INFLUENCE OF DISSOLUTION MEDIUM ON THE ACTIVE SUBSTANCES’ RELEASE FROM THE ORODISPERSIBLE DOSAGE FORMS

The current conditions of the dissolution test are not regulated for the dosage forms that can disintegrate in the oral cavity.

The aim of the study was to investigate the parameters of dissolution medium that could affect the release of active substances from orodispersible dosage forms.

Material and methods. The object of the study was chewing gums "Nicorette" 4 mg "Fresh mint”. Reproduction of the dissolution test was carried out by model that could simulate the chewing process. The content of the active substance was determined by spectrophotometric method using spectrophotometer "SF-56".

Results. When assessing nicotine release from the chewing gum the influence of medium content and its pH was compared, as well as surface tension and viscosity. Using pH=6.0 buffered solution there is 74.30% of nicotine release. Use of purified water, 0.9 % of saline solution, phosphate buffered saline with pH=7.4, solution of nonorganic salts showed nicotine release from chewing gums from 45.30 to 55.90 %. Decreasing the surface tension of the dissolution medium by adding surface acting agent (Tween 80) leads to an increase in nicotine release. Increasing the dissolution medium’s viscosity using a guar gum doesn’t allow to assess the effect on the nicotine’s release.

Conclusion. In the course of the study of nicotine release from chewing gums, the influence of the constituent composition of the dissolution medium that simulated human salivary fluid on the values of pH, surface tension and viscosity was evaluated. We showed the change in nicotine release from chewing gums when dissolution media with different pH values were used. It was confirmed that the addition of surfactants leads to an increase in nicotine release by reducing the surface tension of the dissolution medium. The obtained results can be used as a basis for the development of dissolution media that fully reproduces the physiological conditions of the oral cavity.

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