ИНФОРМАЦИОННО-АЛГОРИТМИЧЕСКАЯ ПОДДЕРЖКА РАЗРАБОТКИ ТВЕРДЫХ ЛЕКАРСТВЕННЫХ ФОРМ

The article deals with the application of the system approach for constructing informationalgorithmic support for the pharmaceutical development of solid dosage forms. Information modeling of the life cycle of pharmaceutical drug development has been carried out starting from the stage of studying the active pharmaceutical substance and ending with the utilization of the drug. These models are built in the IDEF0 nomination. A generalized block diagram is presented that reflects, in its most general form, the iterative process of developing a ready-made dosage form as applied to the further transfer of technology. The basis of the system approach is QbD - "Quality planned in the development". To implement the QbD principle on the basis of the system approach, systemic set-theoretic models of information support of pharmaceutical development in the nomenclature of Melentiev have been constructed. A model for controlling the pressing process is also provided, which takes into account all the technological stages in the development of a solid dosage form. Functional models in the IDEF0 nomenclature of the technological process are constructed from the preparation of premises, personnel and components of the dosage form to the stage of packing and packaging of the finished dosage form. The construction of an informational intellectual control system for pharmaceutical development has been considered in detail with particular attention paid to the construction of a database of medicinal and auxiliary substances using the example of solid dosage forms. In Melentiev's bracket notation, the database of auxiliary substances necessary for the design of a solid dosage form is filled. The "Entity-relationship" model and the relational model for the database of medicinal and auxiliary substances have been constructeВ статье рассматривается применение системного подхода для построения информационно-алгоритмической поддержки фармацевтической разработки твердых лекарственных форм. Проведено информационное моделирование жизненного цикла фармацевтической разработки лекарственного препарата, начиная c этапа изучения активной фармацевтической субстанции и заканчивая утилизацией препарата. Данные модели построены в нотации IDEF0. Приводится обобщенная блок-схема, отражающая в самом общем виде итерационный процесс разработки готовой лекарственной формы применительно к дальнейшему трансферу технологии. В основу применения системного подхода положен принцип QbD - «Качество, запланированное при разработке». Для реализации принципа QbD проведено построение системных теоретико-множественных моделей информационной поддержки фармацевтической разработки в скобочной нотации Мелентьева. Также приведена модель для управления процессом прессования, где учитываются все технологические стадии при разработке твердой лекарственной формы. В статье построены функциональные модели в нотации IDEF0 технологического процесса: от подготовки помещений, персонала и компонентов лекарственной формы до стадии фасовки и упаковки готовой лекарственной формы. Подробно рассмотрено построение информационной интеллектуальной системы управления фармацевтической разработкой, при этом особенное внимание уделено построению базы данных лекарственных и вспомогательных веществ на примере твердых лекарственных форм. В скобочной нотации Мелентьева приведено наполнение базы данных вспомогательных веществ, необходимых для дизайна твердой лекарственной формы. Построены модель «Сущность-связь» и реляционная модель для базы данных лекарственных и вспомогательных веществ

INFORMATION-ALGORITHMIC SUPPORT FOR DEVELOPMENT OF SOLID PHARMACEUTICAL FORM

The article deals with the application of the system approach for constructing informationalgorithmic support for the pharmaceutical development of solid dosage forms. Information modeling of the life cycle of pharmaceutical drug development has been carried out starting from the stage of studying the active pharmaceutical substance and ending with the utilization of the drug. These models are built in the IDEF0 nomination. A generalized block diagram is presented that reflects, in its most general form, the iterative process of developing a ready-made dosage form as applied to the further transfer of technology. The basis of the system approach is QbD - "Quality planned in the development". To implement the QbD principle on the basis of the system approach, systemic set-theoretic models of information support of pharmaceutical development in the nomenclature of Melentiev have been constructed. A model for controlling the pressing process is also provided, which takes into account all the technological stages in the development of a solid dosage form. Functional models in the IDEF0 nomenclature of the technological process are constructed from the preparation of premises, personnel and components of the dosage form to the stage of packing and packaging of the finished dosage form. The construction of an informational intellectual control system for pharmaceutical development has been considered in detail with particular attention paid to the construction of a database of medicinal and auxiliary substances using the example of solid dosage forms. In Melentiev's bracket notation, the database of auxiliary substances necessary for the design of a solid dosage form is filled. The "Entity-relationship" model and the relational model for the database of medicinal and auxiliary substances have been construct