VALIDATION OF THE SPECTROPHOTOMETRIC METHOD FOR COMPARATIVE EXTRACTION IN STUDYING THE DELIVERY OF TICAGRELOR VIA NASOGASTRAL TUBES in vitro

Authors

DOI:

https://doi.org/10.11603/2312-0967.2025.4.15683

Keywords:

Keywords: ticagrelor, tablets, UV-spectrophotometry, validation, nasogastral tube

Abstract

The aim of the work. Validation of the spectrophotometric method for quantitative determination of ticagrelor, for studying the completeness of the degree of extraction, of the finished medicinal product Ticagrelor, film-coated tablets,
90 mg, according to the criteria specificity, accuracy, precision, linearity in the studied concentration range in accordance with the requirements of the State Pharmacopoeia of Ukraine. Monitoring the completeness of extraction of the generic and reference drug after delivery via a nasogastric tube to study bioequivalence.

Materials and methods. The study material is the study drug Ticagrelor film-coated tablets, 90 mg (manufacturer - SLC "INTERCHEM", Ukraine), the reference drug is BRILINTA, film-coated tablets, 90 mg (manufacturer - AstraZeneca AB). Working reference standard (WRS) of ticagrelor according to SP 007-090/RSS-08.1 (manufacturer - SLC "INTERCHEM", Ukraine).

pH meter SevenEasy (Mettler Toledo, China), electronic laboratory balance AUX220 (SHIMADZU, Japan), magnetic stirrer ARE (VELP Scientifica, Italy), spectrophotometer UV-2401 PC (Shimadzu), measuring laboratory glassware class A. Oral syringe - three-component disposable sterile polypropylene, nasogastric tube - polyvinyl chloride material, tube size – 8 French; internal diameter - 2.7 mm; length 1200 mm.

Results and discussion. To develop and validate a method for quantitative determination of ticagrelor, to study the completeness of the degree of extraction, the finished drug Ticagrelor, film-coated tablets, 90 mg, a band in the absorption electronic spectrum in the region from 210 nm to 400 nm at a wavelength of 300 nm was selected. The validation of the method was carried out according to the criteria of specificity, accuracy, precision, linearity in the studied concentration range in accordance with the requirements of the State Pharmacopoeia of Ukraine. The range of its application is within 80 - 120%. The method is specific and is characterized by proper accuracy and precision, as well as linear dependence in the studied concentration range, which allows it to be used to study the completeness of the degree of extraction of the drug when passing through a nasogastric tube. The enteral administration of the generic and reference drug was monitored to study bioequivalence.

Conclusions. A simple and rapid spectrophotometric method for the quantitative determination of ticagrelor was validated in the work. It was proven that the method is specific and characterized by proper accuracy and precision, as well as linear dependence in the studied concentration range, which allows it to be used to study the completeness of the degree of extraction of the drug when passing through an NG tube.

It was found that the generic and reference drugs are equivalent in terms of variability of the degree of extraction when delivered through an NG tube (more than 94% of ticagrelor is extracted after suspension in water and administration through an NG tube with a diameter of 8 French), and the risk of tube blockage or obstruction is low, as almost all suspended drug particles passed through the NG tube after drug delivery

Author Biographies

Yu. V. Skrypynets, O.V. Bogatsky Institute of Chemistry, NASU, Odessa, Ukraine

PhD, Senior Researcher, Laboratory of Bioanalytics and Pharmaceutical Analysis, Department No. 5

I. I. Chebotarska, O.V. Bogatsky Institute of Chemistry, NASU, Odessa, Ukraine

PhD, Senior Researcher, Laboratory of Bioanalytics and Pharmaceutical Analysis, Department No. 5

D. I. Aleksandrova, O.V. Bogatsky Institute of Chemistry, NASU, Odessa, Ukraine

PhD, Researcher, Laboratory of Bioanalytics and Pharmaceutical Analysis, Department No. 5

S, M, Kashutskуy, SLC "ІNTERCHEM"

Head of the Technological Department

A. V. Yegorova, O.V. Bogatsky Institute of Chemistry, NASU, Odessa, Ukraine

Doctor of Chemical Sciences, Professor, Head of the Laboratory of Bioanalytics and Pharmaceutical Analysis, Department No. 5

References

Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry. DRAFT GUIDANCE. June 2021, Pharmaceutical Quality

Тanaka R, Eto D, Goto K, Ohchi Y, Yasuda N, Suzuki Y, Tatsuta R, Kitano T, Itoh H. Pharmacokinetic and adsorptive analyses of administration of oral voriconazole suspension via enteral feeding tube in intensive care unit patients. Biol. Pharm. Bull. 2021;44(5):737-41. doi: 10.1248/bpb.b20-00796 DOI: https://doi.org/10.1248/bpb.b20-00796

Karkossa F, Bading A, Klein S. What to consider for successful administration of oral liquids via enteral feeding tubes? A case study with paediatric ibuprofen suspensions. Int. J. Pharm. 2024; 5(649):123628. doi: 10.1016/j.ijpharm.2023.123628 DOI: https://doi.org/10.1016/j.ijpharm.2023.123628

Santangelo M, Wood JA, Barnett KL, Wooding FGG, Bartlett JA. In vitro assessment for dose preparation and simulated administration of azithromycin suspensions via enteral feeding tubes. Hosp. Pharm. 2022;57 (2):260-7. doi: 10.1177/00185787211024216 DOI: https://doi.org/10.1177/00185787211024216

Teng R. Ticagrelor: Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Profile: An Update. Clin Pharmacokinet. 2015; 54(11):1125-38. doi: 10.1007/s40262-015-0290-2 DOI: https://doi.org/10.1007/s40262-015-0290-2

FDA Draft Guidance on Ticagrelor.

Instruktsiia dlia medychnoho zastosuvannia likarskoho zasobu BRYLINTA, tabletky, vkryti plivkovoiu obolonkoiu po 90 mg.

Derzhavna Farmakopeia Ukrainy: v 3 t. / Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv». – 2-e izd. - Dopovnennia 4. – Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 2020, 123-236.

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Published

2025-12-30

How to Cite

Skrypynets, Y. V., Chebotarska, I. I., Aleksandrova, D. I., Kashutskуy S. M., & Yegorova, A. V. (2025). VALIDATION OF THE SPECTROPHOTOMETRIC METHOD FOR COMPARATIVE EXTRACTION IN STUDYING THE DELIVERY OF TICAGRELOR VIA NASOGASTRAL TUBES in vitro. Pharmaceutical Review Farmacevtičnij časopis, 76(4), 22–30. https://doi.org/10.11603/2312-0967.2025.4.15683

Issue

No. 4 (2025)

Section

Analysis of drugs

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