Quality Assessment of Glibenclamide and Nifedipine tablets in Community Pharmacies in Lagos State
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International Pharmaceutical Federation (FIP)
Background Glibenclamide and Nifedipine are used as mainstay for two common chronic diseases in developing countries, diabetes & hypertension1. Often, patients cannot insist on brand faithfulness and many healthcare workers do not think about therapeutic inequivalence. Both drugs belong to the Biopharmaceutical Classification System (BCS) class II with poor water solubility and ultimately variable absorption2. Methods Three (3) brands each of glibenclamide & nifedipine were purchased from community pharmacies in Lagos. Physicochemical quality tests were carried out as specified by USP (United States Pharmacopoeia) 2007 and results compared to set guidelines. Results The results showed that the products had acceptable physical quality & percentage content (official requirements, within 90-110% of stated content). None of the glibenclamide brands passed the dissolution test with percentage release varying between 31.5-72.5% at 30 minutes. One brand was equivalent to the innovator. This may have an effect on in-vivo bioavailability. For nifedipine, two products passed the compendial requirement at 3, 6 and 12 hours respectively while the 3rdproduct failed. None of the brands was similar to the innovator. Conclusion From the results obtained, invitro dissolution in-equivalence infers in-vivo bio-inequivalence. It is recommended that further studies on in-vivo bio-equivalence of these drugs and in fact, drugs used interchangeably for chronic diseases, be carried out to allow for determination of drug release behavior.
8th International Congress of the International Federation of Pharmacists (FIP) in Glasgow, Scotland from the 2nd to 6th of September 2018.
Quality , Assessment , Nifedipine , Glibenclamide , Antihypertensive drugs , Antidiabetic drugs , Community pharmacies , Lagos State , Research Subject Categories::PHARMACY
Joda, A.E. and Oyadiran, O. Quality assessment of glibenclamide and nifedipine tablets in community pharmacies in Lagos State. Oral Presentation during the 78th International Congress of the International Federation of Pharmacists (FIP) in Glasgow, Scotland from the 2nd to 6th of September 2018. Presentation – Monday, 3rd September 2018 at the Lomond Auditorium, Scottish Event Campus Centre (SECC), Glasgow, Scotland