39 results about "Fluvastatin Sodium" patented technology

The present invention relates to novel anhydrous amorphous forms of bis[(E)[4-(4-fluorophenyl)isopropyl[methyl(methylsulfonyl)amino]pyrimidinyl](3R,5S)-3,5-dihydroxyhept enoic acid]calcium salt (rosuvastatin calcium), (±)7-(3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl)3,5-dihydroxy heptenoic acid monosodium salt (fluvastatin sodium) and bis[(E)-3,5-dihydroxy-7-[4′-(4″-fluorophenyl)-2′-cyclopropyl-quinolin-3′-hept-6-enoic acid]calcium salt (pitavastatin calcium), to processes for their preparation, to pharmaceutical compositions containing them and to methods of treatment using the same. The rosuvastatin calcium, pitavastatin calcium and fluvastatin sodium obtained are known valuable agents useful in treating hyperlipidemia and hypercholestrolemia.

Provided are polymorphic forms of fluvastatin sodium and processes for their preparation.

Provided are polymorphic forms of fluvastatin sodium and processes for their preparation.

Various fluvastatin compositions and methods for preparing them are described. One example is a controlled release pharmaceutical composition comprising fluvastatin and at least one non-ionic hydrophilic polymer, wherein the composition is substantially free of hydroxypropyl methylcellulose. Another example is a stable pharmaceutical composition comprising fluvastatin, preferably, fluvastatin sodium wherein the composition is substantially free of an alkalizing stabilizing agent. Another example is a stable controlled release pharmaceutical formulation, comprising fluvastatin, preferably, fluvastatin sodium, that is stable with a water content greater than 3.5 percent by weight.

The invention provides a refining process of intermediate I (E)-7-[3-(4-fluorophenyl)-1-(1-methyl ethyl)-1H-indole-2-radicial]-5-hydroxy-3-oxygen-6-heptene methyl acetate. The invention refines fluvastatin sodium intermediate I through adopting acetic acid ethyl ester and hexane solvent system, which increases the purity of product which is refined, and simultaneously avoids the inference of impurities for subsequent preparation fluvastatin sodium. Simultaneously, the invention further provides a preparation process of fluvastatin sodium which contains the intermediate refining steps.

Provided is a process for preparing a polymorphic form of fluvastatin sodium, particularly Form XIV.

The invention relates the preparing method of non-shaped fluorine-vastatin sodium. The current technology has many defects. The method comprises the following steps: preparing menthol dissolution liquid, dissolving fluorine-vastatin calcium in the liquid, distilling and getting the menthol dissolution liquid which can be recovered. The invention has the advantages of simple technology and high productivity.

A color stable controlled release pharmaceutical dosage form comprising HMG CoA reductase inhibitor, rate controlling polymers and one or more pharmaceutical excipients wherein the granules are independent of particle size the pharmaceutical dosage form is free of alkalizing/buffering agents. A color stable controlled release pharmaceutical dosage form comprising Fluvastatin Sodium, hydroxypropyl methylcellulose polymer and hydroxypropyl cellulose, wherein the granules are independent of particle size.

The invention discloses an application of fluvastatin sodium in the preparation of drugs for treating corona virus disease 2019. The mechanism by which fluvastatin sodium can alleviate corona virus disease 2019 is to weaken the ability of COVID-19 virus to invade human cells through ACE2, thereby inhibiting replication of COVID-19 virus.

The present invention is directed to a process for preparing Fluvastatin Sodium salt by basic hydrolysis of its alkyl ester. The reaction is performed in conditions suitable to allow a selective hydrolysis of the desired syn isomer, while the unwanted anti isomer is removed by extraction, thus reducing its content in the final product; this diastereomer is the main impurity of Fluvastatin sodium salt and its ester precursor.

Disclosed herein are novel polymorphic forms of Fluvastatin sodium, wherein said polymorphic forms are designated as J_F, J_F1, J_F2, J_F3 and are characterized by their powder X-ray diffraction patterns, Infrared absorption spectrums, thermo gravimetric analysis and differential scanning calorimetry. The processes for preparing said polymorphic forms are also disclosed. The present invention also relates to process for preparing amorphous form of Fluvastatin sodium.

The invention relates to a fuvastatin sodium micro-porous osmotic pump controlled release tablet and preparing method thereof. The fuvastatin sodium micro-porous osmotic pump controlled release tablet comprises tablet core and semi-transparent controlled-release membrane and ordinary thin membrane wrapping the tablet core. The tablet core comprises fuvastatin sodium, filler, retarder, osmotic-pressure active substance, alkali stabilizer and lubricating agent; the semi-transparent membrane comprises cellulose acetate, pore-foaming agent and plasticizer; and ordinary thin membrane is thin-film-covered premix gastric-soluble opadry. The fuvastatin sodium micro-porous osmotic pump controlled release tablet and preparing method thereof alleviates rate of drug release by adding macromolecular retardant in the tablet core and covers the tablet core by semi-transparent controlled-release membrane and lightproof ordinary membrane in order to prepare the fuvastatin sodium micro-porous osmotic pump controlled release tablet that keeps drug release at constant rate in 24 hours in more steady blood concentration more steady, durable effects, minor toxic and side effect and good patient compliance. Besides, the fuvastatin sodium micro-porous osmotic pump controlled release tablet is in simple preparing technology, facilitating industrialized production.

The present invention provides an improved process for preparing HMG-CoA reductase inhibitors such as rosuvastatin calcium, fluvastatin sodium, and pitavastatin calcium under a mild condition, using a novel amide-bond-containing compound having R₂—N—O—R₁ moiety as a key intermediate. And also, the present invention provides the novel compound, an intermediate useful for the preparation thereof, and a process for the preparation thereof.