Экспериментально доказана физико-химическая, фармако-технологическая и микробиологическая стабильность глазных капель кромогликата натрия в полиэтиленовой упаковке при хранении в течение 2-х лет.
Состав, показатели качества и технология получения лекарственного средства стандартизованы в аналитической и технологической документации на “Кромофарм, 2 % глазные капли”. Новизна исследований подтверждена заявками на выдачу патентов Украины (№ u 2007 12154 от 02.11.2007 и № а 2007 12158 от 02.11.2007). Препарат зарегистрирован в Украине и внедрен в промышленное производство на ОАО “Фармак”.
Ключевые слова: аллергия, лекарственное средство, глазные капли, кромогликат натрия, бензалкония хлорид, стабильность, состав, технология, стандартизация.
Fetisova E.G. "The development and standardization of the pharmaceutical composition and technology of eye drops with antiallergic effect". - Manuscript.
Thesis for a competition of an academic degree of candidate of pharmaceutical on speciality 15.00.03 - standardization and management of production of medicinal products.- State Enterprise "The State Scientific Center of Drugs", Kharkov, 2008.
The Thesis is devoted to the development and standardization of the pharmaceutical composition and technology of antiallergic eye drops based on cromoglicate sodium. The method of obtaining of eye drops, that allows to combine incompatible in aqueous solution cromoglicate sodium and antimicrobial preservative benzalkonium chloride, has been suggested.
The rational choose of qualitative and quantitative composition of excipients has allowed to provide physico-chemical and microbiological stability of eye drops during storage and use as well as comfort of the drug application.
According to the results of physico-chemical, technological and microbiological researches for the first time in Ukraine pharmaceutical composition, qualitative indexes and technology of domestic eye drops based on cromoglicate sodium have been substantiated scientifically, verified experimentally and standardized in the analytical specifications and the technical regulations. The novelty of the research has been confirmed by the patent application in Ukraine. The drug has been registered in Ukraine and its technology has been applied in industry at Joint Stock Company “Farmak”.
Key words: allergy, drug, eye drops, cromoglicate sodium, benzalkonium chloride, stability, pharmaceutical composition, technology, standardization