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ECSP19010066A - IMPROVED COMPOSITION OF TENELIGLIPTIN AND METFORMIN AND PROCESS TO PREPARE IT - Google Patents

IMPROVED COMPOSITION OF TENELIGLIPTIN AND METFORMIN AND PROCESS TO PREPARE IT

Info

Publication number
ECSP19010066A
ECSP19010066A ECSENADI201910066A ECDI201910066A ECSP19010066A EC SP19010066 A ECSP19010066 A EC SP19010066A EC SENADI201910066 A ECSENADI201910066 A EC SENADI201910066A EC DI201910066 A ECDI201910066 A EC DI201910066A EC SP19010066 A ECSP19010066 A EC SP19010066A
Authority
EC
Ecuador
Prior art keywords
metformin
improved
teneligliptin
pharmaceutical composition
compressibility
Prior art date
Application number
ECSENADI201910066A
Other languages
Spanish (es)
Inventor
Esteban Alejandro Fiore
Original Assignee
Rhein Siegfried Sa De Cv
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=61196457&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP19010066(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Rhein Siegfried Sa De Cv filed Critical Rhein Siegfried Sa De Cv
Publication of ECSP19010066A publication Critical patent/ECSP19010066A/en

Links

Classifications

    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

La presente invención se refiere a una composición farmacéutica mejorada en la forma de comprimido oral recubierto, con Teneligliptina o sus sales farmacéuticamente aceptables y Metformina o sus sales farmacéuticamente aceptables para el tratamiento de diabetes mellitus tipo 2. Dicha composición farmacéutica es obtenida por granulación húmeda, utilizando Metformina molida a polvo fino y baja carga de excipientes, consistentes en un aglutinante, en este caso Povidona y Estearato de Magnesio como lubricante durante la compresión. El hecho de utilizar la Metformina molida, mejora notablemente la compresibilidad de la misma, permitiendo a su vez optimizar las condiciones operativas. La composición farmacéutica mejorada, comprendiendo la combinación de Teneligliptina y Metformina, comparada con ambos principios activos por separado, vehiculizados en la forma de comprimidos recubiertos, no mostro diferencias en la liberación in vitro (disolución), y por otro lado mejoró la compresibilidad del granulado y la friabilidad de los comprimidos. Los aspectos mencionados hacen que esta composición mejorada se diferencie de otras composiciones que contienen los mismos activos y que utilizan mayor número de excipientes, y es por consiguiente, el objeto principal de la presente invención.The present invention refers to an improved pharmaceutical composition in the form of an oral tablet coated, with Teneligliptin or its pharmaceutically acceptable salts and Metformin or its pharmaceutically acceptable salts for the treatment of type 2 diabetes mellitus. Said pharmaceutical composition is obtained by wet granulation, using Metformin ground to fine powder and low load of excipients, consisting of a binder, in this case Povidone and Magnesium Stearate as lubricant during compression. The fact of using ground Metformin notably improves its compressibility, allowing in turn to optimize operating conditions. The improved pharmaceutical composition, comprising the combination of Teneligliptin and Metformin, compared with both active principles separately, carried in the form of coated tablets, did not show differences in in vitro release (dissolution), and on the other hand, improved the compressibility of the granules. and the friability of the tablets. The aforementioned aspects make this improved composition different from other compositions containing the same active ingredients and using a greater number of excipients, and it is therefore the main object of the present invention.

ECSENADI201910066A 2016-08-17 2019-02-12 IMPROVED COMPOSITION OF TENELIGLIPTIN AND METFORMIN AND PROCESS TO PREPARE IT ECSP19010066A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
MX2016010682A MX384961B (en) 2016-08-17 2016-08-17 IMPROVED COMPOSITION OF TENELIGLIPTIN AND METFORMIN AND PROCESS FOR PREPARING SAME.

Publications (1)

Publication Number Publication Date
ECSP19010066A true ECSP19010066A (en) 2019-11-30

Family

ID=61196457

Family Applications (2)

Application Number Title Priority Date Filing Date
ECSENADI201910066A ECSP19010066A (en) 2016-08-17 2019-02-12 IMPROVED COMPOSITION OF TENELIGLIPTIN AND METFORMIN AND PROCESS TO PREPARE IT
ECSENADI201944926A ECSP19044926A (en) 2016-08-17 2019-06-25 IMPROVED COMPOSITION OF LANSOPRAZOLE AND SYMETICONE AND PROCESS FOR PREPARING

Family Applications After (1)

Application Number Title Priority Date Filing Date
ECSENADI201944926A ECSP19044926A (en) 2016-08-17 2019-06-25 IMPROVED COMPOSITION OF LANSOPRAZOLE AND SYMETICONE AND PROCESS FOR PREPARING

Country Status (8)

Country Link
AR (1) AR109253A1 (en)
CL (1) CL2019000273A1 (en)
CO (1) CO2019001110A2 (en)
DO (1) DOP2019000035A (en)
EC (2) ECSP19010066A (en)
MX (1) MX384961B (en)
PE (1) PE20190402A1 (en)
WO (1) WO2018033808A1 (en)

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014080383A1 (en) * 2012-11-26 2014-05-30 Ranbaxy Laboratories Limited Pharmaceutical composition of dipeptidyl peptidase-iv (dpp-iv) inhibitors in combination with other antidiabetics
WO2015132679A1 (en) * 2014-03-05 2015-09-11 Glenmark Pharmaceuticals Ltd Teneligliptin compositions

Also Published As

Publication number Publication date
CO2019001110A2 (en) 2019-04-12
DOP2019000035A (en) 2019-06-30
BR112019002909A2 (en) 2019-05-21
MX2016010682A (en) 2018-02-16
AR109253A1 (en) 2018-11-14
WO2018033808A1 (en) 2018-02-22
CL2019000273A1 (en) 2019-06-28
MX384961B (en) 2025-03-14
ECSP19044926A (en) 2019-07-31
PE20190402A1 (en) 2019-03-13

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