Abstract: Controlled release dosage forms are described herein. The controlled release formulations described herein provide prolonged delivery of high dose drugs that are highly water soluble and highly hygroscopic. In specific embodiments, controlled release dosage forms for delivery of a drug selected from GHB and pharmaceutically acceptable salts, hydrates, tautomers, solvates and complexes of GHB. The controlled release dosage forms described herein may incorporate both controlled release and immediate release formulations in a single unit dosage form.
Abstract: Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.
Type:
Application
Filed:
July 13, 2011
Publication date:
January 26, 2012
Applicant:
Jazz Pharmaceuticals, Inc.
Inventors:
Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad, Dayton Reardan
Abstract: The present invention provides a solid immediate release dosage form adapted for oral administration of GHB. The solid immediate release dosage form includes an immediate release formulation comprising a relatively high weight-percentage of GHB with a bioavailability similar to that of a liquid GHB dosage form.
Type:
Application
Filed:
May 4, 2010
Publication date:
May 12, 2011
Applicant:
JAZZ PHARMACEUTICALS, INC.
Inventors:
ANDREA MARIE ROURKE, MAURA PATRICIA MURPHY, JAMES FREDERICK PFEIFFER, CLARK PATRICK ALLPHIN, ALYA KHAN MCGINLAY
Abstract: A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug.
Type:
Grant
Filed:
February 11, 2010
Date of Patent:
February 22, 2011
Assignee:
Jazz Pharmaceuticals, Inc.
Inventors:
Dayton T. Reardan, Patti A. Engel, Bob Gagne
Abstract: Disclosed are formulations of gamma-hydroxybutyrate in an aqueous medium that are resistant to microbial growth. Also disclosed are formulations of gamma-hydroxybutyrate that are also resistant to the conversion into GBL. Disclosed are methods to treat sleep disorders, including narcolepsy, with these stable formulations of GHB. The present invention also provides methods to treat alcohol and opiate withdrawal, reduced levels of growth hormone, increased intracranial pressure, and physical pain in a patient.
Type:
Grant
Filed:
July 13, 2007
Date of Patent:
December 14, 2010
Assignee:
Jazz Pharmaceuticals, Inc.
Inventors:
Harry Cook, Martha Hamilton, Douglas Danielson, Colette Goderstad, Dayton Reardan