Effervescent Tablets Formulation of Jicama (Pachyrhizus erosus) Extract with Various Concentrations of Binders and Sweeteners

Abstract

Osteoporosis is a major public health problem. Exogenous estrogen or Hormone Replacement Therapy (HRT) is the potential therapy for osteoporosis. Still, the patient rarely chooses this treatment because of the risk of breast and endometrial cancer. Phytoestrogens or estrogen-like compounds, particularly isoflavones, are a potentially safe alternative to HRT. Jicama (Pachyrhizus erosus) is a plant that contains many phytoestrogens. This research aimed to determine the physicochemical characteristics of jicama extract in effervescent tablets with various concentrations of binder and sweetener. The manufacturing of jicama effervescent tablets used raw materials extracted from 96% p.a. ethanol by maceration. The extract is then formulated with various binder concentrations (PVP 40 and gelatin) and sweeteners (lactose and Mannitol) using the wet granulation method. Based on the test results on the physicochemical properties of tablets, all the formula meets the requirement of a good tablet, and the preferred formula is Formula 4 with 0.75% of PVP40 and 47,75% Mannitol. Ethanol extract of jicama can be formulated into effervescent tablets and has the potential to be developed as a treatment for osteoporosis.


Keywords: Xicama Extract, Fitoestrogen, Estrogen-like therapy, Osteoporosis, Effervescent tablet

References
[1] Katzung Bertram G, Vanderah TW. Basic & Clinical Pharmacology. 15th ed. Mc Graw Hill; 2020.

[2] Appelman-Dijkstra NM, Papapoulos SE. Modulating Bone Resorption and Bone Formation in Opposite Directions in the Treatment of Postmenopausal Osteoporosis. Drugs. 2015 Jul;75(10):1049–58.

[3] Dipiro JT, Yee GC, Posey LM, Haines ST, Nolin TD, Ellingrod V. Pharmacotherapy: A Pathophysiologic Approach. Volume 11. 11th ed. Mc Graw Hill; 2020.

[4] Brunton LL, Knollmann BC. Goodman & Gilman’s: The Pharmacological Basis of Therapeutics. 14th ed. Mc Graw Hill; 2022.

[5] Wei P, Liu M, Chen Y, Chen DC. Systematic review of soy isoflavone supplements on osteoporosis in women [Internet]. Asian Pac J Trop Med. 2012 Mar;5(3):243–8.

[6] Desmawati D, Sulastri D. Phytoestrogens and their health effect. Open Access Maced J Med Sci. 2019 Feb;7(3):495–9.

[7] Siddiqui S, Mahdi AA, Arshad M. Genistein contributes to cell cycle progression and regulates oxidative stress in primary culture of osteoblasts along with osteoclasts attenuation. BMC Complement Med Ther. 2020 Sep;20(1):277.

[8] Zheng X, Lee SK, Chun OK. Soy Isoflavones and Osteoporotic Bone Loss: A Review with an Emphasis on Modulation of Bone Remodeling. J Med Food. 2016 Jan;19(1):1– 14.

[9] Manolagas SC, O’Brien CA, Almeida M. The role of estrogen and androgen receptors in bone health and disease [Internet]. Nat Rev Endocrinol. 2013 Dec;9(12):699–712. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3624763/pdf/nihms412728.pdf

[10] Lukitaningsih E. BIOACTIVE COMPOUNDS IN BENGKOANG (Pachyrhizus erosus) AS ANTIOXIDANT AND TYROSINASE INHIBITING AGENTS. Indones J Pharm. 2014;25(2):68–75.

[11] Jaiswal V, Chauhan S, Lee HJ. The bioactivity and phytochemicals of pachyrhizus erosus (L.) urb.: A multifunctional underutilized crop plant. Antioxidants. 2021 Dec;11(1):1–23.

[12] Arshad MS, Sedhain K, Hussain A, Abbas N, Mudassir J, Mehmood F, et al. Quantification of carbon dioxide released from effervescent granules as a predictor of formulation quality using modified chittick apparatus. Trop J Pharm Res. 2019;18(3):449–58.

[13] Aslani A, Fattahi F. Formulation, characterization and physicochemical evaluation of potassium citrate effervescent tablets. Adv Pharm Bull. 2013;3(1):217–25.

[14] Husni P, Fadhiilah ML, Hasanah U. FORMULASI DAN UJI STABILITAS FISIK GRANUL INSTAN SERBUK KERING TANGKAI GENJER (Limnocharis flava (L.) Buchenau.) SEBAGAI SUPLEMEN PENAMBAH SERAT. J Ilm Farm Farmasyifa. 2020;3(1):1–8.

[15] Das S, Bahadur S, Choudhury A, Saha S. Effect of Solubilization Technique on Dissolution. 2014;2(1):29–33.

[16] Syabania M, Pambudi DB, Wirasti W, Rahmatullah S. Karakteristik dan Evaluasi Granul Ekstrak Daun Kersen (Muntingia calabura L.) dengan Metode Granulasi Basah. Pros Semin Nas Kesehat. 2021;1:1737–46.

[17] United Stated Pharmacopoeia U. United Stated Pharmacopoeia 44. 2021.

[18] Qiu Y, Chen Y, Zhang GG, Yu L, Mantri RV. Developing Solid Oral Dosage Forms: Pharmaceutical Theory & Practice. 2nd ed. Oxford: Elsevier; 2017. 1160 pp.

[19] Troy D. Remington: The Science and Practice of Pharmacy. 21st ed. Philadelphia: Lippincott Williams & Wilkins; 2005. 2417 pp.

[20] Putra DJ, Antari NW, Putri NPR, Arisanti CI, Samirana P. Penggunaan Polivinill Pirolidon (PVP) Sebagai Bahan Pengikat Pada Formulasi Tablet Ekstrak Daun Sirih (Piper betle L.). J Farm Udayana. 2019;8(1):14–21.

[21] Crouter A, Briens L. The effect of moisture on the flowability of pharmaceutical excipients. AAPS PharmSciTech. 2014 Feb;15(1):65–74.

[22] Takeuchi Y, Tomita T, Kuroda J, Kageyu A, Yonekura C, Hiramura Y, et al. Characterization of mannitol granules and powder: A comparative study using two flowability testers [Internet]. Int J Pharm. 2018 Aug;547(1-2):106–13.

[23] Salehi H, Karde V, Hajmohammadi H, Dissanayake S, Larsson SH, Heng JY, et al. Understanding flow properties of mannitol powder at a range of temperature and humidity [Internet]. Int J Pharm. 2021 Mar;596(596):120244.

[24] Herlina, Kuswardhani N, Belgis M, Tiara A. Characterization of Physical and Chemical Properties of Effervescent Tablets Temulawak (Curcuma zanthorrhiza) in the Various Proportion of Sodium Bicarbonate and Tartaric Acid. E3S Web Conf. 2020;142(03006):1–7.

[25] da Cunha-Filho MS, Gustmann PC, Garcia FS, Lima EM, de Sá-Barreto LC. Development and physical evaluation of Maytenus ilicifolia effervescent granules using factorial design. Braz J Pharm Sci. 2014;50(2):243–50.