Glyburide Use in Older Adults: Pharmacy Claims Data Analysis of a Regional Healthcare Organization.

BACKGROUND/OBJECTIVES: Glyburide was added to the 2012 American Geriatrics Society (AGS) Beers Criteria® due to the risk of hypoglycemic events in older adults. The objective of this study was to evaluate trends of glyburide use in persons aged 65 and older with diabetes mellitus, type II, before, during, and after the 2012 AGS Beers Criteria® Update. DESIGN: Multicenter retrospective cohort study comparing pharmacy claims data from four Sharp Rees-Stealy clinic regions over 5 years (2010-2015). SETTING: Pharmacy claims database. PARTICIPANTS: A total of 3,005 patients with diabetes mellitus, type II, aged 65 and older. MEASUREMENTS: Prescription fill history of the sulfonylureas glyburide, glipizide, and glimepiride were collected along with comorbidity (Elixhauser) and demographic information. Odds of glyburide prescribing were stratified by year, clinic region, and by prescriber type. RESULTS: Glyburide use decreased across each study year (35.8%, 27.7%, and 4.2% in 2011, 2013, and 2015, respectively; P < .01). Adjusted odds of glyburide use indicated that regions A and D were 24% (P = .045) and 11% (P < .01) less likely to prescribe glyburide in 2011, regions A and D were 37% (P < .01) and 8% (P = .03) less likely to prescribe glyburide in 2013, respective to the overall average, whereas region B was 41% (P = .04) more likely. No significant regional site variations remained in 2015. Internists were 47% more likely to prescribe glyburide than family medicine providers in 2013; P < .01), but not in any other study years. CONCLUSION: Rates of glyburide use decreased after release of the 2012 AGS Beers Criteria® demonstrating successful adoption of evidence-based medicine at a large multiregional site. However, regional differences may affect timing of implementation. Education, system-level initiatives, and strong professional support may help enhance more uniform adoption. J Am Geriatr Soc 68:2354-2358, 2020.

Fast and environmentally friendly quantitative analysis of active agents in anti-diabetic tablets by an alternative laser-induced breakdown spectroscopy (LIBS) method and comparison to a validated reversed-phase high-performance liquid chromatography (RP-HPLC) method.

Laser-induced breakdown spectroscopy (LIBS) is evaluated as a potential analytic technique for rapid screening and quality control of anti-diabetic tablets. This paper proposes a simple LIBS-based method for the quantitative analysis of two active pharmaceutical ingredients (APIs): metformin (Met) and glybenclamide (Gly). In order to quantify both APIs, chlorine (Cl) concentration was estimated by employing the Cl/Br optical emission ratio, where Br was introduced as internal standard. Calibration curves were prepared, achieving linearity higher than 99%. On the other hand, for comparison to the proposed method, an isocratic reversed-phase high-performance liquid chromatography (RP-HPLC) method was also developed for quantitative determination of the same analytes by ultraviolet (UV) detection. The chromatographic separation was achieved on a Phenomenex Hypersil C18, 250 mm × 4.6 mm, 5 µm column. The mobile phase was K(2)HPO(4)/H(3)PO(4)-CH(3)OH and flow rate was 1.0 mL min(-1). The method is linear over a range of 10-60 µg mL(-1) for Gly and 5-30 µg mL(-1) for Met and the correlation coefficients were ≥0.99. Recoveries were found to be in the range of 95-101%. Furthermore, four different commercial brands of each active agent were evaluated by both proposed LIBS and chromatographic methods and results were compared with each other. The comparison was satisfactorily validated by analysis of variance (ANOVA).

Non-destructive detection of adulterated tablets of glibenclamide using NIR and solid-phase fluorescence spectroscopy and chemometric methods.

This study describes a method for non-destructive detection of adulterated glibenclamide tablets. This method uses near infrared spectroscopy (NIRS) and fluorescence spectroscopy along with chemometric tools such as Soft Independent Modeling of Class Analogy (SIMCA), Partial Least Squares-Discriminant Analysis (PLS-DA) and Unfolded Partial Least Squares with Discriminant Analysis (UPLS-DA). Both brand name (Daonil) and generic glibenclamide tablets were used for analysis. The levels of glibenclamide in each type of tablet were evaluated by derivative spectrophotometry in the ultraviolet region. The results obtained from the NIR and fluorescence spectroscopy along with those obtained from multivariate data classification show that this combined technique is an effective way to detect adulteration in drugs for the treatment of diabetes. In the future, this method may be extended to detect different types of counterfeit medications.

Determination of metformin hydrochloride and glyburide in an antihyperglycemic binary mixture using high-performance liquid chromatographic-UV and spectrometric methods.

Three methods were developed for simultaneous determination of metformin hydrochloride and glyburide in an antihyperglycemic binary mixture without previous separation. In the first method, a reversed-phase HPLC column with acetonitrile-water (60 + 40, v/v) mobile phase at 0.9 mL/min flow rate was used to separate both compounds, with UV detection at 254 nm. Linearity was obtained in the concentration range of 0.06--0.24 microg/mL for glyburide and 1.5-6.0 microg/mL for metformin hydrochloride. The second method depended on first- and second-derivative UV spectrometry with zero-crossing measurements. The first-derivative amplitude at 261 nm was selected for the assay of glyburide, and the second-derivative amplitude at 235 nm was selected for the assay of metformin hydrochloride. The third method depended on measuring the first derivative of the ratio-spectra at 241 nm for glyburide and 227 nm for metformin hydrochloride. For the second and third methods, Beer's law was obeyed in the range of 10-55 microg/mL for glyburide and 20-200 microg/mL for metformin. The proposed methods were extensively validated and applied for the analysis of some pharmaceutical formulations containing binary mixtures of the mentioned drugs.

A rapid and highly sensitive method for the determination of glimepiride in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry: application to a pre-clinical pharmacokinetic study.

A sensitive and specific liquid chromatography-positive electrospray ionization-tandem mass spectrometry method has been developed and validated for the determination of glimepiride (GPD) in human plasma. GPD and the internal standard (IS, glibenclamide) were extracted from a small aliquot of human plasma (200 microL) by a simple liquid-liquid extraction technique using ethyl acetate as extraction solvent. The compounds were separated on a YMC Propack, C18, 4.6x50 mm column using a mixture of ammonium acetate buffer, acetonitrile and methanol (30:60:10, v/v) as mobile phase at 0.5 mL/min on an API 4000 Sciex mass spectrometer connected to an Agilent HPLC system. Method validation and pre-clinical sample analysis was performed as per FDA guidelines and the results met the acceptance criteria. GPD and IS were detected without any interference from human plasma matrix. The method was proved to be accurate and precise at linearity range of 0.02-100.00 ng/mL with a correlation coefficient of 0.999. The method was robust with a lower limit of quantitation of 0.02 ng/mL. Intra- and inter-day accuracies for GPD were 88.60-113.50 and 96.82-103.93%, respectively. The inter-day precision was better than 12.21%. This method enabled faster and reliable determination of GPD in a pre-clinical study.

Fast HPLC method for the determination of glimepiride, glibenclamide, and related substances using monolithic column and flow program.

This work presents a fast method for the simultaneous separation and determination of glimepiride, glibenclamide, and two related substances by RP LC. The separation was performed on a Chromolith Performance (RP-18e, 100 mm x 4.6 mm) column. As mobile phase, a mixture of phosphate buffer pH 3, 7.4 mM, and ACN (55:45 v/v) was used. Column oven temperature was set to 30 degrees C. The total chromatographic run time was 80 s. This was achieved using a flow program from 5 to 9.9 mL/min. Precisions of the interday and the intraday assay for both retention times and peak areas for the four analyzed compounds were less than 1.2%. The method showed good linearity and recovery. The short analysis time makes the method very valuable for quality control and stability testing of drugs and their pharmaceutical preparations.

Studies on hypoglycaemic activity of Solanum xanthocarpum Schrad. & Wendl. fruit extract in rats.

Aqueous extract of the fruits of Solanum xanthocarpum Schrad. & Wendl. (Solanaceae) was investigated for hypoglycaemic activity in rats and mice. Screening for the hypoglycaemic activity was assessed on normoglycaemic, alloxan treated hyperglycaemic and glucose loaded rats along with in vitro study on glucose utilization by isolated rat hemidiaphragm. The various haematological and biochemical parameters were also studied. The extract was found to possess significant hypoglycaemic activity when compared with the reference standard glibenclamide. The in vitro study on glucose utilization by isolated rat hemidiaphragm suggests that the aqueous extract may have direct insulin like activity which enhances the peripheral utilization of glucose and have extra pancreatic effect. The toxicity studies report safety usage of the plant extract.