Microbiologically sound and stable solutions of...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...

Reexamination Certificate

Rate now

  [ 0.00 ] – not rated yet Voters 0   Comments 0

Details

C514S553000, C514S473000, C514S529000

Reexamination Certificate

active

10841709

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.

REFERENCES:
patent: 4393236 (1983-07-01), Klosa
patent: 4738985 (1988-04-01), Kluger et al.
patent: 4983632 (1991-01-01), Gessa et al.
patent: 5380937 (1995-01-01), Koehler et al.
patent: 5594030 (1997-01-01), Conte et al.
patent: 5753708 (1998-05-01), Koehler et al.
patent: 5840331 (1998-11-01), Van Cauter et al.
patent: 5990162 (1999-11-01), Scharf
patent: 6472431 (2002-10-01), Cook et al.
patent: 0 235 408 (1987-09-01), None
patent: 0344704 (1989-05-01), None
patent: 0616804 (1994-03-01), None
patent: 0635265 (1994-07-01), None
patent: 5990162 (1999-11-01), None
patent: 922029 (1963-03-01), None
patent: 04-049212 (1992-02-01), None
patent: WO-96/40105 (1996-12-01), None
Arena, C, et al., “Absorption of Sodium Y-Hydroxybutyrate and its Prodrug Y-butyrolactone: relationship between n vitro transport and in vivo absorption”,Journal of Pharmaceutical Sciences, 69(3), (Mar. 1980),356-358.
Bedrard, M A., “Nocturnal y-Hydroxybutyrate—Effect on Periodic Leg Movements and Sleep Organization of Narcoleptic Patients”,Clin Neuropharmacol., 12(1), (Feb. 1989),29-36.
Berthier, M, et al., “Possible Involvement of a Gamma-Hydroxybutyric Acid Receptor in Startle Disease”,Acta Paediatr, 83(6), (1994),678-680.
Broughton, Roger, “The Treatment of Narcolepsy-Cataplexy with Nocturnal Gamma-Hydroxybutyrate”,le Journal Canadien des Sciences Neurologiques, 6(1), (1979),285-289.
Carter Snead, O. , et al., “Ontogeny of Gamma-Hydroxybutyric Acid. Regional Concentration in Developing Rat, Monkey and Human Brain”,Brain Res., 227(4), (1981),579-589.
Ferrara, S D., et al., “Pharmacokinetics of Y-Hydroxybutyric Acid in Alcohol Dependent Patients After Single and Repeated Oral Doses”,Br. J. Clin. Pharmacol., 34(3), (1992),231-235.
Gallimberti, L , “Gamma-Hydroxybutric Acid in the Treatment of Alcohol Dependence: A Double-Blind Study”,Alcohol Clin. Exp. Res., 16(4), (1992),673-676.
Gallimberti, L , “Gamma-hydroxybutyric Acid for Treatment of Alcohol Withdrawal Syndrome”,Clinical Pharmacology, 2(8666), (1989),787-789.
Gessa, G L., et al., “Gamma-hydroxybutyric acid (GHB) for treatment of ethanol dependence”,European Neuropsychopharmacology, 3(3), (1993),224-225.
Gessa, G L., “Gamma-hydroxybutyric Acid in the Treatment of Alcohol Dependence”,Clin. Neuropharm., 15 Suppl 1 Pt A, (1992),303a-304a.
Grove-White, I G., “Critical Flicker Frequency after Small Doses of Methohexitone, Diazepam and Sodium 4-Hydroxybutyrate”,Brit. J. Anaesth, 43(2), (1971),110-2.
Grove-White, et al., “Effect of Methohexitone, Diazepam and Sodium 4-Hydroxybutyrate on Short-Term Memory”,Brit. J. Anaesth., 113, (1971),43.
Hasenbos, M A., “Anaesthesia for bullectomy. A technique with spontaneous ventilation and extradural blockade”,Anaesthesia, 40(10), (1985),977-980.
Hoes, M J., “Gamma-hydroxybutyric acid as hypnotic. Clinical and pharmacokinetic evaluation of gamma-hydroxybutyric acid as hypnotic in man”,Encephale, 6(1), (1980),93-99.
Laborit, H. , “Gamma-Hydroxybutyrate, Succinic Semialdehyde and Sleep”,Laboratoire d'Eutonologie, (1973),257-274.
Ladinsky, Herbert , “Mode of Action of Gamma-Butyrolactone on the Central Cholinergic System”,Naunyn-Schmiedeberg's Arch. Pharmacol., 322, (1983),42-48.
Lammers, G J., “Gammahydroxybutyrate and Narcolepsy: A Double-Blind Placebo-Controlled Study”,Sleep, 16(3), (1993),216-220.
Lapierre, O. , “The Effect of Gamma-Hydroxybutyrate on Nocturnal and Diurnal Sleep of Normal Subjects: Further Considerations on REM Sleep-Triggering Mechanisms”,Sleep, 13, (1990),24-30.
Lee, C R., “Evidence for the B-Oxidation of Orally Administered 4-Hydroxybutyrate in Humans”,Biochemical Medicine, 17(3), (1977),284-291.
Lettieri, J , et al., “Improved Pharmacological Activity via Pro-Drug Modification: Comparative Pharmacokinetics of Sodium Y-Hydroxybutyrate and Y-Butyrolactone”,Research Communications in Chemical Pathology and Pharmacology, 22(1), (1978),107-118.
Mamelak, M , “Gamma-hydroxybutyrate (GHB): An endogenous Regulator of Energy Metabolism”,Neuroscience and Biobehavioral Reviews, 13(4), (1989),187-198.
Mamelak, M , “Sleep-Inducing Effects of Gammahydroxybutyrate”,The Lancet, 2(7824), (1973),328-329.
Mamelak, Mortimer, “The Effects of Gamma-Hydroxybutyrate on Sleep”,Biological Psychiatry, 12(2), (1977),273-288.
Nema, S , et al., “Excipients and Their Use in Injectable Products”,PDA J. Pharm. Sci. Technol, 51(4) (1997),166-171.
Palatini, P , “Dose Dependent Absorption and Elimination of Gamma-Hydroxybutyric Acid in Healthy Volunteers”,Eur. J. Clin. Pharmacol., 45(4), (1993),353-356.
Roth, et al., “Y-Butyrolactone and Y-Hydroxybutyric Acid-I, Distribution and Metabolism”,Biochemical Pharmacology, 15, (1966),1333-1348.
Scharf, M B., “The Effects and Effectiveness of y-Hydroxybutyrate in Patients with Narcolepsy”,J. Clin. Psychiatry, 46(6), (1985),222-225.
Scrima, et al., “Effect of Gamma-Hydroxybutyrate on a Patient with Obstructive Sleep Apnea”,Sleep Research, 16, (1987),137.
Scrima, et al., “Effects of High Altitude on a Patient with Obstructive Sleep Apnea”,Sleep Research, 16, (1987),427.
Scrima, et al., “Effects of Gamma-Hydroxybutyrate (GHB) on Narcolepsy-Cataplexy Symptoms and MSLT Results in Male and Female Patients”,Association of Professional Sleep Societies, (1988),251.
Scrima, L , et al., “Efficacy of Gamma-Hydroxybutyrate Versus Placebo in Treating Narcolepsy-Cataplexy: Double-blind Subjective Measured”,Biol. Psychiatry, 26(4), (1989),331-343.
Scrima, et al., “Gamma-Hydroxybutyrate Effects on Cataplexy and Sleep Attacks in Narcoleptics”,Sleep Research, 16, (1987),134.
Scrima, L , “The Effects of Y-Hydroxybutyrate on the Sleep of Narcolepsy Patients: A Double-Blind Study”,Sleep, 13(6), (1990),479-490.
Series, F , “Effects of Enhacing Slow-Wave Sleep by Gamma-Hydroxybutyrate on Obsturctive Sleep Apnea”,Am. Rev. Respir. Dis., 145(6), (1992),1378-1383.
Stock, G , “Increase in brain dopamine after axotomy or treatment with Gammahydroxybutyric acid due to elimination of the nerve impulse flow”,Naunyn-Schmiedeberg's Arch. Pharmacol., 278(4), (1973),347-361.
Strong, A J., “gamma-Hydroxybutyric acid and intracranial pressure”,The Lancet, 1(8389), (1984),1304.
Vickers, M D., “Gammahydroxybutyric Acid”,Int. Anesth. Clinic, 7(1), (1969),75-89.
Yamada, Y. , “Effect of Butyrolactone and Gamma-Hydroxybutyrate on the EEG and Sleep Cycle in Man”,Electoenceph. clin. Neurophysiol., 22, (1967),558-562.

LandOfFree

Say what you really think

Search LandOfFree.com for the USA inventors and patents. Rate them and share your experience with other people.

Rating

Microbiologically sound and stable solutions of... does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Microbiologically sound and stable solutions of..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Microbiologically sound and stable solutions of... will most certainly appreciate the feedback.

Rate now

     

Profile ID: LFUS-PAI-O-3898031

  Search
All data on this website is collected from public sources. Our data reflects the most accurate information available at the time of publication.