Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
2001-02-22
2003-04-01
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S451000, C424S464000, C424S489000, C424S490000, C424S492000, C424S497000, C424S502000
Reexamination Certificate
active
06541014
ABSTRACT:
This invention relates to an antiviral product, as well as the use and formulation thereof.
A wide variety of antivirals have been used, and will be used, in order to combat viral infection. In general, such antivirals can be administered by a repeated dosing of immediate release dosage forms, which results in poor compliance or as a controlled release formulation (slow release) at higher administered doses. The present invention is directed to providing for an improved antiviral product.
In accordance with one aspect of the present invention, there is provided an antiviral pharmaceutical product which is comprised of at least two, preferably at least three, antiviral dosage forms. Such dosage forms are formulated so that each of the dosage forms has a different release profile.
In a particularly preferred embodiment, there are at least two, preferably at least three dosage forms, each of which has a different release profile and the release profile of each of the dosage forms is such that the dosage forms each start release of the antiviral contained therein at different times after administration of the antiviral product.
Thus, in accordance with an aspect of the present invention, there is provided a single or unitary antiviral product that has contained therein at least two, preferably at least three antiviral dosage forms, each of which has a different release profile, whereby the antiviral contained in each of such dosage forms is released at different times.
In accordance with a further aspect of the invention, the antiviral product may be comprised of at least four different dosage forms, each of which starts to release the antiviral contained therein at different times after administration of the antiviral product.
The antiviral product generally does not include more than five dosage forms with different release times.
In accordance with a preferred embodiment, the antiviral product has an overall release profile such that when administered the maximum serum concentration of the total antiviral released from the product is reached in less than twelve hours, preferably in less than eleven hours. In an embodiment, the maximum serum concentration of the total antiviral released from the antiviral product is achieved no earlier than four hours after administration.
In accordance with one preferred embodiment of the invention, there are at least three dosage forms. One of the at least three dosage forms is an immediate release dosage form whereby initiation of release of the antiviral therefrom is not substantially delayed after administration of the antiviral product. The second and third of the at least three dosage forms is a delayed dosage form (which may be a pH sensitive or a non-pH sensitive delayed dosage form, depending on the type of antiviral product), whereby the antiviral released therefrom is delayed until after initiation of release of the antiviral from the immediate release dosage form. More particularly, the antiviral release from the second of the at least two dosage forms achieves a C
max
(maximum serum concentration in the serum) at a time after the antiviral released from the first of the at least three dosage forms achieves a C
max
in the serum, and the antiviral released from the third dosage form achieves a C
max
in the serum after the C
max
of antiviral released from the second dosage form.
In one embodiment, the second of the at least two dosage forms initiates release of the antiviral contained therein at least one hour after the first dosage form, with the initiation of the release therefrom generally occurring no more than six hours after initiation of release of antiviral from the first dosage form of the at least three dosage forms.
In general, the immediate release dosage form produces a C
max
for the antiviral released therefrom within from about 0.5 to about 2 hours, with the second dosage form of the at least three dosage forms producing a C
max
for the antiviral released therefrom in no more than about four hours. In general, the C
max
for such second dosage form is achieved no earlier than two hours after administration of the antiviral product; however, it is possible within the scope of the invention to achieve C
max
in a shorter period of time.
As hereinabove indicated, the antiviral product may contain at least three or at least four or more different dosage forms. For example, if the antiviral product includes a third dosage form, the antiviral released therefrom reaches a C
max
at a time later than the C
max
is achieved for the antiviral released from each of the first and second dosage forms. In a preferred embodiment, release of antiviral from the third dosage form is started after initiation of release of antiviral from both the first dosage form and the second dosage form. In one embodiment, C
max
for antiviral release from the third dosage form is achieved within eight hours.
In another embodiment, the antiviral product contains at least four dosage forms, with each of the at least four dosage forms having different release profiles, whereby the antiviral release from each of the at least four different dosage forms achieves a C
max
at a different time.
As hereinabove indicated, in a preferred embodiment, irrespective of whether the antiviral contains at least two or at least three or at least four different dosage forms each with a different release profile, C
max
for all the antiviral released from the antiviral product is achieved in less than twelve hours, and more generally is achieved in less than eleven hours.
In a preferred embodiment, the antiviral product is a once a day product, whereby after administration of the antiviral product, no further product is administered during the day; i.e., the preferred regimen is that the product is administered only once over a twenty-four hour period. Thus, in accordance with the present invention, there is a single administration of an antiviral product with the antiviral being released in a manner such that overall antiviral release is effected with different release profiles in a manner such that the overall C
max
for the antiviral product is reached in less than twelve hours. The term single administration means that the total antiviral administered over a twenty-four hour period is administered at the same time, which can be a single tablet or capsule or two or more thereof, provided that they are administered at essentially the same time.
Applicant has found that a single dosage antiviral product comprised of at least three antiviral dosage forms each having a different release profile is an improvement over a single dosage antiviral product comprised of an antiviral dosage form having a single release profile. Each of the dosage forms of antiviral in a pharmaceutically acceptable carrier may have one or more antivirals and each of the dosage forms may have the same antiviral or different antivirals.
It is to be understood that when it is disclosed herein that a dosage form initiates release after another dosage form, such terminology means that the dosage form is designed and is intended to produce such later initiated release. It is known in the art, however, notwithstanding such design and intent, some “leakage” of antiviral may occur. Such “leakage” is not “release” as used herein.
If at least four dosage forms are used, the fourth of the at least four dosage form may be a sustained release dosage form or a delayed release dosage form. If the fourth dosage form is a sustained release dosage form, even though C
max
of the fourth dosage form of the at least four dosage forms is reached after the C
max
of each of the other dosage forms is reached, antiviral release from such fourth dosage form may be initiated prior to or after release from the second or third dosage form.
The antiviral product of the present invention, as hereinabove described, may be formulated for administration by a variety of routes of administration. For example, the antiviral product may be formulated in a way that is suitable for topical administration; administration in the eye
Isbister James D.
Rudnic Edward M.
Treacy, Jr. Donald J.
Wassink Sandra E.
Advancis Pharmaceutical Corp.
Olstein Elliot M.
Page Thurman K.
Sheikh Humera N.
Stauffer Raymond E.
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