Post Reconstitution Stability of Co-Amoxiclav Injection for Multiple Usages in Developing Countries
Abstract
OBJECTIVE: Co-amoxiclav injections are stored after reconstitution by healthcare givers for multiple usage contrary to manufacturer’s instructions in pediatric patients to reduce the cost of treatment in developing countries. The purpose of this study is to determine the percentage content of amoxicillin and clavulanic acid in co-amoxiclav injections at the point of administering of second dose after reconstitution.
METHODS: Samples were reconstituted according to manufacturers’ instructions and stored in a refrigerator (2-5°C) and at tropical temperature (30°C and 75% RH). The samples were assayed immediately and then 8 hours after reconstitution. The assay was carried out using HPLC according to the USP monograph for amoxicillin-clavulanic acid suspension and the percentage content during the administration of the second dose was calculated in reference to a freshly prepared samples.
RESULTS: The percentage content of amoxicillin and clavulanic acid in refrigerated samples was <70% and <35% of the freshly prepared samples respectively, While at simulated tropical room temperature, it was <45% and <15% of the freshly prepared samples respectively.
CONCLUSION: The study showed that storage of reconstituted co-amoxiclav injection will lead to administering of lower dose at the point of admistration of the second dose; this will lead to treatment and antibiotic resistance.Full Text:
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Klein JO. Amoxicillin/clavulanate for infections in infants and children: past, present and future. Pediatr Infect Dis J 2003;22:139-148.
Martínez MA, Inglada L, Ochoa C, Villagrasa JR. Assessment of antibiotic prescription in acute urinary tract infections in adults. J Infect 2007;54:235-244.
British Pharmacopiea Commission. British Pharmacopoeia. 2015
GlaxoSmithKline. Augmentine Intravenous 2018. Available at: https://www.medicines.org.uk/emc/product/1153/smpc#companyDetails. Accessed 8th October, 2018.
British Medical Association. British National Formulary. 2012
Rajesh K, Yadav A, Patel A. Development and Validation of Stability Indicating HPLC Method for Estimation of Co-Amoxyclav Injection. Pharmagene 2013; 1:60-64
Tippa DMR, Singh N. Development and validation of stability indicating HPLC method for simultaneous estimation of amoxicillin and clavulanic acid in injection. Am J Analyt Chem. 2010; 1:95-101.
Carlier M, Verstraete AG, De Waele JJ, Stove V. Stability of amoxicillin and amoxicillin/clavulanic acid reconstituted in isotonic saline. J Chemother 2016;1-3.
Newton D (1978) Physicochemical determinants of incompatibility and instability in injectable drug solutions and admixtures. Am J Health Syst Pharm 1978; 35:1213-1222.
Nur A, Hassan A, Gadkariem EA, Osman Z, Ali G (2015) Stability of Co-Amoxiclav Reconstituted Injectable Solution. Eur J Pharm Med Res 2015; 2:109-123.
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Stability testing of new drug substances and products Q1A (R2). 2003.
United States Pharmacopoiea Convention. The United States Pharmacopeia. Amoxicillin and Clavulanate Potassium Oral Suspension 2014
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Validation of analytical procedures: text and methodology Q2 (R1) 2005.
Jassim A-M (2010) In-home drug storage and self-medication with antimicrobial drugs in Basrah, Iraq. Oman Med J 2010; 25:79-87.
Peace N, Olubukola O, Moshood A Stability of reconstituted amoxicillin clavulanate potassium under simulated in-home storage conditions. J Appl Pharm Sci 2012;2:28-31.
Mehta A, Hart‐Davies S, Paynet J, Lacey R Stability of amoxycillin and potassium clavulanate in co‐amoxiclav oral suspension. J Clin Pharm Ther 1994;19:313-315.
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