Technology and characterization of medicinal polymer films with doxorubicin

Abstract

Medicinal polymer films with the antitumor antibiotic doxorubicin have been developed for the treatment of malignant neoplasms of mucous membranes. The optimum concentration of doxorubicin in the films is 0.14 mg cm2, and the optimum base material is hydroxypropylmethylcellulose. The optimum conditions of doxorubicin determination by HPLC have been established, which stipulate the use of a reverse-phase sorbent column Nova-Pak C18 (150 × 3.9 mm), an isopropanol — acetate (3: 7) buffer (pH = 4,5) as the mobile phase, and a photodiode matrix detector. The chromatographic process parameters and the characteristics of the chromatographic peak of doxorubicin have been determined. A linear dependence of the area under chromatographic peak on the drug content in a sample is valid in the interval from 0.01 to 0.6 µg. The proposed method of the quantitative determination of doxorubicin in the parent substance and ready-to-use medicinal films is characterized by high sensitivity, reproducibility, and accuracy. Using this method, the stability of the main quality parameters of the polymer films with doxorubicin is established for a 24-month storage (observation time) at 4 ± 2°C in a place protected from sunlight. It is established that the films with doxorubicin produce rather insignificant cytotoxic action on the healthy tissues of mucous membranes of the oral cavity in rabbits.