EP4045048A4 - Oral formulations comprising sitagliptin hci monohydrate with improved pharmaceutical characteristics - Google Patents

Oral formulations comprising sitagliptin hci monohydrate with improved pharmaceutical characteristics Download PDF

Info

Publication number
EP4045048A4
EP4045048A4 EP19949416.2A EP19949416A EP4045048A4 EP 4045048 A4 EP4045048 A4 EP 4045048A4 EP 19949416 A EP19949416 A EP 19949416A EP 4045048 A4 EP4045048 A4 EP 4045048A4
Authority
EP
European Patent Office
Prior art keywords
sitagliptin
oral formulations
improved pharmaceutical
pharmaceutical characteristics
hci monohydrate
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.)
Pending
Application number
EP19949416.2A
Other languages
German (de)
French (fr)
Other versions
EP4045048A1 (en
Inventor
Ersin Yildirim
Bayram Kanik
Fatma ÖZTÜRK
Tansel AKTA
Celil ÜNLÜ
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.)
Santa Farma Ilac Sanayi AS
Original Assignee
Santa Farma Ilac Sanayi AS
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 Santa Farma Ilac Sanayi AS filed Critical Santa Farma Ilac Sanayi AS
Publication of EP4045048A1 publication Critical patent/EP4045048A1/en
Publication of EP4045048A4 publication Critical patent/EP4045048A4/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
EP19949416.2A 2019-10-14 2019-10-14 Oral formulations comprising sitagliptin hci monohydrate with improved pharmaceutical characteristics Pending EP4045048A4 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/TR2019/050865 WO2021076066A1 (en) 2019-10-14 2019-10-14 Oral formulations comprising sitagliptin hci monohydrate with improved pharmaceutical characteristics

Publications (2)

Publication Number Publication Date
EP4045048A1 EP4045048A1 (en) 2022-08-24
EP4045048A4 true EP4045048A4 (en) 2023-05-24

Family

ID=75538207

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19949416.2A Pending EP4045048A4 (en) 2019-10-14 2019-10-14 Oral formulations comprising sitagliptin hci monohydrate with improved pharmaceutical characteristics

Country Status (2)

Country Link
EP (1) EP4045048A4 (en)
WO (1) WO2021076066A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022074664A1 (en) * 2020-10-05 2022-04-14 V-Ensure Pharma Technologies Private Limited An immediate release composition of sitagliptin hydrochloride

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015114152A1 (en) * 2014-02-03 2015-08-06 Galenicum Health S.L. Stable pharmaceutical compositions containing sitagliptin in the form of immediate release tablets
EP2691083B1 (en) * 2011-03-29 2017-08-02 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition of sitagliptin

Family Cites Families (17)

* 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
JO2625B1 (en) 2003-06-24 2011-11-01 ميرك شارب اند دوم كوربوريشن Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
WO2006033848A1 (en) 2004-09-15 2006-03-30 Merck & Co., Inc. Amorphous form of a phosphoric acid salt of a dipeptidyl peptidase-iv inhibitor
GT200600008A (en) 2005-01-18 2006-08-09 FORMULATION OF DIRECT COMPRESSION AND PROCESS
WO2007078726A2 (en) * 2005-12-16 2007-07-12 Merck & Co., Inc. Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin
EP1852108A1 (en) 2006-05-04 2007-11-07 Boehringer Ingelheim Pharma GmbH & Co.KG DPP IV inhibitor formulations
JP2010521492A (en) 2007-03-15 2010-06-24 ネクティド，インク． Anti-diabetic combination comprising sustained release biguanide composition and immediate dipeptidyl peptidase IV inhibitor composition
CA2713361A1 (en) 2008-02-05 2009-08-13 Merck Sharp & Dohme Corp. Pharmaceutical compositions of a combination of metformin and a dipeptidyl peptidase-iv inhibitor
CN101959406A (en) 2008-03-04 2011-01-26 默沙东公司 Pharmaceutical compositions of a combination of metformin and a dipeptidyl peptidase-IV inhibitor
EP2356985A1 (en) 2010-02-10 2011-08-17 LEK Pharmaceuticals d.d. Novel pharmaceutical compositions comprising a combination of metformin and sitagliptin
EP2578208B1 (en) 2011-10-06 2014-05-21 Sanovel Ilac Sanayi ve Ticaret A.S. DPP-IV inhibitor solid dosage formulations
WO2013110085A1 (en) 2012-01-20 2013-07-25 Handa Pharmaceuticals, Llc Oral dosage forms for delivering metformin and sitagliptin
WO2014170770A1 (en) 2013-03-28 2014-10-23 Wockhardt Limited Solid oral pharmaceutical compositions comprising fixed dose combination of metformin and sitagliptin or salts thereof
IN2014MU00651A (en) * 2014-02-25 2015-10-23 Cadila Healthcare Ltd
WO2016016770A1 (en) 2014-07-26 2016-02-04 Wockhardt Limited A novel modified release pharmaceutical composition of sitagliptin or pharmaceutically acceptable salt thereof
CN104771377B (en) * 2015-04-15 2017-06-09 海南华益泰康药业有限公司 A kind of preparation method of the oral preparation of quick releasing containing sitagliptin or its pharmaceutical salts
TR201610368A2 (en) 2016-07-26 2018-11-21 World Medicine Ilac Sanayi Ve Ticaret Anonim Sirketi CITAGLIPTIN PHOSPHATE ANHYDRUS FORMULATIONS WITH ADVANCED RESOLUTION SPEED

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2691083B1 (en) * 2011-03-29 2017-08-02 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition of sitagliptin
WO2015114152A1 (en) * 2014-02-03 2015-08-06 Galenicum Health S.L. Stable pharmaceutical compositions containing sitagliptin in the form of immediate release tablets

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"Antidiabetic drug formulations ED - Darl Kuhn", IP.COM, IP.COM INC., WEST HENRIETTA, NY, US, 5 July 2018 (2018-07-05), XP013179268, ISSN: 1533-0001 *
See also references of WO2021076066A1 *

Also Published As

Publication number Publication date
EP4045048A1 (en) 2022-08-24
WO2021076066A1 (en) 2021-04-22

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