Development of a New Dosage Form of Herbal Medicinal Products

The «cut-and-pressed granules» dosage form was developed to improve the technological properties of cut and powdered herbal substances in order to compensate for their insufficient flowability, as well as to facilitate dosing, reduce the contamination of the production equipment with dust and contamination of water extracts with dietary fibers. Based on the results of the information research the authors chose an optimal technology for the production of cut-and-pressed granules from some types of herbal substances (Rose hips, Bearberry leaf, Thyme herb, Melissa herb, Oregano herb, Motherwort grass, Matricaria flower). The authors standardised the new dosage form, developed the list of test parameters, test methods, and regulatory requirements for the quality of medicinal products based on the technological features of the new dosage form. Cut-and-pressed granules should not be produced from herbal substances that contain essential oils and coumarins, as it was demonstrated that the content of these compounds may decrease in the process of wet granulation. To determine whether it is possible to produce cut-and-pressed granules from a particular type of raw material, it is necessary to conduct comparative experimental studies confirming that the quality of aqueous extracts obtained from powdered herbal substances in sachets is comparable to that of tinctures or decoctions obtained from cut-and-pressed granules packed in sachets. The materials of the study were used to draft the general chapter OFS.1.4.1.0022.15 «Cut-and-pressed granules». This dosage form is not described in any foreign pharmacopoeias.

1. Bogoyavbnskiy AP, Abksyuk PG, Turmagambetova AS, Вегеит VE. Current problems of standardization of phytopreparations and plant materials for their production. Fundamentalnye issledovaniya = Fundamental Research. 2013;(6-5):1184-7 (In Russ.)

2. Sakanyan EI, Shemeryankina TB, Lyakina MN, Rukavitsyna NP. Current issues of standardization of herbal substances and herbal medicinal products in the Russian Federation and in the Eurasian Economic Union. In: Biological properties of medicinal plants and aromatic herbs and their role in medicine. Collection of scientific papers of the International Research and Practical Conference devoted to the 85th anniversary of VILAR. Moscow; 2016. P. 522–5 (In Russ.)]

3. Evdokimova OV, Stryapushkin PA, Stulovskiy SS, Semionova MV. Cut and pressed raw Nettle and St. John's wort as а new product type. In: Materials of the XIV Russian National Congress «Human and Medicine». Moscow; 2007. P. 820 (In Russ.)

4. Rukavitsyna NP, Antonova NP, Sakanyan EI, Shemeryankina TB, Lyakina MN. Modern approaches to the quality standardisation of medicinal products and herbal medicines in terms of granulation and impurities. In: Collection of research papers of the International Conference «Biological characteristics of medicinal and aromatic plants and their role in medicine». Moscow: Shcherbinskaya tipografiya; 2016. P. 519-23 (In Russ.)

5. Tskhay EV, Evdokimova OV, Devyatkina IA, Strya-pushkin PA, Stulovskiy SS. Study of a new product type — Nettle leaves, cut and pressed. Vestnik Voronezhskogo gosudarstven-nogo universiteta. Seriya: Khimiya. Biologiya. Farmatsiya = Proceedings of Voronezh State University. Chemistry. Biology. Pharmacy. 2007;(2):191-6 (In Russ.)

6. Balandina IA. Development of pharmacopoeial analysis methods and principles for the standardisation of herbal substances and herbal medicinal products. Cand. Pharm. Sci. [thesis]. Moscow; 2004 (In Russ.)

7. Sakanyan EI, Bunyatyan ND, Sakaeva IV, Lyakina MN, Shemeryankina TB, Postoyuk NA, et al. Modern approaches to the structure of monographs on herbal substances. Farmatsiya = Pharmacy. 2015;(4):9-11 (In Russ.)

8. Trifоnоva OB, Evdоkimоva OV. A cоmparative study оf mоrphоlоgical and anatоmical characteristics оf herbal pоwder and cut-pressed granules derived from tripartite bur-marigоld. Asian доurnal оf Pharmaceutics. 2017;11(1):S146— 1.

9. Trifonova OB, Evdоkimоva OV. Anatomical and diagnostic characters of the hawthorn berry powder and granules. Farmatsiya = Pharmacy. 2017;66(7):16-8 (In Russ.)

10. Sokolskaya TA, Dargaeva TD, Shemeryankina TB. The role of standards in the pharmacopoeial analysis of herbal substances and herbal medicines. Voprosy biologiches-koy, meditsinskoy i farmatsevticheskoy khimii = Problems of Biological, Medical and Pharmaceutical Chemistry. 2009;(3):10-3 (In Russ.)

11. Shemeryankina TB, Sokolskaya TA, Dargaeva TD. Requirements for standardisation of herbal substances and herbal medicines. Voprosy biologicheskoy, meditsinskoy i farmatsevticheskoy khimii = Problems of Biological, Medical and Pharmaceutical Chemistry. 2010;(3):9-12 (In Russ.)

12. Tereshkina OI, Rudakova IP, Gravel IV, Gus'kova TA, Samy-lina IA. Problems of standardisation of ecotoxicants in herbal medicines. In: Materials of the XVII Russian National Congress «Human and Medicine». Moscow; 2010. P. 726 (In Russ.)

13. Tereshkina OI, Rudakova IP, Gravel IV, Samylina IA. Problems of standardisation of heavy metals content in herbal substances. Farmatsiya = Pharmacy. 2010;(2):7—11 (In Russ.)

14. Gravel IV, Ivanova EA. Foreign pharmacopoeia requirements for pesticide content in herbal substances. Farmatsiya = Pharmacy. 2010;(7):50—3 (In Russ.)

15. Tereshkina OI, Samylina IA, Rudakova IP, Gravel IV. Harmonisation of approaches to the evaluation of herbal medicines safety. Biomeditsina = Biomedicine. 2011;(3):80—6 (In Russ.)

16. Tereshkina OI, Rudakova IP, Gus'kova TA, Samylina IA. Standardisation of residual pesticides in herbal substances and herbal medicines. Farmatsiya = Pharmacy. 2011;(2):3—5 (In Russ.)