analgesic and antiinflammation activities, we suggested to introduce SAD into the
ointment base as a DMSO solution.
The most part of the dermatological pharmaceutical dosage forms for local
treatment have an oil phase. Data show, the optimal and the most frequent using oil
concentration in pharmaceutical emulsions is 20 %. This oil content provides preparing
steady emulsion with good consumer's and viscoelastic properties. In the developing
of the SAD ointment the paraffin oil has been used as an oil phase of emulsion. The
aqueous part of the pharmaceutical emulsion may contain glycerol which has unique
bioactive properties and is used in the medical practice in the dilutions with the aim to
decrease irritating of dry skin. As a rule, glycerol is used in concentration from 5 % to
80 %. During developing the topical pharmaceutical form, the choosing of the
auxiliary substances which provide steady of the preparing emulsion has been done.
The good static and kinetic stability of the emulsions are achieved by combining of
different kinds of emulsifiers. In this research, emulsifier № 1 (Lanette® SX 60) was
used as a base emulsifier in concentration 7 – 8 % that meets the requirements of the
technological guidelines. This component is the mix of the high molecular synthetic
fatty alcohols with the sulfoathers of the same alcohols [6].
During this research, the modern physical (particle size analysis), technological
(solubility, uniformity of content, temperature and colloidal stability, osmotic action,
thermogravimetric analysis, rheological properties) and chemical methods have been
used. Thus, the choosing of components of the pharmaceutical dosage form for topical
treatment of the diabetic skin lesion has been purposefully carried out. The aim of this
investigation was the creation of the o/w emulsion or gel bases which are the most
suitable for this kind of remedies. With the purpose of choosing the most effective
pharmaceutical composition based on SAD, the preclinical trials of the test samples
have been carried out. The acute and chronic toxicity of the pharmaceutical
composition have been also estimated (formulation of test samples is given in tab. 1)
Table 1 – Formulation of the test samples for preclinical screening
Name of the
Content, %
substance
№ 1
№ 2
№ 3
№ 4
№ 5
SAD
0.5
1.0
0.5
1.0
1.0
DMSO
-
-
5.0
5.0
5.0
Sodium Lauryl Sulfate
1.0
1.0
1.0
1.0
1.0
Carbopol
-
-
-
0.5
-
Lanette SX 60
8.0
8.0
8.0
3.0
8.0
Glycerol
20.0
20.0
20.0
20.0
20.0
Paraffin oil
20.0
20.0
20.0
20.0
20.0
Distilled water
up to 100.0 up to 100.0 up to 100.0 up to 100.0 up to 100.0
Researching of the specific activity and safety of the pharmaceutical
composition. The research of the specific activities has been conducted on the
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