Abstract

Dyslipidemia or hyperlipidemia comprised mainly hypertriglyceridemia and/or hypercholesterolemia; it is now well established as their control is considered to have an impact on public health. Therefore, in an overcrowded field to find appropriate answers to lower blood levels of cholesterol and triglycerides, here we report findings of formulation studies, aimed to combine statins and n-3 PUFA, overcoming drawbacks related to solubility and stability. A new formulation has been made creating a solvent system that allows for a complete solubilization of statin drugs such as atorvastatin, rosuvastatin, and pitavastatin. With simvastatin, a preliminary dehydration with molecular sieves was also needed for stability purpose. These findings are of great importance and could be applied widely in all cases where a co-administration of the two active therapeutic ingredients are routinely required.

Highlights

  • The sedentary lifestyle of Western populations is closely associated to the use of hyper caloric and hyperlipidemic diets, is one of the important risk factors for Cardiovascular Disease (CVD), the major cause of mortality in the world.Western lifestyle and its spread to a growing number of people worldwide, is increasingly worrying the World Health Organization (WHO) that recently revealed that ischemic heart disease and cerebrovascular disease would be in first and second position, respectively, in rank order of deaths in the frame time through the year 2030

  • The purpose of this paper is not to analyze the different statins according to their absorption and bioavailability, pharmacokinetic and metabolism, but to describe statins according to their chemical structure being responsible of different limitations in the fish oil formulation

  • We report the results of a study on fluid formulations containing n-3 Omega-3 Polyunsaturated Fatty Acid (PUFA) and statins; the synergistic effects of statins associated to PUFA have been documented in several papers [1318], it is known that certain statins are sensitive to acidic environment causing their degradation to their lactone forms and various isomers

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Summary

Introduction

The sedentary lifestyle of Western populations is closely associated to the use of hyper caloric and hyperlipidemic diets, is one of the important risk factors for Cardiovascular Disease (CVD), the major cause of mortality in the world.Western lifestyle and its spread to a growing number of people worldwide, is increasingly worrying the World Health Organization (WHO) that recently revealed that ischemic heart disease and cerebrovascular disease would be in first and second position, respectively, in rank order of deaths in the frame time through the year 2030. The sedentary lifestyle of Western populations is closely associated to the use of hyper caloric and hyperlipidemic diets, is one of the important risk factors for Cardiovascular Disease (CVD), the major cause of mortality in the world. CVD, as well as type 2 diabetes mellitus incidence, cancers and other terrible diseases, could be prevented with appropriate interventions to reduce the effects of risk factors. Control of triglycerides and cholesterol levels in blood is one of the most followed practices for preventing Dyslipidemia [3,4]. The most therapeutically and commercially successful class of drugs of the last century, are used to lower blood levels of cholesterol, and PUFAs (omega-3 polyunsaturated fatty acids) which are mainly fish oil, are widely used to reduce triglycerides

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