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1. WO2020109319 - PHARMACEUTICAL COMPOSITION COMPRISING RAMIPRIL AND INDAPAMIDE

Publication Number WO/2020/109319
Publication Date 04.06.2020
International Application No. PCT/EP2019/082610
International Filing Date 26.11.2019
IPC
A61K 9/24 2006.01
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
22Sustained or differential release type
24Layered or laminated unitary dosage forms
A61K 31/403 2006.01
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
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403condensed with carbocyclic rings, e.g. carbazole
A61K 31/404 2006.01
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
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403condensed with carbocyclic rings, e.g. carbazole
404Indoles, e.g. pindolol
A61P 9/12 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
9Drugs for disorders of the cardiovascular system
12Antihypertensives
CPC
A61K 31/403
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
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403condensed with carbocyclic rings, e.g. carbazole
A61K 31/404
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
40having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403condensed with carbocyclic rings, e.g. carbazole
404Indoles, e.g. pindolol
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 9/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
9Drugs for disorders of the cardiovascular system
12Antihypertensives
Applicants
  • ZAKLADY FARMACEUTYCZNE POLPHARMA S.A [PL]/[PL]
Inventors
  • HRAKOVSKY, Julia
  • MADANECKA, Anna
  • SZYMON, Przerada
Agents
  • ZBM PATENTS - ZEA, BARLOCCI & MARKVARDSEN
Priority Data
18460069.027.11.2018EP
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) PHARMACEUTICAL COMPOSITION COMPRISING RAMIPRIL AND INDAPAMIDE
(FR) COMPOSITION PHARMACEUTIQUE COMPRENANT DU RAMIPRIL ET DE L'INDAPAMIDE
Abstract
(EN)
It relates to an oral multilayer tablet comprising (a) a first layer comprising an indapamide compound, and one or more pharmaceutically acceptable excipients, and (b) a second layer comprising a ramipril compound, and a stabilizing agent; and wherein the second layer has an impurity level of (2S,3aS,6aS)-1-[(S)-2-[[(S)-1- carboxy-3-phenylpropyl]amino]propanoyl]octahydrocyclopenta-[b]pyrrole2-carboxylic acid (impurity E) equal to or lower than 1.0% after 6 months at 40°C/75% RH as measured by ultra performance liquid chromatography (UPLC). It also relates to a process for the preparation of the multilayer tablet.
(FR)
L'invention concerne un comprimé oral multicouche comprenant (a) une première couche comprenant un composé indapamide, et un ou plusieurs excipients pharmaceutiquement acceptables, et (b) une seconde couche comprenant un composé ramipril, et un agent de stabilisation ; et la seconde couche ayant un niveau d'impureté d'acide (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-carboxy-3-phénylpropyl]amino]propanoyl]octahydrocyclopenta[b]pyrrole2-carboxylique (impureté E) inférieur ou égal à 1,0 % après 6 mois à 40°C/75 % HR tel que mesuré par chromatographie liquide ultra-performance (UPLC). L'invention concerne également un procédé de préparation du comprimé multicouche.
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