By a News Reporter-Staff News Editor at Pharma Business Week A patent application by the inventors DHARMADIKARI, Nitin Bhalachandra (MUMBAI, IN); ZALA, Yashoraj (MUMBAI, IN); GADKARI, Ashwini (MUMBAI, IN), filed on February 12, 2016, was made available online on March 9, 2017, according to news reporting originating from Washington, D.C., by NewsRx correspondents (see also Sun Pharma Advanced Research Company Ltd.).
This patent application is assigned to Sun Pharma Advanced Research Company Ltd.
The following quote was obtained by the news editors from the background information supplied by the inventors: "Rosuvastatin is marketed as rosuvastatin calcium in the form of tablets containing 5, 10, 20 and 40 mg of rosuvastatin calcium, under the brand name of Crestor.RTM.. It is indicated in patients with primary hyperlipidemia as an adjunct to diet to reduce elevated total cholesterol, low density lipoprotein and triglyceride levels and to increase high density lipoprotein. As The prevalence of hyperlipidemia increases with age and requires chronic therapy, these HMG-CoA inhibitors, such as rosuvastatin calcium, are generally prescribed to patients for the rest of their lives. Further, it is known that geriatric populations generally may need to take more than one medication.
"Solid unit oral dosage forms are available in a variety of sizes and shapes. It is always preferable to design a dosage form that is patient compliant in terms of adhering to the therapy. Sometimes such solid dosage forms pose problems while swallowing as a result of, example, their size, stickiness, taste, aftertaste or frequency of administration. Particularly, in patients suffering from dysphagia, the swallowing of solid oral dosage form may be very painful, if not impossible. Thus, there is a need for a dosage form that eases oral administration."
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent application: "The present inventors have discovered a novel multi-particulate pharmaceutical composition, each particle having a higher percentage of rosuvastain or its pharmaceutically acceptable salt, loaded into it. The high percentage loading makes the single unit dosage form of the pharmaceutical composition compact, and causes it to contain fewer excipients, allowing the patient to administer it by sprinkling onto a minimum portion, for instance, a teaspoon, of a vehicle. The multiparticulate composition has been found to be not only patient compliant but also chemically stable throughout the shelf life of the product.
"The present invention provides a stable multi-particulate pharmaceutical composition comprising pellets, the pellets comprising a mixture of rosuvastatin or its pharmaceutically acceptable salts as a sole active ingredient, one or more osmotic release modifiers and one or more stabilizers. Also, the present inventors have discovered a novel stable multi-particulate pharmaceutical composition comprising pellets, the pellets comprising at least 5% by weight of pharmaceutically acceptable salt of rosuvastatin as a sole active ingredient, by weight of the pellets.
"The present inventors have discovered that the osmotic release modifiers are critical to accelerate release of rosuvastatin from the pellets. Such a stable multi-particulate pharmaceutical composition of rosuvastatin calcium is particularly advantageous as it can be administered by sprinkling on soft food, such as applesauce, pudding, custard, oatmeal or yoghurt. The pellets are of such a size that they escape chewing or mastication and are palatable. Thus a stable, multi-particulate pharmaceutical composition of rosuvastatin calcium that is very patient compliant is presented. Alternatively, the pellets can also be administered via a nasogastric tubing for hospitalized patients."
URL and more information on this patent application, see: DHARMADIKARI, Nitin Bhalachandra; ZALA, Yashoraj; GADKARI, Ashwini. Stable Multiparticulate Pharmaceutical Composition of Rosuvastatin. Filed February 12, 2016 and posted March 9, 2017. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220170056401%22.PGNR.&OS=DN/20170056401&RS=DN/20170056401
Keywords for this news article include: Anticholesteremic, Antihyperlipidemic Agents, Dosage Forms, Lipoproteins, Drugs and Therapies, Rosuvastatin Therapy, HMG-CoA Reductase Inhibitor, Sun Pharma Advanced Research Company Ltd.
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