Conformity Studies of Ciprofloxacin Commercial Brands (Yemeni and Importation)

Sabati A.M.A1, and Al-Mikhlafi S. A. 2 Othman A. M.3.

Department of Pharmaceutics, 2 Department of Medicinal Chemistry, Faculty of Pharmacy, Sana'a University , Republic of Yemen.

Introduction:

Drugs have the potential to reduce morbidity and mortality from illness for millions of people. The main pillars of the essential drug concepts are establish safety and efficacy, proven quality, constant availability and rational use, studies have been reported in the area of rational drug use1, but not much information available concerning the quality of the essential drugs in the Yemeni market2. Ciprofloxacin is approved for use in U.T.I, lower respiratory infection, typhoid fever, urethral & cervical gonococcal infection, sinusitis, bone and joints3. Ciprofloxacin tablets, are synthetic broad spectrum antimicrobia
agents for oral administration. Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive microorganisms4. Ciprofloxacin

hydrochloride, a fluoroquinolone derivative, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-
piperazinyl)-3-quinolinecarboxylic acid5. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8, it is practically insoluble in water6. Its structural formula is C17H18FN3O3 . HCl . H2O 5,7. Ciprofloxacin film-coated tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths8. Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the GIT. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin 6,8.

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