Evaluation of Film-Coated Tablets of Ethyl Acetate Fraction of <i>Uncaria gambir</i> (Hunter) Roxb
http://www.doi.org/10.26538/tjnpr/v8i1.28
Keywords:
Uncaria gambir, Stability, Dissolution profile, Film-coated tablet, CatechinAbstract
Gambir (Uncaria gambir [Hunter] Roxb) is a plant that can effectively treat hyperlipidemia. Its pharmacological effect is influenced by the high concentration of catechin, the major active compound, especially in the ethyl acetate fraction of gambier (EAFG). The EAFG can be utilized commercially, and it is produced into film-coated tablets to boost its stability because catechins are less stable when exposed to humidity and light. The present study was conducted to produce EAFG film-coated tablets and evaluate their physicochemical characteristics and stability during storage. Gambir leaf extract was prepared and fractionated with ethyl acetate as a solvent. The EAFG was granulated, followed by the tablet compacting and coating processes. The film-coated tablets of EAFG were subjected to physicochemical evaluation, dissolution, and accelerated stability tests. The physicochemical analysis revealed that the film-coated tablets met the standards for general appearance, hardness, friability, disintegration time, and catechin content. After 60 minutes, the dissolution profile of EAFG revealed that at least 75% of the catechin was dissolved in the media at pH 1.2, 4.5, and 6.8. Accelerated stability studies indicated good stability over six months. The formulation demonstrated no changes in the physicochemical properties of EAFG film-coated tablets. The development of film-coated tablets of EAFG showed good quality in terms of physicochemical, dissolution, and stability during storage. This is suitable for improving catechin's moisture and light protection.
References
Tsao CW, Aday AW, Almarzooq ZI, Alonso, A, Beaton AZ, Bittencourt MS, Carissa M. Baker-Smith, Beaton AZ, Boehme AK, Buxton AE, Elkind MSV, Evenson KR. Heart disease and stroke statistics: 2023 update. A Report from the Ame Heart Assoc. 2023; 147(8): 93-621.
Talreja O, Kerndt CC, Cassagnol M. Simvastatin. Treasure Island: StatPearls Publishing. 2018; PMID:30422514.
Yunarto N, Intan PR, Kurniatri AA, Sulistyowati I, Aini N. Anti-Inflammatory activities of ethyl acetate fraction from Uncaria gambir leaves through the inhibition of edema, COX-2 and iNOS expression. Adv Health Sci Res. 2020; 22:108–112.
Hidayati MD, Rahmatulloh A. Antioxidant activity of Uncaria gambir (Hunter) Roxb extracts. Trop J Nat Prod Res. 2022; 6(8):1215-1218.
Yunarto N, Sulistyowati I, Reswandaru UN, Elya B, Sauriasari R, & Konadi L. (2023, January). Inhibitory activity of Uncaria gambir Roxb extract, ethyl acetate fraction, and catechin isolate on lipase. AIP Conf Proc. 2023; 2606(1):020011-6.
Ocieczek A, Pukszta T, Żyłka K, Kirieieva N. The influence of storage conditions on the stability of selected health-promoting properties of tea. LWT. 2023; 184:115029.
Yuann JMP, Lee SY, Yang MJ, Huang ST, Cheng CW, Liang JY. A study of catechin photostability using photolytic processing. Processes. 2021; 9(2):293.
Seo KS, Bajracharya R, Lee SH, Han HK. Pharmaceutical application of tablet film coating. Pharmaceut. 2020; 12(9): 853.
Yunarto N, Calvin CC, Sulistyowati I, Oktoberia IS, Reswandaru UN, Elya B, Sauriasari R, Mihardja LK. Development and validation of a high-performance liquid chromatography-based method for catechin isolated from the leaves of gambir (Uncaria gambir Roxb). Trop J Nat Prod Res. 2023; 7(3):2569-2579.
United States Pharmacopeia, USP 42/The National Formulary, NF 37. <2040> Disintegration and Dissolution of Dietary Supplements. Rockville, MD: U.S. Pharmacopeial Convention, Inc. 2019; p 8533.
World Health Organization. Stability testing of active pharmaceutical ingredients and finished pharmaceutical products, Annex 10. WHO Expert Comm Specif Pharm Prep. 2018; 52:309-351.
ACCSQ-Pharmaceutical Product Working Group. ASEAN Guideline on Stability Study of Drug Product (R1). 25th ACCSQ-PPWG Meeting. 2018; 3-7.
Indonesian Ministry of Health. Indonesian Herbal Pharmacopoeia. 2nd ed. Jakarta; 2017.
Kurniatri AA, Sulistyaningrum N, Rustanti L. Purification of catechin from gambir (Uncaria gambir Roxb.) extracts. Med Pen Peng Kes. 2019; 29(2):153-160.
Khan A. Prediction of quality attributes (mechanical strength, disintegration behavior, and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation. Plos one. 2021; 16(12): e0261051.
Kotlowska H, Krotka J, Szymanska M, Kubiak B, Sznitowska M, Nalluri BN. The use of novel tools for the assessment of powders and granules flow properties and for the analysis of minitablets compression process. Drug Dev Ind Pharm. 2020; 46(4):547-556.
Almutairy BK, Khafagy ES, Alalaiwe A, Aldawsari MF, Alshahrani SM, Alsulays BB, Fayed MH. Enhancing the poor flow and tableting problems of high drug-loading formulation of canagliflozin using continuous green granulation process and design-of-experiment approach. Pharmaceut. 2020;13(12):473.
Juarez‐Enriquez E, Olivas GI, Zamudio‐Flores PB, Perez‐Vega S, Salmeron I, Ortega‐Rivas E. A review on the influence of water on food powder flowability. J Food Process Eng. 2022; 45(5): e14031.
Davis MT, Potter CB, Walker GM. Downstream processing of a ternary amorphous solid dispersion: The impacts of spray drying and hot melt extrusion on powder flow, compression, and dissolution. Int J Pharm. 2018; 544(1):242-253.
Teckoe J, Mascaro T, Farrell TP, Rajabi-Siahboomi AR. Process optimization of a novel immediate-release film coating system using QbD principles. Aaps Pharm. 2013; 14(2):531-540.
Vanamu J, Sahoo A. An overview of dry powder coating in advancement to electrostatic dry powder coating used in the pharmaceutical industry. Powder Technol. 2022; 399: 117214.
Cabiscol R, Finke JH, Kwade A. A bi-directional DEM-PBM coupling to evaluate chipping and abrasion of pharmaceutical tablets. Adv Powder Technol. 2021; 32(8):2839-2855.
Yunarto N, Isnawati A, Aini N, Kurniatri AA, Adelina R, Setyorini HA. Formulation of Dihydroartemisinin-Piperaquine (DHP) Generic Tablet as Antimalarials Drug. Indones Pharm J. 2018; 6(1): 8-15.
Dehdari S, Hajimehdipoor H, Esmaeili S, Mortazavi, SA, Choopani R. Formulation and fingerprinting of a polyherbal film-coated tablet for treatment of hemorrhoids. Res J Pharmacogn. 2020; 7(4):39-47.
Min MH, Park JH, Hur JH, Shin HC, Cho Y, Kim DD. Formulation and bioequivalence studies of choline alfoscerate tablet comparing with soft gelatin capsule in healthy male volunteers. Drug Des Devel Ther. 2019:1049-1058
Elder D. Design, formulation and manufacture of film-coated drug products. Eur Pharm Rev. 2017 22(5):37-40.
Hamed R. Physiological parameters of the gastrointestinal fluid impact the dissolution behavior of the BCS class IIa drug valsartan. Pharm Devel Technol. 2018; 23(10):1168-1176.
Gusev PA, Andrews KW, Savarala S, Tey PT, Han F, Oh L, Dweyer JT, Costello R, Saldanha LG. Disintegration and dissolution testing of green tea dietary supplements: Application and evaluation of United States Pharmacopeial standards. J Pharm Sci. 2020; 109(6):1933-1942.
Elder, D. Design, formulation, and manufacture of film-coated drug products. Eur Pharm Rev. 2017; 22(5):37-40.
Ng LH, Ling JKU, Hadinoto K. Formulation strategies to improve the stability and handling of oral solid dosage forms of highly hygroscopic pharmaceuticals and nutraceuticals. Pharmaceutics. 2022; 14(10): 2015.
Chen LY, Wu JY, Liang JY. Using chromatography and mass spectrometry to monitor the isomerization of catechin in alkaline aqueous with thermal processing. J Food Process Preserv. 2018; 42(1): e13365.
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Tropical Journal of Natural Product Research (TJNPR)
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
