Bioequivalence of Fixed Dose Combination of Atorvastatin 10 mg and Aspirin 150 mg Capsules: A Randomized, Open-Label, Single-Dose, Two-way Crossover Study in Healthy Human Subjects

Tippabhotla, Sudhakar Koundinya; Betha, Madhava Rao; Gadiko, Chaitanya; Battula, Ramakrishna; Nakkawar, Mukesh; Cheerla, Raju; Khan, Sohel Md.; Yergude, Sandeep; Thota, Satyanarayana; Venkateswarlu, Vobalaboina

doi:10.1055/s-0033-1337931

Cited by 4 publications

(2 citation statements)

References 6 publications

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“…30 Non-inferiority and bioequivalence of an aspirin/clopidogrel/statin FDC formulations to concomitant use of separate pills were already demonstrated. 31 Another strategy we devised in our deprescription tool was to prefer extended release preparations of tablets to reduce the dosage frequency. We applied this to six patients who were taking Nifedipine and Metoprolol tartarate.…”

Section: Discussionmentioning

confidence: 99%

Active deprescribing program in chronic kidney disease patients undergoing haemodialysis

et al. 2021

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Background: Deprescribing is gaining attention of medical community to address polypharmacy. Existing deprescribing tools were not validated in haemodialysis population. We designed this study to assess the pill burden of patients undergoing haemodialysis and to measure the outcome after implementation of an active deprescribing program.Methods: An evidence based deprescription tool was formulated. All patients who were on dialysis for 3 months or more were eligible to participate. Medication reconciliation followed by medication list evaluation for appropriateness was done for all patients. All inappropriate medications were discontinued followed by monitoring for 6 months for complications. Primary outcome was the average number of medications and pills per patient before and 12 weeks after implementation of deprescribing program. Results:We enrolled 150 patients to the active deprescribing program. Mean age was 60.4 ± 10.9 years. After deprescription, there were significant reduction in the number of medications from 11 (Interquartile range 8-13.25) to 8 (IQR 6-9) (p < .001) and reduction in the number of pills from 16 to 11 (IQR 8-14.25) (p < .001). Pill burden accessed using Living with Medication Questionnaire-Visual Analogue Scale score also had a significant reduction from 7 (IQR 5-8) to 4 (IQR 3-5) (p < .001). Conclusion:Polypharmacy is a significant problem in haemodialysis patients, which can lead to poor quality of life and health hazards due to side effects of medications.Implementation of a proactive deprescribing program can cut down polypharmacy to a significant extent.

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Section: Discussionmentioning

confidence: 99%

Active deprescribing program in chronic kidney disease patients undergoing haemodialysis

et al. 2021

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“…Literature survey shows that RP-HPLC stability indicating methods for rosuvastatin alone or with combination [2], LC-MS/MS methods for plasma for rosuvastatin alone or with metabolites/combination of other drugs [3][4][5][6][7][8][9][10][11][12][13][14][15][16], LC-MS/MS methods for plasma for aspirin alone or with metabolites/combination of other drugs [17][18][19][20][21][22][23][24][25] are reported. It is noted that method for simultaneous estimation of RVT with metabolites and ASP with metabolite is not available.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a Method for the Simultaneous Quantification of Aspirin, Salicylic Acid, Rosuvastatin, Rosuvastatin Lactone and N-Desmethyl Rosuvastatin in Human Plasma Using UPLC-MS/MS-API-5500

Thennati¹,

Shahi²,

Patel³

et al. 2017

Pharm Anal Chem

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A rapid and sensitive LC-MS/MS method has been developed and fully validated for simultaneous quantification of aspirin (ASP), salicylic acid (SLA), rosuvastatin (RVT), rosuvastatin lactone (RVL) and N-desmethyl rosuvastatin (DM RVT) in human plasma using a polarity switch with 400 µL of sample human blank plasma. Deuterated Internal Standards (IS) were used for each analyte. The solid phase extraction was used as sample preparation techniques. Chromatograph was monitored on a zorbax SB-phenyl column with a gradient mode with API-5500 triple quadrupole mass spectrometer as detector. The assay method was validated over the concentration range of 0.1-25 ng/mL for RVT; 50-10000 pg/mL for RVL and DMRVT; 5-2000 ng/mL for ASP; and 0.1-8 µg/mL for SLA. Intra and inter-day precision and accuracy were within acceptance limit. The mean recovery was >85% for all analytes. The analytes were stable at RT for 6 h in solution, at 2-8°C for 15 days in solution, for RT for 6 h in plasma, RT for 2 h in blood, till 3 freeze/thaw cycles, 104 h in auto-sampler at 6°C. This proposed method can be used for measurement of reliable concentration for dossier submission.The method was linear with weighing factor (1/x 2 ) in the range of 0.1-25 ng/mL for RVT, 50-10000 pg/mL for RVL and DMRVT, 5-2000 ng/mL for ASP and 0.1-8 µg/mL for SLA with intra and inter-day accuracy and precision within the acceptance criteria as per FDA and EMA guidelines (Table 4). The mean regression coefficient was >0.99 for all analytical run for all analytes.

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Statins for the prevention of proliferative vitreoretinopathy: cellular responses in cultured cells and clinical statin concentrations in the vitreous

Mysore

Amo

Loukovaara

et al. 2021

Sci Rep

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Proliferative vitreoretinopathy (PVR) with rhegmatogenous retinal detachment (RRD) is a complex inflammatory ocular disease. Statins are widely used cholesterol-lowering drugs with putative anti-inflammatory properties. In this study, we have explored their efficacy in controlling post-surgical PVR formation. Simvastatin (SIM), atorvastatin (ATV), or rosuvastatin (RSV) were added to cultures of human retinal pigment epithelial cells (ARPE-19) prior to exposure with the bacterial lipopolysaccharide (LPS), and the production of pro-inflammatory cytokines (IL-6, IL-8, MCP-1) was examined using an enzyme-linked immunosorbent assay. In addition, the concentrations of simvastatin, atorvastatin, rosuvastatin, and their metabolites were measured from the vitreal samples of 20 patients undergoing vitrectomy (16 of them receiving oral statin therapy) using an ultra-performance liquid chromatography-tandem mass spectrometer technique. All statins alleviated LPS-induced inflammation at 5 µM concentration in the ARPE-19 cell cultures. Statin levels in the vitreous samples ranged from 6 to 316 pg/mL (ca. 0.1–7 M−10). Vitreal statin concentrations were similar to the typical steady-state unbound statin concentrations in plasma, indicating that only the unbound drug distributes from the blood circulation into the vitreous. Pharmacokinetic simulations of the intravitreal delivery of statins indicate that the measured clinical statin concentrations could be maintained with existing drug delivery technologies for months. Our results suggest that intravitreal statin therapy may have the potential in alleviating the risk of post-surgical PVR.

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Bioequivalence of Fixed Dose Combination of Atorvastatin 10 mg and Aspirin 150 mg Capsules: A Randomized, Open-Label, Single-Dose, Two-way Crossover Study in Healthy Human Subjects

Cited by 4 publications

References 6 publications

Active deprescribing program in chronic kidney disease patients undergoing haemodialysis

Active deprescribing program in chronic kidney disease patients undergoing haemodialysis

Development and Validation of a Method for the Simultaneous Quantification of Aspirin, Salicylic Acid, Rosuvastatin, Rosuvastatin Lactone and N-Desmethyl Rosuvastatin in Human Plasma Using UPLC-MS/MS-API-5500

Statins for the prevention of proliferative vitreoretinopathy: cellular responses in cultured cells and clinical statin concentrations in the vitreous

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