Appeal No. 2001-1235 Paper 14
Application No. 08/951,943 Page 2
a period of time sufficient to prevent the formation and/or growth of a
crystalline structure in any film or laminate; and
c) allowing each film or laminate to cool to ambient conditions.
2. The method according to claim 1 further comprising the step of
providing that each dispersion of said liquid drug in a matrix is placed
between two non-porous substrates prior to heating.
3. The method according to claim 2 further comprising the steps
of:
c) laminating the individual films or laminates to form a final
laminate;
d) heating the final laminate to said predetermined temperature
immediately following lamination and maintaining the final laminate at the
temperature for a period of time sufficient to prevent formation and/or
growth of a crystalline structure in the final laminate; and
e) allowing the final laminate to cool to ambient conditions.
4. The method according to claim 3 further comprising the steps
of:
e) cutting subunits from said final laminate and forming said
delivery devices;
f) packaging said delivery devices in sealed containers;
g) heating the devices in said containers to a predetermined
temperature and maintaining the devices at the temperature for a period
of time sufficient to prevent formation and/or growth of a crystalline
structure in the devices; and
h) allowing the sealed devices to cool to ambient conditions.
8. The method of claim 2 wherein the drug is scopolamine.
9. The method of claim 8 wherein the predetermined temperature
is within the range of 75-90o C and the period of time is 2-10 minutes.
26. A drug delivery device for the transdermal administration of
scopolamine manufactured by the method according to any one of claims
1, 14, or 25.
The examiner relies on the following reference as evidence of obviousness:
Campbell et al. (Campbell) 4,832,953 May 23, 1989
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