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1. WO2013130785 - EXTENDED RELEASE PHARMACEUTICAL FORMULATIONS OF WATER-SOLUBLE ACTIVE PHARMACEUTICAL INGREDIENTS AND METHODS FOR MAKING THE SAME

Publication Number WO/2013/130785
Publication Date 06.09.2013
International Application No. PCT/US2013/028289
International Filing Date 28.02.2013
IPC
A61K 9/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders
A61K 9/20 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
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 31/155 2006.01
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 31/70 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
CPC
A61J 3/10
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
3Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
10into the form of compressed tablets
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 31/403
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 31/7004
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
70Carbohydrates; Sugars; Derivatives thereof
7004Monosaccharides having only carbon, hydrogen and oxygen atoms
A61K 9/146
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
141Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
146with organic macromolecular compounds
A61K 9/1682
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
14Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
1682Processes
Applicants
  • BRISTOL-MYERS SQUIBB COMPANY [US]/[US]
Inventors
  • ERDEMIR, Deniz
  • CHANG, Shih-Ying
  • DESAI, Divyakant
  • KIANG, San
Agents
  • SUGGS, James, V.
Priority Data
61/605,62201.03.2012US
61/608,15208.03.2012US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) EXTENDED RELEASE PHARMACEUTICAL FORMULATIONS OF WATER-SOLUBLE ACTIVE PHARMACEUTICAL INGREDIENTS AND METHODS FOR MAKING THE SAME
(FR) FORMULATIONS PHARMACEUTIQUES À LIBÉRATION PROLONGÉE DE PRINCIPES PHARMACEUTIQUES ACTIFS SOLUBLES DANS L'EAU ET LEURS PROCÉDÉS DE FABRICATION
Abstract
(EN)
The present disclosure relates to methods for making extended-release formulations of water-soluble active pharmaceutical ingredients such as metformin HCl. In one aspect, the disclosure provides a method that includes adding an aqueous solution of an active pharmaceutical ingredient to an agitated mixture of one or more release-modifying polymers and optionally one or more binders in one or more organic solvents, the one or more organic solvents together being an antisolvent for the active pharmaceutical ingredient, water being sufficiently soluble in the one or more organic solvents such that the water added as part of the aqueous solution dissolves in the mixture, the addition thereby precipitating the active pharmaceutical ingredient; separating the active pharmaceutical ingredient and the one or more release-modifying polymers and, if present, the one or more binders from the one or more organic solvents to yield co-processed particles; and drying the co-processed particles. The methods can be used to make dosage forms such as tablets having reduced amounts of release-modifying polymers.
(FR)
La présente invention concerne des procédés de fabrication de formulations à libération prolongée de principes pharmaceutiques actifs solubles dans l'eau tels que la metformine HCl. Dans un aspect, l'invention concerne un procédé qui comprend l'addition d'une solution aqueuse d'un principe pharmaceutique actif à un mélange agité d'un ou plusieurs polymères de modification de libération et facultativement d'un ou plusieurs liants dans un ou plusieurs solvants organiques, le ou les solvants organiques étant conjointement un antisolvant pour le principe pharmaceutique actif, l'eau étant suffisamment soluble dans le ou les solvants organiques de telle sorte que l'eau ajoutée en tant que partie de la solution aqueuse se dissolve dans le mélange, l'addition faisant ainsi précipiter le principe pharmaceutiquement actif; la séparation du principe pharmaceutique actif et du ou des polymères de modification de libération et, s'il y en a, du ou des liants à partir du ou des solvants organiques pour fournir des particules co-traitées; et le séchage des particules co-traitées. Les procédés peuvent être utilisés pour fabriquer des formes posologiques telles que des comprimés ayant des quantités réduites de polymères de modification de libération.
Also published as
Latest bibliographic data on file with the International Bureau