Pharmaceutical composition

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...

Reexamination Certificate

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Details

C514S772000, C514S785000, C514S816000, C514S025000

Reexamination Certificate

active

06936605

ABSTRACT:
A liquid pharmaceutical composition is described comprising from about 7.5 mg/mL to about 12.5 mg/mL of midazolam in the form of midazolam maleate in solution in an aqueous liquid medium comprising ethanol and a polyhydroxy solvent. This composition can be administered by the buccal route for the treatment of patients suffering epileptic siezures or as an anaesthetic.

REFERENCES:
patent: 4777065 (1988-10-01), Hirao et al.
patent: WO 99/09989 (1999-03-01), None
patent: WO 00/62764 (2000-10-01), None
patent: WO 01/30391 (2001-05-01), None
Caplus DN 127:336674, Kondo T, JP 09278671, 19971028, abstract.
Micromedex, Inc., online Drug Information for Midazolam, revised Jan. 13, 2002, pp. 1-3.
James Fish, “Midazolam” University of Michigan Department of Anesthesiology Web Project, University of Michigan Medical School, Ann Arbor, Michigan, USA (Apr. 15, 1997) pp. 1-3.
Eli Lahat et al. “Comparison of Intransal Midazolam with Intravenous Diazepam for Treating Febrile Seizures in Children: Prospective Randomised Study” BMJ, vol. 2000, No. 321 (Jul. 8, 2000) pp. 83-86.
Roche “Versed (midazolam HCl) Syrup”product information from printed from the Roche Laboratories websites at www.rocheusa.com/products/versed/pi_syr.html (Dec. 1998) pp. 1-19.
Rod C. Scott et al. “Buccal Midazolam and Rectal Diazepam for Treatment of Prolonged Seizures in Childhood and Adolescence: A Randomised Trial” The Lancet, vol. 353 (Feb. 20, 1999) pp. 623-626.
Roelofse et al.; Intranasal Midazolam Spray in Adults; Rsearch Article; Jun. 2000, SAJAA.

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