Drug delivery device containing neuraminidase inhibitor and an H1 antagonist
AssigneeOsmotica Corp.
InventorsJoaquina Faour, Juan A. Vergez, Marcelo A. Ricci
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Abstract
The present invention provides a dual release solid dosage form containing a first composition that releases a neuraminidase inhibitor, such as oseltamivir, zanamivir, or peramivir, in a controlled manner and a second composition that releases an H1 antagonist in a rapid and/or immediate manner. A wide range of H1 antagonist antihistamines, especially fexofenadine and loratadine, can be used in this device. Particular embodiments of the invention provide osmotic devices having predetermined release profiles. The device is useful for the treatment of respiratory congestion and other viral infection associated symptoms.
Claims50
A dual release drug delivery device comprising:
- a first composition comprising a therapeutically effective amount of an antiviral neuraminidase inhibitor and at least one pharmaceutical excipient;
- and
- a different second composition comprising a therapeutically effective amount of an H1 histamine receptor antagonist;
- wherein the first composition provides a controlled, extended, retarded and/or sustained release of the antiviral neuraminidase inhibitor and the second composition provides a rapid and/or immediate release of an H1 histamine receptor antagonist.
A dual release osmotic device comprising:
- a core comprising a therapeutically effective amount of an antiviral neuraminidase inhibitor and at least one osmotic agent or osmopolymer, wherein the core provides a controlled release of the neuraminidase inhibitor;
- a semipermeable membrane surrounding the core and having a passageway there through;
- and
- a drug-containing coat comprising a therapeutically effective amount of an H1 antagonist and surrounding the semipermeable membrane, wherein the external coat provides a rapid release of the H1 antagonist.
A combination rapid release and controlled release device comprising:
- (a) a core comprising a therapeutically effective amount of an antiviral neuraminidase inhibitor which is delivered at a controlled rate over a period of at least about 18-24 hours;
- (b) a semipermeable membrane surrounding the core and a passageway through the semipermeable membrane;
- (c) an inert water soluble or erodible coating surrounding the semipermeable membrane and plugging the passageway;
- and
- (d) an H1 antagonist-containing water soluble coating surrounding the inert water soluble coating for delivering all of the H1 antagonist at a rapid rate over a period of less than about 120 min.
A dual release capsule comprising:
- a first composition consisting essentially of plural granules comprising a therapeutically effective amount of an antiviral neuraminidase inhibitor and at least one pharmaceutical excipient;
- and
- a different second composition comprising a therapeutically effective amount of an H1 histamine receptor antagonist;
- wherein the first composition provides a controlled or sustained release of the antiviral neuraminidase inhibitor and the second composition provides a rapid release of an H1 histamine receptor antagonist.
A dual release drug delivery device comprising:
- an antiviral neuraminidase inhibitor selective for neuraminidase A or B, wherein the inhibitor is present in controlled, sustained, extended or prolonged release form;
- an H1 antihistamine receptor antagonist present in rapid release form such that it is substantially completely released within two hours after exposure of the device to an aqueous environment;
- and
- at least one pharmaceutical excipient.
Dependencies are inferred from the claim text.