Development of Technology and Equipment for Enisamium Iodide Drying
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Pharmaceutical Chemistry Journal, Vol. 54, No. 5, August, 2020 (Russian Original Vol. 54, No. 5, May, 2020)
EQUIPMENT FOR CHEMICO-PHARMACEUTICAL PLANTS MECHANIZATION AND AUTOMATION OF TECHNOLOGICAL PROCESSES DEVELOPMENT OF TECHNOLOGY AND EQUIPMENT FOR ENISAMIUM IODIDE DRYING M. S. Vasilishin,1,2 Yu. A. Kryukov,1 A. G. Karpov,1 O. S. Ivanov,1,* D. B. Ivanova,1 S. V. Sysolyatin,1 and A. V. Balakhnina2 Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 5, pp. 55 – 57, May, 2020.
Original article submitted May 8, 2019. A methodological approach to selecting the optimal drying method for enisamium iodide, an antiviral agent with a broad spectrum of pharmacological activities, is considered. A vacuum drying method in an apparatus with a tape mixing device is proposed and verified based on studies of the main properties of the product. An industrial setup prototype and design features of the apparatus are described. The basic technological regimes of enisamium iodide drying ensuring the product quality are established. The kinetic drying and heating curves of the product, including those in the optimal regime, are presented. Test results were used to determine the specific technical parameters of the setup operation. Keywords: enisamium iodide, drying, industrial setup prototype.
One of the problems facing the domestic pharmaceutical industry is increased manufacturing of import-replacing preparations. They include enisamium iodide (N-methyl4-benzylcarbamidopyridinium iodide, I), which is also known under the trademarks Amizon® and Nobazit® and is an antiviral agent that reduces acute clinical manifestations of viral infection and helps to shorten disease duration [1]. The drug is recommended for influenza and acute infections of upper respiratory pathways. Industrial pilot manufacturing of I at IPCET, SB, RAS, met requirements of MPM 000233 – 101111. The quality indicators of the commercial product are determined largely by the sophistication of the design of the drying apparatus and technology, which should comply with modern requirements for energy efficiency and industrial hygiene and safety 1 2 *
[2 – 4]. The selected technology should be sufficiently universal and be capable of rapid rearrangement as necessary for conversion into another configuration of processed materials. Therefore, it seemed interesting to consider a methodological approach to the selection of the optimal drying method for I taking into account the main properties of the product, the required safety level, and the manufacturing scale. EXPERIMENTAL PART Drug substance I was a yellow and odorless polydisperse powder that was very soluble in H2O and poorly soluble in EtOH and Me2CO. Figure 1 shows a photomicrograph of crystals of the product obtained using a PIP 9.1 optical particle-size analyzer (China). The crystals were prismatic with characteristic dimensions 1:3 – 1:5. The equivalent particle size dp = 0.16·10–3 m; angle of natural repose g = 38°. The true density of I measured using an AccuPyc II 1340 gel
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