Pharmaceutical quality evaluation of different glimepiride brands marketed in Karachi (Pakistan): In pursuance to global issue of availability and affordability of quality medicines.

Availability of economical quality medicines is always required for chronic disease management. Price differences among multiple brands of a product do not essentially displays low quality for the more affordable brand, however in a few occurrences it appears. Glimepiride, an oral anti-diabetic drug, is produced by several national and multinational industries in Pakistan with considerable cost variation. The study aimed to evaluate the quality and economy of various Glimepiride brands available in Karachi, specifically of public sector hospitals. For this, eight glimepiride brands were collected and analyzed for the pharmaceutical quality using physical parameters, disintegration test, dissolution profile, spectrophotometric assay and content uniformity. Pharmacoeconomic assessment was also carried out such as availability, affordability and price variation. A profound discrepancy was observed among the prices of selected brands. All of the products found to be equivalent to the reference product except G5, the most inexpensive and highest consumed product of a public sector hospital. Study concludes that products with higher quality and lesser price can be used as a substitute to the costly brands while availability of a substandard product looks for consideration of pertinent authorities to assure the distribution of quality medicines.

Long-Term Clinical Benefits of Canagliflozin 100 mg Versus Sulfonylurea in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin in India.

OBJECTIVES: To simulate the long-term health outcomes of canagliflozin 100 mg versus glimepiride over 20 years in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin from the perspective of the Indian health care system. METHODS: Health outcomes were simulated using the validated Economic and Health Outcomes Model of T2DM. Patient demographic characteristics, biomarker values, and treatment effects were sourced from a subgroup of Indian patients enrolled in a 52-week, head-to-head study of canagliflozin versus glimepiride (mean maximum dose of 5.6 mg/d) in patients with T2DM inadequately controlled with metformin. Outcomes were discounted at 5%. Sensitivity analyses were conducted using alternative values for key model inputs. RESULTS: Relative to glimepiride, treatment with canagliflozin 100 mg was associated with approximately 14 more patients surviving at year 20 per 1,000 patients treated and 0.43 quality-adjusted life-years gained, largely because of improved body weight and reduced risk of macrovascular and microvascular morbidity over 20 years. Risk reductions were the largest for microvascular complications (e.g., chronic kidney disease and albuminuria). Improved health outcomes were driven by better glycated hemoglobin control associated with canagliflozin versus glimepiride, which also delayed the need for rescue therapy. Key components of quality-adjusted life-year gains included the avoidance of hypoglycemic episodes, chronic kidney disease, and weight gain, as well as increased survival with canagliflozin compared with glimepiride. CONCLUSIONS: Simulation results suggest that canagliflozin 100 mg may provide better long-term health outcomes compared with glimepiride in Indian patients with T2DM inadequately controlled with metformin.

Quality and behavior of glimepiride generics versus amaryl under stressed conditions.

BACKGROUND: The use of generic versions of drugs, such as those for glimepiride [Amaryl, Amarel, Solosa (sanofi-aventis, Paris, France)], a third-generation sulfonylurea, can reduce healthcare costs. However, the quality and performance of these generics should be carefully evaluated. METHODS: We compared the quality and behavior of 23 marketed generic forms with Amaryl (all 2 mg) under stressed conditions. Deblistered samples were stored at 60 degrees C for 21 days in order to mimic temperature-stressed conditions. Samples were analyzed at Days 0, 7, and 21 for content of active compound, levels of impurities, levels of residual solvent (Day 0 only), and dissolution profile, and results were compared against Amaryl specifications. RESULTS: Levels of the degradation product GS [corrected] were < or = 1% in all products at Day 0; however, GS levels [corrected] increased to above Amaryl specifications [corrected] in two generics at Day 7 (Dolcyl and GLA-DM) [corrected] and in four generics at Day 21 [Dolcyl, GLA-DM, glimepiride (Hanni), and glimepirida (Esterlina)] (Fig. 2) [corrected] Total levels of other impurities and levels of residual solvents were above Amaryl specifications (1,400 ppm, respectively) in two generics at Day 0. At Day 0, the dissolution of 12 generics (52%) failed to meet Amaryl specifications (>or=85% dissolved in 15 min); this trend was confirmed at Day 21. Overall, 74% (17 of 23) of the generics were not of equivalent quality or performance compared with Amaryl. CONCLUSIONS: This study indicates that a relevant percentage of glimepiride generics may offer reduced quality and performance when compared with the original drug.

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.