An investigation into the effects of excipients on quality characteristics of a dry herbal extract containing capsule

Branka Grujić, Zdenka Vuković, Jelena Veljković-Giga, Svetlana Ibrić, Dragana Dekanski


Nutrition and dietary supplements have a significant role in the prevention and treatment of cardiovascular disease. Olive and vine leaves, thanks to their constituents, represent powerful natural antioxidants exhibiting cardioprotective activity. High concentrations of active ingredients can be provided by means of extraction. Dry herbal extracts are highly sensitive to moisture and elevated temperature and from the pharmaceutical and technological point of view these are raw materials with inadequate technological properties. The aim of this study was to investigate and to compare the influence of different excipients in capsule formulation of these two dry extracts i.e. the selection of excipients that will ensure appropriate critical process parameters in the manufacturing procedure. The monitored quality characteristics include flowability, bulk density and tapped density that are critical for technological feasibility of the capsule-filling operation. The effects of excipients on the above parameters have been experimentally studied and the appropriate capsule formulations have been developed based on the obtained results, which will ensure homogeneity and stability of the preparation.


dry herbal extracts; olive leaf; vine leaf; capsules; critical quality attributes

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Naghavi M, Abajobir AA, Abbafati C et al. (GBD 2016 Causes of Death Collaborators). Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017; 390: 1151-1210.

Martinez-Gonzalez MA, Bes-Rastrollo M, Serra-Majem L, Lairon D, Estruch R, Trichopoulou A. Mediterranean food pattern and the primary prevention of chronic disease: recent developments. Nutr Rev. 2009; 67: 111–116.

Schwingshackl L, Heiner B, Stelmach-Mardas M, Gottschald M, Dietrich S, Hoffmann G, Chaimani A. Dietary supplements and risk of cause-specific death, cardiovascular disease, and cancer: A systematic review and meta-analysis of primary prevention trials. Adv Nutr. 2017; 8: 27–39.

Lockyer S, Yaqoob P, Spencer JPE, Rowland I. Olive leaf phenolics and cardiovascular risk reduction: Physiological effects and mechanisms of action. Nutr Aging. 2012; 1: 125–140.

Lockyer S, Rowland I, Spencer JPE. Impact of phenolic-rich olive leaf extract on blood pressure, plasma lipids and inflammatory markers: a randomised controlled trial. Eur J Nutr. 2017; 56: 1421-1432.

Ivanov M, Vajic UJ, Mihailovic-Stanojevic N, Miloradovic Z, Jovovic D, Grujic-Milanovic J, Karanovic D, Dekanski D. Highly potent antioxidant Olea europaea L. leaf extract affects carotid and renal haemodynamics in experimental hypertension: the role of oleuropein. EXCLI J. 2018; 1: 29-44.

Susalit E, Agus N, Effendi I, Tjandrawinata RR, Nofiarny D, Perrinjaquet-Moccetti T. Olive (Olea europaea) leaf extract effective in patients with stage-1 hypertension: Comparison with Captopril. Phytomedicine. 2011; 18: 251–258.

Aouey B, Samet AM, Fetoui H, Simmonds MSJ, Bouaziz M. Anti-oxidant, anti-inflammatory, analgesic and antipyretic activities of grapevine leaf extract (Vitis vinifera) in mice and identification of its active constituents by LC-MS/MS analyses. Biomed Pharmacother. 2016; 84: 1088-1098.

EMA/HMPC/464684/2016 Committee on Herbal Medicinal Products (HMPC). European Union herbal monograph on Vitis vinifera L., folium, 2017.

Kunle OF, Egharevba HO, Ahmadu PO. Standardisation of herbal medicines- A review. Int J Biodvers.2012; 4: 101-112.

Gibson M. Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form. CRC Press; 2001: 441-453.

Rastogi S, Pandey MM, Rawat AK. Traditional herbs: a remedy for cardiovascular disorders. Phytomedicine. 2016; 23: 1082-1089.

Costa LJL, Fereira MRA, Souza TP, Soares LAL. Influence of excipients on mixtures containing high amount of dry extract from Aesculus hippocastanum L. Rev Fitos. 2016; 10: 469-485.


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