Chemical and Biological Stability under Forced Degradation and Accelerated Storage Conditions of the Anti-Acne Formulation of Pra-Sa-Mang-Khud Ethanolic Extract

Authors

  • Kalyarut Phumlek Student of Doctor of Philosophy Program in Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
  • Arunporn Itharat Department of Applied Thai Traditional Medicine and Center of Excellence in Applied Thai Traditional Medicine Research (CEATMR), Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
  • Ubonwan Saesiw Student of Doctor of Philosophy Program in Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
  • Weerachai Pipatrattanaseree Regional Medical Science Center 12 Songkhla, Department of Medical Sciences, Songkhla, Thailand
  • Krit Piwngam Department of Applied Thai Traditional Medicine and Center of Excellence in Applied Thai Traditional Medicine Research (CEATMR), Faculty of Medicine, Thammasat University, Pathum Thani, Thailand
  • Papawee Sookdee Department of Applied Thai Traditional Medicine, College of Allied Health Sciences, Suan Sunandha Rajabhat University, Samut Songkhram, Thailand
  • Neal M. Davies Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada

DOI:

https://doi.org/10.14456.2022030103

Keywords:

Forced degradation, Accelerated storage conditions, Pra-Sa-Mang-Khud, α-Mangostin, Pectolinaligenin

Abstract

Introduction: Pra-Sa-Mang-Khud (PSM) formula is the mixture of Garcinia mangostana pericarp and Ha-Rak remedy developed for acne treatment. However, the chemical and biological stability of PSM extract is necessary for an optimal manufacturing process. Therefore, this study was aimed to investigate the stability of PSM ethanolic extract under forced degradation and accelerated storage conditions.
Methods: Thermal degradation, moisture hydrolysis, acid hydrolysis, alkaline hydrolysis, and oxidation were performed in forced degradation studies. In addition, PSM extract was kept in accelerated storage conditions at 40 ± 2ºC with 75 ± 5% RH for 6 months. Finally, PSM extracts under forced degradation and accelerated storage conditions were evaluated for α-mangostin and pectolinarigenin contents by high performance liquid chromatography and antibacterial activity against C. acnes.
Results: PSM extract under acid hydrolysis and oxidation conditions had significantly degraded α-mangostin content and reduced anti-C. acnes activity. In contrast, the treatments with high temperature, moisture hydrolysis, and alkaline hydrolysis increased α-mangostin content. For accelerated storage conditions, α-mangostin content, pectolinaligenin content, and anti-C.acnes activity were shown to be stable in all samples.
Conclusions: Avoiding preparation in an acidic environment is essential for optimal PSM extract efficacy. Moreover, an antioxidant agent that prevents degradation is necessary. Both the hot and cold processes can be effectively used to prepare the product containing PSM extract. PSM extract can have a tentative shelf-life of two years due to its demonstrated stability under accelerated storage conditions.

Downloads

Download data is not yet available.

Author Biographies

Kalyarut Phumlek, Student of Doctor of Philosophy Program in Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand

KP is Ph.D student in Applied Thai Traditional medicine program undersupervision of AI. She worked all experiment and wrote first draft of this manuscript.

Ubonwan Saesiw, Student of Doctor of Philosophy Program in Applied Thai Traditional Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, Thailand

US help KP to prepare to PSM extract .

Weerachai Pipatrattanaseree, Regional Medical Science Center 12 Songkhla, Department of Medical Sciences, Songkhla, Thailand

WP provide the HPLC method for analysis PSM extract.

Krit Piwngam, Department of Applied Thai Traditional Medicine and Center of Excellence in Applied Thai Traditional Medicine Research (CEATMR), Faculty of Medicine, Thammasat University, Pathum Thani, Thailand

KW help preformulated experiment.

Papawee Sookdee, Department of Applied Thai Traditional Medicine, College of Allied Health Sciences, Suan Sunandha Rajabhat University, Samut Songkhram, Thailand

PS  help  to  provide HPLC technical method

Neal M. Davies, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada

ND revised and suggestion on writing manuscript. 

References

Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research. ICH guidelines, Q1A (R2): Stability Testing of New Drug Substances and Products (revision 2). U.S. food & drug administration. https://www.fda.gov/regulatory-information/searchfda-guidance-documents/q1ar2-stabilitytesting-new-drug-substances-and-products. Published 2003. Accessed April 5, 2022.

Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs-A review. J Pharm Anal. 2014;4:159-165.

Maheswaran R. FDA Perspectives: Scientific Considerations of Forced Degradation Studies in ANDA Submissions. Pharm Technol. 2012;36:73-80.

Intusaitrakul C. Thai herbal medicines used in primary health care. Bangkok: Duabgjamol publishing; 2008.

Pothitirat W, Chomnawang MT, Gritsanapan W. Anti-acne-inducing bacterial activity of mangosteen fruit rind extracts. Med Princ Pract. 2010;19(4):281-286.

Pothitirat W, Chomnawang MT, Supabphol R, Gritsanapan W. Comparison of bioactive compounds content, free radical scavenging and anti-acne inducing bacteria activities of extracts from the mangosteen fruit rind at two stages of maturity. Fitoterapia. 2009;80(7):442-447.

Chomnawang MT, Surassmo S, Nukoolkarn VS, Gritsanapan W. Antimicrobial effects of Thai medicinal plants against acne-inducing bacteria. J Ethnopharmacol. 2005;101 (1-3):330-333.

National drug system development committee. National List of Essential Medicines. Bangkok:The agricultural cooperative federation of Thailand; 2013. 9. Ayuraved-Wittayarai Foundation. Thai traditional medicine textbook (pâet sàat sŏng krór). Bangkok: See Thai press; 1998.

Nuaeissara S, Kondo S, Itharat A. Antimicrobial Activity of the Extracts from Benchalokawichian Remedy and Its Components. J Med Assoc Thai. 2011;94(S7):172-177.

Sakpakdeejaroen I, Juckmeta T, Itharat A. Development and validation of RP-HPLC method to determine anti-allergic compound in Thai traditional remedy called Benjalokawichien. J Med Assoc Thai. 2014;97(8):76-80.

Pan-In P, Wongsomboon A, Kokpol C, Chaichanawongsaroj N, Wanichwecharungruang S. Depositing α-mangostin nanoparticles to sebaceous gland area for acne treatment. J Pharmacol Sci. 2015;129(4):226-232.

Ibrahim MY, Hashim NM, Mariod AA, Mohan S, Abdulla MA, Abdelwahab SI, Arbab IAαMangostin from Garcinia mangostana Linn:An updated review of its pharmacological properties. Arab J Chem. 2016;9(3):317-329.

Juckmeta T, Pipatrattanaseree W, Jaidee W, et al., Cytotoxicity to Five Cancer Cell Lines of the Respiratory Tract System and Anti-inflammatory Activity of Thai Traditional Remedy. Nat Prod Commun. 2019;14(5):1-6.

Mulia K, Hasanah F, Krisanti EA. The effect of heating temperature on cytotoxicity and α-mangostin yield: Mangosteen pericarp juice and mangosteen extract. IOP Conf Ser: Mater Sci Eng. 2018;316:1-7.

Pedraza CJ, Cardenas RN, Orozco IM, Perez RJM. Medicinal properties of mangosteen (Garcinia mangostana). Food Chem Toxicol. 2008;46(10):3227-3239.

Deshpande MM. Analytical, Bioanalytical, Stability-Indicating Methods: Key Part of Regulatory Submissions. In: Srivastva AN, ed. Analytical Chemistry - Advancement, Perspectives and Applications. IntechOpen; 2021.

Downloads

Published

2022-12-28

How to Cite

[1]
Phumlek, K. , Itharat, A., Saesiw, U., Pipatrattanaseree, W. , Piwngam, K., Sookdee, P. and Davies, N.M. 2022. Chemical and Biological Stability under Forced Degradation and Accelerated Storage Conditions of the Anti-Acne Formulation of Pra-Sa-Mang-Khud Ethanolic Extract. Asian Medical Journal and Alternative Medicine. 22, 3 (Dec. 2022), 185–193. DOI:https://doi.org/10.14456.2022030103.

Issue

Section

Original Articles