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• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/02—Halogenated hydrocarbons
  • A61K31/025—Halogenated hydrocarbons carbocyclic
  • A61K31/03—Halogenated hydrocarbons carbocyclic aromatic
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  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/12—Ketones
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/13—Amines
  • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
  • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
  • A61K31/19—Carboxylic acids, e.g. valproic acid
  • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
  • A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
  • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
  • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
  • A61K31/365—Lactones
  • A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
  • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
  • A61K31/404—Indoles, e.g. pindolol
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
  • A61K31/409—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
  • A61K31/4418—Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
  • A61K31/47—Quinolines; Isoquinolines
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
  • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/56—Materials from animals other than mammals
  • A61K35/60—Fish, e.g. seahorses; Fish eggs
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
  • A61K35/66—Microorganisms or materials therefrom
  • A61K35/74—Bacteria
  • A61K35/748—Cyanobacteria, i.e. blue-green bacteria or blue-green algae, e.g. spirulina
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K38/00—Medicinal preparations containing peptides
  • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
  • A61K38/164—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P9/00—Drugs for disorders of the cardiovascular system

Definitions

• the present invention relates to a synergistic LDL-lowering and HDL-increasing pharmaceutical composition
• a synergistic LDL-lowering and HDL-increasing pharmaceutical composition comprising a) HMG CoA reductase inhibitor, b) NADPH oxidase inhibitor, and optionally c) oil containing long-chain polyunsaturated fatty acids, for the treatment of cardiovascular diseases.
• the invention also discloses a method of preparation for the said composition.
• Cardiovascular disease is a complex and multifactorial disease and characterized by multiple factors. Epidemiologic studies have identified these as elevated serum lipids (cholesterol and triglycerides), increased plasma fibrinogen and coagulation factors, increased platelet activation, alterations in glucose metabolism, and smoking.
• LDL low density lipoprotein
• ROS reactive oxygen species
• Hypercholesterolemia is the presence of high levels of cholesterol in the blood. It is not a disease but a metabolic derangement that can be caused by many diseases, notably cardiovascular disease. It is closely related to the terms “hyperlipidemia” (elevated levels of lipids in the blood) and “hyperlipoproteinemia” (elevated levels of lipoproteins in the blood).
• Elevated cholesterol in the blood is due to abnormalities in the levels of lipoproteins, the particles that carry cholesterol in the bloodstream. This may be related to diet, genetic factors (such as LDL receptor mutations in familial hypercholesterolemia) and the presence of other diseases such as diabetes and an underactive thyroid.
• the type of hypercholesterolemia depends on which type of particle (such as low-density lipoprotein) is present in excess.
• hypercholesterolemia itself is asymptomatic, longstanding elevation of serum cholesterol can lead to atherosclerosis. Over a period of decades, chronically elevated serum cholesterol contributes to formation of atheromatous plaques in the arteries. This leads to progressive narrowing or even complete blockage of the involved arteries. Blood supply to the tissues and organs served by these occluded arteries gradually diminishes until organ function becomes impaired.
• the inadequate blood flow to the heart muscles is caused by the narrowed coronary arteries, which are the vessels that supply blood to the heart, lead to myocardial ischemia or angina, which may ultimately result in myocardial infarction, heart attack or failure.
• Therapeutic agents used to prevent myocardial ischemia or infarction generally include ⁇ -blockers, statins and aspirin.
• ⁇ -Blockers exert their beneficial effects predominantly through heart rate control, whereas statins reduce blood cholesterol levels and prevent development and rupture of atherosclerotic plaque and aspirin reduces platelet activation and vasoconstriction, thereby limiting ischemic events.
• HMG-CoA reductase inhibitors often called “statins”; these are drugs that block an enzyme called “HMG-CoA reductase.” These are the most effective cholesterol lowering agents available and in recent years have received increased attention for their benefits beyond helping patients with high cholesterol.
• omega-3 fatty acids have been used to treat post-myocardial infarction (MI) and adult endogenous hyperlipidemias of hypercholesterolemias and of hypertriglyceridemias by lowering serum triglycerides, increasing serum HDL- cholesterol, lowering systolic and diastolic blood pressure and the pulse rate, and lowering the activity of the blood coagulation factor VH-phospholipid complex.
• MI post-myocardial infarction
• US 20100172971 disclose phycobilins as inhibitors of NADPH oxidase activity and are useful in the prophylaxis and/or treatment of medical conditions associated with or linked to an NADPH oxidase activity.
• NADPH oxidase overactivity can stimulate proinflammatory mechanisms, promote tissue fibrosis and bone resorption, and, in the vascular system, antagonize the crucial protective activity of nitric oxide.
• US 5763496 disclose a method for the prevention and treatment of atherosclerosis and its related diseases in which an NADPH oxidase inhibitor, preferably apocyanin is administered.
• the NADPH oxidase inhibitor prevents the production of reactive oxygen species upon exposure of endothelial cells to atherogenic LDL levels, resulting in decreased endocytosis and vascular hyperpermeability.
• WO 2006096806 discloses a composition of statin and omega-3 fatty acids and method of preparation for the said composition
• the inventors of the present invention have surprisingly found that the combination of HMG CoA reductase inhibitor, NADPH oxidase inhibitor and optionally a polyunsaturated fatty acids synergistically lowers the low density lipoprotein (LDL) and increase the high density lipoprotein (HDL) in patients with hyperlipidemia.
• LDL low density lipoprotein
• HDL high density lipoprotein
• An object of the present invention is to provide a synergistic LDL-lowering and HDL- increasing pharmaceutical composition
• a synergistic LDL-lowering and HDL- increasing pharmaceutical composition comprising:
• Another object of the present invention is to provide a synergistic LDL-lowering and HDL-increasing pharmaceutical composition comprising:
• Yet another object of the present invention is to provide a process for preparing a synergistic LDL-lowering and HDL-increasing pharmaceutical composition comprising: a) HMG CoA reductase inhibitor,
• synergistic LDL- lowering and HDL-increasing pharmaceutical composition comprising
• HMG CoA reductase inhibitor in the range from 5 to 80 mg
• NADPH oxidase inhibitor in the range from 5 to 300 mg, and optionally c) omega-3 fatty acid in the range from 100 to 1000 mg.
• the present invention relates to a synergistic LDL-lowering and HDL-increasing pharmaceutical composition
• a synergistic LDL-lowering and HDL-increasing pharmaceutical composition comprising a) HMG CoA reductase inhibitor, b) NADPH oxidase inhibitor, and optionally c) long-chain polyunsaturated fatty acids, for the treatment of cardiovascular diseases, specifically hyperlipidemia.
• the present invention provides a synergistic LDL lowering and HDL increasing pharmaceutical composition
• a synergistic LDL lowering and HDL increasing pharmaceutical composition comprising:
• the present invention provides a synergistic LDL lowering and HDL increasing pharmaceutical composition comprising:
• composition or “dosage form” as used herein means any physical form of the formulation that contains an amount of active substance(s) with pharmaceutically acceptable excipient (s) sufficient to produce a therapeutic effect on administration.
• pharmaceutically acceptable in context with excipient(s) means approved by a regulatory agency of the federal or a state government or listed in recognized pharmacopoeia for use in humans.
• HMG-CoA reductase (or 3-hydroxy-3-methyl-glutaryl-CoA reductase) is the rate-limiting step in cholesterol synthesis and represents the sole major drug target for contemporary cholesterol-lowering drugs.
• the medical significance of HMG-CoA reductase has continued to expand beyond its direct role in cholesterol synthesis following the discovery that it can offer cardiovascular health benefits independent of cholesterol reduction.
• HMG-CoA reductase inhibitors inhibit the HMG-CoA reductase enzyme and lower cholesterol level.
• HMG CoA reductase inhibitor as used in the present invention is selected from the group of statins comprising of atorvastatin, simvastatin, pitavastatin, lovastatin, fluvastatin, pravastatin, cerivastatin, rosuvastatin or a combination thereof.
• Statins as used herein includes free base, or pharmaceutically acceptable salts thereof or mixtures thereof. It also includes anhydrous form, hydrous form, different crystalline forms, amorphous form, prodrugs, metabolites, enantiomers or mixtures thereof.
• the NADPH oxidase (Nicotinamide adenine dinucleotide phosphate-oxidase) is a membrane-bound enzyme complex.
• NADPH oxidase is a major cause of atherosclerosis. Atherosclerosis is caused by the accumulation of macrophages containing cholesterol (foam cells) in artery walls. NADPH oxidase produces ROSs. These ROSs activate an enzyme that makes the macrophages adhere to the artery wall.
• NADPH oxidase inhibitor as used in the present invention is selected from the group comprising of phycocyanin, C-phycocyanin, phycocynobilin, Spirulina extract, aminoethyl- benzenesulfonylfluoride, apocynin, diphenylene iodonium or a combination thereof.
• NADPH oxidase inhibitor is phycocyanin or C- phycocyanin.
• Polyunsaturated fatty acid containing oil or omega-3 fatty acid source includes, but not limited to Krill oil, Fish Oil, Flax-seed oil, Chia-seed oil, or any other oil containing omega-3 fatty acid or oleoresin or extract derived from any terrestrial or aquatic plants or algae, or any marine animal species including fish and crustaceans or a combination thereof.
• polyunsaturated fatty acid is oil containing omega-3 fatty acid.
• the said Omega-3 fatty acid is chemically synthesized or produced through enzymatic or microbial transformation of the precursor materials.
• Omega-3 fatty acid is extracted from the raw materials using an appropriate extraction method, preferably an organic solvent or CO 2 extraction method.
• Polyunsaturated fatty acid is selected from the group comprising of cis 5,8,11,14,17-eicosapentanoic acid (EPA) and cis 4,7, 10,13, 16, 19-docosahexanoic acid (DHA), one of their esters or pharmaceutically acceptable salts.
• Phospholipid as used in the present invention includes, but not limited to naturally occurring lecithins, phosphatidylcholine, phosphatidylethanolamine, phosphotidylinositol or a combination thereof.
• phospholipid is lecithin.
• the present invention provides a synergistic LDL-lowering and HDL- increasing pharmaceutical composition comprising:
• the present invention provides a synergistic LDL-lowering and HDL-increasing pharmaceutical composition
• a synergistic LDL-lowering and HDL-increasing pharmaceutical composition comprising:
• the present invention provides a synergistic LDL-lowering and HDL- increasing pharmaceutical composition
• a synergistic LDL-lowering and HDL- increasing pharmaceutical composition comprising:
• the present invention provides a process for preparing a synergisticLDL- lowering and HDL-increasing pharmaceutical composition comprising: a) HMG CoA reductase inhibitor,
• the present invention provides a process for the preparation of synergistic LDL-lowering and HDL-increasing pharmaceutical composition, comprising the steps of:
• the present invention provides a process for the preparation of synergistic LDL-lowering and HDL-increasing pharmaceutical composition, comprising the steps of:
• statins and NADPH oxidase inhibitor 1) Premixing the required amounts of statins and NADPH oxidase inhibitor, by first dissolving them in their respective liquid media and subsequently mixing the two in desired ratio.
• the present invention provides a process for the preparation of synergistic LDL-lowering and HDL-increasing pharmaceutical composition, comprising the steps of: 1) Dissolving statin and NADPH oxidase inhibitor optionally with an equimolar concentration of PC (80 % purity grade of soya-phospholipids), in a liquid media and mixing subsequently.
• Liquid media used in the process for the preparation according to the present invention include, but not limited to water, saline solution, ringers solution, dextrose, short chain alcohols, suitable organic solvent or a mixture thereof.
• “Surfactant and/or co-surfactant” used in the process for the preparation according to the present invention include, but not limited to Capryol, Gelucire, Cremophor, Imwitor, Labrafil, Lauroglycol 90, Tween20, Tween80, PEG400, glycerin, ethylene glycol, propylene glycol, or a mixture thereof.
• agents may also used for the process for the preparation according to the present invention include, but not limited to emulsifying agent, preservatives, stabilizers, wetting agent, secondary emulsifier, buffer.
• the amount present in the synergistic pharmaceutical formulation of HMG CoA reductase inhibitor is in a range from 5 to 80 mg, NADPH oxidase inhibitor is in a range from 4 to 300 mg, and omega-3 fatty acid is in a range from 100 to 2000 mg.
• compositions of the present invention may possibly act in reducing dose of individual active ingredients when administered together either in one fixed dose composition or as a kit separately as distinct units.
• the present invention provides a method of use of the synergistic lipid lowering pharmaceutical composition comprising: a) HMG CoA reductase inhibitor
• the present invention provides a method of use of said synergistic lipid lowering pharmaceutical composition in maintaining healthy lipid profile, reducing LDL oxidation, inhibiting platelet aggregation and vascular inflammation.
• the present invention provides a synergistic lipid lowering pharmaceutical composition in the treatment of atherosclerosis, myocardial infarction, myocardial ischemia, angina pectoris, stroke and any other cardiovascular events which involve deposition of lipids in blood vessels.
• the present invention provides additional advantage of the synergistic lipid lowering pharmaceutical composition for clinical management of cardiovascular diseases, whereby composition may help in reducing some of the side effects associated with statins.
• the present invention provides a pharmaceutical kit comprising the said synergistic lipid lowering pharmaceutical composition in a single or multiple units in a single or multiple pack/container which comprising:
• Suitable dosage forms according to the present invention include, without limitation, solid dosage forms (eg. powders and granules, capsules, and/or tablets); liquid dosage forms (eg. solutions and disperse systems); and/or sterile dosage forms and delivery systems (eg parentrals, and/or biologies).
• Methods of administering the synergistic pharmaceutical composition according to the present invention by any suitable route include, but are not limited to, intramuscular, intrathecal, intradermal, intraperitoneal (ip), intravenous (iv), subcutaneous (sc), intranasal, epidural, intradural, intracranial, intraventricular, and oral routes.
• Convenient routes for administration include, for example, infusion or bolus injection, topical, absorption through epithelial or mucocutaneous linings, ophthalmic, nasal, and transdermal. Administration can be systemic or local.
• Examples 1-4 can be formulated using any of the manufacturing processes described above or by any other process known to the person skilled in the art.
• Example 5 For the purpose of examples the data generated with Atorvastatin represents the class of HMG CoA reductase inhibitors (statins)
• Atorvastatin, Phycocyanin, Omega 3 fatty acid oil compositions were evaluated accordingly six study groups were designed as below.
• Tl Atorvastatin ( 1.45mg/kg).
• T2 Atorvastatin ( 1.45mg/kg) + Omega3 fat ty ac id oil 300mg + Phycocyanin 50mg.
• T3 Atorvastatin ( 1.45mg/kg) + Phycocyanin 50mg.
• T4 Atorvastatin ( 1.45mg/kg) + Omega3 fatty acid oil 300mg.
• Rats were weighed and marked. Before initiation of the study on day 1 the weight, HDL, LDL, TC and TG of the individual animal was estimated. Then the rats were fed on high fat diet for 14 days of the study for the induction of hyperlipidemia. On day 14, HDL and LDL and body weight was assessed to confirm the occurrence of hyperlipidemia and to rule out any kind of hepatotoxicity. From Day 14 the study drug as per the groups assigned were administered to the rats for 4 weeks. After 2 weeks of study treatment on day 28 HDL and LDL body weight was assessed. Final evaluation was done on day 42 including the LDL and HDL levels assessment. Blood was withdrawn from the tail vein to analyze lipid profiles.
• Table 2 LDL levels measured in various treatment groups from day 0 to day 28 (Treatment period)
• Data in table 3 indicates a marked increase in the HDL levels i.e. 163% in the group treated with combination of Atorvastatin and Phycocyanin at the end of 28 day treatment.
• the group treated with Atorvastatin 1.45mg/kg + Omega-3 300mg + Phycocyanin 50mg showed an increase of 125% when compared to the group treated with Atorvastatin alone i.e. 74%.
• compositions of the present invention can reduce intake of the high dose of HMG CoA reductase inhibitor by administrating them along with NADPH oxidase inhibitor optionally with an omega-3 fatty acid source, exhibiting both increase in high density lipoproteins and decrease in low density lipoproteins for treatment of cardiovascular diseases in humans.
• compositions of the present invention are suitable for veterinary use.
• the combination of atorvastatin and phycocyanin and combination of atorvastatin, phycocyanin and omega-3 fatty acid source exhibits superior efficacy in reduction of LDL and boosting HDL levels as compared to statin administered alone.

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• 2013
  • 2013-03-13 WO PCT/IB2013/051987 patent/WO2013136277A1/fr not_active Ceased

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