceutical composition which has been stored during 36 months, allow to exclude
antimicrobial preservatives in the pharmaceutical composition. The basic quality
indices of the pharmaceutical composition and its quality control methods have been
chosen.
The topical soft pharmaceutical dosage form based on SAD has inhibited an
exudative phase of acute aseptical inflammation and has shown antialterative effect on
the experimental models of inflammation in rats with presence and absence of the
experimental diabetes. The elaborated pharmaceutical composition hasn't caused toxic
influence on the general condition and functions of male and female rat’s organs and
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