The substantiation for introduction of the innovative technological process for industrial production of parenteral dosage forms by the example of torasemіde, solution for injection
DOI:
https://doi.org/10.24959/nphj.16.2051Keywords:
parenteral dosage forms, Torasemide, solution for injection, innovative technological process, algorithm, monitoring, critical parameters of the technological process, risk management of pharmaceutical productionAbstract
The introduction of the innovative technological process for industrial production of parenteral dosage forms by the example of Torasemide, solution for injection has been substantiated in the article. The experimental studies for improving the manufacturing technology of Torasemide, solution for injection, 5 mg/ml, the choice of the filter material, the scientific substantiation of the innovative technological process are presented. In particular, the aseptic conditions of production have been selected using sterile filtration and thermal sterilization (stabilization), the algorithm of monitoring of the critical parameters has been developed using the elements of risk management design of pharmaceutical production.References
- Achhammer J., Metz P. // Drugs. – 1991. –Vol. 41. – P. 80–91.
- Engelhardt S., Meineke I., Brockmöller J.// Journal of Chromatography B. –2006. – Vol. 831, Issues 1–2. – P. 31–35.
- European Pharmacopeia 7.5. General Notices apply to all monographs and other texts. – P. 4701-4702.
- Jovic Z., Zivanovic L., Protic A. et al. // Journal of Liquid Chromatography and Related Technologies. – 2013. – Vol. 36, Issue 15. – P. 2082-2094.
- Masereel, B. et al // European Journal of Medicinal Chemistry. – 1995. – Vol. 30, №4. – Р. 343-351.
Downloads
Published
2016-03-11
Issue
Section
Technology of Medicines
License
Copyright (c) 2016 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
