The choice of the optimal pH range for a parenteral drug based on salts of aldonic and polycarboxylic acids
Keywords:complexation, pH, stability, stability constant, primary packing
Studies on creation of a new solution for infusion containing the complex compound obtained by the reaction of alkaline earth salt of aldonic and alkali salts of polycarboxylic acids have been carried out. Based on the study of physical and chemical properties of the initial reagents and factors affecting the completeness of complexation, the optimal reaction conditions have been determined. Conditional constants of the complex formation have been calculated. The possibility to obtain a stable complexonate solution in the presence of other substances, and at different pH values have been evaluated. Percentage of the complex in solution with these pH has been calculated. The value of the medium acidity, which provides the complexation effect at least 99%, has been determined. The study in selecting the acceptable pH range of the solution with the concentration calculated on the basis of a given single therapeutic dose and the molar ratio of the initial ingredients has been carried out. The optimal pH range – from 6.2 to 6.5 has been determined. The stability of the experimental batches of the drug placed in bottles of two types of glass and sealed with stoppers of two types has been observed. The quality of the drug solution in the process of preparation, during the entire technological cycle and during storage in the primary packing has been examined. It has been found that the quality parameters of a freshly prepared solution during and at the end of the regulated period of storage in all types of the primary packing corresponds to the parameters of normative documents. These data confirm the acceptability of the pH range proposed for providing the reaction efficiency and the drug stability. The studies carried out have revealed the limits for one of the most important variable pharmaceutical parameters (pH), and it will be used at the next stages of pharmaceutical development.
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