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1. WO2011098483 - PHARMACEUTICAL COMPOSITIONS COMPRISING A COMBINATION OF METFORMIN AND SITAGLIPTIN

Publication Number WO/2011/098483
Publication Date 18.08.2011
International Application No. PCT/EP2011/051888
International Filing Date 09.02.2011
IPC
A61K 9/20 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, lozenges or tablets
A61K 31/155 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
13Amines, e.g. amantadine
155Amidines , e.g. guanidine , isourea , isothiourea
A61K 31/4985 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two nitrogen atoms as the only ring hetero atoms, e.g. piperazine
4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
A61P 3/10 2006.1
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3Drugs for disorders of the metabolism
08for glucose homeostasis
10for hyperglycaemia, e.g. antidiabetics
CPC
A61K 31/155
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
13Amines
155Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
A61K 31/4985
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
33Heterocyclic compounds
395having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
495having six-membered rings with two ; or more; nitrogen atoms as the only ring heteroatoms, e.g. piperazine ; or tetrazines
4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
A61K 9/2013
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2013Organic compounds, e.g. phospholipids, fats
A61K 9/2054
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
A61K 9/209
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
20Pills, tablets, ; discs, rods
2072characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
209containing drug in at least two layers or in the core and in at least one outer layer
A61P 3/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3Drugs for disorders of the metabolism
08for glucose homeostasis
10for hyperglycaemia, e.g. antidiabetics
Applicants
  • LEK PHARMACEUTICALS D.D. [SI]/[SI] (AllExceptUS)
  • SMRDEL, Polona [SI]/[SI] (UsOnly)
  • STANIC LJUBIN, Tijana [SI]/[SI] (UsOnly)
  • PETERNEL, Luka [SI]/[SI] (UsOnly)
  • KLANCAR, Uros [SI]/[SI] (UsOnly)
Inventors
  • SMRDEL, Polona
  • STANIC LJUBIN, Tijana
  • PETERNEL, Luka
  • KLANCAR, Uros
Agents
  • KUNIC-TESOVIC, Barbara
Priority Data
10153151.510.02.2010EP
Publication Language English (en)
Filing Language English (EN)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITIONS COMPRISING A COMBINATION OF METFORMIN AND SITAGLIPTIN
(FR) COMPOSITIONS PHARMACEUTIQUES COMPRENANT UNE COMBINAISON DE METFORMINE ET DE SITAGLIPTINE
Abstract
(EN) The present invention relates to a pharmaceutical composition, preferably a pharmaceutical dosage form, comprising at least two separate compartments, wherein one compartment contains a composition comprising metformin or a pharmaceutically acceptable salt thereof and wherein another compartment contains a composition comprising sitagliptin. The present invention also relates to a process for preparing dosage forms comprising metformin or a pharmaceutically acceptable salt thereof and sitagliptin or a pharmaceutically acceptable salt thereof, the process comprising the steps of: a) providing one composition containing metformin or a pharmaceutically acceptable salt thereof and optionally also sitagliptin, b) providing a further composition containing sitagliptin or a pharmaceutically acceptable salt thereof and optionally also metformin, and c) combining the compositions to form compartments. The present invention also refers to a process for preparing dosage forms comprising at least one compartment comprising metformin or a pharmaceutically acceptable salt thereof and sitagliptin or a pharmaceutically acceptable salt thereof, the process comprises providing a composition containing metformin or a pharmaceutically acceptable salt thereof, and sitagliptin or a pharmaceutically acceptable salt thereof, and a matrix agent. Moreover, the present invention related to a dosage form obtained by said process, and to the use of said dosage form for the treatment of diabetes.
(FR) Cette invention concerne une composition pharmaceutique, de préférence, une forme galénique pharmaceutique, comprenant au moins deux compartiments distincts, un des compartiments contenant une composition comprenant la metformine ou un de ses sels pharmaceutiquement acceptables et l'autre contenant une composition comprenant la sitagliptine. Cette invention concerne également un procédé de préparation desdites formes galéniques contenant la metformine ou un de ses sels pharmaceutiquement acceptables et la sitagliptine ou un de ses sels pharmaceutiquement acceptables, le procédé comprenant les étapes consistant à : a) préparer une composition contenant la metformine ou un de ses sels pharmaceutiquement acceptables et éventuellement, également, la sitagliptine, b) préparer une autre composition contenant la sitagliptine ou un de ses sels pharmaceutiquement acceptables et, éventuellement, également, la metformine, et c) combiner les compositions pour former des compartiments. Cette invention concerne également un procédé de préparation desdites formes galéniques contenant au moins un compartiment contenant la metformine ou un de ses sels pharmaceutiquement acceptables et la sitagliptine ou un de ses sels pharmaceutiquement acceptables, le procédé comprenant les étapes consistant à préparer une composition contenant la metformine ou un de ses sels pharmaceutiquement acceptables, et la sitagliptine ou un de ses sels pharmaceutiquement acceptables, et un agent formant matrice. De plus, cette invention concerne une forme galénique obtenue par ledit procédé, et l'utilisation de ladite forme galénique dans le traitement du diabète.
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