The present invention relates to novel formulations comprising a sprayable composition comprising tranexamic acid and chitosan for use in the treatment of wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention and the process for preparation thereof.
The present invention relates to an orally fast dissolving film formulation comprising rivaroxaban or pharmaceutically acceptable salts thereof and the process for preparation thereof. The present invention further relates to the fast dissolving film formulation comprising rivaroxaban or a pharmaceutically acceptable salt thereof and at least one solubilizer, wherein the film has high dissolution rate, causes no risk of damage to oral tissues and gives a good feeling, when placed on the tongue.
A61K 47/12 - Carboxylic acidsSalts or anhydrides thereof
A61K 47/20 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
A61K 47/32 - Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers
A61K 47/36 - PolysaccharidesDerivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
None of the approved & marketed desmopressin injection products is stable at room temperature. All the desmopressin injection products are advised to be stored at refrigerated conditions 2°C-8°C to prevent degradation of the active principle. It has been more than 35 years; however, a room temperature stable desmopressin injection is still not available. Therefore, in an attempt to meet the long felt need, the present invention provides room temperature stable aqueous compositions of desmopressin for intravenous or subcutaneous administration. The room temperature stable compositions of the present invention are advantageous over products stored under refrigeration conditions from manufacturing, storage and logistic point of view. The room temperature stable product does not require be storing and shipping at a controlled temperature (i.e. 2-8°C). It also does not require cold chain transport. It requires less care to be taken as compared to refrigerated formulations.
The present invention relates to the pharmaceutical compositions comprising nor-UDCA or pharmaceutically acceptable salt or ester thereof and the process for preparation. The present invention most preferably discloses the solid oral dosage form of nor-UDCA preferably in the form of tablets, capsules, disintegrating tablets and effervescent tablets.
The present invention relates to a pharmaceutical composition, preferably in form of tablet(s), in particular a dispersible, especially a fast dispersible pharmaceutical composition, preferably in the form of tablet(s), further in particular a water dispersible, especially a fast water-dispersible pharmaceutical composition, preferably in form of tablet(s), comprising capecitabine with at least one pharmaceutically acceptable excipient, preferably the pharmaceutical composition being intended to be dispersed in water and/or other aqueous liquids before oral administration; in particular, this pharmaceutical composition can be characterized with disintegration time of less than 3 minutes using purified water at 15° C. to 25° C. (Ph. Eur Disintegration Test).
A61K 31/7068 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
The present invention relates to novel formulations comprising a sprayable composition comprising tranexamic acid and chitosan for use in the treatment of wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention and the process for preparation thereof.
The present relates to stable aqueous pharmaceutical composition of adalimumab comprising (a) buffer system (b) a surfactant and (c) a polyol and the process for the preparation thereof, particularly the suitable aqueous pharmaceutical compositions comprising adalimumab which is free of stabilizers selected from group consisting of sodium chloride and/or amino acids.
The present invention relates to oral liquid formulations comprising lenvatinib or pharmaceutically acceptable salts or solvates thereof with improved stability and palatability. Further the present invention relates to an oral pharmaceutical suspension comprising lenvatinib or pharmaceutically acceptable salt, solvate or hydrate thereof and pharmaceutically acceptable excipients, wherein pharmaceutically acceptable excipients are selected from suspending agents, wetting agents, stabilizing agents, vehicle, organic co-solvents, sweeteners, flavoring agents, preservatives, antioxidants and buffering agents.
The present invention provides a topical spray composition comprising palmitoylethanolamide and menthol and the process for preparation thereof. The topical spray composition comprising palmitoylethanolamide as per the present invention are used for the treatment of pain and inflammation.
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/352 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. cannabinols, methantheline
The present invention relates to an injectable composition for extended release of fingolimod comprising a suspension of at least about 0.5 mg/ml of fingolimod, wherein fingolimod release is for at least 7 days and the process for preparation thereof.
The present invention relates to stable orally dissolving formulations e.g., tablets (ODTs) and films (ODFs) comprising prucalopride succinate or pharmaceutically acceptable salts thereof and the process for preparation thereof for the treatment of chronic idiopathic constipation.
A61K 31/4525 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
A61K 9/00 - Medicinal preparations characterised by special physical form
The present invention provides the method and/or compositions for administering a therapeutically effective amount of ursodeoxycholic acid (UDCA) intravenously for the treatment and/or the prevention of liver diseases, preferably chronic liver diseases. The present invention also relates to methods of intravenous administration of UDCA in a dose of about 15 mg/kg to about 200 mg/ kg at a dosage interval of once every 12 hours to once every 72 hours.
A61K 31/575 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
A61K 9/00 - Medicinal preparations characterised by special physical form
A61P 1/16 - Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
14.
FAST DISSOLVING ORAL FILM PREPARATION COMPRISING RIVAROXABAN
The present invention relates to an orally fast dissolving film formulation comprising rivaroxaban or pharmaceutically acceptable salts thereof and the process for preparation thereof. The present invention further relates to the fast dissolving film formulation comprising rivaroxaban or a pharmaceutically acceptable salt thereof and at least one solubilizer, wherein the film has high dissolution rate, causes no risk of damage to oral tissues and gives a good feeling, when placed on the tongue.
A61K 47/58 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. poly[meth]acrylate, polyacrylamide, polystyrene, polyvinylpyrrolidone, polyvinylalcohol or polystyrene sulfonic acid resin
The present invention is directed to an injectable pharmaceutical composition comprising (a) ursodeoxycholic acid and (b) sulfobutylether-β-cyclodextrin. Such compositions exhibit unexpected solubility and stability of ursodeoxycholic acid permitting therapeutic dosages of the ursodeoxycholic acid to be administered without the use of high amounts of strong bases that are present in an amount stoichiometrically equivalent to the ursodeoxycholic acid. The present invention is directed to an injectable pharmaceutical composition comprising (a) ursodeoxycholic acid and (b) sulfobutylether-β-cyclodextrin. Such compositions exhibit unexpected solubility and stability of ursodeoxycholic acid permitting therapeutic dosages of the ursodeoxycholic acid to be administered without the use of high amounts of strong bases that are present in an amount stoichiometrically equivalent to the ursodeoxycholic acid.
A61K 31/575 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
A61K 9/00 - Medicinal preparations characterised by special physical form
The present invention relates to a controlled release injectable ondansetron formulation comprising ondansetron or pharmaceutically acceptable salt, derivative or metabolite thereof which releases ondansetron over a period of at least 2 days period from the date of administration and the process for preparation thereof.
The present invention relates to a composition for topical application for preventing hair loss, androgenic alopecia (AA) and stimulating hair growth having dutasteride. The composition for topical application for preventing hair loss and stimulating hair growth according to the present invention provides equal or superior hair loss prevention and hair growth stimulating effects while using much smaller dosage than the conventional compositions (oral dosage form) which use finasteride and dutasteride.
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
A61K 9/00 - Medicinal preparations characterised by special physical form
A61P 17/14 - Drugs for dermatological disorders for baldness or alopecia
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
The present invention relates to the stable liquid pharmaceutical composition comprising (a) cabazitaxel or a pharmaceutically acceptable salt or solvate thereof, (b) one or more solubilizers selected from the group consisting of soya phosphatidyl choline, polyethylene glycol and glycocholic acid, (c) a solvent and (d) a co-solvent, wherein the pharmaceutical composition is substantially free of (i) polysorbates and (ii) stabilizers selected from the group consisting of preservatives, antioxidants and chelating agents and the process for preparation thereof, and the methods of using the stable liquid pharmaceutical composition of cabazitaxel for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing treatment regimen.
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
A61K 47/24 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
A61K 47/28 - Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
A61K 47/32 - Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers
The present invention relates to a dispersible tablet comprising at least 70% w/w of abiraterone acetate based on the total weight of the tablet and at least one pharmaceutically excipient selected from group consisting of diluents, binders, surfactants, glidants, disintegrants, lubricants, sweeteners and flavorants and further relates to the process for the preparation thereof.
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
A61K 9/00 - Medicinal preparations characterised by special physical form
20.
Composition of docetaxel liposomal injection with high drug loading
The present invention relates to a pharmaceutical liposomal composition comprising of about 0.8% w/w to about 1% w/w of docetaxel, about 30% w/w to about 38% w/w of Soya Phosphatidyl Choline, about 0.2% w/w to about 0.8% w/w of Sodium Cholesteryl Sulfate, about 61% w/w to about 68% w/w of Sucrose and a pH adjusting agent, wherein the pH of liposomal composition is less than 3.5 and the process for preparation thereof.
A61K 9/127 - Synthetic bilayered vehicles, e.g. liposomes or liposomes with cholesterol as the only non-phosphatidyl surfactant
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharidesDerivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
A61K 47/24 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
A61K 47/28 - Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid
A61K 9/00 - Medicinal preparations characterised by special physical form
The present invention relates to novel green tea water-soluble film composition comprising (a) green tea extract, (b) water-soluble polymer selected from group consisting of sodium alginate, cross-linked polyacrylate and carrageenan, and (c) additives and the process for the preparation thereof. As per the present invention green tea is conveniently prepared by dissolving the novel water-soluble green tea film of the said invention in hot water. The present invention more specifically relates to the water-soluble film composition comprising (a) green tea extract, and (b) water-soluble polymer mixture consisting of sodium alginate and carrageenan.
The present invention relates to a pharmaceutical composition, preferably in form of tablet(s), in particular a dispersible, especially a fast dispersible pharmaceutical composition, preferably in the form of tablet(s), further in particular a water dispersible, especially a fast water-dispersible pharmaceutical composition, preferably in form of tablet(s), comprising capecitabine with at least one pharmaceutically acceptable excipient, preferably the pharmaceutical composition being intended to be dispersed in water and/or other aqueous liquids before oral administration; in particular, this pharmaceutical composition can be characterized with disintegration time of less than 3 minutes using purified water at 15°C to 25°C (Ph.Eur Disintegration Test).
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 31/7068 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
The present invention relates to oral liquid formulations comprising lenvatinib or pharmaceutically acceptable salts or solvates thereof with improved stability and palatability. Further the present invention relates to an oral pharmaceutical suspension comprising lenvatinib or pharmaceutically acceptable salt, solvate or hydrate thereof and pharmaceutically acceptable excipients, wherein pharmaceutically acceptable excipients are selected from suspending agents, wetting agents, stabilizing agents, vehicle, organic co-solvents, sweeteners, flavoring agents, preservatives, antioxidants and buffering agents.
The present invention provides the method and/or compositions for administering a therapeutically effective amount of ursodeoxycholic acid (UDCA) intravenously for the treatment and/or the prevention of liver diseases, preferably chronic liver diseases. The present invention also relates to methods of intravenous administration of UDCA in a dose of about 15 mg/kg to about 200 mg/kg at a dosage interval of once every 12 hours to once every 72 hours.
A61K 31/575 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
The present invention relates to an injectable composition for extended release of fingolimod comprising a suspension of at least about 0.5 mg/ml of fingolimod, wherein fingolimod release is for at least 7 days and the process for preparation thereof.
The present invention relates to an improved process for the preparation of Liraglutide. The present invention further related an improved process for the preparation of substantially pure material having a purity of greater than or equal to 99.5% by HPLC.
The present invention relates to stable orally dissolving formulations e.g., tablets (ODTs) and films (ODFs) comprising prucalopride succinate or pharmaceutically acceptable salts thereof and the process for preparation thereof for the treatment of chronic idiopathic constipation.
A61K 31/4525 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with oxygen as a ring hetero atom
The present invention is directed to an injectable pharmaceutical composition comprising (a) ursodeoxycholic acid and (b) sulfobutylether-?- cyclodextrin. Such compositions exhibit unexpected solubility and stability of ursodeoxycholic acid permitting therapeutic dosages of the ursodeoxycholic acid to be administered without the use of high amounts of strong bases that are present in an amount stoichiometrically equivalent to the ursodeoxycholic acid.
The present invention is directed to an injectable pharmaceutical composition comprising (a) ursodeoxycholic acid and (b) sulfobutylether-β- cyclodextrin. Such compositions exhibit unexpected solubility and stability of ursodeoxycholic acid permitting therapeutic dosages of the ursodeoxycholic acid to be administered without the use of high amounts of strong bases that are present in an amount stoichiometrically equivalent to the ursodeoxycholic acid.
The present invention relates to a controlled release injectable ondansetron formulation comprising ondansetron or pharmaceutically acceptable salt, derivative or metabolite thereof which releases ondansetron over a period of at least 2 days period from the date of administration and the process for preparation thereof.
The present invention relates to the stable liquid pharmaceutical composition comprising (a) cabazitaxel or a pharmaceutically acceptable salt or solvate thereof, (b) one or more solubilizers selected from the group consisting of soya phosphatidyl choline, polyethylene glycol and glycocholic acid, (c) a solvent and (d) a co-solvent, wherein the pharmaceutical composition is substantially free of (i) polysorbates and (ii) stabilizers selected from the group consisting of preservatives, antioxidants and chelating agents and the process for preparation thereof, and the methods of using the stable liquid pharmaceutical composition of cabazitaxel for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel containing treatment regimen.
The present invention relates to a dispersible tablet comprising at least 70% w/w of abiraterone acetate based on the total weight of the tablet and at least one pharmaceutically excipient selected from group consisting of diluents, binders, surfactants, glidants, disintegrants, lubricants, sweeteners and flavorants and further relates to the process for the preparation thereof.
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
The present invention provides a stable liquid bendamustine pharmaceutical composition comprising: (i) bendamustine, a pharmaceutically acceptable salt, and/or a hydrate thereof, (ii) diethylene glycol monoethyl ether, and (iii) a pH adjusting agent, wherein the pharmaceutical composition has a pH of about 3.0 to about 4.0. The present invention further provides the process for the preparation of stable liquid bendamustine pharmaceutical composition.
The present invention relates to a composition for topical application for preventing hair loss, androgenic alopecia (AA) and stimulating hair growth having dutasteride. The composition for topical application for preventing hair loss and stimulating hair growth according to the present invention provides equal or superior hair loss prevention and hair growth stimulating effects while using much smaller dosage than the conventional compositions (oral dosage form) which use finasteride and dutasteride.
A61K 31/435 - 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
A61P 17/14 - Drugs for dermatological disorders for baldness or alopecia
A61K 9/00 - Medicinal preparations characterised by special physical form
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
The present invention relates to novel green tea water soluble film composition comprising a) green tea extract, b) water soluble polymer mixture consisting of sodium carboxymethyl cellulose and sodium alginate, and c) additives. Green tea is conveniently prepared by dissolving the novel water soluble green tea film of the said invention in hot water.
The present invention relates to topical spray compositions comprising chitosan and the process for preparation thereof. The topical spray compositions comprising chitosan are used for the treating burn wounds, wounds resulting from chemical burns, wounds from physical trauma, neuropathic ulcers, pressure sores, diabetic ulcers. Further the spray compositions composition is used for treating gynaecological diseases, urogenital infections (vaginal bacteriosis, urinary tract infection and vaginitis) with good effect, safe, natural, and good biocompatibility by restoring and/or maintaining the pH of vagina. More specifically the present invention relates to topical spray compositions comprising chitosan and carbonic acid and the process for preparation thereof.
The present invention relates to stable liquid pharmaceutical composition of decitabine comprising decitabine and at least one pharmaceutically acceptable excipient, wherein moisture content of the liquid composition is less than about 2.0% by weight. The invention further relates to stable liquid composition of decitabine wherein the total impurities of the composition is less than about 2.0% by weight when stored at 25°C/60%RH for at least 6 months. The invention further relates to method of using such stable liquid compositions of decitabine for parenteral administration either as ready-to-use or ready-to-dilute for treating various cancer disorders.
A61K 31/706 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
A61K 31/7068 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical and veterinary preparations, sanitary
preparations for medical purposes, dietetic substances
adapted for medical use, food for babies, plasters,
materials for dressings, material for stopping teeth, dental
wax, disinfectants, preparations for destroying vermin,
fungicides, herbicides.
The present invention relates to an aqueous ophthalmic solution for treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma, the solution comprising at least 0.5 w/v% brinzolamide dissolved in the solution; hydroxy-propyl-β-cyclodextrin; polyvinyl caprolactam-polyvinyl acetate- polyethylene glycol graft copolymer; and water and/or the process for preparation thereof.
The present invention relates to fast dissolving film composition comprising paracetamol or a pharmaceutically acceptable salt thereof as an active ingredient whose bitter taste is to be masked. More specifically, the present invention relates to a fast dissolving film composition containing paracetamol and taste masking agent; wherein taste masking agent is a mixture of sodium carbonate, citric acid and magnesium aluminometasilicate.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Pharmaceutical and veterinary preparations for the treatment of hypovolemia, plasma or blood volume deficit and the oncotic deficit resulting from hypoproteinemia, product mainly of recombinant plasma, being raw and/or semi-finished products for the pharmacy and dietetics industry
The present invention relates to novel crystalline and amorphous polymorphic forms of Ribociclib(l) mono succinate. (I) Said crystalline forms may be useful in the improved preparation of oral dosage forms for the treatment of cancer.
The present invention relates to a topical pharmaceutical composition containing of about 0.01 % w/w to about 0.1 % w/w of methotrexate in topical solution form for external use for the treatment of psoriasis. The present invention also further encompasses the process for the preparation of the methotrexate in topical solution form.
The present invention relates to a pharmaceutical liposomal composition comprising of about 0.8% w/w to about 1% w/w of docetaxel, about 30% w/w to about 38% w/w of Soya Phosphatidyl Choline, about 0.2% w/w to about 0.8% w/w of Sodium Cholesteryl Sulfate, about 61% w/w to about 68% w/w of Sucrose and a pH adjusting agent, wherein the pH of liposomal composition is less than 3.5 and the process for preparation thereof.
The present invention relates to liposomal injection for patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability, more specifically, a liposomal injection containing fingolimod or pharmaceutically acceptable salts thereof and most specifically fingolimod hydrochloride salt.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Biochemical preparations for use in health care for small
molecule analysis, for research, diagnostic and imaging
uses. Pharmaceuticals and diagnostic products for medical use;
pharmaceutical preparations for the treatment oncology,
multiple sclerosis and auto-immune diseases; pharmaceutical
preparations; chemicals and chemical preparations used for
medical and pharmaceutical purpose and in medicines;
diagnostic preparations for use in disease testing, health
monitoring, hematology oncology, central nervous system
diagnostics, Alzheimer's disease, and more generally,
predictive, preventive, personalized, and participatory
medicine.
The present invention relates to novel formulations comprising a sprayable composition comprising tranexamic acid and chitosan for use in the treatment of wounds or injuries, in particular for use as a topical hemostatic composition or for surgical intervention and the process for preparation thereof.
The present invention relates to the ophthalmic composition comprising from about 0.03% to about 2% by weight of cyclosporine, from about 0.05% to about 5% by weight of tamarind seed polysaccharide and a pharmaceutically acceptable carrier. Further the invention relates to the process for preparation of ophthalmic compositions and its use for the treatment of dry eye.
A61K 31/715 - Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkagesDerivatives thereof, e.g. ethers, esters
A61K 47/44 - Oils, fats or waxes according to two or more groups of Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
The present invention relates to a composition for topical application for preventing hair loss, androgenic alopecia (AA) and stimulating hair growth having dutasteride. The composition for topical application for preventing hair loss and stimulating hair growth according to the present invention provides equal or superior hair loss prevention and hair growth stimulating effects while using much smaller dosage than the conventional compositions (oral dosage form) which use finasteride and dutasteride.
A61K 31/473 - QuinolinesIsoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
A61K 31/58 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
The present invention relates to a topical composition for the treatment of pain and inflammation associated with lesions of skin or mucous membrane comprising lidocaine HC1, and sulfobutyl ether beta-cyclodextrin and the process for preparation thereof. Preferably the topical compositions are in the form of gel or spray dosage forms, which has superior transdermal flux properties.
A61K 31/167 - Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen atom of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
The present invention relates to an amorphous form of Panobinostat Lactate hydrate. In particular, the present invention relates to processes for the preparation of amorphous form of Panobinostat Lactate. More particular the present invention relates to the pharmaceutical composition comprising an amorphous Panobinostat Lactate and one or more of pharmaceutically acceptable carriers, excipients or diluents used for the treatment of Multiple myeloma. The present invention relates to an amorphous form of Panobinostat and its process for the preparation thereof.
The present invention provides a stable, ophthalmic aqueous composition for topical administration comprising acetazolamide and an aqueous liquid capable of forming a pharmaceutically acceptable gel in situ when applied topically to a patient, said composition has the pH of less than 4.5.
A61K 31/00 - Medicinal preparations containing organic active ingredients
A61K 31/41 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which is nitrogen, e.g. tetrazole
The present invention relates to hemostatic scaffold compositions and the method of preparation thereof. In present invention, hemostatic scaffold compositions for wound care and dental care, uses chitosan and tranexamic acid.
The present invention relates to novel crystalline forms of L-alanine,N-[(S)-[[(lR)-2-(6- amino-9H-purin-9-yl)-1methylethoxy]methyl]phenoxyphosphinyl]-1-methylethyl ester, (2E)- 2-butenedioate or Tenofovir Alafenamide hemi fumarate(I). The present invention further relates to a process for the enantiomerically pure Tenofovir Alafenamide hemi fumarate having an enantiomeric purity of greater than 99.5%
The present invention relates to a process for the preparation of N-[5-(4-Bromophenyl)- 6-[2-[(5-bromo-2-pyrimidinyl)oxy]ethoxy]-4-pyrimidinyl]-N'propylsulfamide or Macitentan of Formula (I). The present invention further relates to a process for the preparation highly pure N-[5- (4-Bromophenyl)-6- [2- [(5 -bromo-2-pyrimidinyl)oxy]ethoxy] -4-pyrimidinyl] - N'propylsulfamide or Macitentan of Formula (I). Said substantially pure Macitentan is useful in the preparation of pharmaceutical composition for the treatment of cardiac disorders.
A61K 31/505 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim
C07D 403/12 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group containing two hetero rings linked by a chain containing hetero atoms as chain links
The present invention relates to novel salt of 3,4-diaminopyridine as 3,4-diaminopyridine dihydrochloride (or Amifampridine dihydrochloride), useful in the preparation of pharmaceutical composition thereof. The present application also relates to an improved process for the preparation of substantially pure Amifampridine dihydrochloride (I) having purity of greater than 99.5% (by HPLC).
The present invention relates to a process for the preparation of 1-[(3R)-3 -[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl] -1-piperidinyl]-2-propen-1-one or Ibrutinib of Formula (I). The present invention further relates to a process for the preparation highly pure 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1 H-pyrazolo[3,4-d]pyrimidin-1-yl] -1-piperidinyl]-2-propen-l-one or Ibrutinib.
The present invention relates to a process for preparation of stable Dasatinib base (I). The present invention further, relates to a process for preparation of amorphous Dasatinib base (I). Said stable Dasatinib base (I) may be useful in preparing pharmaceutical dosage form for the treatment of cancer.
The present invention relates to an improved process for the preparation Sofosbuvir Formula (I). The present further relates to Sofosbuvir having a purity of greater than 99.5%.
A61K 31/7072 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
The Present invention provides the orally administrable, disintegrating film dosage forms comprising fingolimod or pharmaceutically acceptable salts or solvates thereof.
The present invention relates to novel crystalline polymorphic forms of Axitinib Formula (I). Said crystalline forms may be useful in the improved preparation of oral dosage forms for the treatment of cancer.
A61K 31/4375 - 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring hetero atom, e.g. quinolizines, naphthyridines, berberine, vincamine
The present invention relates to an improved process for the preparation Axitinib Formula (I). The present further relates to Axitinib containing the process related impurities A, B, C, D, E and F collectively below 0.3% and having a purity of greater than 99.5%.
C07D 401/06 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
The present Invention relates to a process for the preparation substantially pure propane- 1 -sulfonicacid- { 3 -[5 -(4-chiorophenyI)-1 H-pyrrolo [2,3-b]pyridine-3 -carbonyl]-2,4-difluoro-phenyl} -amide or Vemurafenib of Formula (1), The present invention further relates to a process for the preparation substantially pure propane- 1 -sulfonic acid- { 3 - [5-(4-chlorophenyi)-1H-pyrrolo [2,3-b]pyridine-3 -carbonyl] -2,4-difluoro-phenyl} -amide trifluoro methane sulfonic acid salt or Vemurafenib triflate of Formula (VII).
A61K 31/437 - 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 ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
The present invention relates to stable pharmaceutical compositions comprising bortezomib or pharmaceutically acceptable salt or solvate thereof, and Orthophosphoric acid. The present invention also relates to use of stable pharmaceutical compositions comprising bortezomib or pharmaceutically acceptable salt or solvate thereof, for treating cancer in mammals.
The present invention relates to a process for the preparation of 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]-N-methylpyridine-2-carboxamide or Regorafenib (I): Formula (I). The present invention further relates to a process for the purification of 4-[4-({[4-chloro-3-(trifluoromethyl) phenyl] carbamoyl} amino)-3-fluorophenoxy]-N-methylpyridine-2- carboxamide or Regorafenib (I) to provide highly pure material. The present invention further relates to a process for the preparation stable crystalline material of 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)-3-fluorophenoxy]- N-methyl pyridine-2-carboxamide or Regorafenib (I) useful in the preparation of pharmaceutical compositions for the treatment of cancer.
The present application relates to an improved process for preparation of Enzalutamide (I). The present application also relates to an improved process for the preparation of substantially pure Enzalutamide (I) having purity of greater than 99.5%. The present application also relates to a novel process for the preparation of Enzalutamide intermediate useful in the industrially viable synthesis of Enzalutamide.
The present application provides pharmaceutical compositions derived from pemetrexed dipotassium Nonahydrate and its process thereof. The present application also provides a method of treating cancer by administering intravenously the reconstituted lyophilized compositions into a patient in need thereof.
The present invention relates to a process for the preparation of compound of Formula (I). The present invention further relates to novel intermediates useful in the preparation of Bosutinib. The present invention also relates to a process for the preparation of novel Bosutinib intermediates.
The invention relates to a dispersible tablet composition comprising a therapeutically effective amount of Ursodiol or its pharmaceutically acceptable salts thereof, with one or more pharmaceutically acceptable excipients, having disintegration time of less than 2 minutes in a dispersion medium. The invention further, relates to a method of administering the medicament in a liquid administration form containing Ursodiol, for the treatment of Primary biliary cirrhosis in adults and geriatrics, and cholestatic hepatic diseases in infants and children.
A61K 31/575 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systemsDerivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
The present invention relates to a process for preparation of Echothiophate Iodide Echothiophate Iodide (I) obtained by the process of the present invention is obtained as crystalline form designated as Form-SET. (I) The process for preparation of Echothiophate Iodide (I) according to present invention is an ecofriendly process that avoids the use of hazardous solvent systems and provides Echothiophate Iodide (I) of high purity. Pharmaceutical composition of the said crystalline Form-SET of Echothiophate Iodide (I) of high purity is useful in the treatment of ocular disorders like Glaucoma.
The present invention provides process for preparing crystalline Pemetrexed dipotassium (I) Form-SP9 formula (I) characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2θ° peaks selected from the XRPD peak set of 5.0, 12.5, 17.2, 20.8, 22.4, 25.7, 26.9 and 27.9 ± 0.2 2θ°. The invention also provides process for preparing its pharmaceutical composition thereof, which may be useful for anti-cancer treatment.
The present invention relates to a process for preparation of crystalline Form-SDI of Dasatinib (I). Said crystalline Form-SDI of Dasatinib is characterized by X-ray powder diffraction pattern comprising of at least seven 2θ° peaks selected from the XRPD peak set of 5.8, 11.5, 12.7, 13.2, 17.3, 17.5, 18.1, 20.1, 20.5, 22.1, 25.4, 26.6, 26.8 ± 0.20 2θ°; IR spectrum having at least five absorption peaks selected from about 3390 cm-1, 2923 cm-1, 1621 cm-1, 1615 cm-1, 1537 cm-1, 1316 cm-1, 1061 cm-1, 815 cm-1 and 783 cm-1; and DSC isotherm comprising at least two endothermic peaks ranging between- 130 °C to 150 °C, 160 °C to 175 °C or 280 °C to 290 °C. The pharmaceutical compositions of the crystalline Form-SDI of Dasatinib or its hydrate thereof may be useful as an anti-cancer agent.
C07D 417/12 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing two hetero rings linked by a chain containing hetero atoms as chain links
A61K 31/506 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
A61K 35/00 - Medicinal preparations containing materials or reaction products thereof with undetermined constitution
The present invention relates to novel pharmaceutically acceptable substituted aryl acrylic acid addition salts of Crizotinib (I) or its hydrate or solvate thereof. The present invention further relates to processes for preparation of the said substituted aryl acrylic acid addition salts of Crizotinib (I). The present application also provides pharmaceutically acceptable substituted aryl acrylic acid addition salts of Crizotinib (I) or its hydrate or solvate useful as active pharmaceutical ingredient in pharmaceutical composition comprising thereof, possessing anti-cancer activity.
A61K 31/4545 - Non-condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
A61K 31/4465 - Non-condensed piperidines, e.g. piperocaine only substituted in position 4
C07D 401/04 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring- member bond
C07D 401/14 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
75.
DASATINIB GLUCURONATE SALT AND PROCESS FOR PREPARATION THEREOF
The present invention relates to novel pharmaceutically acceptable glucuronic acid addition salt of Dasatinib (I) or its hydrate or solvate thereof. (I) The present invention further relates to the processes for preparation of the said glucuronic acid addition salt of Dasatinib. The glucuronic acid addition salt of Dasatinib or its hydrate or solvate thereof may be useful as an anti-cancer agent.
A61K 31/506 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
C07D 417/12 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing two hetero rings linked by a chain containing hetero atoms as chain links
The invention relates to a granulate composition comprising 90-99.95 % w/w of Imatinib mesylate, 0.05-0.2% w/w of binder and 0-8% w/w of disintegrant, wherein the granulate composition is prepared using binder in isopropyl alcohol solvent. The invention also relates to pharmaceutical compositions comprising Imatinib mesylate, with high polymorphic stability and processes for preparation thereof. Said granulate composition comprising 90-99.95 % w/w of Imatinib mesylate and their pharmaceutical compositions derived may be useful in the treatment of cancer.
The present invention relates to Film Compositions of Ondansetron or its pharmaceutically acceptable salt thereof, which dosage forms are useful for the treatment of various medical conditions.
The present invention relates to a process for preparation of amorphous (R)-3-[1-(2,6- Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine (I) or its premix. (I) The present invention also relates to the amorphous (R)-3-[1-(2,6-Dichloro-3- fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin-2-amine (I) having mass spectrum peak at about [M+] = 450.1, at least three IR peaks selected from 3470 cm -1, 3388 cm -1, 1117 cm -1, 1252 cm -1, or 740 cm -1 ± 2.0 cm -1 and less than 2% w/w of volatiles measured up to 170 °C by TGA. The invention further relates to pharmaceutical compositions comprising amorphous (R)-3-[1-(2,6-Dichloro-3-fluorophenyl)ethoxy]-5-[1-(piperidin-4-yl)-1H-pyrazol-4-yl]pyridin- 2-amine or its premix, having anti-cancer activity.
C07D 413/00 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and oxygen atoms as the only ring hetero atoms
79.
PROCESS FOR PREPARATION OF DIMETHYL-(E)-BUTENEDIOATE
The present invention relates to a process for preparation of dimethyl-(E)-butenedioate (I). The process for preparation of dimethyl-(E) -but enedioate (I), comprises reaction of Fumaric acid with methanol in the presence of C2-C4 alkanoyl halide as coupling catalyst.
The present invention relates to a process for preparation of crystalline non-needle shaped Form-SA of Imatinib mesylate (Formula (I)). The invention also relates to crystalline Form-SA obtained by the process of the present invention, the said Form-SA being substantially pure, stable, non-needle shaped and characterized by X-ray powder diffraction pattern comprising of atleast five 2θ° peaks selected from 10.67, 12.90, 15.34, 19.49, 19.80, 26.06, 26.32 and 28.89 ± 0.05 2θ°. The invention further relates to pharmaceutical compositions comprising non-needle shaped crystalline Form-SA of Imatinib mesylate, useful for the treatment of cancer.
A61K 31/506 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
C07D 401/14 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
The present invention provides lyophilized pharmaceutical compositions comprising nitrogen mustards; particularly the nitrogen mustard is bendamustine, e.g., bendamustine HCl. The present invention also relates to use of lyophilized pharmaceutical compositions for the treatment of various disease states, especially neoplastic diseases and autoimmune diseases.
The present invention relates to amorphous 4-(3-(4-cyano-3-(trifluoromethyl) phenyl)- 5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide (I) (I) and process for preparation thereof. The invention further relates to a solid dispersion of 4-(3-(4-cyano-3-(trifluoromethyl) phenyl)-5, 5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide and at least one pharmaceutically acceptable carrier. The amorphous 4-(3-(4-cyano-3-(trifluoromethyl) phenyl)-5,5-dimethyl-4-oxo-2- thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide (I) and/or its solid dispersion of the present invention can be useful in the treatment of cancer.
A61K 31/4166 - 1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
C07D 233/02 - Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having no double bonds between ring members or between ring members and non-ring members
83.
SUNITINIB GLUCURONATE SALT & PROCESS FOR PREPARATION THEREOF
The present invention relates to novel pharmaceutically acceptable glucuronic acid addition salt of Sunitinib Formula (I) or its solvate thereof. The present invention further relates to the processes for preparation of the glucuronic acid addition salt of Sunitinib. Glucuronic acid addition salt of Sunitinib (I) prepared according to the process of the present invention is obtained as a solid material. The pharmaceutical compositions comprising glucuronic acid addition salt of Sunitinib or its solvate thereof may be useful as anti-cancer agent.
The present invention relates to process for the preparation of highly pure Lenalidomide (I). The invention also relates to crystalline Form-SL obtained by the process of the present invention, the said Form-SL being substantially pure and characterized by X-ray powder diffraction pattern comprising of atleast seven peaks selected from 7.061, 12.860, 6.531, 18.698, 27.925, 33.212, 34.187, 35.253, 35.921 and 38.765 ± 0.1 °2θ; a single un-split °2θ peak at 7.813± 0.1 °2θ; and a three-way-split °2θ peak at 20.467 ± 0.1 °2θ. The invention further relates to pharmaceutical compositions comprising crystalline Form-SL of Lenalidomide, which may be useful for the treatment of cancer.
C07D 401/04 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings directly linked by a ring-member-to-ring- member bond
85.
PROCESS FOR PREPARATION OF 2-CHLORO-N-(4-CHLORO-3-PYRIDIN-2-YLPHENYL)-4-METHYLSULFONYLBENZAMIDE SOLID FORMS
The present invention relates to crystalline 2-Chloro-N-(4-chloro-3-pyridin-2-ylphenyl)-4- methylsulfonylbenzamide (I) designated as Form-SV and process for preparation thereof. (I) The invention further relates to pharmaceutical compositions comprising crystalline Form–SV or non-crystalline form of (2-chloro-N-(4-chloro-3-(pyridin-2-yl) phenyl)-4- (methylsulfonyl)benzamide, useful in the treatment of cancer.
C07D 213/38 - Radicals substituted by singly-bound nitrogen atoms having only hydrogen or hydrocarbon radicals attached to the substituent nitrogen atom
The present invention provides process for preparation of Fingolimod hydrochloride (I). Formula (I): Fingolimod hydrochloride (I) as Form-β obtained by the process of present invention may be useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of autoimmune related disorder including multiple sclerosis.
C07C 209/50 - Preparation of compounds containing amino groups bound to a carbon skeleton by reduction of carboxylic acids or esters thereof in presence of ammonia or amines, or by reduction of nitriles, carboxylic acid amides, imines or imino-ethers by reduction of carboxylic acid amides
C07C 215/28 - Compounds containing amino and hydroxy groups bound to the same carbon skeleton having hydroxy groups and amino groups bound to acyclic carbon atoms of the same carbon skeleton the carbon skeleton being unsaturated and containing six-membered aromatic rings
C07C 211/17 - Compounds containing amino groups bound to a carbon skeleton having amino groups bound to acyclic carbon atoms of a saturated carbon skeleton containing rings other than six-membered aromatic rings containing only non-condensed rings
The present invention provides a process for preparing amorphous Cabazitaxel from the solvate form of Cabazitaxel. The present invention also provides novel diisopropyl ether solvate form of Cabazitaxel (I) and process for preparation thereof. Said amorphous Cabazitaxel and crystalline diisopropyl ether solvate of Cabazitaxel of the present invention can be utilized in preparing the pharmaceutical composition/s useful in the treatment of cancer.
C07D 305/14 - Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
The present invention provides process for preparation of crystalline Bortezomib (Ia) as its monohydrate which is designated as crystalline Form-SB (Ia) and characterized by having water content ranging between 3.5 - 6.0 % w/w; X-ray powder diffraction pattern comprising characteristic 2θ° peaks selected from the XRPD peak set of 5.6, 7.5, 9.8, 10.2, 11.3, 15.1, 18.0, 20.5, 21.5and 23.6 ± 0.20 2θ°, wherein peaks at 9.8 and 11.39 ± 0.20 2θ° are un-split and 100 % intensity peak is present at 5.6± 0.20 2θ°, DSC isotherm comprising the endothermic peaks ranging between 45 to 60°C (Peak -1) and 175 to 185°C (Peak -2) and IR absorption characteristic peaks approximately at 3387 cm-1, 3304 cm-1, 2953 cm-1,2927 cm-1, 2868 cm-1, 1627 cm-1, 1455 cm-1, 1400 cm-1, 1201cm-1, 1150cm-1, 1020 cm-1, 747 cm-1and 702 cm-1and Raman absorption spectra having characteristic peaks approximately at 3066 cm-1, 1583 cm-1, 1528 cm-1,1281cm-1, 1213 cm-1, 1035 cm-1, 1022cm-1and 1004 cm-1. The invention also provides the use of said crystalline Form-SB as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of cancer.
A61K 31/517 - PyrimidinesHydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with carbocyclic ring systems, e.g. quinazoline, perimidine
The present invention relates to lyophilized formulations comprising Crystalline 5-azacytidine and process for preparing lyophilized formulations comprising Crystalline 5-azacytidine.
A61K 31/706 - Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
A01N 43/04 - Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with one or more oxygen or sulfur atoms as the only ring hetero atom with one hetero atom
The present invention provides crystalline pemetrexed dipotassium hemiheptahydrate (I) - characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 29° peaks selected from the XRPD peak set of 5.00, 13.70, 14.90, 15.20, 16.90, 20.00, 20.50, 21.40, 23.6, 24.2, 25.10, 27.5 and 28.30 ± 0.20 29°, DSC isotherm comprising the endothermic peaks ranging between 65 to 85°C (Peak -1), 86 to 105°C (Peak -2), 120 to 132°C (Peak -3), 250 to 265°C (Peak -4), and IR absorption characteristic peaks at approximately 2936 cm-1, 2857 cm-1, 1396 cm-1, 1184 cm-1, 1158 cm-1, 1092 cm-1, 1076 cm-1, 819 cm-1 and 788 cm-1 useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of cancer. The invention also provides process for preparing pemetrexed dipotassium hemiheptahydrate (I) and its pharmaceutical composition thereof.
The present application provides pharmaceutical composition/s comprising pemetrexed dipotassium hydrate and its uses thereof. The invention also provides process for preparing lyophilized compositions of pemetrexed dipotassium hemiheptahydrate.
The present invention relates to Di potassium (S)-2-(4-(2-(2-amino-4-oxo4,7,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido) pentanedioate (I) and its hydrates useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment of cancer. The present invention also relates to a process for preparation thereof.
Provided is a process for preparation of Crystalline Erlotinib HCl Form-SE characterized by X-ray powder diffraction pattern comprising at least 5 characteristic 2θ° peaks selected from the XRPD peak set of 5.60, 10.00, 11.40, 13.00, 13.50, 15.20, 18.40, 20.65, 21.86, 23.5, 31.80, 32.13, 32.80, 34.40 ± 0.20 2θ°, DSC isotherm comprising the endothermic peaks ranging between 213 to 217°C (Peak -1) and 225 to 235 °C (Peak -2) and IR absorption characteristic peaks at approximately 3278 cm-1, 1948 cm-1, 1871 cm-1, 1632 cm-1, 1164 cm-1, 1024 cm-1, 940 cm-1 and 742 cm-1 useful as active pharmaceutical ingredient in pharmaceutical compositions for the treatment cancer.
C07D 403/06 - Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
The present invention provides an industrially suitable process for the preparation of substantially pure 4-{4-[({[4-chloro-3-(trifluoromethyl)-phenyl]amino}carbonyl)amino]phenoxy}-N-methylpyridine-2-carboxamide or Sorafenib and its tosylate salt, with a suitable impurity profile and without requirement of any additional purification steps. The present invention also provides Sorafenib base (II) as stable crystalline Form-SSB. The present invention further relates to a process for the preparation of crystalline Sorafenib tosylate Form-I which is free from contamination of any other polymorphic form of Sorafenib tosylate, for e.g. Form II or Form III, and does not involve any seeding requirement for crystallization step.
Provided is an improved process for preparing N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-l-piperazinyl]-2-methyl-4- byrimidinyl]amino]-5-thiazole carboxamide monohydrate or Dasatinib monohydrate.
C07D 417/12 - Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group containing two hetero rings linked by a chain containing hetero atoms as chain links
The present invention provides a non-solvated amorphous form of (2?,5?,7?,10?,13?)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I), (I) and process for preparation thereof. The present application also provides a non-solvated amorphous form of (2?,5?,7?,10?,13?)-4-acetoxy-13-({(2R,3S)-3[ (tert-butoxy carbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate or Cabazitaxel (I) having an XRPD pattern as per Fig-1, and IR spectrum as per Fig-3 and is useful as an active pharmaceutical in a pharmaceutical composition comprising thereof and has anti-cancer activity.
C07D 305/14 - Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
99.
PROCESS FOR PREPARING DOCETAXEL TRIHYDRATE POLYMORPH
A crystalline form of docetaxel trihydrate designated as Form-VK and process for preparation thereof are provided. A substantially pure trihydrate crystalline product obtained by the process is also provided. The crystalline product of the process which has an XRPD pattern as per Fig-1 is useful as an active pharmaceutical in pharmaceutical composition and has anti-cancer activity.
C07D 305/14 - Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
A61K 31/335 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
A61K 31/337 - Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
Crystalline strontium ranelate form-S and process for preparation thereof are provided. Also provided is a substantially pure crystalline product obtained by the process having characteristic XRPD peak set of 7.70, 15.33, 16.46, 19.55, 20.11, 22.08, 27.90, 29.47±0.10 20° and water content in the range of 20.5 to 23.0% w/w, which is therapeutically used for the treatment of bone diseases like osteoporosis.
