Doris Kumadoh, Kwabena Ofori Kwakye


There has been an upsurge in the use of herbal medicinal products across both developing and advanced countries. Finished herbal products are presented in various dosage forms such as decoctions, herbal powders, alcoholic beverages, capsules, tablets, ointments and creams. The growing demand for herbal medicinal products across the world has resulted in the large scale manufacture of these products. Large scale production leads to longer storage periods which could lead to deterioration of products, thereby compromise product quality with adverse consequences on patient safety. Stability studies on herbal products have become necessary to help determine the shelf-life and enhance product quality at all times during storage periods and usage. Appropriate guidelines for stability testing of finished herbal products provides manufacturers, regulatory authorities and research institutions with a harmonized system for stability testing. This paper presents an overview of the various herbal dosage forms commonly available and their stability considerations. This information will help in the production of safe, stable and efficacious herbal medicinal products for use.


Herbal medicines, Herbal dosage forms, Finished herbal products, Stability testing, Shelf-life, Storage temperature

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Ekor M. The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety. Front Pharmacol 2014;4:177.

Thakur L, Ghodasra U, Patel N, Dabhi M. Novel approaches for stability improvement in natural medicines. Pharmacogn Rev 2011;5:48-54.

Dodoo ANO, Appiah-Dankwah A, Gyansa-Lutterodt M, Duwiejua M. Safety monitoring of herbal medicines in Ghana: challenges and opportunities. Drug Safety 2006;29:352.

Mukherjee PK, Houghton PJ. Evaluation of Herbal Medicinal Products-Perspectives on quality, safety and efficacy. London, UK, Pharmaceutical Press; 2009.

Mukherjee PK. Evidence-Based Validation of Herbal Medicine. 1st ed. Netherlands: Elsevier; 2015.

Benzie IFF, Wachtel-Galor S. Herbal Medicines, Biomolecular and Clinical Aspects. 2nd ed. New York: CRC Press; 2011.

Gafner S, Bergeron C. The challenges of chemical stability testing of herbal extracts in finished products using state-of-the-art analytical methodologies. Curr Pharm Anal 2005;1:203-15.

Aulton ME. Aulton’s pharmaceutics-the design and manufacture of medicines. 3rd ed. London: Churchill Livingstone; 2007.

World Health Organization (WHO). Stability Testing of Active Substances and Pharmaceutical Products. Restricted Working document QAS/06.179; 2006. p. 10-32.

European Medicines Agency (EMA). Reflection paper on stability testing of herbal medicinal products and traditional herbal medicinal products. EMA/HMPC/3626/2009 Committee on Herbal Medicinal Products (HMPC); 2009.

European Pharmacopoeia. Vol. 1. Herbal drug preparations; 2005.

Green J. The Herbal medicine-makers Handbook: A Home Manual. USA: Crossing Press; 2002.

Yi YD, Chang LM. An overview of traditional Chinese herbal formulae and a proposal of a new code system for expressing the formulae titles. J Evidence-Based Complementary Altern Med 2004;1:125-32.

Ghiware Nitin B, Gattani Surendra G, Chalikwar Shailesh S. Design, development and evaluation of oral herbal formulations of Piper nigrum and Nyctanthes arbortristis. Int J PharmTech Res 2010;2:171-6.

Bone K, Mills S. Principles and practice of phytotherapy: modern herbal medicine. 2nded. Elsevier Health Sciences; 2013.

Hoffman D. Medical Herbalism: The Science and Practice of Herbal Medicine. Vermont: Healing Arts Press; 2003.

Liu Y, Yang J, Cai Z. Chemical investigation on Sijunzi decoction and its two major herbs Panax ginseng and Glycyrrhiza uralensis by LC/MS/MS. J Pharm Biomed Anal 2006;41:1642-7.

Chewchinda S, Wuthi-udomlert M, Gritsanapan W. HPLC quantitative analysis of rhein and anti dermatophytid activity of cassia fistula pod pulp extracts of various storage conditions. BioMed Res Int 2013. 821295

Bascom A. Incorporating Herbal Medicine into Clinical Practice. Philadelphia: F. A. Davis Company; 2002.

Politi M, Zloh M, Pintado ME, Castro PML, Heinrich M, Prieto JM. Direct metabolic fingerprinting of commercial herbal tinctures by nuclear magnetic resonance spectroscopy and mass spectrometry. Phytochem Anal 2009;20:328-34.

Bone K. Dosage considerations in herbal medicine Part 3. Mediherb Professional Review; 1993. Available from: [Last accessed on 25th Aug 2016]

Morgan M. Ethanol in medicine–a phytotherapist’s perspective; 2009, p. 1-4.

Bruton-Seal J, Seal M. Backyard medicine-harvest and make your own herbal remedies. New York: Skyhouse Publishing; 2009.

Bilia AR, Bergonzi MC, Gallori S, Mazzi G, Vincieri FF. Stability of the constituents of Calendula, Milk-thistle and Passionflower tinctures by LC-DAD and LC-MS. J Pharm Biomed Anal 2002;30:613-24.

Beal GD, Walters KL, Block Jr P. Stability of iodine solutions and tinctures. J Pharm Sci 1947;36:203-7.

Peschel W. Quality control of traditional cannabis tinctures: pattern, markers, and stability. Sci Pharm 2016;84:567-84.

Ogbonnia SO, Mbaka GO, Igbokwe NH, Anyika EN, Alli P, Nwakakwa N. Antimicrobial evaluation, acute and subchronic toxicity studies of Leone Bitters, a Nigerian polyherbal formulation, in rodents. Agric Biol J North Am 2010;1:366-76.

Komes D, Belscak-Cvitanovic A, Horzic D, Drmic H, Skrabal S, Milicevic B. Bioactive and sensory properties of herbal spirit enriched with cocoa (Theobroma cacao L.) polyphenolics. Food Bioprocess Tech 2012;5:2908-20.

Buglass AJ. Handbook of alcoholic beverages: technical, analytical and nutritional aspects. Vol. I. Wiley Publications; 2011.

Karabegovic IT, Vukosavljevic PV, Novakovic MM, Gorjanovic SZ, Dzamic AM, Lazic ML. Influence of the storage on bioactive compounds and sensory attributes of herbal liqueur. Digest J Nanomaterials Biostructures 2012;7:1587-98.

Rodriguez M, Sadler GD, Sims CA, Braddock RJ. Chemical changes during storage of an alcoholic orange juice beverage. J Food Sci 1991;56:475-9.

Winfield AJ, Rees AJ, Smith I. Pharmaceutical practice. London: Churchill Livingstone; 2009.

Bayor MT, Johnson R, Gbedema SY. The oral capsule-the most appropriate dosage form for Croton membranaceus. Int J Pharm Sci Res 2011;2:55-62.

Johnson R, Bayor MT, Adotey J. Formulation and evaluation of Bridelia ferruginea and Canthium glabriflorum herbal capsules. J Herbal Med Plants 2010;1:18-22.

Bankoti K, Rana MS, Bharadwaj MK. Accelerated stability study of herbal capsules. IOSR J Pharm 2012;2:1-6.

Pranskuniene Z, Bernatoniene J, Kalveniene Z, Masteikova R, Mekas T, Velziene S, et al. New formula herbal pellets demonstrate a uniform and stable release of the active ingredients in vitro. Acta Pol Pharm 2013;70:727-36.

Daberte I, Barene I, Rubens J, Daugavietis M, Sazhenova N. Stability of soft gelatin capsules containing thick extract of pine needles. Medicina (Kaunas) 2011;47(Suppl 2):71-7.

Mishra US, Murthy PN, Sahoo SK, Sahu KC. Formulation and evaluation of herbal tablet containing methanolic extract of Calophyllum inophyllum. Int J Pharm 2012;2:181-6.

Kucinskaite A, Sawicki W, Briedis V, Sznitowska M. Fast disintegrating tablets containing Rhodiola rosea L. Extract Acta Pol Pharm 2007;64:63-7.

Al-Achi A. An introduction to botanical medicines: History, Science, Uses and Dangers. Connecticut: Praegers Publishers; 2008.

Zdoryk OA, Khokhlova KO, Georgiyants VA, Vyshnevska LI. Investigation of physical and chemical stability of ointment with herbals. Int J Pharm Compd 2014;18:248-52.

Vincent WM. The complete guide to growing healing and medicinal herbs: Everything you need to know simply explained. Atlantic publishing company; 2011.

Russell ND, LW Sneyd LW. Healthy solutions: a guide to simple healing and healthy wisdom. Basic Health Publications Inc. USA; 2006.

Turek C, Stintzing FC. Stability of essential oils: a review. Compr Rev Food Sci Food Saf 2013;12:40-53.

Jones M. The Complete Guide to Creating Oils, Soaps, Creams, and Herbal Gels for your Mind and Body. Atlantic Publishing Company; 2011.

Grosso A. The Everything Soapmaking Book: Learn How to Make Soap at Home with Recipes. Massachusetts: Adams Media; 2013.

Panda H. Herbal soaps and detergents handbook. Natl Institute Industrial Res 2000;1:194-6.

Van Loveren C. Toothpastes. Amsterdam: Karger Medical and Scientific Publishers; 2013.

Packer L, Ong CN, Halliwell B. Herbal and Traditional Medicine, Molecular Aspects of Health. New York: Marcel Dekker; 2004.

Bouwman Y, Fenton-May V, Le Brun P. Practical Pharmaceutics, An International Guideline for the Preparation, Care and Use of Medicinal Products. Netherlands: Springer; 2015.

Tiwari M. Ayurveda: the secrets of healing. Delhi: Motilal Banarsidass Publishers, India; 1995.

Castleman M. The New Healing Herbs: The Classic Guide to Nature's Best Medicines. Rodale Inc., USA; 2001.

Ameh S, Obodozie O, Gamaniel S, Abubakar M, Garba M. Physicochemical variables and real time stability of the herbal substance of Niprd-AM1®-an antimalarial developed from the root of Nauclea latifolia S. M. (Rubiaceae). Int J Phytomed 2010;2:332-40.

Page L. Linda Page’s Healthy Healing; a guide to self-healing for everyone. 12th ed. Healthy healing Inc; 2004.

Philips N, Philips M. The Herbalist's Way: The Art and Practice of Healing with Plant Medicine. Chelsea Green Publishing; 2005.

Shao L, Chow SC. Drug shelf-life estimation. Stat Sin 2001;11:737-45.

Kruse SO. Stability testing of herbal medicinal products; Bridging Science to Industry. Planta Med; 2013. p. 79-PK15.

Gautam A, Kashyap SJ, Sharma PK, Garg VK, Visht S, Kumar N. Identification, evaluation and standardization of herbal drugs: a review. Pharm Lett 2010;2:302-15.

Awang DVC. Standardization of herbal medicinal products. Acta Hort 2004;629:112-4.

Bodhisattwa M, Nagori BP, Rambir S. Recent trends in herbal drugs: a review. Int J Drug Res Tech 2011;1:17-25.

Jain SK. Stability protocols for different dosage forms. Department of Pharmacy, Institute of Biomedical Education and Research, Magalayatan University; 2011. Available from: [Last accessed on 18th Aug 2016]

Joshi DD. Herbal drugs and fingerprints: evidence based herbal drugs. Springer Sciences and Media; 2012.

Ngoc ATP. The microbiological requirements of a stability study. AMS Laboratories Pty Ltd; 2012. p. 6-15. Available from: [Last accessed on 18th Aug 2016]

Food and Drugs Authority (FDA), Ghana. Guidelines for Registration of Herbal Medicinal Products in Ghana. FDA/HMD/GL-HB/2012/01 2013;1:5-7.

British Pharmacopoeia. Vol. IV. Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal products. British Pharmacopoeia Commission, MHRA, London; 2013.

Chhetri HP, Yogol NS, Sherchan J, Anupa KC, Mansoor S, Thapa P. Formulation and evaluation of antimicrobial herbal ointment. Kathmandu University J Sci Eng Technol 2010;6:102-7.

Lam YWF, Huang SM, Hall SD. Herbal supplements–drug interactions: scientific and regulatory perspectives. New York: CRC Press, USA; 2006.

Leung PC. A comprehensive guide to Chinese medicine. 2nd ed. World Scientific; 2015.

ICH Q1 AR2, Stability testing guidelines: stability testing of new drug substances and products. Available from: http:// Last accessed on 18th Aug 2016].

Guidelines on specifications, test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products’ (CPMP/QWP/2820/00, EMEA/CVMP/815/00, current version). Available from: en_GB/ document_library/Scientific_guideline/2009/09/WC500003393.pdf. [Last accessed on 23rd Aug 2016].

Ahuja S, Scypinski S. Handbook of modern pharmaceutical analysis. 2nd ed. Academic Press; 2011.

Zahn M, Kållberg PW, Slappendel GM, Smeenge HM. A risk-based approach to establish stability testing conditions for tropical countries. J Pharm Sci 2006;95:946-65.

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Herbal medicines, Herbal dosage forms, Finished herbal products, Stability testing, Shelf-life, Storage temperature





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Vol 4, Issue 4 (July-Aug), 2017 Page: 1-8

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Authors & Affiliations

Doris Kumadoh
1Centre for Plant Medicine Research (CPMR), Mampong-Akuapem, Ghana

Kwabena Ofori Kwakye
Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, College of Health Sciences, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana


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