WO2008116179 PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE

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Publication Number WO/2008/116179

Publication Date 25.09.2008

International Application No. PCT/US2008/057888

International Filing Date 21.03.2008

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Applicants

BRISTOL-MYERS SQUIBB COMPANY [US]/[US] (AllExceptUS)
BINDRA, Dilbir, S. [US]/[US] (UsOnly)
DALI, Mandar, V. [IN]/[US] (UsOnly)
PARAB, Prakash, V. [US]/[US] (UsOnly)
PATEL, Jatin, M. [US]/[US] (UsOnly)
TAO, Li [CN]/[US] (UsOnly)
TEJWANI, Ravindra, W. [US]/[US] (UsOnly)
VATSARAJ, Nipa [IN]/[US] (UsOnly)
WU, Yongmei [US]/[US] (UsOnly)

Inventors

BINDRA, Dilbir, S.
DALI, Mandar, V.
PARAB, Prakash, V.
PATEL, Jatin, M.
TAO, Li
TEJWANI, Ravindra, W.
VATSARAJ, Nipa
WU, Yongmei

Agents

TERPSTRA, Anita, J.

Priority Data

60/896,286

22.03.2007

Publication Language English (en)

Filing Language English (EN)

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Title

(EN) PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE

(FR) PRÉPARATIONS PHARMACEUTIQUES CONTENANT DE L'HYDRATE DE PROPYLÈNEGLYCOL DE DAPAGLIFLOZINE

Abstract

(EN) Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include dapagliflozin propylene glycol hydrate is: Formula (Ia) or Formula (Ib) and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release. The formulations are used for the treatment of diabetes and related diseases.

(FR) L'invention concerne des préparations pharmaceutiques qui se présentent sous forme de capsules ou de comprimés à administration orale et qui contiennent de l'hydrate de propylèneglycol de dapagliflozine, de formule (Ia) ou de formule (Ib), et un excipient pharmaceutiquement acceptable, ladite préparation étant conçue pour une libération immédiate du produit. Les préparations selon l'invention sont utilisées pour le traitement du diabète et de maladies apparentées.

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
70	Carbohydrates; Sugars; Derivatives thereof

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3	Drugs for disorders of the metabolism
08	for glucose homeostasis
10	for hyperglycaemia, e.g. antidiabetics

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
70	Carbohydrates; Sugars; Derivatives thereof

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
P	SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
3	Drugs for disorders of the metabolism
08	for glucose homeostasis
10	for hyperglycaemia, e.g. antidiabetics

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
13	Amines
155	Amidines (), e.g. guanidine (H₂N—C(=NH)—NH₂), isourea (N=C(OH)—NH₂), isothiourea (—N=C(SH)—NH₂)

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1. WO2008116179 - PHARMACEUTICAL FORMULATIONS CONTAINING DAPAGLIFLOZIN PROPYLENE GLYCOL HYDRATE

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
33	Heterocyclic compounds
395	having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40	having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403	condensed with carbocyclic rings, e.g. carbazole

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31	Medicinal preparations containing organic active ingredients
33	Heterocyclic compounds
395	having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
40	having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
403	condensed with carbocyclic rings, e.g. carbazole

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
0087	Galenical forms not covered by A61K9/02 - A61K9/7023
0095	Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches

A	HUMAN NECESSITIES
61	MEDICAL OR VETERINARY SCIENCE; HYGIENE
K	PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9	Medicinal preparations characterised by special physical form
14	Particulate form, e.g. powders, ; Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
16	Agglomerates; Granulates; Microbeadlets ; ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction