QUALITY CONTROL AND STANDARDIZATION OF MEDICAL PENCILS CONTAINING WALNUT OIL
DOI:
https://doi.org/10.11603/2312-0967.2026.1.15992Keywords:
quality control, standardization, medical pencils, semi-solid dosage forms, walnut oil, stability, quality attributes, pharmacopoeial testsAbstract
ABSTRACT
Medical pencils are a topical dosage form used for the treatment and prevention of skin and mucosal disorders. The assessment of their quality is essential to ensure safety and consistent performance. Despite the availability of pharmacopoeial recommendations for semi-solid dosage forms, issues related to the quality control and standardization of medical pencils containing natural oils remain relevant.
The aim of the study was to perform quality control of medical pencils containing walnut oil and to substantiate approaches to their standardization in order to confirm the stability of the formulation and its safety during storage and use.
Materials and methods. The study objects were medical pencils containing walnut oil. Organoleptic, physical, physicochemical, microscopic, and statistical methods were applied.
Results and discussion. Based on the results of the conducted studies, the standardization parameters of the medical pencils were established: organoleptic (appearance, color, odor, consistency), pharmaco-technological (mass uniformity of the single-dose medicinal product, softening time, disintegration time, content uniformity), physical and physicochemical parameters (melting point, pH, acid value, and peroxide value). It was experimentally demonstrated that the medical pencils containing walnut oil remained stable over an 18-month storage period and showed no changes in the above-mentioned parameters.
Conclusions. Quality control of the medical pencils was carried out according to organoleptic, physical, physicochemical, and microscopic parameters. The stability of the proposed formulation was experimentally confirmed over 18 months of storage.
References
Velchynska OV, Nizhenkovska IV. [Modern definitions of drug standardization]. Health & Education. 2024;2:125-31. https://doi.org/10.32782/health-2024.2.16 DOI: https://doi.org/10.32782/health-2024.2.16
Shulga LI, Lukienko OV. [Issues of standardization of medicines in the form of medical pencils]. Modern achievements and prospects for the development of apitherapy in Ukraine: materials of the All-Ukrainian scientific and practical conference with international participation (January 25, 2020, Kharkiv). Kh.: Publishing house "Original". 2020. Р. 202.
Zaychenko V, Ruban O, Maslii Yu, Gerbina N. Physico-chemical and pharmaco-technological research at a substantiation of rational composition and technology of suppositories «Indoxam». Scientific Journal «ScienceRise: Pharmaceutical Science». 2018;5(15):17–23. https://doi:10.15587/2519-4852.2018.146500 DOI: https://doi.org/10.15587/2519-4852.2018.146500
Law of Ukraine “On Standardization” [Electronic resource]. Access mode: http://www.moz.gov.ua. https://zakon.rada.gov.ua/laws/show/1315-18#Text.
Frolova OYe, Tikhonov OI, Shpychak ОS, Novikov SM, Lenchin VM. Development of the technology of vials-pencils for storage and application of medicated products on the skin and its appendages. The Pharma Innovation Journal. 2016;5(10):43-8.
Dubel NI, Grytsyk LM, Grytsyk AR, Lehin NI. [Development of the composition of walnut oil-based medical pencils]. Farmatsevtychnyy chasopys. 2025;3:27-34. DOI: 10.11603/2312-0967.2025.3.15576 DOI: https://doi.org/10.11603/2312-0967.2025.3.15576
Dubel NI, Grytsyk LM, Shemota YаM, Lehin NI, Grytsyk AR. [Technology of manufacturing medical pencils with walnut oil]. Pharmaceutical Journal. 2025;4:15-21. DOI: https://doi.org/10.11603/2312-0967.2025.4.15789 DOI: https://doi.org/10.11603/2312-0967.2025.4.15789
State Pharmacopoeia of Ukraine: 2nd ed. Kharkiv: State Enterprise «Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicinal Products”. 2015;1:1128.
State Pharmacopoeia of Ukraine. 2nd ed. Supplement 4. Kharkiv: State Enterprise “Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicinal Products”. 2020:600 p.
State Pharmacopoeia of Ukraine. 2nd ed. Supplement 1. Kharkiv: State Enterprise “Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicinal Products”. 2016:360 p.
State Pharmacopoeia of Ukraine. 2nd ed. Supplement 3. Kharkiv: State Enterprise “Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicinal Products”. 2018:416 p.
Shulga LI, Rolik-Attia SM, Gubchenko TD, Piminov OF. [Study of the stability of an extemporaneous medicinal product in the form of medical pencils]. Modern aspects of the creation of extemporaneous allopathic, homeopathic and cosmetic medicinal products: collection of scientific works. Kharkiv: National University of Physics and Technology. 2021;6:100-1.
Tomchuk VV. [Study and establishment of quality indicators of suppositories in the process of developing their composition and technology]. Ukrayinskyy zhurnal viyskovoyi medytsyny. 2023;4(2):114-8. DOI –10.46847/ujmm.2023.2(4)‐114 DOI: https://doi.org/10.46847/ujmm.2023.2(4)-114
Melnyk GM, Yarnykh TG, Gerasimova IV, Rukhmakova OA. [Study of the stability of pessaries intended for preparation of the birth canal before childbirth]. Pharmaceutical Journal. 2021;76(3):33-40. DOI: https://doi.org/10.32352/0367-3057.3.21.04
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Accepted 2026-03-08
Published 2026-03-31