Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/20—Pills, tablets, discs, rods
  • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
  • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
  • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/13—Amines
  • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
  • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone

Definitions

• pseudoephedrine and appropriate non-toxic carriers and to methods of using said compositions in the therapy or cure of sinusitis, or sinus
• headaches generally exemplified by discomfort, pain, pressure, and dizziness.
• inflammatory drugs such as naproxen
• naproxen are widely administered orally in the treatment of mild to severe pain. These drugs have been disclosed
• Naproxen as non-steroidal anti-inflammatory pain reliever has greater advantage than other pain relievers acetaminophen, aspirin, and
• Naproxen has a significantly greater duration or half-life that leads to twice a day dosage. It is generally accepted that decreased dosing leads to patient convenience and better compliance.
• a timed-released combination product suitable for oral administration comprising naproxen and pseudoephedrine combined with or without an appropriate base salt.
• the preferred dosage form that provides for immediate release of naproxen and pseudoephedrine, and specific timed release of pseudoephedrine.
• the release of naproxen and pseudoephedrine takes place together up to 12 hours, preferably 10 hours.
• One or two tablets are administered orally, preferably two.
• Concentration ranges for the active ingredients are naproxen, 50-500 mg per tablet; pseudoephedrine 30- 240 mg per tablet. The concentration ranges represent 7- 30% of coated tablet weight of pseudoephedrine and 15- 60% of naproxen.
• the dosage range for naproxen is from 50-800 mg per day depending upon pain management requirements.
• the range of pseudoephedrine is between 30-240 mg per day depending blood pressure values and overall health of the patient. Both drugs will vary depending upon the age and weight of the patient, the seventy of the symptoms and the incidence of side effects for humans.
• binders used in the granulation of the drug polymer mixture include povidine and corn starch. Such binders are present at a concentration of about .5% to 3% of the tablet core weight.
• the means of preparing compositions of the present invention e.g. tablet mixing, compaction, and coating are all well known to those skilled in the art.

Landscapes

• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Epidemiology (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Chemical & Material Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Emergency Medicine (AREA)
• Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
• Medicinal Preparation (AREA)

Applications Claiming Priority (1)

Publications (2)

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ID=22267747

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• 1998
  • 1998-08-25 MX MXPA01001969A patent/MXPA01001969A/es unknown
  • 1998-08-25 CA CA002341485A patent/CA2341485A1/en not_active Abandoned
  • 1998-08-25 EP EP98941051A patent/EP1107740A4/de not_active Withdrawn
  • 1998-08-25 AU AU89198/98A patent/AU758880B2/en not_active Ceased
  • 1998-08-25 JP JP2000565859A patent/JP2002523358A/ja not_active Withdrawn

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