Formulation, stability and analytical method validation of peppermint oil solution

Year 2019, Volume: 6 Issue: 2, 25 - 31, 28.06.2019

İlker Demirbolat

Abstract

Tension type headache is the most common type of
headaches causing mild, moderate and intense pain in the forehead and neck. There
are prescription medicines -usually nonsteroidal anti-inflammatory drugs- and
herbal remedies to alleviate the pain. As peppermint (Mentha piperita L.) is one of those most used medicinal plants in
the world, essential oil has also a wide range of medical applications like
tension type headache. The legislation to conventional medicines applies to
herbal medicinal products too, which makes registered herbal medicinal products
reliable in production and quality. A CTD application dossier which contains production
and quality control data in module three should be provided while registering a
product in European Union. In this study a peppermint oil solution is developed
and analytical method is validated to control the stability of solution
indicated for tension type headaches.

Keywords

Peppermint, Mentha piperita L., Analytical Method Validation, Formulation

References

• Asao, T., Mochiki, E., Suzuki, H., Nakamura, J., Hirayama, I., Morinaga, N., Shoji, H., Shitara, Y., & Kuwano, H. (2001). An easy method for the intraluminal administration of peppermint oil before colonoscopy and its effectiveness in reducing colonic spasm. Gastrointestinal Endoscopy, 53(2), 172-177.
• Community Herbal Monograph on Mentha x piperita L., Aetheroleum (2007). Europhean Medicine Agency. London.
• Davies, S. J., Harding, L. M., & Baranowski, A. P. (2002). A novel treatment of postherpetic neuralgia using peppermint oil. The Clinical Journal of Pain, 18(3), 200-202.
• European Pharmacopoeia (2013). Peppermint Oil, 07/2012:0405. 8th ed. European Pharmacopoeia. European Directorate for the Quality of Medicines and Healthcare. Strasbourg: 1353-1354.
• Evans, M. (1991). Herbal Plants, History and Use. London: Studio Editions.
• Giachetti, D., Taddei, E., & Taddei, I. (1986). Pharmacological Activity of Mentha piperita, Salvia officinalis and Rosmarinus officinalis Essences on Oddi’s sphincter. Planta Medica, 52(6), 543-544.
• Gobel, H., Fresenius, J., Heinze, A., Dworschak, M., & Soyka, D. (1996). Effectiveness of Oleum menthae piperitae and paracetamol in therapy of headache of the tension type. Der Nervenarzt ,67(8), 672-681.
• Graves, R. (1955). The Greek Myths I. London: Penguin Books.
• Grigoleit, H. G., & Grigoleit, P. (2005). Peppermint oil in irritable bowel syndrome. Phytomedicine ,12(8), 601-606.
• Grimal, P. (1996). The Dictionary of Classical Mythology. New Jersey: Wiley-Blackwell.
• Hiki, N., Kurosaka, H., Tatsutomi, Y., Shimoyama, S., Tsuji, E., Kojima, J., Shimizu, N., Ono, H., Hirooka, T., Noguchi, C., Mafune, K., & Kaminishi, M. (2003). Peppermint oil reduces gastric spasm during upper endoscopy: a randomized, double- blind, double-dummy controlled trial. Gastrointestinal Endoscopy, 57(4), 475-482.
• ICH Q1A(R2); Stability Testing of New Drug Substances and Products (2003). International Conference on Harmonization. Geneva, Switzerland.
• ICH Q2 (R1); Validation of Analytical Procedures: Text and methodology (2005). International Conference on Harmonization. Geneva, Switzerland.
• İşcan, G., Kirimer, N., Kürkcüoglu, M., & Demirci, F. (2002). Antimicrobial Screening of Mentha piperita Essential Oils. Journal of Agricultural and Food Chemistry, 50, 3943−3946.
• Morice, A. H., Marshall, A. E., Higgins, K. S., & Grattan, T. J. (1994). Effect of inhaled menthol on citric acid induced cough in normal subjects. Thorax, 49(10), 1024-1026.
• Pimentel, M., Bonorris, G. G., Chow, E. J., & Lin, H. C. (2001). Peppermint oil improves the manometric findings in diffuse esophageal spasm. Journal of Clinical Gastroenterology, 33(1), 27-31.
• USP 41-NF 36 Validation of Compendial Procedures. (2016). United States Pharmacopeial Convention. Rockville MD, USA