Determination of the critical parameters of the technological process control for pessaries with acyclovir and essential oils during industrial production
Keywords:acyclovir, essential oils, critical parameters, pessaries, technological process
Aim. To determine the critical parameters for controlling the technological stages by the example of the technology for preparing pessaries with acyclovir and essential oils at the industrial site of JSC “Lekhim-Kharkov”, to set the critical limits when introducing this technology into industrial production in order to obtain high-quality, efficient, safe and affordable drugs for the treatment of genital herpes.
Materials and methods. Pessaries with acyclovir and essential oils were prepared at the industrial site of JSC “Lekhim-Kharkov”. The active pharmaceutical ingredients (API) and excipients used in the technology of pessaries with acyclovir and essential oils meet the requirements of the State Pharmacopoeia of Ukraine (SPhU).
Results. The critical parameters of control in the process of scaling the technology of pessaries with acyclovir and essential oils at the industrial site of JSC “Lekhim-Kharkov” have been determined. The study conducted is the basis of the document “Pharmaceutical development”, and it will accelerate the introduction of pessaries into industrial production.
Conclusions. The results of the studies conducted can be used when introducing the technology of pessaries into industrial production, and it will significantly improve the quality of the drug.
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