Myanmar Health Sciences Research Journal
Volume 26, Number 3
TITLE: Pharmaceutical Equivalence and Quality Assurance of Different Types of Quinolone Antimicrobials Available in Myanmar
AUTHOR: Moe Moe Aye; Khin Chit; Min Wun; Nyi Nyi Win; KYi Kyi Myint; Thri Aung; Swe Swe Aung; Khin Moe Latt
SOURCE: Myanmar Health Sciences Research Journal. 2014; 26(3): 180-182
ABSTRACT: Antibiotics are the most frequently prescribed medications in modern medicine. Along with increase usage, antimicrobial resistance has become a serious problem. Substandard antibiotics, genuine drug products which do not meet quality specifications set for them. Being one of the main reasons. Has been recognized as an emerging public health problem. Quinolone antibiotics such as ciprofloxacin, norfloxacin, levotloxacin and ot1oxacin have been widely used in Myanmar, both in hospitals and in general practice. A laboratory-based study of 47 different brands of quinolones including 18 ciprofloxacin, 16 norlloxacin, 8 levofloxacin and 5 ofloxacin brands were done. They were purchased by mystery clients from New Bogyoke market and Shwepyaesone market in Yangon. All were coded and standard quality assurance tests were done according to USP (United States Pharmacopeia) and BP (British Pharmacopeia). In uniformity of weight, 2(12.5%) brands of norfloxacin and I (20%) brand of olloxacin failed. Then in disintegration test. I (6.25%) brand of norfloxacin failed. Regarding dissolution test, 1 (2.13%) brand of ciprofloxacin failed. Fourrier Transform Infra-Red (FTIR) spectrum results showed 2 (4.26%) brands of ciprofloxacin and 3(6.3g %) brands of nortloxacin were unsatisfactory. In quantitative analysis, norfioxacin 7(14.89%) brands, ciprofoxacin 5(10.34%) brands, levofloxacin 3(6.38%) brands and ofloxacin 1(2.13%) brand failed. Overall results showed 24(51.06%) samples were substandard, indicating the existence of substandard drugs in markets and it was likely to be due to incomplete packaging, improper transport and storage conditions such as temperature and humidity. The results of this study will provide valuable data on the quality assurance of quinolone antibiotics in Myanmar market and such kind of information is always necessary to help not only authorized body but also for the public.
SUBJECT HEADINGS: Pharmaceutical equivalence; Quality assurance; Fluroquinolone; Dissolution and Disintegration