STABILITY STUDIES ON FLUCLOXACILLIN SODIUM IN CAPSULE DOSAGE FORMS
Objective: Flucloxacillin is easily broken down by moisture and this raises stability concerns of the drug in a country where humidity is very high.
Stability studies on flucloxacillin sodium in capsule formulations were done with three pharmaceutical excipients. The studies sought to determine the best of three excipients for the formulation of flucloxacillin that gives the best stability in an environment of high humidity. The study also sought to establish if the amount of excipient influences the stability of flucloxacillin in the formulation.
Methods: Fixed amounts of flucloxacillin sodium were mixed with varying amounts of dried starch, undried starch and sodium carboxymethylcellulose (sodium cmc) in Petri dishes. The mixtures were exposed to humidity in a room for 12 w and iodimetry was used to monitor the amounts of flucloxacillin sodium in the mixtures for 12 w.
Results: It was noticed after 12 w that, the mixtures with the dried starch experienced the least breakdown or gave the most stable products, followed by those with the undried starch while those with sodium cmc experienced the most breakdown. Also, the higher the amounts of excipients used, the more stable the drug.
Conclusion: Dried starch should be preferred and in higher amounts in formulating capsule dosage forms of flucloxacillin sodium.
Keywords: Stability studies, Flucloxacillin sodium, Sodium carboxymethylcellulose, Dried starch, Undried starch, Iodimetry
2. Sternbach G, Varon J. Alexander fleming: the spectrum of penicillin. World J Emerg Med 1992;10:89â€“91.
3. Schneider T, Sahl HG. An oldie but a goodie-cell wall biosynthesis as antibiotic target pathway. Int J Med Microbiol 2010;300:161â€“9.
4. Sutherland R, Croydon EA, Rolinson GN. Flucloxacillin, a new isoxazolyl penicillin, compared with oxacillin, cloxacillin, and dicloxacillin. Br Med J 1970;4:455â€“60.
5. Ritchie SR, Rupali P, Roberts SA, Thomas MG. Flucloxacillin treatment of staphylococcus aureus meningitis. Eur J Clin Microbiol Infect Dis 2007;26:501â€“4.
6. Cunha BA. Antibiotic selection in the penicillin-allergic patient. Med Clin North Am 2006;90:1257â€“64.
7. British Pharmacopoeia. Electronic. London, UK: Her Majestyâ€™s Stationery Office; 2009.
8. Deshpande AD, Baheti KG, Chatterjee NR. Degradation of Î²-lactam antibiotics. Curr Sci 2004;87:1684â€“986.
9. Loudon GM. Organic chemistry. 3rd editer. Scanlan-Rohrer A, Leslie W, Butterer C. editors. California, USA: The Benjamin/Cummings Publishing Company, Inc; 1995. p. 348-50.
10. Florence TA, Attwood D. Physicochemical principles of pharmacy. 4th ed. Pharmaceutical Press: London; 2006. p. 94-107.
11. British Pharmacopoeia. Electronic. London, UK: Her Majestyâ€™s Stationery Office; 2007.
12. British Pharmacopoiea. In: Electronic. London: The Stationery Office; 2009.
13. British Pharmacopoeia. In: Vol. 1. London, UK: Her Majestyâ€™s Stationery Office; 1980. p. 343.
14. Aulton ME. Pharmaceutics, The science of dosage form design. Second. London, UK: Churchill Livingstone; 2002. p. 101-5.
15. Curran-Everett D. Explorations in statistics: correlation. Adv Physiol Education 2010;34:186â€“91.
16. Sweetman CS. Martindale: The complete drug reference. 36th ed. China: Everbest Company Ltd; 2009. p. 213, 277.