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1. (CA3013326) EXTENDED RELEASE DRUG FORMULATION WITH OVERDOSE PROTECTION AND ABUSE DETERRENCE

Office : Canada
Application Number: 3013326 Application Date:
Publication Number: 3013326 Publication Date: 10.08.2017
Publication Kind : A1
Prior PCT appl.: Application Number:PCTUS2017016076 ; Publication Number: Click to see the data
IPC:
A61K 9/50
A61K 31/485
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
48
Preparations in capsules, e.g. of gelatin, of chocolate
50
Microcapsules
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
47
Quinolines; Isoquinolines
485
Morphinan derivatives, e.g. morphine, codeine
Applicants: KASHIV PHARMA LLC
Inventors:
Priority Data: 62/289,733 01.02.2016 US
62/331,285 03.05.2016 US
Title: (EN) EXTENDED RELEASE DRUG FORMULATION WITH OVERDOSE PROTECTION AND ABUSE DETERRENCE
(FR) FORMULATION A LIBERATION DE MEDICAMENT PROLONGEE AVEC PROTECTION CONTRE LES SURDOSES ET DISSUASION CONTRE LES ABUS
Abstract: front page image
(EN) The presently disclosed subject matter provides solid, oral, extended release, pharmaceutical particulate and multi-particulate dosage forms with abuse deterrent and overdose protection features / characteristics comprising at least one or two populations of particulates. In certain embodiments, the first population of particulates comprises a therapeutically effective amount of at least one opioid embedded in a polymer matrix, a primary functional coat layer (FC 1), a secondary functional coat layer (FC 2), and an over coat; wherein FC 1 comprises a nonionic water-insoluble polymer and, optionally, at least one of a cationic polymer, a nonionic water-soluble polymer, and a water-soluble plasticizer; FC 2 comprises a cationic polymer and, optionally, a nonionic water- insoluble polymer; and the over coat comprises a nonionic water-soluble polymer. The second population of particulates comprises an alkaline agent and, optionally, a pH- stabilizing agent. In certain embodiments, the extended release pharmaceutical dosage form contains at least three different populations of multi-particulates. Each population of particulates is designed for a specific function to accomplish the desired combination of abuse deterrence and overdose protection. The presently disclosed subject matter also provides methods related to the solid, oral, extended release, particulate and multi-particulate dosage forms.


Also published as:
WO/2017/136460