SG11201908977SA - Niraparib formulations - Google Patents

Niraparib formulations

Info

Publication number
SG11201908977SA
SG11201908977SA SG11201908977SA SG11201908977SA SG 11201908977S A SG11201908977S A SG 11201908977SA SG 11201908977S A SG11201908977S A SG 11201908977SA SG 11201908977S A SG11201908977S A SG 11201908977SA
Authority
SG
Singapore
Prior art keywords
tesaro
waltham
north
massachusetts
winter
Prior art date
Application number
Inventor
Simon Mcgurk
Padma Narayan
Clare Medendorp
George Wu
Stephen Ruddy
Heidi Kempinski
Alistair Stewart
Original Assignee
Tesaro Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tesaro Inc filed Critical Tesaro Inc
Publication of SG11201908977SA publication Critical patent/SG11201908977SA/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4523Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems
    • A61K31/454Non condensed piperidines, e.g. piperocaine containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. pimozide, domperidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4891Coated capsules; Multilayered drug free capsule shells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic 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
    • C07D401/02Heterocyclic 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
    • C07D401/10Heterocyclic 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 aromatic rings

Abstract

INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 04 October 2018 (04.10.2018) W I PO I PCT Iiiimmoimiolollm onolomoniinomicionio oimIE (10) International Publication Number WO 2018/183349 Al (51) International Patent Classification: A61K 31/454 (2006.01) C07D 401/10 (2006.01) (21) International Application Number: PCT/US2018/024597 (22) International Filing Date: 27 March 2018 (27.03.2018) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/477,425 27 March 2017 (27.03.2017) US (71) Applicant: TESARO, INC. [US/US]; 1000 Winter St. North #3300, Waltham, Massachusetts 02451 (US). (72) Inventors: MCGURK, Simon; c/o Tesaro, Inc., 1000 Winter St. North #3300, Waltham, Massachusetts 02451 (US). NARAYAN, Padma; c/o Tesaro, Inc., 1000 Win- ter St. North #3300, Waltham, Massachusetts 02451 (US). MEDENDORP, Clare; c/o Tesaro, Inc., 1000 Winter St. North #3300, Waltham, Massachusetts 02451 (US). WU, George; c/o Tesaro, Inc., 1000 Winter St. North #3300, Waltham, Massachusetts 02451 (US). RUDDY, Stephen; c/o Tesaro, Inc., 1000 Winter St. North #3300, Waltham, Massachusetts 02451 (US). KEMPINSKI, Heidi; c/o Tesaro, Inc., 1000 Winter St. North #3300, Waltham, Mass- achusetts 02451 (US). STEWART, Alistair; c/o Tesaro, Inc., 1000 Winter St. North #3300, Waltham, Massachusetts 02451 (US). (74) Agent: MCANDREW, Christopher W.; Wilson Sonsini Goodrich & Rosati, 650 Page Mill Road, Palo Alto, Cali- fornia 94304 (US). = (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.1700) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: with international search report (Art. 21(3)) before the expiration of the time limit for amending the claims and to be republished in the event of receipt of amendments (Rule 48.2(h)) (54) Title: NIRAPARIB FORMULATIONS (57) : The present invention relates to pharmaceutical capsule compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are capsule formulations containing niraparib formed by the disclosed methods, and therapeutic uses of such capsule formulations for treating various disorders and conditions. The niraparib is distributed with substantial uniformity throughout a pharmaceutically acceptable carrier of the capsule formulations and exhibit good long-term stability and dissolution properties.
SG11201908977S 2017-03-27 2018-03-27 Niraparib formulations SG11201908977SA (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201762477425P 2017-03-27 2017-03-27
PCT/US2018/024597 WO2018183349A1 (en) 2017-03-27 2018-03-27 Niraparib formulations

Publications (1)

Publication Number Publication Date
SG11201908977SA true SG11201908977SA (en) 2019-10-30

Family

ID=63677008

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201908977S SG11201908977SA (en) 2017-03-27 2018-03-27 Niraparib formulations

Country Status (14)

Country Link
US (2) US20200016142A1 (en)
EP (1) EP3606523A1 (en)
JP (1) JP2020512347A (en)
KR (1) KR20190130625A (en)
CN (1) CN110709083A (en)
AU (1) AU2018246213A1 (en)
BR (1) BR112019020191A2 (en)
CA (1) CA3058372A1 (en)
EA (1) EA201992162A1 (en)
IL (1) IL269621A (en)
MX (1) MX2019011491A (en)
SG (1) SG11201908977SA (en)
TW (1) TW201842908A (en)
WO (1) WO2018183349A1 (en)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201992177A1 (en) 2017-03-27 2020-02-25 Тесаро, Инк. COMPOSITIONS BASED ON NIRAPARIB
WO2018200517A1 (en) 2017-04-24 2018-11-01 Tesaro, Inc. Methods of manufacturing of niraparib
BR112019024135A2 (en) 2017-05-18 2020-06-02 Tesaro, Inc. COMBINATION THERAPIES FOR CANCER TREATMENT
US11730725B2 (en) 2017-09-26 2023-08-22 Tesaro, Inc. Niraparib formulations
BR112020006286A2 (en) 2017-09-30 2020-10-20 Tesaro, Inc. combination therapies for cancer treatment
MX2020003799A (en) 2017-10-06 2020-11-06 Tesaro Inc Combination therapies and uses thereof.
MX2020008258A (en) 2018-02-05 2020-11-13 Tesaro Inc Pediatric niraparib formulations and pediatric treatment methods.
CA3087392A1 (en) 2019-07-16 2021-01-16 Apotex Inc. Crystalline forms of niraparib tosylate
WO2021163530A1 (en) * 2020-02-14 2021-08-19 KSQ Therapeutics, Inc. Therapeutic combinations comprising ubiquitin-specific-processing protease 1 (usp1) inhibitors and poly (adp-ribose) polymerase (parp) inhibitors
KR102306319B1 (en) 2020-12-01 2021-09-30 주식회사 진원온원 Method, Program, Computing Device for generating pose estimation mapping data
US11738014B2 (en) 2021-11-10 2023-08-29 Crititech, Inc. Niraparib particles and uses thereof
WO2023159066A1 (en) 2022-02-15 2023-08-24 Tesaro, Inc. Use of niraparib for the treatment of brain cancer

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0700432D0 (en) * 2007-01-10 2007-02-21 Angeletti P Ist Richerche Bio Therapeutic compounds
GB0606663D0 (en) * 2006-04-03 2006-05-10 Angeletti P Ist Richerche Bio Therapeutic compounds
CN106008460B (en) * 2008-01-08 2022-08-12 默沙东公司 Pharmaceutically acceptable salts of 2- {4- [ (3S) -piperidin-3-yl ] phenyl } -2H-indazole-7-carboxamide
CA2779052A1 (en) * 2012-05-31 2013-11-30 Pharmascience Inc. Pharmaceutical composition of entecavir and process of manufacturing
EP2928473B1 (en) * 2012-12-07 2017-06-28 Merck Sharp & Dohme Corp. Regioselective n-2 arylation of indazoles
EP3317281B1 (en) * 2015-07-02 2020-04-22 Acerta Pharma B.V. Solid forms and formulations of (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide

Also Published As

Publication number Publication date
JP2020512347A (en) 2020-04-23
EA201992162A1 (en) 2020-02-28
US20210038585A1 (en) 2021-02-11
KR20190130625A (en) 2019-11-22
TW201842908A (en) 2018-12-16
CA3058372A1 (en) 2018-10-04
MX2019011491A (en) 2020-01-23
EP3606523A1 (en) 2020-02-12
US20200016142A1 (en) 2020-01-16
BR112019020191A2 (en) 2020-04-22
WO2018183349A1 (en) 2018-10-04
IL269621A (en) 2019-11-28
CN110709083A (en) 2020-01-17
AU2018246213A1 (en) 2019-11-07

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