Development of the technology for the production of a medicinal product from fennel (Foeniculum vulgare) fruits in a filter bag

Authors

DOI:

https://doi.org/10.24959/nphj.23.116

Keywords:

foeniculum vulgare, filter bags, technology, stability

Abstract

Aim. To develop the technology of a medicinal product with a dry extract of fennel (Foeniculum vulgare) fruits in a filter bag with carminative, antispasmodic, analgesic, anti-inflammatory, antimicrobial and mild diuretic effects, which improves digestion, the motor evacuation function and the functional state of the gastrointestinal tract.

Materials and methods. To solve the tasks set in the work, such research methods as bibliosemantic, analytical and logical, generally accepted organoleptic (appearance, color, odor, etc.), biopharmaceutical (the study of the effect of the degree of grinding of the substance and excipients on the quality of the finished product), pharmacotechnological (description, weight of the contents of the container) and mathematical (statistical processing of results according to the requirements of the State Pharmacopoeia of Ukraine, using Statistica (StatSoft, USA) and Excel (Microsoft, USA) programs) were used.

Results and discussion. One of the biopharmaceutical indicators is a properly selected primary packaging, which will deliver the drug in a timely manner, ensuring the patient’s safety. Based on a complex of preliminary pharmacotechnological studies, the technology of the drug under the conditional name “Fenelmet, filter bags” has been developed.

Conclusions. Based on the research conducted, the technological process has been developed. The technology for the production of the medicinal product “Fenelmet, filter bags” and the draft technological regulations have been developed. Critical stages of the technological process have been identified; control parameters of critical stages and acceptance criteria that affect the quality indicators have been determined.

Author Biographies

O. M. Tkachuk, Municipal Institution of Higher Education “Rivne Medical Academy” of the Rivne Region Council

PhD, senior teacher of the Department of Chemical and Pharmaceutical Disciplines

О. О. Shmalko, Medical Institute of BSNU named after Petro Mohyla

Аssociate professor of the Department of Pharmacy, Pharmacology, Medical, Bioorganic and Biological Chemistry

Т. М. Nesteruk, Specialized Medical College Municipal Institution of Higher Education “Rivne Medical Academy” of the Rivne Region Council

PhD, head of the Cycle Commission of Pharmaceutical Disciplines of the Specialized Medical College

L. I. Vyshnevska, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv

Doctor of Pharmacy (Dr. habil.), professor, head of the Drug Technology Department

References

Baula O. P., Derkach T. M. (2017). Quality control of herbal medicines: current state and prospects. Pharmaceutical review. № 2. 79-78.

Fylypiuk O., Shmalko О., Vyshnevska L. (2021). Aqua foeniculi: different approaches to the compounded technology. Pharmacology Online. Vol. 3. 1256‒1264.

Ravikumar Chandini. (2014). Review on herbal teas. Journal of Pharmaceutical Sci-ences and Research. Vol. 6, № 5. 236.

Musharaf Khan, Shahana Musharaf. (2014). Foeniculum vulgare Mill. A Medicinal Herb. Medicinal Plant Research. Vol. 4, № 6, 46–54.

Stepanov Yu. M., Skirda I. Yu., Petishko O. P. (2017). Chronic inflammatory bowel disease: features of epidemiology in Ukraine. Gastroenterology. № 2 (51), 97‒105.

De Bortoli N, Tolone S, Frazzoni M. (2018). Gastroesophageal reflux disease, func-tional dyspepsia and irritable bowel syndrome: common overlapping gastrointestinal disorders. Ann Gastroenterol. Vol. 31, № 6, 639-648.

Shmalko О. О., Fylypiuk O. М., Vyshnevska L. І. (2022). Modern achievements of pharmaceutical technology and biotechnology : material of the collection of scientific papers. Kharkiv International science and practical conference, Kharkiv, November 10-11.22. Kharkiv : NFaU.

Fylypiuk O. М., Vyshnevska L. І. (2022). Investigation of some pharmacotechnologi-cal, physicochemical and pharmacognostic properties of common fennel (Foeniculum vulgare) fruits. Farmatsevtychnyi zhurnal. № 4, 84–91. doi: https://doi.org/10.32352/0367-3057.4.22.09.

Pharmaceutical development (ICH Q8): quality guidelines: Guideline СТ-Н MoH 42-3.0:2011 / M. Lyapunov and others. Publishing House. Kyiv: Мinistry of Health of Ukraine, 2011. 33 p.

Fylypiuk O. М., Vyshnevska L. І. Biopharmaceutical and microbiological studies of infusions of common fennel fruit. News of pharmacy. 2022. № 2 (104). P. 21-25. doi: https://doi.org/10.24959/nphj.22.96.

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Published

2023-10-23

Issue

Vol. 106 No. 2 (2023)

Section

Technology of Medicines

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