ES2421956B1 - Nueva forma cristalina de sulfato de sitagliptina - Google Patents

Nueva forma cristalina de sulfato de sitagliptina Download PDF

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Publication number
ES2421956B1
ES2421956B1 ES201230319A ES201230319A ES2421956B1 ES 2421956 B1 ES2421956 B1 ES 2421956B1 ES 201230319 A ES201230319 A ES 201230319A ES 201230319 A ES201230319 A ES 201230319A ES 2421956 B1 ES2421956 B1 ES 2421956B1
Authority
ES
Spain
Prior art keywords
sulfate
sitagliptina
crystal form
new crystal
crystalline form
Prior art date
Legal status (The legal status 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 status listed.)
Expired - Fee Related
Application number
ES201230319A
Other languages
English (en)
Other versions
ES2421956A1 (es
Inventor
María del Carmen Bernabeu Martínez
Alicia Dobarro Rodríguez
Cristobal Galán Rodríguez
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Moehs Iberica SL
Original Assignee
Moehs Iberica SL
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
Priority to ES201230319A priority Critical patent/ES2421956B1/es
Application filed by Moehs Iberica SL filed Critical Moehs Iberica SL
Priority to HUE13706567A priority patent/HUE033496T2/en
Priority to PCT/EP2013/054164 priority patent/WO2013128000A1/en
Priority to NZ629511A priority patent/NZ629511A/en
Priority to PT137065678T priority patent/PT2820019T/pt
Priority to EP13706567.8A priority patent/EP2820019B1/en
Priority to AU2013224897A priority patent/AU2013224897A1/en
Priority to PL13706567T priority patent/PL2820019T3/pl
Priority to US14/381,954 priority patent/US9181260B2/en
Priority to SI201330671A priority patent/SI2820019T1/sl
Priority to ES13706567.8T priority patent/ES2628920T3/es
Priority to DK13706567.8T priority patent/DK2820019T3/en
Priority to MX2014010433A priority patent/MX2014010433A/es
Publication of ES2421956A1 publication Critical patent/ES2421956A1/es
Priority to IL234401A priority patent/IL234401A/en
Priority to ZA2014/06431A priority patent/ZA201406431B/en
Application granted granted Critical
Publication of ES2421956B1 publication Critical patent/ES2421956B1/es
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains two hetero rings
    • C07D487/04—Ortho-condensed systems
    • 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
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • 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
    • A61K31/395—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
    • A61K31/435—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
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non 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
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide

Abstract

Nueva forma cristalina de sulfato de sitagliptina.#La presente invención está dirigida a una nueva forma cristalina del sulfato de sitagliptina, a un procedimiento para su obtención, a composiciones farmacéuticas que comprenden la nueva forma cristalina y al uso de dicha forma cristalina para la fabricación de un medicamento.

Description

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Claims (1)

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ES201230319A 2012-03-02 2012-03-02 Nueva forma cristalina de sulfato de sitagliptina Expired - Fee Related ES2421956B1 (es)

Priority Applications (15)

Application Number Priority Date Filing Date Title
ES201230319A ES2421956B1 (es) 2012-03-02 2012-03-02 Nueva forma cristalina de sulfato de sitagliptina
ES13706567.8T ES2628920T3 (es) 2012-03-02 2013-03-01 Forma cristalina novedosa de sulfato de sitagliptina
NZ629511A NZ629511A (en) 2012-03-02 2013-03-01 Novel crystalline form of sitagliptin sulfate
PT137065678T PT2820019T (pt) 2012-03-02 2013-03-01 Nova forma cristalina de sulfato de sitagliptina
EP13706567.8A EP2820019B1 (en) 2012-03-02 2013-03-01 Novel crystalline form of sitagliptin sulfate
AU2013224897A AU2013224897A1 (en) 2012-03-02 2013-03-01 Novel crystalline form of sitagliptin sulfate
PL13706567T PL2820019T3 (pl) 2012-03-02 2013-03-01 Nowa krystaliczna forma siarczanu sitagliptyny
US14/381,954 US9181260B2 (en) 2012-03-02 2013-03-01 Crystalline form of sitagliptin sulfate
HUE13706567A HUE033496T2 (en) 2012-03-02 2013-03-01 New sitagliptin sulfate crystal form
PCT/EP2013/054164 WO2013128000A1 (en) 2012-03-02 2013-03-01 Novel crystalline form of sitagliptin sulfate
DK13706567.8T DK2820019T3 (en) 2012-03-02 2013-03-01 Hitherto crystalline form of sitagliptin sulfate
MX2014010433A MX2014010433A (es) 2012-03-02 2013-03-01 Nueva forma cristalina de sulfato de sitagliptina.
SI201330671A SI2820019T1 (sl) 2012-03-02 2013-03-01 Nova kristalna oblika sitagliptin sulfata
IL234401A IL234401A (en) 2012-03-02 2014-08-31 Crystalline structures of sitglyphatin sulfate
ZA2014/06431A ZA201406431B (en) 2012-03-02 2014-09-02 Novel crystalline form of sitagliptin sulfate

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ES201230319A ES2421956B1 (es) 2012-03-02 2012-03-02 Nueva forma cristalina de sulfato de sitagliptina

Publications (2)

Publication Number Publication Date
ES2421956A1 ES2421956A1 (es) 2013-09-06
ES2421956B1 true ES2421956B1 (es) 2014-09-29

Family

ID=47754555

Family Applications (2)

Application Number Title Priority Date Filing Date
ES201230319A Expired - Fee Related ES2421956B1 (es) 2012-03-02 2012-03-02 Nueva forma cristalina de sulfato de sitagliptina
ES13706567.8T Active ES2628920T3 (es) 2012-03-02 2013-03-01 Forma cristalina novedosa de sulfato de sitagliptina

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES13706567.8T Active ES2628920T3 (es) 2012-03-02 2013-03-01 Forma cristalina novedosa de sulfato de sitagliptina

Country Status (14)

Country Link
US (1) US9181260B2 (es)
EP (1) EP2820019B1 (es)
AU (1) AU2013224897A1 (es)
DK (1) DK2820019T3 (es)
ES (2) ES2421956B1 (es)
HU (1) HUE033496T2 (es)
IL (1) IL234401A (es)
MX (1) MX2014010433A (es)
NZ (1) NZ629511A (es)
PL (1) PL2820019T3 (es)
PT (1) PT2820019T (es)
SI (1) SI2820019T1 (es)
WO (1) WO2013128000A1 (es)
ZA (1) ZA201406431B (es)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9171343B1 (en) 2012-09-11 2015-10-27 Aseko, Inc. Means and method for improved glycemic control for diabetic patients
US9897565B1 (en) 2012-09-11 2018-02-20 Aseko, Inc. System and method for optimizing insulin dosages for diabetic subjects
US9486580B2 (en) 2014-01-31 2016-11-08 Aseko, Inc. Insulin management
US9233204B2 (en) 2014-01-31 2016-01-12 Aseko, Inc. Insulin management
PL3102187T3 (pl) 2014-02-03 2020-10-19 Galenicum Health S.L. Stabilne kompozycje farmaceutyczne zawierające sitagliptynę w postaci tabletek o natychmiastowym uwalnianiu
WO2016034710A1 (en) * 2014-09-05 2016-03-10 Sanovel Ilac Sanayi Ve Ticaret A.S. Pharmaceutical combinations of sitagliptin
US11081226B2 (en) 2014-10-27 2021-08-03 Aseko, Inc. Method and controller for administering recommended insulin dosages to a patient
EP3050023B1 (en) 2014-10-27 2021-08-25 Aseko, Inc. Subcutaneous outpatient management
CA2993275C (en) 2015-08-20 2022-06-21 Aseko, Inc. Diabetes management therapy advisor

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA74912C2 (en) 2001-07-06 2006-02-15 Merck & Co Inc Beta-aminotetrahydroimidazo-(1,2-a)-pyrazines and tetratriazolo-(4,3-a)-pyrazines as inhibitors of dipeptylpeptidase for the treatment or prevention of diabetes
AR043515A1 (es) 2003-03-19 2005-08-03 Merck & Co Inc Procedimiento para preparar derivados quirales beta aminoacidos mediante hidrogenacion asimetrica
JO2625B1 (en) 2003-06-24 2011-11-01 ميرك شارب اند دوم كوربوريشن Phosphoric acid salts of dipeptidyl betidase inhibitor 4
US20080227786A1 (en) 2004-01-16 2008-09-18 Ferlita Russell R Novel Crystalline Salts of a Dipeptidyl Peptidase-IV Inhibitor
BR122018073405B1 (pt) 2004-01-20 2023-04-25 Novartis Ag Comprimido farmacêutico produzido por compressão direta compreendendo inibidor de dipeptidilpeptidase iv
US20090221592A1 (en) 2005-07-25 2009-09-03 Ellison Martha E Dodecylsulfate Salt Of A Dipeptidyl Peptidase-Iv Inhibitor
WO2009064476A1 (en) 2007-11-13 2009-05-22 Teva Pharmaceutical Industries Ltd. Preparation of sitagliptin intermediate
JP2011507890A (ja) * 2007-12-20 2011-03-10 ドクター・レディーズ・ラボラトリーズ・リミテッド シタグリプチンおよびその薬学的に許容可能な塩の調製のためのプロセス
EP2650299A1 (en) * 2008-07-03 2013-10-16 Ratiopharm GmbH Crystalline salts of sitagliptin
EP2218721A1 (en) 2009-02-11 2010-08-18 LEK Pharmaceuticals d.d. Novel salts of sitagliptin
WO2010117738A2 (en) * 2009-03-30 2010-10-14 Teva Pharmaceutical Industries Ltd. Solid state forms of sitagliptin salts
US8183373B2 (en) * 2010-03-31 2012-05-22 Teva Pharmaceutical Industries Ltd. Solid state forms of sitagliptin salts

Also Published As

Publication number Publication date
EP2820019A1 (en) 2015-01-07
DK2820019T3 (en) 2017-07-03
ES2421956A1 (es) 2013-09-06
ZA201406431B (en) 2016-05-25
NZ629511A (en) 2016-04-29
AU2013224897A1 (en) 2014-09-18
HUE033496T2 (en) 2017-12-28
PL2820019T3 (pl) 2017-09-29
US9181260B2 (en) 2015-11-10
IL234401A (en) 2017-11-30
MX2014010433A (es) 2015-04-13
ES2628920T3 (es) 2017-08-04
SI2820019T1 (sl) 2017-07-31
WO2013128000A1 (en) 2013-09-06
EP2820019B1 (en) 2017-03-22
PT2820019T (pt) 2017-06-26
US20150037406A1 (en) 2015-02-05

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