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1. NZ564069 - Prolonged release formulation of active principles having a pH-dependent solubility

Office New Zealand
Application Number 564069
Application Date 26.06.2006
Publication Number 564069
Publication Date 27.04.2012
Grant Number
Grant Date 06.08.2012
Publication Kind B
IPC
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
20
Pills, lozenges or tablets
22
Sustained or differential release type
24
Layered or laminated unitary dosage forms
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, rifamycins
435
having six-membered rings with one nitrogen as the only ring hetero atom
4353
ortho- or peri-condensed with heterocyclic ring systems
437
the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
A HUMAN NECESSITIES
61
MEDICAL OR VETERINARY SCIENCE; HYGIENE
K
PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47
Medicinal preparations characterised by the non-active ingredients used, e.g. carriers, inert additives
06
Organic compounds
08
containing oxygen
12
Carboxylic acids; Salts or anhydrides thereof
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
20
Pills, lozenges or tablets
28
Dragees; Coated pills or tablets
30
Organic coatings
36
containing carbohydrates or derivatives thereof
A61K 9/24
A61K 31/437
A61K 47/12
A61K 9/36
CPC
A61K 9/2013
A61K 9/2054
A61K 9/209
A61K 31/437
Applicants Sanofi-Aventis
Inventors Alaux, Gerard
Andre, Frederic
Lewis, Gareth
Serre, Veronique
Agents AJ PARK
Priority Data 05 0506539 28.06.2005 FR
Title
(EN) Prolonged release formulation of active principles having a pH-dependent solubility
Abstract
(EN)
Patent 564069 Disclosed is a prolonged-release formulation that can be used with zolpidem or an addition salt thereof having a pH-dependent solubility, comprising a matricial excipient based on a hydrophilic polymer selected from hydroxypropylmethylcellulose, hydroxyethylcellulose, hydroxypropylcellulose or carboxymethylcellulose, plant gums and derivatives thereof, alginic acid derivatives, and starch and derivatives thereof, the matricial excipient containing a given dose of zolpidem or an addition salt thereof, comprising one or more acidifying agents in the form of an acid salt of an organic acid wherein the acid salt of the acidifying agent is monopotassium tartrate, monosodium tartrate, monosodium citrate, bisodium citrate, and/or mixtures thereof. The disclosure further relates to formulations comprising a first immediate-release layer comprising zolpidem or an addition salt thereof whose solubility is pH-dependent, and one or more binders, the first layer optionally containing one or more other excipients; and a second prolonged-release layer, adjacent to the first layer, comprising zolpidem or an addition salt thereof whose solubility is pH-dependent, one or more acidifying agents in the form of an acid salt, and one or more matricial excipients, the second layer optionally containing one or more other excipients...