Oral pharmaceutical dispersion compositions

• US 10,966,926 B2
• Filed: 10/19/2011
• Issued: 04/06/2021
• Est. Priority Date: 04/14/2010
• Status: Active Grant

• Current Assignee: Vitux Group AS
• Original Assignee: Vitux Group AS
• Inventors: Draget, Kurt Ingar, Engelsen, Steinar Johan, Seternes, Tore, Hattrem, Magnus, Haug, Ingvild Johanne
• Primary Examiner(s): Henley, III, Raymond J
• Application Number:
  US14/111,442
• Publication Number:
  US 20140163108A1
• Time in Patent Office: 3,457 Days
• Field of Search: 514570
• CPC Class Codes: A61K 31/165 having aromatic rings, e.g. colchicine, atenolol, progabide
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/42 Oxazoles
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/4985 Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
• CPC Class Codes: A61K 31/5415 ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
• CPC Class Codes: A61K 9/06 Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/10 Dispersions; Emulsions A61K9/06 takes precedence; composition of dispersions, emulsions A61K47/00
• CPC Class Codes: A61K 9/107 Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 15/10 for impotence
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/06 for tuberculosis
• CPC Class Codes: A61P 31/08 for leprosy
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 33/06 Antimalarials
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/12 : Antihypertensives
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention provides an oral pharmaceutical composition, optionally in dose unit form, comprising a lipophilic drug substance in dispersion in a physiologically tolerable aqueous carrier, preferably an aqueous gel, wherein said drug substance contains a functional electrostatic group having a pKa value of from 2 to 10, characterised in that said aqueous carrier has a pH at least 0.3 below or above said pKa value, said pH being below said pKa where said group is acidic and above said pKa where said group is basic.

Claims

1. An oral pharmaceutical composition which is set and in uncoated dose unit form, wherein said composition is a physiologically tolerable continuous aqueous gel which is not an oil-in-water emulsion, said continuous aqueous gel comprising water, gelatin as a gelling agent, and a pH modifier, and having dispersed therein uncoated crystalline ibuprofen, and said continuous aqueous gel having a pH in the range of 4 to 4.5.

2. The composition as claimed in claim 1 wherein the gelatin in the physiologically tolerable continuous aqueous gel comprises a type B gelatin.

3. The composition as claimed in claim 1 wherein the gelatin in the physiologically tolerable continuous aqueous gel comprises a type A gelatin.

4. The composition as claimed in claim 2 wherein the gelatin in the physiologically tolerable continuous aqueous gel further comprises a type A gelatin.

5. A method of treatment of a human or non-human animal subject comprising the step of orally administering an effective amount of an oral pharmaceutical composition according to claim 1.