Quality of Povidone-iodine and Chlorhexidine Based Mouthwash/gargle Products in Nairobi City County, Kenya

Abstract

Introduction Povidone-iodine (PV-I) and chlorhexidine (CHX) are broad spectrum antimicrobial agents that are active against a number of gram-negative and gram-positive bacteria. Povidone-iodine and CHX are listed as essential drugs by the Ministry of Health (MoH) Kenya and World Health Organization (WHO) for the management of sores, gum swelling and bad breath as gargles and mouth rinses/mouthwashes. Most gargle and mouth rinse products are readily available and have been used as over-the-counter medication. Despite the increase in the number of PV-I and CHX based mouthwash and gargle brands in the Kenyan market in recent years, only a few have been registered with the Pharmacy and Poison Board (PPB). The increased influx of unregistered products from multiple sources in the Kenyan market poses challenges on the regulatory body when it comes to the evaluation and monitoring of their quality in the market. Furthermore, a comprehensive database containing all products that are meant to be used as gargles and mouthwashes is not available at PPB. Therefore, there is need to survey, sample and analyze the different brands of PV-I and CHX mouthwashes and gargle products in the market to establish their quality. Study objective The objective of this study was to determine the quality of mouthwash and gargles products containing CHX and PV-I in Nairobi County Methodology In this study, a convenience sampling was used to select 15 brands (34 samples) of PV-I and 9 brands (15 samples) of CHX mouthwashes and gargles from retail pharmacies in Nairobi County. Povidone-iodine samples were analyzed using potentiometric titration for iodine content while chlorhexidine samples were assayed using High Performance Liquid Chromatography (HPLC). Both analytical methods were as per BP (2017) pharmacopoeia (BP, 2017a) specifications. The values for the assay were compared with the limits set in the BP (2017) (85% to 120 %, chlorhexidine – 95% to 105%). Analysis of Variance (ANOVA) was conducted on the assay values for both products to detect inter-batch variations.

Results The results obtained showed that about 16 samples (47.1 %) from 8 brands of PV-I products complied with BP (2017) specifications for the assay of PV-I while 10 samples (66.7 %) from 5 brands of CHX complied with the assay of chlorhexidine mouthwash and gargle products as per BP (2017) specifications (BP, 2017a). Conclusion From the assay results, not all PV-I and CHX mouth wash and gargle products met the required regulatory standards. Therefore, PPB should conduct continuous market surveillance on all the PV-I and CHX containing mouth wash and gargle products to ensure quality assured products circulate in Kenya.