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1. WO2007143158 - SUSTAINED RELEASE PHARMACEUTICAL FORMULATION COMPRISING PHENYLEPHRINE

Publication Number WO/2007/143158
Publication Date 13.12.2007
International Application No. PCT/US2007/013050
International Filing Date 01.06.2007
IPC
A61K 9/22 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
A61K 9/36 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
28Dragees; Coated pills or tablets
30Organic coatings
36containing carbohydrates or derivatives thereof
A61K 31/137 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
135having aromatic rings, e.g. methadone
137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine
CPC
A61K 31/137
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
31Medicinal preparations containing organic active ingredients
13Amines
135having aromatic rings ; , e.g. ketamine, nortriptyline
137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine ; or methadone
A61K 31/4545
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
435having six-membered rings with one nitrogen as the only ring hetero atom
44Non condensed pyridines; Hydrogenated derivatives thereof
445Non condensed piperidines, e.g. piperocaine
4523containing further heterocyclic ring systems
4545containing a six-membered ring with nitrogen as a ring hetero atom, e.g. pipamperone, anabasine
A61K 47/12
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
08containing oxygen, ; e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
12Carboxylic acids; Salts or anhydrides thereof
A61K 47/38
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
47Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
38Cellulose; Derivatives thereof
A61K 9/167
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
167with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
A61K 9/2054
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
2004Excipients; Inactive ingredients
2022Organic macromolecular compounds
205Polysaccharides, e.g. alginate, gums; Cyclodextrin
2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
Applicants
  • SCHERING-PLOUGH HEALTHCARE PRODUCTS, INC. [US]/[US] (AllExceptUS)
  • MONTEITH, David [GB]/[US] (UsOnly)
  • O'MULLANE, John [US]/[US] (UsOnly)
  • REO, Joseph, P. [US]/[US] (UsOnly)
  • NOWAK, Robert, T. [US]/[US] (UsOnly)
  • WAN, Jiansheng [US]/[US] (UsOnly)
  • KABIR, Mohammed, A. [US]/[US] (UsOnly)
  • ABUTARIF, Malaz, A. [JO]/[US] (UsOnly)
  • FRITZ, Glenn, E. [US]/[US] (UsOnly)
Inventors
  • MONTEITH, David
  • O'MULLANE, John
  • REO, Joseph, P.
  • NOWAK, Robert, T.
  • WAN, Jiansheng
  • KABIR, Mohammed, A.
  • ABUTARIF, Malaz, A.
  • FRITZ, Glenn, E.
Agents
  • ZARADIC, Sandy
Priority Data
60/810,02101.06.2006US
60/874,83014.12.2006US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) SUSTAINED RELEASE PHARMACEUTICAL FORMULATION COMPRISING PHENYLEPHRINE
(FR) FORMULATIONS PHARMACEUTIQUES DE PHÉNYLÉPHRINE ET COMPOSITIONS POUR ABSORPTION PAR LE CÔLON
Abstract
(EN)
The invention discloses a pharmaceutical composition comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is for oral administration wherein the composition delivers phenylephrine or a pharmaceutically acceptable salt thereof via absorption in the colon. The pharmaceutical composition comprises a core comprising phenylephrine or a pharmaceutically acceptable salt thereof and an erodible layer which is in a time-dependent, pH-dependent, or colon-specific enzyme-dependent erodible layer that degrades to expose the core to release phenylephrine in the colon. In one preferred embodiment, the erodible layer encases the core. The composition optionally further comprises phenylephrine in the erodible layer or other additional layer(s). The pharmaceutical composition can further comprise one or more additional therapeutically active agents selected from one or more of the group consisting of antihistamines, analgesics, anti-pyretics, and non-steroidal anti-inflammatory agents. The invention also discloses methods of administering phenylephrine via the colon, thereby increasing the bioavailable amount of therapeutically active unconjugated phenylephrine relative to the total phenylephrine in the plasma.
(FR)
L'invention concerne une composition pharmaceutique comprenant de la phényléphrine ou un sel acceptable du point de vue pharmaceutique de celle-ci et une couche érodable, ladite composition étant destinée à une administration orale, ladite composition administrant de la phényléphrine ou un sel acceptable du point de vue pharmaceutique de celle-ci via l'absorption dans le côlon. La composition pharmaceutique comprend un cœur comprenant de la phényléphrine ou un sel acceptable du point de vue pharmaceutique de celle-ci et une couche érodable qui se trouve dans une couche érodable avec le temps, avec le pH ou avec une enzyme spécifique du côlon qui se décompose pour exposer le cœur pour libérer la phényléphrine dans le côlon. Dans un mode de réalisation préféré, la couche érodable enveloppe complètement le cœur. La composition comprend en outre éventuellement de la phényléphrine dans la couche érodable ou une ou plusieurs autres couches supplémentaires. La composition pharmaceutique peut en outre comprendre un ou plusieurs agents actifs du point de vue thérapeutique supplémentaires sélectionnés parmi un ou plusieurs éléments du groupe constitué d'antihistamines, d'analgésiques, d'antipyrétiques et d'agents anti-inflammatoires non stéroïdiens. L'invention concerne également des procédés d'administration de phényléphrine via le côlon, ce qui augmente de cette manière la quantité biodisponible de phényléphrine non conjuguée active du point de vue thérapeutique par rapport à la phényléphrine totale dans le plasma.
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