The substantiation of the technology of the bigel hydrophilic faction for the complex therapy of mastopathy in the aspect of methodological approaches to drug creation

Abstract

Aim. To develop methodological approaches to creation of a bigel and substantiate the technology of the hydrogel fraction as one of the components of the bigel for the complex therapy of mastopathy and prevention of breast cancer.

Materials and methods. The study objects were a hydrophilic gelling agent – hydroxyethyl cellulose (HЕС) and active pharmaceutical ingredients (AFI) – indomethacin, a liquid extract of hop cones (1 : 2), potassium iodide and magnesium sulfate. The methods of analysis of electronic and paper sources of information on advantages, technology, and methods of analysis of bigels were used. The methods of pharmacotechnological studies were applied when developing the technology and studying the critical parameters of the hydrophilic fraction of the bigel.

Results. Over the last several decades, different types of gels have been widely studied as potential carriers for drug delivery. In recent years, many scientists proposed the development of formulations by mixing a hydrogel and an oleogel. These compositions are regarded as bigels. Since hydrogels are polar, while oleogels are non-polar, the bigel can be considered as emulsions with the internal and external immobilized phases. The advantages of the bigel system include the possibility of introducing both hydrophilic and lipophilic substances, providing the local action or transdermal drug delivery, improving the consumption properties of drugs. In addition, in the scientific papers of Almeida at el. it has been shown that bigel-based preparations have a moisturizing and cooling effect. Considering the number of advantages of the bigel systems over mono- and emulsion gels, the possibility of reproduction of their technology and research methods we can conclude that the development of this dosage form for the treatment of local and systemic diseases is promising. Because of the lack of soft medicines in the form of bigels at the domestic pharmaceutical market the aim of the work was to develop the composition and technology of a bigel for the complex therapy of mastopathy. The general methodological approach to pharmaceutical drug development (LP) is standardized in the ICH Q8 guidance, with which the guidance of ST-N MOH 42-3.0:2011 “Medicines. Pharmaceutical development (ICH Q8)” is harmonized. Taking into account the above we have proposed the algorithm for the methodological approach to the development of the composition of the hydrogel fraction as a component of the bigel for the complex therapy of mastopathy.

Conclusions. The modern results of studying bigels in the world pharmaceutical practice (advantages, principles of development and analysis) have been analyzed and systematized. The methodological approach to the bigel development has been proposed. The technological parameters of the hydrogel fraction production and the rational way of introducing AFI to the composition of the hydrophilic gel base have been determined.