The dissertation is devoted to the development of a scienсу-based composition and technology of a soft dosage form with a natural antibiotic of the bacteriostatic direction Fusidic Acid and Panthenol (anti-inflammatory and reparative action).
In carrying out the study, of the assortment of dermatological drugs for the treatment of infectious skin diseases, it was noted that the prospects for using Fusidic Acid in the development of modern local dermatological agent. Fusidic Acid belongs to the group of fusidans, is a natural antibiotic, which exhibits a narrow spectrum of antimicrobial action. Fusidic Acid highly active against a wide range of gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., Corynebacterium minutissimum и P.).
We studied the physicochemical and rheological properties of the gel bases in which were introduced an ethanol solution of Fusidic Acid (2.0%) and Glycerol (5.0%). For the experiment, were used gel-forming agents, which are most often used in the development of dermatological gels (Carbomer Ultrez 10, Xanthan Gum, Guar Gum, Sodium alginate, Hydroxyethylcellulose. It was established that is optimal use of the Xanthan: Ssodium Alginate gel composition (1.5: 0.5).
Using technological, physico-chemical, structural-mechanical and microbiological studies are substantiated the type of carrier base and its optimal composition: Xanthan:Sodium Alginate - 1.5: 0.5 %, Glycerol - 5.0 %, Sodium Benzoate - 0.1 %, Ethanol 96% - 20.0 %, Purified Water - up to 100.0%. Based on microbiological studies is justified the concentration of Fusidic Acid (high antimicrobial effect, in particular against Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes тощо) – 2.0 %. It was established that the addition of APhI and auxiliary substances were not affect the type of flow, and as well as was not affected by the change reoparameters.
Justified sequence introducing components and developed technology of gel in laboratory and industrial conditions.
The technology consists of the following stages: 1. Weighing of the gel components; 2. Dissolution of Fusidic Acid in Ethanol; 3. Obtaining of gel base; 4. Obtaining of gel; 5. Homogenization of the gel; 6. Packing the gel into tubes; 7. Packing tubes in packs; 8. Packing packs in a group container.
The technology of gel has been tested in industrial manufacturing on PJSC "Chervona Zirka" Chemical & Pharmaceutical Plant" (Kharkiv).
Developed methods for the qualitative and quantitative determination of APhI (Fusidic Acid, Panthenol) and preservative (Sodium Benzoate) by HPLC.
Identified quality indicators for gel (descroption, identification and quantitative content of AphI, pH, stability). Based on the conducted studies, the stability of the gel has been proved and the shelf life of them was se two years at temperature not exceeding 25 °C in the tubes aluminum. It is proven that the gel is non-toxic. Established expressed the anti-inflammatory effect of the gel "Fusipan-Derma" (Panthenol concentration
5. 0%) compared with similar indicators of the reference drugs: gel "Pantestin-Darnitsa" and ointment "Vundekhil".
Dermatological gel showed pronounced reparative action exceeding similar indicators wound healing under the influence reference drug ointment "Vundekhil."
The scientific novelty of the results obtained is protected by the Ukrainian patent application utility model No 88421 "Pharmaceutical composition «Fuzіpan-Derma» for the treatment of acne disease of I and II stages".
APhI is unchanged for the intended shelf life indicated in the draft MСQ tested in the conditions of PJSC "Chervona Zirka"Chemical & Pharmaceutical Plant" (Kharkiv).
