FORMULATION AND STABILITY EVALUATION OF ANTI-OBESITY NUTRACEUITCAL BLEND OF WHITE KIDNEY BEAN EXTRACT (PHASEOLUS VULGARIS L.), PROPOLIS ETHANOLIC EXTRACT AND CRPIC3

Authors

  • DOAA SALAH ELDIN ABDELFATTAH National Nutrition Institute, Cairo-11435, Egypt. Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Giza-11562, Egypt https://orcid.org/0000-0001-8449-2556
  • MERVAT A. FOUAD National Nutrition Institute, Cairo-11435, Egypt
  • ALIAA N. ELMESHAD Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Giza-11562, Egypt. Department of Pharmaceutics, Faculty of Pharmacy and Drug Technology, the Egyptian Chinese University, Cairo-11786, Egypt https://orcid.org/0000-0002-9454-7458
  • MOHAMED A. El-NABARAWI Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Giza-11562, Egypt https://orcid.org/0000-0003-0070-1969
  • SAMMAR FATHY ELHABAL Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Modern University for Technology and Information (MTI), Cairo-11571, Egypt

DOI:

https://doi.org/10.22159/ijap.2024v16i3.50705

Keywords:

Obesity, Nutraceutical, WKBE, PEE, CrPic3, Hausner’s ratio, Carr’s index, Angle of repose, Disintegration, Stability study

Abstract

Objective: This study aimed to formulate and evaluate the stability profile of an anti-obesity nutraceutical combination in different dosage forms.

Methods: Active and inactive ingredients were formulated into pharmaceutical dosage forms. The quality parameters of the dosage forms were determined, followed by accelerated stability testing (40±2 °C and 75±5% Relative Humidity (RH)) for 180 d was completed to evaluate their physical, chemical and microbiological attributes throughout the storage period.

Results: Pre-formulation parameters of the powder blend of active and inactive ingredients for each dosage form showed a satisfactory flowability with Hausner's ratio falling between 1.16 and 1.18, average angle of repose between 22.29° and 22.90° and acceptable compressibility with Carr’s index below 25%. Tablets assessments were acceptable with a mean friability value of 0.21±0.03%, hardness of 4.12±0.09 kg/cm2. The average disintegration time of 5 min 10 sec for tablets and 4 min and 30 sec for capsules. The accelerated stability study revealed that tablet dosage forms are stable for longer period that can reach up to 180 d (24 mo real-time), while sachets and capsules are stable for a period of 135 d (18 mo real-time).

Conclusion: The anti-obesity blend of White Kidney Bean Extract (WKBE), Propolis Ethanolic Extract (PEE) and CrPic3 can be successfully formulated in acceptable and convenient dosage forms that can be stable for 18-24 mo.

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References

Yuan H, Ma Q, Ye L, Piao G. The traditional medicine and modern medicine from natural products. Molecules. 2016;21(5):559. doi: 10.3390/molecules21050559, PMID 27136524.

Orhan IE. Pharmacognosy: science of natural products in drug discovery. BioImpacts. 2014;4(3):109-10. doi: 10.15171/bi.2014.001, PMID 25337461.

Khan M, Ahmad I. New look to phytomedicine. 1st ed. US, Cambridge, MA: Academic Press; 2019.

Mirmiran P, Bahadoran Z, Azizi F. Functional foods-based diet as a novel dietary approach for management of type 2 diabetes and its complications: a review. World J Diabetes. 2014;5(3):267-81. doi: 10.4239/wjd.v5.i3.267, PMID 24936248.

Chooi YC, Ding C, Magkos F. The epidemiology of obesity. Metabolism. 2019;92:6-10. doi: 10.1016/j.metabol.2018.09.005, PMID 30253139.

Caballero B. The global epidemic of obesity: an overview. Epidemiol Rev. 2007;29:1-5. doi: 10.1093/epirev/mxm012, PMID 17569676.

World Health Organization. Obesity and Overweight. Available from: https://www.who.int/en/news-room/factsheets/detail/obesity-and-overweight [Last accessed on 12 Apr 2024]

Garces C, Gutierrez Guisado J, Benavente M, Cano B, Viturro E, Ortega H. Obesity in Spanish schoolchildren: relationship with lipid profile and insulin resistance. Obes Res. 2005;13(6):959-63. doi: 10.1038/oby.2005.111, PMID 15976136.

Meigs JB, Wilson PW, Fox CS, Vasan RS, Nathan DM, Sullivan LM. Body mass index, metabolic syndrome, and risk of type 2 diabetes or cardiovascular disease. J Clin Endocrinol Metab. 2006;91(8):2906-12. doi: 10.1210/jc.2006-0594, PMID 16735483.

Raud B, Gay C, Guiguet Auclair C, Bonnin A, Gerbaud L, Pereira B. Level of obesity is directly associated with the clinical and functional consequences of knee osteoarthritis. Sci Rep. 2020;10(1):3601. doi: 10.1038/s41598-020-60587-1, PMID 32107449.

Taroeno Hariadi KW, Hardianti MS, Sinorita H, Aryandono T. Obesity, leptin, and deregulation of microRNA in lipid metabolisms: their contribution to breast cancer prognosis. Diabetol Metab Syndr. 2021;13(1):10. doi: 10.1186/s13098-020-00621-4, PMID 33482868.

Vijayalaxmi AS. Comprehensive review of post-COVID-19 infections: a multifaceted analysis. Int J Curr Pharm Res. 2023;15(6):43-9.

Apovian CM, Aronne LJ, Bessesen DH, McDonnell ME, Murad MH, Pagotto U. Pharmacological management of obesity: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2015;100(2):342-62. doi: 10.1210/jc.2014-3415, PMID 25590212.

Chandrasekaran CV, Vijayalakshmi MA, Prakash K, Bansal VS, Meenakshi J, Amit A. Review article: herbal approach for obesity management. Am J Plant Sci. 2012;03(7):1003-14. doi: 10.4236/ajps.2012.327119.

Jakab J, Miskic B, Miksic S, Juranic B, Cosic V, Schwarz D. Adipogenesis as a potential anti-obesity target: a review of pharmacological treatment and natural products. DMSO. 2021;(14):67-83. doi: 10.2147/DMSO.S281186.

Slavin JL. Dietary fiber and body weight. Nutrition. 2005;21(3):411-8. doi: 10.1016/j.nut.2004.08.018, PMID 15797686.

Erdman JW, MacDonald IA, Zeisel SH. Present knowledge in nutrition. 10th ed. NJ: Wiley-Blackwell; 2012.

Anton SD, Morrison CD, Cefalu WT, Martin CK, Coulon S, Geiselman P. Effects of chromium picolinate on food intake and satiety. Diabetes Technol Ther. 2008;10(5):405-12. doi: 10.1089/dia.2007.0292, PMID 18715218.

Manore MM. Dietary supplements for improving body composition and reducing body weight: where is the evidence? Int J Sport Nutr Exerc Metab. 2012;22(2):139-54. doi: 10.1123/ijsnem.22.2.139, PMID 22465867.

Tian H, Guo X, Wang X, He Z, Sun R, Ge S. Chromium picolinate supplementation for overweight or obese adults. Cochrane Database Syst Rev. 2013 Nov 29;2013(11):CD010063. doi: 10.1002/14651858.CD010063.pub2, PMID 24293292.

Willoughby D, Hewlings S, Kalman D. Body composition changes in weight loss: strategies and supplementation for maintaining lean body mass, a brief review. Nutrients. 2018;10(12). doi: 10.3390/nu10121876, PMID 30513859.

Lukaski HC. The nutritional biochemistry of chromium(III) Vincent JB, editor. US, Amsterdam: Elsevier; 2019.

Nolan R, Shannon OM, Robinson N, Joel A, Houghton D, Malcomson FC. It’s no has bean: a review of the effects of white kidney bean extract on body composition and metabolic health. Nutrients. 2020;12(5):1398. doi: 10.3390/nu12051398, PMID 32414090.

Wang S, Chen L, Yang H, Gu J, Wang J, Ren F. Regular intake of white kidney beans extract (Phaseolus vulgaris L.) induces weight loss compared to placebo in obese human subjects. Food Sci Nutr. 2020;10:5763.

Barrett ML, Udani JK. A proprietary alpha-amylase inhibitor from white bean (Phaseolus vulgaris): a review of clinical studies on weight loss and glycemic control. Nutr J. 2011;10:24. doi: 10.1186/1475-2891-10-24, PMID 21414227.

Anjum SI, Ullah A, Khan KA, Attaullah M, Khan H, Ali H, et al. Composition and functional properties of propolis (bee glue): a review. Saudi J Biol Sci. 2019;26(7):1695-703. doi: 10.1016/j.sjbs.2018.08.013, PMID 31762646.

Bankova V, Popova M, Trusheva B. The phytochemistry of the honeybee. Phytochemistry. 2018;155:1-11. doi: 10.1016/j.phytochem.2018.07.007, PMID 30053651.

Balica G, Vostinaru O, Stefanescu C, Mogosan C, Iaru I, Cristina A. Potential role of propolis in the prevention and treatment of metabolic diseases. Plants (Basel). 2021;10(5):883. doi: 10.3390/plants10050883, PMID 33925692.

Abdl El Hady FK, Hegazi AG. Gas chromatography-mass spectrometry (GC/MS) study of the Egyptian propolis 1-aliphatic, phenolic acids and their esters. J Appl Sci. 1994;9:749-60.

Koya Miyata S, Arai N, Mizote A, Taniguchi Y, Ushio S, Iwaki K. Propolis prevents diet-induced hyperlipidemia and mitigates weight gain in diet-induced obesity in mice. Biol Pharm Bull. 2009;32(12):2022-8. doi: 10.1248/bpb.32.2022, PMID 19952422.

Chen LH, Chien YW, Chang ML, Hou CC, Chan CH, Tang HW. Taiwanese green propolis ethanol extract delays the progression of type 2 diabetes mellitus in rats treated with streptozotocin/high-fat diet. Nutrients. 2018;10(4):503. doi: 10.3390/nu10040503, PMID 29670038.

Abdelfattah DSE, Fouad MA, Elmeshad AN, El-Nabarawi MA, Elhabal SF. Anti-obesity effect of combining white kidney bean extract, propolis ethanolic extract and CrPi3 on Sprague-Dawley rats fed a high-fat diet. Nutrients. 2024;16(2):310. doi: 10.3390/nu16020310, PMID 38276548.

World Health Organization. Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products. https://extranet.who.chromeextension://efaidnbmnnnibpcajpcglclefindmkaj.int/prequal/sites/default/files/document_files/27%20Stability%20requirements_March2016.pdf [Last accessed on 20 Dec 2023]

European Medicines Agency. Guideline on quality of herbal medicinal products/traditional herbal medicinal products. London, England: European Medicines Agency; 2011.

Stability Testing of New Drug Substances and Products. [cited 2023 Dec]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-1-r2-stability-testing-new-drug-substances-and-products-step-5_en.pdf.

Mukherjee PK. Evidence-based validation of herbal medicine. 2nd ed. US, Amsterdam: Elsevier; 2015.

Pinki R, Atul KS, Gautam SS, Raj KP, Singh V, Nair SK. Formulation and evaluation of clarithromycin co-crystals tablets dosage forms to enhance the bioavailability. J Pharm Innov. 2016;5:05-13.

Fuhrman LC Jr. Ansel’s pharmaceutical dosage forms and drug delivery systems. Am J Pharm Educ. 2006;70:71.

USP 37-NF32. Particle size distribution estimated by analytical sieving/physical tests. Available from: https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/harmonization-april-2022-m99584.pdf [Last accessed on 12 Apr 2024]

Meghana R, Malarkodi V. Design, development and evaluation of novel mouth dissolving film of tofacitinib citrate. Int J Appl Pharm. 2023;15:324-32.

Banerjee ND, Singh M. Formulation and evaluation of compression coated tablets of cefpodoxime proxetil. Int J Pharm Sci Res. 2013;4:104-12.

Budiman A, Husni P, Shafira TQA, Alfauziah TQ. The development of glibenclamide-saccharin cocrystal tablet formulations to increase the dissolution rate of the drug. Int J App Pharm. 2019;11:359-64. doi: 10.22159/ijap.2019v11i4.33802.

ICH, Topic Q 1 A (R2. Stability testing of new drug substances and products. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q1ar2-stability-testing-new-drug-substances-and-products. [Last accessed on 10 Aug 2023]

Bankoti K. Accelerated stability study of herbal capsules. IOSR J. 2012;2(5):1-6. doi: 10.9790/3013-254016.

Fischer K. Neues Verfahren zur maßanalytischen bestimmung des wassergehaltes von flussigkeiten und festen korpern. Angewandte Chemie. 1935;48(26):394-6. doi: 10.1002/ange.19350482605.

European pharmacopoeia. 7th ed. Strasbourg: European Directorate for the Quality of Medicines EDQM; 2010. p. 163-7, 519-20.

Wang HH, Chen CL, Jeng TL, Sung JM. Comparisons of α-amylase inhibitors from seeds of common bean mutants extracted through three-phase partitioning. Food Chem. 2011;128(4):1066-71. doi: 10.1016/j.foodchem.2011.04.015.

Siddiqui N, Rauf A, Latif A, Mahmood Z. Spectrophotometric determination of the total phenolic content, spectral and fluorescence study of the herbal Unani drug Gul-e-Zoofa (Nepeta bracteata Benth). J Taibah Univ Med Sci. 2017;12(4):360-3. doi: 10.1016/j.jtumed.2016.11.006, PMID 31435264.

Lagouri V, Prasianaki D, Krysta F. Antioxidant properties and phenolic composition of greek propolis extracts. Int J Food Prop. 2014;17(3):511-22. doi: 10.1080/10942912.2012.654561.

Deng H, Zhang Z, Chang C, Wang Y. Trace metal concentration in great tit (Parus major) and greenfinch (Carduelis sinica) at the Western Mountains of Beijing, China. Environ Pollut. 2007;148(2):620-6. doi: 10.1016/j.envpol.2006.11.012, PMID 17240025.

Nawrocka A, Szkoda J. Determination of chromium in biological material by electrothermal atomic absorption spectrometry method. Bull Vet Inst Pulawy. 2012;56(4):585-9. doi: 10.2478/v10213-012-0103-4.

Wang ZQ, Cefalu WT. Current concepts about chromium supplementation in type 2 diabetes and insulin resistance. Curr Diab Rep. 2010;10(2):145-51. doi: 10.1007/s11892-010-0097-3, PMID 20425574.

Komorowski J, Juturu V. Chromium supplementation does not improve glucose tolerance, insulin sensitivity, or lipid profile: a randomized, placebo-controlled, double-blind trial of supplementation in subjects with impaired glucose tolerance: response to Gunton et al. Diabetes Care. 2005;28(7):1841-2. doi: 10.2337/diacare.28.7.1841-a, PMID 15983360.

Zar JH. Biostatistical analysis. 4th ed. Englewood Cliffs: Prentice Hall Int.; 1999.

Everard A, Cani PD. Diabetes, obesity and gut microbiota. Best Pract Res Clin Gastroenterol. 2013;27(1):73-83. doi: 10.1016/j.bpg.2013.03.007, PMID 23768554.

Braakhuis A. Evidence on the health benefits of supplemental propolis. Nutrients. 2019;11(11):2705. doi: 10.3390/nu11112705, PMID 31717277.

Burdock GA. Review of the biological properties and toxicity of bee propolis (propolis). Food Chem Toxicol. 1998;36(4):347-63. doi: 10.1016/s0278-6915(97)00145-2, PMID 9651052.

Alkis H, Kuzhan A, Dirier A, Tarakcioglu M, Demir E, Saricicek E. Neuroprotective effects of propolis and caffeic acid phenethyl ester (CAPE) on the radiation-injured brain tissue (neuroprotective effects of propolis and CAPE). Int J Radiat Res. 2015;13:297-303.

US Food and Drug Administration. Daily value and percent daily value: changes on the new nutrition and supplement facts labels. Available from: https://www.fda.gov/food/nutrition-facts-label/daily-value-nutrition-and-supplement-facts-labels [Last accessed on 12 Apr 2024]

Pawar K, Thompkinson DK. Changes in the shelf life parameters of dietary supplement during storage. Curr Res Nutr Food Sci. 2017;5(1):15-24. doi: 10.12944/CRNFSJ.5.1.03.

Arora A. Shelf life evaluation of instant dalia mix powder [M.Sc. thesis]. Karnal, India: NDRI University; 2006.

Semeniuc C, Muste S, Rotar A, Suharoschi R, Tofana M. Influence of the storage conditions on physicochemical parameters of infant formula. J Agroaliment Processes Technol. 2012;18:61-4.

Peddio S, Padiglia A, Cannea FB, Crnjar R, Zam W, Sharifi Rad J. Common bean (Phaseolus vulgaris L.) α-amylase inhibitors as safe nutraceutical strategy against diabetes and obesity: an update review. Phytother Res. 2022;36(7):2803-23. doi: 10.1002/ptr.7480, PMID 35485365.

Nori MP, Favaro Trindade CS, Matias de Alencar S, Thomazini M, de Camargo Balieiro JC, Contreras Castillo CJ. Microencapsulation of propolis extract by complex coacervation. LWT Food Sci Technol. 2011;44(2):429-35. doi: 10.1016/j.lwt.2010.09.010.

Russo A, Cardile V, Sanchez F, Troncoso N, Vanella A, Garbarino JA. Chilean propolis: antioxidant activity and antiproliferative action in human tumor cell lines. Life Sci. 2004;76(5):545-58. doi: 10.1016/j.lfs.2004.07.019, PMID 15556167.

Saarniit K, Lang H, Kuldjarv R, Laaksonen O, Rosenvald S. The stability of phenolic compounds in fruit, berry, and vegetable purees based on accelerated shelf-life testing methodology. Foods. 2023;12(9):1777. doi: 10.3390/foods12091777, PMID 37174315.

Marquele Oliveira F, Fonseca YM, de Freitas O, Fonseca MJV. Development of topical functionalized formulations added with propolis extract: stability, cutaneous absorption and in vivo studies. Int J Pharm. 2007;342(1-2):40-8. doi: 10.1016/j.ijpharm.2007.04.026, PMID 17600647.

Yeghiazaryan K, Schild HH, Golubnitschaja O. Chromium-picolinate therapy in diabetes care: individual outcomes require new guidelines and navigation by predictive diagnostics. Infect Disord Drug Targets. 2012;12(5):332-9. doi: 10.2174/187152612804142215, PMID 23017160.

Kakade AR, Yadav S. Analysis of chromium (III) picolinate in capsule dosage form by using stability indicating HPTLC method. Int J ChemTech Res. 2019;12(6):101-8. doi: 10.20902/IJCTR.2019.120613.

Myemba DT, Bwire GM, Sangeda RZ. Microbiological quality of selected local and imported non-sterile pharmaceutical products in Dar es Salaam, Tanzania. Infect Drug Resist. 2022;15:2021-34. doi: 10.2147/IDR.S355331, PMID 35480052.

Paul SC. Technological aspects of manufacturing low lactose infant formula [Ph.D. thesis]. Kurukshetra: Kurukshetra University; 1984.

Published

07-05-2024

How to Cite

ELDIN ABDELFATTAH, D. S., FOUAD, M. A., ELMESHAD, A. N., El-NABARAWI, M. A., & ELHABAL, S. F. (2024). FORMULATION AND STABILITY EVALUATION OF ANTI-OBESITY NUTRACEUITCAL BLEND OF WHITE KIDNEY BEAN EXTRACT (PHASEOLUS VULGARIS L.), PROPOLIS ETHANOLIC EXTRACT AND CRPIC3. International Journal of Applied Pharmaceutics, 16(3), 225–235. https://doi.org/10.22159/ijap.2024v16i3.50705

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