1. A process for preparing a pharmaceutical composition comprising an ibuprofen shell completely surrounding a coated core tablet wherein the coated core tablet comprises famotidine and a barrier layer, wherein said process comprises
blending a therapeutically effective amount of famotidine with at least one pharmaceutically acceptable excipient to yield a blended famotidine mixture;
pressing said blended famotidine mixture;
coating said pressed blended famotidine mixture with a barrier layer to yield a coated core tablet;
blending a therapeutically effective amount of ibuprofen with at least one pharmaceutically acceptable excipient to yield a blended ibuprofen mixture;
granulating said blended ibuprofen mixture to yield a granulated ibuprofen; and
compressing said granulated ibuprofen around the coated core tablet to yield an ibuprofen shell such that the ibuprofen shell completely surrounds the coated core tablet.
2. The process of claim 1, wherein the core tablet comprises from about 6.9 wt % to about 7.9 wt % of the total weight of the pharmaceutical composition.
3. The process of claim 1, wherein the coated core tablet comprises from about 7.4 wt % to about 8.4 wt % of the total weight of the pharmaceutical composition.
4. The process of claim 1, wherein the ibuprofen shell comprises from about 91.6 wt % to about 92.6 wt % of the total weight of the pharmaceutical composition.
5. (canceled)
6. (canceled)
7. (canceled)
8. (canceled)
9. The process of claim 1, wherein the pharmaceutical composition comprises from about 24 mg to about 28 mg famotidine.
10. The process of claim 9, wherein the pharmaceutical composition comprises about 26.6 mg famotidine.
11. The process of claim 1, wherein the pharmaceutical composition comprises from about 750 mg to about 850 mg ibuprofen.
12. The process of claim 11, wherein the pharmaceutical composition comprises about 800 mg ibuprofen.
13. The process of claim 1, wherein the barrier layer comprises Opadry white.
14. (canceled)
15. A pharmaceutical composition prepared by a process of claim 1.
16. A pharmaceutical composition comprising:
a first compartment comprising
a therapeutically effective amount of famotidine;
from about 42 mg to about 46 mg of microcrystalline cellulose;
from about 10 mg to about 19 mg of at least one binder other than microcrystalline cellulose; and
from about 0.9 mg to about 1.9 mg of at least one lubricant, and
a second compartment comprising
a therapeutically effective amount of ibuprofen;
from about 200 to about 250 mg of at least one binder; and
from about 2.5 mg to about 3.5 mg of at least one lubricant,
wherein said first compartment is separated from said second compartment.
17. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition is in the form of a tablet.
18. The pharmaceutical composition of claim 17, wherein said pharmaceutical composition comprises a coated core tablet and a shell completely surrounding the coated core tablet,
wherein the coated core tablet comprises a barrier layer coating and a core tablet coated with the barrier layer and
wherein the core tablet comprises the first compartment and the shell comprises the second compartment.
19. The pharmaceutical composition of claim 16, wherein the first compartment comprises
from about 24 mg to about 28 mg famotidine;
from about 42 mg to about 46 mg of microcrystalline cellulose;
from about 10 mg to about 19 mg of at least one binder other than microcrystalline cellulose; and
from about 0.9 mg to about 1.9 mg of at least one lubricant.
20. The pharmaceutical composition of claim 16 wherein the second compartment comprises
from about 750 mg to about 850 mg ibuprofen;
from about 200 to about 250 mg of at least one binder; and
from about 2.5 mg to about 3.5 mg of at least one lubricant.
21. The pharmaceutical composition of claim 17, wherein the first compartment corresponds to a first layer of the pharmaceutical composition and the second compartment corresponds to a second layer of the pharmaceutical composition, wherein the first layer and the second layer are separated by a barrier layer.
22. The pharmaceutical composition of claim 17, wherein the first compartment corresponds to a first layer of the pharmaceutical composition, a portion of the second compartment corresponds to a second layer of the pharmaceutical composition adjacent to a first side of said first layer, and the remainder of the second compartment corresponds to a third layer of the pharmaceutical composition adjacent to a second side of the first layer.
23. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition is in the form of a soft gel capsule.
24. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition is in the form of a hard gel capsule.
25. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition is in a chewable form.
26. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition is in a form that dissolves andor disintegrates orally.
27. (canceled)
28. (canceled)
29. The pharmaceutical composition of claim 16, wherein the second compartment comprises from about 775 mg to about 825 mg of ibuprofen.
30. The pharmaceutical composition of claim 29, wherein the pharmaceutical composition comprises about 800 mg ibuprofen.
31. The pharmaceutical composition of claim 16, wherein the pharmaceutical composition comprises about 26.6 mg famotidine.
32. A method for reducing the risk of developing ibuprofen-induced ulcers in a human subject requiring ibuprofen for an ibuprofen-responsive condition comprising administering to the human subject a pharmaceutical composition of claim 16.
33. (canceled)
34. (canceled)
35. A method for reducing gastric acid while treating a subject with an ibuprofen-responsive condition comprising prescribing or administering to the subject a pharmaceutical composition of claim 16.
36. (canceled)
37. A method of reducing symptoms of a famotidine-responsive condition in a subject in need of NSAID treatment who has experienced symptoms of a famotidine-responsive condition associated with NSAID administration, comprising prescribing or administering a pharmaceutical compositions of claim 16.
38. (canceled)
39. The method of claim 32 further comprising, prior to administering the pharmaceutical composition, determining an approximate serum creatinine concentration for the subject; if the subject has a creatinine clearance rate of greater than about 50 mLminute, then prescribing or administering a first dose of the pharmaceutical composition.
40. The method of claim 32, further comprising prior to administering the pharmaceutical composition, determining if the subject is being administered one or more additional therapeutic agents chosen from diuretics, angiotensin converting enzyme inhibitors, and angiotensin receptor blockers, if the subject is being administered one or more of said additional therapeutic agents, then determining an approximate creatinine clearance rate for the individual; then if the subject has a creatinine clearance rate of greater than about 50 mLminute, prescribing or administering a first dose of a pharmaceutical composition.
41. A method for reducing the risk of an adverse event in an subject requiring ibuprofen for an ibuprofen-responsive comprising:
a) determining an approximate serum creatinine concentration for the individual;
b) if the subject has a creatinine clearance rate of greater than about 50 mLminute, then prescribing or administering a first dose of a pharmaceutical composition of claim 16;
c) prescribing or administering to the subject a second dose of the pharmaceutical composition; and
d) prescribing or administering to the subject a third dose of the pharmaceutical composition.
42. A method for the treatment of cystic fibrosis comprising prescribing or administering a pharmaceutical composition of claim 16.
43. The method of claim 32 wherein the pharmaceutical composition is administered three times a day (TID).
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
What is claimed is:
1. An applicator for applying and distributing a substance onto a target surface, said applicator comprising:
(a) a substantially planar sheet of compressible, conformable material having opposed first and second surfaces and an interior region between said first and second surfaces, said sheet of material having a thickness between said first and second surfaces which decreases when said sheet of material is subjected to an externally-applied force in a direction substantially normal to said first surface;
(b) at least one discrete reservoir extending inwardly of said first surface into the interior of said sheet of material;
(c) a substance at least partially filling said reservoir; and
(d) at least one discrete aperture formed in said first surface, said aperture being in fluid communication with said reservoir;
whereby compression of said sheet of material via an externally-applied force substantially normal to said first surface expresses said product from said aperture and translational motion of said first surface relative to a target surface applies and distributes said product onto said target surface.
2. The applicator of claim 1, wherein said applicator includes a plurality of apertures forming a delivery zone adjacent to one end of said applicator.
3. The applicator of claim 1, wherein said substance fills said reservoir to a level at least equal to said first surface.
4. The applicator of claim 1, wherein said reservoir defines an interior volume which decreases when said thickness is reduced by an externally-applied force.
5. The applicator of claim 1, wherein said applicator includes a plurality of apertures.
6. The applicator of claim 1, wherein said applicator includes a plurality of reservoirs.
7. The applicator of claim 1, wherein said applicator includes a plurality of apertures and a corresponding plurality of reservoirs, each of said apertures being in fluid communication with one of said reservoirs.
8. The applicator of claim 1, wherein said aperture fully penetrates said first and second surfaces and said reservoir is formed between said second surface and a backing sheet peripherally joined thereto.
9. The applicator of claim 1, wherein said reservoir extends inwardly of said first surface into the interior of said sheet of material but does not penetrate said second surface.
10. The applicator of claim 1, wherein said reservoir extends inwardly of said first surface into the interior of said sheet of material a distance which is less than said thickness.
11. The applicator of claim 1, wherein said sheet material is resilient in compression.
12. The applicator of claim 1, wherein said sheet material is resilient in bending.
13. The applicator of claim 1, wherein said sheet material comprises a closed-cell foam material.
14. The applicator of claim 1, wherein said applicator includes a removable cover sheet for enclosing said aperture prior to use.
15. The applicator of claim 1, wherein said applicator includes a plurality of reservoirs and a corresponding plurality of apertures, and wherein said reservoirs include multiple diverse substances.
16. An applicator for applying and distributing a substance onto a target surface, said applicator comprising:
(a) a substantially planar sheet of compressible, conformable material having opposed first and second surfaces and an interior region between said first and second surfaces;
(b) at least one discrete aperture extending inwardly of said first surface into the interior of said sheet of material a distance which is less than the distance between said opposed first and second surfaces to form a corresponding product reservoir.
17. The applicator of claim 16, wherein said compressible, conformable material comprises a closed-cell foam material.
18. A method of making an applicator for applying and distributing a substance onto a target surface, said method comprising the steps of:
(a) providing a substantially planar sheet of compressible, conformable material having opposed first and second surfaces and an interior region between said first and second surfaces, said sheet of material having a thickness between said first and second surfaces which decreases when said sheet of material is subjected to an externally-applied force in a direction substantially normal to said first surface;
(b) forming at least one discrete reservoir extending inwardly of said first surface into the interior of said sheet of material;
(c) at least partially filling said reservoir with a substance; and
(d) forming at least one discrete aperture in said first surface, said aperture being in fluid communication with said reservoir.
19. The method of claim 18, wherein said reservoir is formed by thermal embossing.
20. The method of claim 18, wherein said substance is injected into said reservoir.
21. The applicator of claim 1, wherein said reservoir is a slot type reservoir.
22. The applicator of claim 1, wherein said reservoir is an aperture-channel type reservoir.
23. The applicator of claim 1, wherein said reservoir is an aperture-channel type reservoir positioned diagonally at a 45 angle.
24. The applicator of claim 1, wherein said reservoir has an aspect ratio of about 5 or below.