A presentation on Quality assessment of the brands of glibenclamide by Oyadiran Oluwateniola Oluwatosin and Reddy Vinay Kumar

1. Quality Assessment of the
brands of Glibenclamide in
Community Pharmacies
Oyadiran Oluwateniola Oluwatosin and Reddy Vinay Kumar

2. INTRODUCTION
 Drug quality is a commitment to patients and healthcare
professionals. It is important that drugs are manufactured under
conditions and practices prescribed by current good manufacturing
practice (cGMP) regulations to ensure that quality is built into the
design and manufacturing process at every step.
 The poor quality of drugs has been linked to counterfeiting of
medicines, chemical instability especially in tropical climates and
poor quality control during manufacture.

3.  Fake and counterfeit medicines pose a public health risk because
their content can be dangerous or lack active ingredients. At best,
the regular use of substandard or counterfeit medicines can result in
treatment failure and contribute to increased resistance (for example,
in the case of anti-malarial that contains insufficient active
ingredients) and even death.

4.  Glibenclamide is an oral hypoglycemic agent classified under second
generation sulphonylurea and a BCS (Biopharmaceutical Classification
System) class II drug with poor water solubility and dissolution rate and
ultimately, variable absorption.
 The poor water solubility of glibenclamide is responsible for its poor
dissolution rate which ultimately leads to variable absorption.
 This study was designed to assess the quality of brands of glibenclamide
tablets obtained from community pharmacies in Lagos state, Nigeria

5. METHODS
 Ten brands of Glibenclamide tablets were purchased from various community
pharmacies in Lagos, Nigeria.
 Various quality tests were carried out as specified by the United States
Pharmacopoeia (USP) 2007 and British Pharmacopoeia (BP) 2009, including
uniformity of weight, friability, hardness, disintegration, dissolution and analysis
of content using UV/Visible spectrophotometric method.
 The data obtained was assessed against the official recommendation to determine
the quality of the brands tested.

6. RESULTS
 The brands complied with official specifications for uniformity of weight,
friability, hardness and disintegration test.
 All the brands passed the assay of active ingredients of glibenclamide tablets,
falling within 90-110% of the stated content as specified by the USP.
 None of the brands passed the dissolution test and significant differences were
observed in the dissolution profiles of glibenclamide brands as percentage release
varied between 31.5-72.5% in 30 minutes.
 Only two brands showed equivalence to the innovator brand. This may reflect in
vivo bioavailability performance with potential ramifications for their clinical
effects.

7. Graphical Representation of Dissolution curves
of various brands of Glibenclamide.

8. Standard calibration curve of Glibenclamide
y = 0.012x + 0.041
R = 0.998
0
0.02
0.04
0.06
0.08
0.1
0.12
0.14
0.16
0.18
0 2 4 6 8 10 12
Series1
Linear (Series1)
Standard calibration curve of Glibenclamide

9. CONCLUSION
 In vitro dissolution inequivalence of the different brands is likely to
infer in vivo bio-inequivalence.
 It is recommended that further studies on in vivo bio-equivalence of
glibenclamide be carried out to allow for determination of its drug
release behaviour in vivo.

10. REFERENCES
 Nachum Z, Yefet E. Response to Comment on Nachum et al. Glyburide Versus
Metformin and Their Combination for the Treatment of Gestational Diabetes
Mellitus: A Randomized Controlled Study. Diabetes Care 2017;40 (8):332-337. doi:
10.2337/dci17-0016. PMID: 28733385