Appeal 2007-0318
Application 09/766,362
STATEMENT OF THE CASE
The Specification
The field of the invention is “pharmaceutical formulations, and more
particularly related to methods and compositions for nasally administering
antihistamines.” (Specification (hereafter “Spec.”) 1.)
According to the Specification: “Azelastine hydrochloride is a potent,
long acting antihistamine currently administered via the intranasal route in
an aqueous solution . . . .” (Spec. 1.) When used in this form, it “imparts a
long lasting, very bitter taste.” (Id.)
The Specification summarizes the invention as follows:
Dry powder formulations of drugs such as anti-
histamine for nasal administration are provided where the
drug is retained in the nasal cavity, and systemic side effects
minimized or eliminated, through the selection of a narrow
particle size range, between approximately 10 and 20
microns in diameter. In a preferred embodiment wherein the
drug is an antihistamine, retention of the antihistamine at the
nasal mucosa is improved and the bitter aftertaste associated
with liquid antihistamine formulations significantly reduced.
By making a dry powder formulation of an antihistamine
(e.g., azelastine) having an average particle size of between
10 and 20 microns, the antihistamine is restricted primarily to
the desired target organ, the nasal mucosa. Because the active
ingredient stays in the nasal region, a lower dose can be used
to achieve the same desired effect. As demonstrated by the
examples, . . . this formulation does not impart a bitter taste.
(Spec. 2 (emphasis added).)
There are five examples in the Specification. Examples 1 and 2 each
disclose a dry powder formulation having “an average particle size of
between 10 and 20 microns” but also having a relatively wide “particle size
2
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