QUALITY CONTROL AND IN-VITRO STUDY RELEASE BEHAVIOUR OF EURYCOMANONE IN HERBAL PRODUCTS SUPPLEMENT IN CAPSULE FORM
DOI:
https://doi.org/10.61841/r9dmm666Keywords:
quality control,, independent model method,, in-vitro study release behaviour, herbal products supplementAbstract
Controlled releasedelivery system of active ingredients has a significant effect on their pharmacological activity. In fact, it is considered as one of the most important quality control test to predict their bioavailability. In this study the in-vitro study release behaviour was carried out using dissolution testing apparatus USP type-11 and submit to an independent model methods using time point approach whereby the percentage drug releases at a given time were determined. Three brands (TA, TB, TC) of herbal product supplements from different manufacturers which consist of Eurycomanone as active ingredients were compared. Brand TS is a pure extract of Eurycomanone used as a benchmark. The parameters employed to compare in-vitro study release behaviour are different dissolution media namely 0.1 N HCl, 30% EtOH, acetate buffer (pH 4.8) and phosphate buffer pH 6.8 for each brands for 105 minutes. Samples were withdrawn at 15 minutes time interval and analysed for the Eurycomanone release by using HPLC technique. Content of the Eurycomanone for brand TA and brand TS analysed via HPLC were the highest.When submitted to in-vitro release study, the release rate of Eurycomanonein brands TA was the highest in both acidic and alkaline medium (0.1 M HCl and 0.1 M PBS medium)while the release rate of Eurycomanonein brands TB was the highest in the alkaline medium compared to acidic medium. Amongst the three sample, brand TC showed the lowest released rate of Eurycomanone in all medium.The highest percent of drug release at a given time (Y30) for brand TA, brand TB and brand TC were 39.7% (0.1 M HCl), 33.5% (0.1 M PBS) and3.2% (0.1 % PBS), respectively. In this study, both results from in-vitro released study and HPLC testwere compliment and Eurycomanone used as chemical marker could be applied for quality control for the development of herbal products supplements in markets.
Downloads
References
1. Mandloi, D. K., Tyagi, P. K., Rai, V. K., Dey, S., Ashada, R. K., & P. M. (2009). Method development and validation of RP- HPLC in the application of in vitro dissolution study of Lamivudine in bulk drug and tablet formulation . Journal of Chemical and Pharmaceutical Research, 286–296.
2. Tadey T, Carr G. (2009). Dissolution Testing for Solid Oral Dosage Forms”, Pharmaceutical Formulation and Quality, 11(4), 22-27.
3. Mubarak N., Al Ameriab., NandaNayunia K.G., Anil K., David P., Arthur T., Atholl J. (2012) The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing. https://doi.org/10.1016/j.rinphs.2011.12.001
4. Basanth B., Ian G.Tucker., Shyamal C.D. (2019) In vitro dissolution testing of respirable size anti- tubercular drug particles using a small volume dissolution apparatus. https://doi.org/10.1016/j.ijpharm.2019.01.035
5. Marques,G.S., Leão,W.S. Lyra, M.A.M., Peixoto, M.S., Monteiro, R.P.M., Rolim, L.A., Xavier, Z H.S., RolimNeto., P.J. Soares., L.A.L. Comparative evaluation of UV/VIS and HPLC analytical methodologies applied for quantification of flavonoids from leaves of Bauhinia forficate Rev. Bras. Farmacogn., 23 (2013), pp. 51-57
6. Zollner, M. Schwarz. Herbal reference standards: applications, definitions and regulatory requirements Rev. Bras. Farmacogn., 23 (2013), pp. 1-21
7. Talbott, S. M., Talbott, J. A., George, A., & Pugh, M. (May 26, 2013). Effect of Tongkat Ali on stress hormones and psychological mood state in moderately stressed subjects. Journal of the International Society of Sports Nutrition, 10. doi: 10.1186/1550-2783-10-28
8. Abubakar, B. M., Salleh, F. M., &Wagiran, A. (2017). Chemical Composition of Eurycomalongifolia (Tongkat Ali) and the Quality Control of its Herbal Medicinal Products. Journal of Applied Sciences, 17, 324–338.
9. Masahisa S., Susumu T., Masaru S., Kazutaka H., Makoto K., Shinji Y. (2015). Analysis of Intra- and Intersubject Variability in Oral Drug Absorption in Human Bioequivalence Studies of 113 Generic Products. https://doi.org/10.1021/acs.molpharmaceut.5b00602
10. Laura D.S., Luciana, P., Mariela, Baldut., Silvina L.B., Adriana, InésS. (2018). Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina. https://doi.org/10.1016/j.jsps.2018.01.015
11. The United Pharmacopoeia and National Formulary USP 23– NF 18; The United States Pharmacopoeial Convention, Inc.: Rockville, MD, 1995; p 1235.
12. The United State Pharmacopoeia, Pharmacopeiaal Forum, 30 (2004) pp. 351-363
13. Food and Act Administration, 1997. Guidance for industry, Testing of Immediate Release Solid Oral Dosage Forms, U.S. Department of Health and Human Services, Centre for Drug Evaluation and Research (CDER), U.S. government Printing Office: Washington, D.C
14. Chandrasekaran, A.; Han, C. Y.; Chung, A. C. Y.; Cheang, L. W.; Ping, L. S. Post market in vitro equivalency evaluation of paracetamol tablets in Kedah, Malaysia. Int. J. Pharm. Sci. Nanotech. 2011, 4, 1403–1407.
15. R, KARTHIK., MIRUTHULA. A, and NITHEESWARI. N. "WEB BASED ONLINE MACHINE CONTROLLING AND MONITORING USING PLC VIA MODBUS
COMMUNICATION." International Journal of Communication and Computer Technologies 7 (2019), 22-
26. doi:10.31838/ijccts/07.02.06
16. Di Biase, F.Quantum-holographic informational consciousness(2009) NeuroQuantology, 7 (4), pp. 657-
664.
17. Gersten, A., Perle, J., Raz, A., Fried, R.Probing brain oxygenation with near infrared spectroscopy(2009) NeuroQuantology, 7 (2), pp. 258-266.
Downloads
Published
Issue
Section
License

This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format for any purpose, even commercially.
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
- The licensor cannot revoke these freedoms as long as you follow the license terms.
Under the following terms:
- Attribution — You must give appropriate credit , provide a link to the license, and indicate if changes were made . You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
Notices:
You do not have to comply with the license for elements of the material in the public domain or where your use is permitted by an applicable exception or limitation .
No warranties are given. The license may not give you all of the permissions necessary for your intended use. For example, other rights such as publicity, privacy, or moral rights may limit how you use the material.