Pharmaceutical composition

• US 8,188,108 B2
• Filed: 05/31/2011
• Issued: 05/29/2012
• Est. Priority Date: 11/15/2002
• Status: Expired due to Fees

• Current Assignee: Branded Products For The Future
• Original Assignee: Branded Products For The Future
• Inventors: Mayo-Alvarez, Ricardo, McNeil, Ronny
• Primary Examiner(s): Flood, Michele C.
• Application Number:
  US13/149,692
• Publication Number:
  US 20110230512A1
• Time in Patent Office: 364 Days
• Field of Search: None
• US Class Current: 514/282
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/716 Glucans
• CPC Class Codes: A61K 31/74 Synthetic polymeric materials
• CPC Class Codes: A61K 33/06 Aluminium, calcium or magnesium; Compounds thereof , e.g. clay
• CPC Class Codes: A61K 33/42 Phosphorus; Compounds thereof
• CPC Class Codes: A61K 36/68 Plantaginaceae (Plantain Family)
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/00 Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 1/10 Laxatives
• CPC Class Codes: A61P 25/04 Centrally acting analgesics, e.g. opioids
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

A pharmaceutical composition comprising an analgesic or analgesic combination and a stool softener is disclosed. The analgesic is selected from morphine, meperidine, fentanyl, hydromorphone, oxymorphone, oxycodone, hydrocodone, methadone, propoxyphene, pentazocine, levorphanol, codeine, acetaminophen and combinations of these analgesics. The composition is formulated for oral administration as a liquid or solid dosage form for immediate, slow, delayed or sustained-release characteristics.

Claims

1. A mono-phasic pharmaceutical composition suitable for single dose administration for reducing the risk of constipation caused by the administration of hydrocodone consisting essentially of about 2.5 mg/dose to about 15 mg/dose of hydrocodone, about 300 mg/dose of acetaminophen, about 60 mg/dose of docusate, and a pharmaceutically acceptable carrier.

2. The pharmaceutical composition of claim 1 wherein the composition contains about 2.5 mg/dose of hydrocodone.

3. The pharmaceutical composition of claim 1 wherein the composition contains about 5 mg/dose of hydrocodone.

4. The pharmaceutical composition of claim 1 wherein the composition contains about 7.5 mg/dose of hydrocodone.

5. The pharmaceutical composition of claim 1 wherein the composition contains about 10 mg/dose of hydrocodone.

6. The pharmaceutical composition of claim 1 wherein the composition contains about 15 mg/dose of hydrocodone.

7. The pharmaceutical composition of claim 1 formulated as at least one member of the group consisting of an oral solution, oral syrup, soft gelatin capsule, hard gelatin capsule, tablet, capsule and sterile packaged powder.

8. The pharmaceutical composition of claim 1 further comprising a sustained release carrier that causes the hydrocodone to be released over a time period of about 4 to about 16 hours when orally administered to a human patient.

9. The pharmaceutical composition of claim 1 further comprising a sustained release carrier that causes the hydrocodone to be released over a time period of about 8 to about 24 hours when orally administered to a human patient.