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 constructe

system approach, solid medicines, QbD principle, set-theoretic models, functional modeling, information models, information-intellectual control systems, databases, V. A. Melentiev’s notation, IDEF0 notation, model «entity-relationship», relational model

1. am Ende D.J. Manufacture of medicines. Chemical technology from R & D to production: transl. from English. St. Petersburg: OCP "Profession", 2015. 1280 p. (in Russ.)

2. am Ende D., Bronk K.S., Mustakis J., O’Connor G., Santa Maria Ch.L., Nosal R., Watson T.J.N. API quality by design example from the Torcetrapib manufacturing process. Journal of Pharmaceutical Innovation. 2007; 2(3-4): 71-76.

3. Taptunov V.N., Ekimov S.D., Guseva E.V. Information intellectual system for the development of schemes for the production of solid medicinal forms. Programmnyye produkty i sistemy (Software Products and Systems). 2008; (4): 160-161. (in Russ.)

4. Volkova V.N., Denisov A.A. Theory of systems and systems analysis. Moscow: Yurait Publishing House, 2012. 679 р. (in Russ.)

5. Rubin E., Tummala S., Both D., Wang C., Delany E. Emerging technologies supporting chemical process R&D and their increasing impact on productivity in the pharmaceutical industry. Chem.Rev. 2006; 106(7): 2794-2810.

6. Zhukov D. Foreign experience in managing innovation activity of pharmaceutical companies. Innovatsionnaya ekonomika: informatsiya, analitika, prognozy (Innovative Economics: Information, Analytics, Forecasts). 2011; (1): 35-38. (in Russ.)

7. Borisova I.A., Sazhneva L.P. Prospects and directions of development of products of information and communication systems. Ekonomika i predprinimatel'stvo (Economics and Entrepreneurship). 2017; 12-2 (89): 1169-1172. (in Russ.)

8. Melentyev V.A. Bracket form of the graph description and its use in the structural investigations of enduring computer systems. Avtometriya (Autometry). 2000; 38(4): 36-52. (in Russ.)

9. Federsen H.-J. In search of sustainability: Process R&D in light of current pharmaceutical R&D challenges. Drug Discov.Today. 2006; 11(21-22): 966-974.

10. Alekseev K.V., Kedik S.A., Blynskaya E.V. [et al.] Pharmaceutical technology. Solid dosage forms: a training manual. Ed. by S.А. Kedik. Moscow: Institute of Pharmaceutical Technology, 2011. 662 p. (in Russ.)

11. Meshalkin V.P. Expert systems in chemical technology. Moscow: Khimiya Publ., 1995. 367 p. (in Russ.)

12. Menshutina N.V., Matasov A.V. Modern information systems for data storage, processing and analysis for chemical and related industries. Moscow: RСTU Publ., 2011. 308 p. (in Russ.)

13. Pharmaceutical development: the concept and practical recommendations. Scientific and practical guide for the pharmaceutical industry. Eds. Bykovsky S.N., Vasilenko I.A., Demina N.B., Shokhin I.E., Novozhilova O.V., Meshkovskiy A.P., Spitskiy O.R. Moscow: Pero Publ., 2015. 472 p. (in Russ)

14. Kornushko V.F., Panov A.V., Bogunova I.V., Nikolaeva O.M., Flid A.A. System approach to informational support of pharmaceutical development of finished medicinal products. Tonkiye khimicheskiye tekhnologii / Fine Chemical Technologies. 2018; 13(2): 91-99. (in Russ.)

15. Kornushko V.F., Panov A.V., Bogunova I.V., Nikolaeva O.M., Flid A.A. The application of the system approach for building the information space for the development of the production of ready medicines. Prikladnaya informatika (Applied Informatics). 2018; 13(3): 83-100. (in Russ.)

16. Alkayev Р.Р., Uchvatov S.А., Tolstykh N.D. Overview of EMS SQL manager for SQL server. Apriori. Seriya: Estestvennyye i tekhnicheskiye nauki (Apriori. Series: Natural and Technical Sciences). 2016; (3): 14-18. (in Russ.)