Update on compatibility assessment of empagliflozin with the selected pharmaceutical excipients employed in solid dosage forms by thermal, spectroscopic and chromatographic techniques.

Update on compatibility assessment of empagliflozin with the selected pharmaceutical excipients employed in solid dosage forms by thermal, spectroscopic and chromatographic techniques. Drug Dev Ind Pharm. 2020 Jan 14;:1-26 Authors: Niguram P, Polaka SN, Rathod R, Kalia K, Kate AS Abstract Empagliflozin (EGF) received USFDA approval in 2014 for oral use to control the glucose levels in adults with type 2 diabetes mellitus. Albeit, a systematic drug-excipient compatibility study of EGF has not been reported in the open literature. As physical and chemical interactions affect the performance of the formulation, this study intended to unveil the drug and excipients interactions which would later help in development of a robust solid dosage form. Differential scanning calorimetry (DSC) was applied as a screening tool for the assessment of compatibility between EGF and the list of excipients mentioned in the EMEA summary of product characteristics (SmPC)-section 6.1, along with mannitol and polyvinylpyrrolidone. Thermogravimetric analysis (TGA), Fourier Transform Infrared Spectroscopy (FTIR), X-ray Powder Diffraction (PXRD) and Hot Stage Microscopy (HSM) methods were utilized to appraise the interpretation of DSC results adequately. Isothermal stress testing (IST) studies of EGF were performed using the selected excipients to check the presence of interaction products (IPs) and the drug content by HPLC. Additional peaks were observed in the EGF-macrogol mixture...
Source: Drug Development and Industrial Pharmacy - Category: Drugs & Pharmacology Tags: Drug Dev Ind Pharm Source Type: research

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Authors: Maejima T, Kumagai K, Yabe K, Yasuno K, Ishikawa K, Okado K, Sasaki N, Kai K, Mori K Abstract A 40-week-old male spontaneous diabetic Torii rat, an animal model of type 2 diabetes mellitus, was found to have marked urinary calculi with hematuria in the urinary bladder on necropsy. Histological findings in the urinary bladder included a papillary growth pattern with a fibrovascular stroma without atypia. Fine granular materials in the bladder lumen were positive for Von Kossa staining but negative for periodic acid-Schiff or Gram staining, indicating no apparent bacterial infection in the urinary bladder. S...
Source: Journal of Toxicologic Pathology - Category: Toxicology Tags: J Toxicol Pathol Source Type: research
Authors: Z S, J F, R K, F K, S K, A T, S R Abstract Introduction: Diabetes mellitus has assumed the status of an epidemic in the last century. High prevalence of diabetes in South Asian population and presence of other cardiovascular risk factors in this region, make up the relationship between coronary artery disease (CAD) and diabetes more pronounced. Keeping in view the high susceptibility of diabetic patients for CAD, these patients are recognized as a high risk group .Emphasis has been laid on the early recognition of CAD, even in silent or asymptomatic state. Coronary artery calcium scoring (CACS), owing to i...
Source: Journal of the Association of Physicians of India - Category: General Medicine Tags: J Assoc Physicians India Source Type: research
It is unclear how microangiopathic changes in skeletal muscle vary among systemic vascular pathologies. We therefore analyzed the capillary fine structure in skeletal muscle from patients with arterial hypertension (HYPT), diabetes mellitus type 2 (T2DM) or intermittent claudication – peripheral arterial disease (IC/PAD). Tablet-based image analysis (TBIA) was carried out to largely re-evaluate 5,000 transmission electron micrographs of capillaries from 126 vastus lateralis biopsies of 75 individuals (HYPT, T2DM or IC/PAD patients as well as healthy individuals before and after endurance exercise training) used in pr...
Source: Frontiers in Physiology - Category: Physiology Source Type: research
Abstract Objective: Type 2 diabetes mellitus (T2DM) is a well-defined risk factor of periodontitis and it can affect expression of human beta-defensins (hBDs) and cathelicidin (LL-37) as well. The aim of the present study was to evaluate the impact of periodontitis and T2DM on salivary concentrations of these antimicrobial peptides.Material and methods: Unstimulated saliva samples, together with full-mouth periodontal recordings were collected from 92 individuals with periodontitis (63 with T2DM and 21 smokers) and 86 periodontally healthy controls (58 with T2DM and 21 smokers). Salivary hBD-1, -2, -3, LL-37, and ...
Source: Acta Odontologica Scandinavica - Category: Dentistry Authors: Tags: Acta Odontol Scand Source Type: research
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Source: International Journal of Diabetes in Developing Countries - Category: Endocrinology Source Type: research
ConclusionsWe hypothesized that only insulin monotherapy is associated to a reduced bone mineral density and content in type 2 diabetic postmenopausal women.
Source: Archives of Cardiovascular Diseases Supplements - Category: Cardiology Source Type: research
Abstract The present work embarks upon increasing the dissolution rate and the bioavailability of model anti-diabetic drug, gliquidone, a sulfonylurea class drug used for treating diabetes mellitus type 2. The gliquidone nanoparticles were prepared by using anti-solvent precipitation technique in which, gliquidone solution in acetone was added at a controlled rate to an aqueous solution containing polyvinylpyrrolidone K25 (PVP K25) as stabilizer. The effect of drug concentration (X1), polymer concentration (X2) and solvent to anti-solvent ratio (X3) on particle size and dissolution was studied using Box-Behnken de...
Source: AAPS PharmSciTech - Category: Drugs & Pharmacology Authors: Tags: AAPS PharmSciTech Source Type: research
CONCLUSIONS: There was a high prevalence of LSTT, LSFT and androgen deficiency symptoms in this study. Serum TT and FT were lower in men with T2DM than in control subjects. Risk factors associated with LSFT or LSTT included higher BMI and WC and older age. The AMS score was a poor predictor of low testosterone. More research is required locally before any screening policy can be recommended. PMID: 31865960 [PubMed - in process]
Source: South African Medical Journal - Category: African Health Tags: S Afr Med J Source Type: research
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Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Publication date: Available online 23 August 2019Source: Canadian Journal of DiabetesAuthor(s): Paolo RaggiAbstractIf a disease state is highly prevalent and its consequences are severe, it may be appropriate to seek methods to identify it early to forestall its development and complications. Diabetes mellitus is a proven risk factor for the development of atherosclerosis, although its face and outcome are changing, as shown in contemporary clinical trials. In fact, decompensated heart failure seems to drive the hospitalization rate in patients with diabetes, and mortality from heart failure is reduced with modern hypoglyc...
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
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