1. A pharmaceutical composition comprising fexofenadine or a pharmaceutical acceptable salt thereof, about 10 wt. % to about 70 wt. % of lactose, and about 1 wt. % to about 40 wt. % of a low-substituted hydroxypropyl cellulose, wherein the weight percents are based on the total weight of the pharmaceutical composition.
2. The composition according to claim 1, wherein the salt of fexofenadine is fexofenadine hydrochloride.
3. The composition according to claim 1, wherein the amount of fexofenadine or pharmaceutical acceptable salt thereof is from about 1 wt. % to about 80 wt. %, based on the total weight of the pharmaceutical composition.
4. The composition according to claim 3, wherein the amount of fexofenadine or pharmaceutical acceptable salt thereof is from about 5 wt. % to about 50 wt. %, based on the total weight of the pharmaceutical composition.
5. The composition according to claim 4, wherein the amount of fexofenadine or pharmaceutical acceptable salt thereof is from about 20 wt. % to about 35 wt. %, based on the total weight of the pharmaceutical composition.
6. The composition according to claim 1, wherein the amount of fexofenadine or pharmaceutical acceptable salt thereof is from about 10 mg to about 200 mg.
7. The composition according to claim 6, wherein the amount of fexofenadine or pharmaceutical acceptable salt thereof is from about 30 mg to about 180 mg.
8. The composition according to claim 1, wherein the lactose is selected from the group consisting of lactose monohydrate, lactose anhydrous, \u03b1-lactose, \u03b2-lactose, and combinations thereof.
9. The composition according to claim 8, wherein the lactose is lactose monohydrate.
10. The composition according to claim 1, wherein the amount of lactose is from about 25 wt. % to about 65 wt. %, based on the total weight of the pharmaceutical composition.
11. The composition according to claim 10, wherein the amount of lactose is from about 50 wt. % to about 60 wt. %, based on the total weight of the pharmaceutical composition.
12. The composition according to claim 1, wherein the low-substituted hydroxypropyl cellulose when dried at 105\xb0 C. for 1 hour contains 5-16% of hydroxypropoxy groups.
13. The composition according to claim 12, wherein the low-substituted hydroxypropyl cellulose when dried at 105\xb0 C. for 1 hour contains 10-13% of hydroxypropoxy groups.
14. The composition according to claim 13, wherein the low-substituted hydroxypropyl cellulose is selected from the group consisting of: LH-11 having a hydroxypropoxy content of 11% and an average particle size of 50 microns; LH-21 having a hydroxypropoxy content of 11% and an average particle size of 40 microns; LH-31 having a hydroxypropoxy content of 11%, and an average particle size of 25 microns; LH-22 having a hydroxypropoxy content of 8%, and an average particle size of 40 microns; LH-32 having a hydroxypropoxy content of 8%, and an average particle size of 25 microns; LH-20 having a hydroxypropoxy content of 13%, and an average particle size of 40 microns; and LH-30 having a hydroxypropoxy content of 13%, and an average particle size of 25 microns.
15. The composition according to claim 14, wherein the low-substituted hydroxypropyl cellulose is LH-21 or LH-11.
16. The composition according to claim 1, wherein the low-substituted hydroxypropyl cellulose is present in an amount of from about 2 wt. % to about 25 wt. %.
17. The composition according to claim 16, wherein the low-substituted hydroxypropyl cellulose is present in an amount of from about 3 wt. % to about 15 wt. %.
18. A method of preparing a pharmaceutical composition comprising fexofenadine or a pharmaceutical acceptable salt thereof, about 10 wt. % to about 70 wt. % of lactose, and about 1 wt. % to about 40 wt. % of a low-substituted hydroxypropyl cellulose, wherein the weight percents are based on the total weight of the pharmaceutical composition, said method comprising:
(a) mixing fexofenadine, lactose, low-substituted hydroxypropyl cellulose, and optionally one or more excipients to form a premix;
(b) adding a solvent and optionally a surfactant to the premix formed in Step (a) to form a wet granulation; and
(c) drying the wet granulation to form dried granules;
(d) optionally milling the dried granules; and
(e) mixing at least one excipient with the dried granules to form a pharmaceutical composition.
19. A method of preparing a pharmaceutical composition comprising fexofenadine or a pharmaceutical acceptable salt thereof, about 10 wt. % to about 70 wt. % of lactose, and about 1 wt. % to about 40 wt. % of a low-substituted hydroxypropyl cellulose, wherein the weight percents are based on the total weight of the pharmaceutical composition, said method comprising:
(a) mixing fexofenadine, lactose, low-substituted hydroxypropyl cellulose, and optionally one or more excipients to form a premix;
(b) adding a solvent and optionally a surfactant to the premix formed in Step (a) to form a wet granulation; and
(c) drying the wet granulation using a tray dryer to form dried granules;
(d) optionally milling the dried granules using a low shear mill; and
(e) mixing at least one excipient with the dried granules to form a pharmaceutical composition.
20. The method according to claim 19 wherein the low shear mill is a conical screen mill.
The claims below are in addition to those above.
All refrences to claim(s) which appear below refer to the numbering after this setence.
1. A tool for adjusting the position of a set of support wheels for a floor edger, the edger having a rotatable disk with a support surface for supporting a sanding element, the tool comprising:
a body, the body having a leading end, a mid-portion and a trailing end;
a leading gage surface, the leading gage surface being mounted from the leading end of the body;
an angle gage surface, the angle gage surface being mounted through from the body at a location between the leading end of the body and the trailing end of the body, the leading gage surface and the angle gage surface being of one-piece unitary construction; and
a pair of wheel setting surfaces, the wheel setting surfaces being spaced apart from one another and mounted from the trailing end of the body, the leading gage surface and the angle gage surface lying along a support plane, and said pair of wheel setting surfaces lying on a wheel plane, the wheel plane being at wheel support distance from the support plane.
2. A tool according to claim 1 wherein said body comprises a V-shaped frame, said V-shaped frame being defined by a pair of legs joined at an angle to one another near a vertex point, each of the legs having a first end and a second end, the first ends of the legs being closest to one another near the vertex point, the vertex point being near the leading end of said body, the second end of said legs defining the trailing end of said body.
3. A tool according to claim 2 wherein said legs are of adjustable length.
4. A tool according to claim 1 wherein said body comprises a V-shaped frame, said V-shaped frame being defined by a pair of legs joined to one another near a vertex point, each of the legs having a first end and a second end, the first ends of the legs being closest to one another near the vertex point, the vertex point being near the leading end of said body, the second end of said legs defining the trailing end of said body.
5. A tool according to claim 1 wherein said angle gage surface is mounted from said body at a distance from said body.
6. A tool according to claim 5 wherein said distance is adjustable.
7. A tool for adjusting the position of a pair of support wheels for a floor edger the edger having a casing that includes wheel supports, the edger further having a rotatable disk with a support surface for supporting a sanding element, the rotatable disk being supported at a sanding angle to a floor to be sanded, the angle being defined by the position of the wheels relative to the casing, the tool comprising:
a body, the body having a leading end, a mid-portion and a trailing end;
a leading gage surface, the leading gage surface being mounted from the leading end of the body;
an angle gage surface, the angle gage surface being mounted from the body at a location between the leading end of the body and the trailing end of the body, the leading gage surface and the angle surface being of unitary one-piece construction; and
a pair of wheel setting surfaces, the wheel setting surfaces being spaced apart from one another and mounted from the trailing end of the body and being supported with a threaded connector rom the body to allow adjustment of the distance of the wheel setting surfaces from the body, the leading gage surface and the angle gage surface lying along a support plane, and said pair of wheel setting surfaces lying on a wheel plane, the wheel plane being at a tool angle to the support plane, the tool angle being equal to the sanding angle.
8. A tool according to claim 7 wherein said body comprises a V-shaped frame, said V-shaped frame being defined by a pair of legs joined at an angle to one another near a vertex point, each of the legs having a first end and a second end, the first ends of the legs being closest to one another near the vertex point, the vertex point being near the leading end of said body, the second end of said legs defining the trailing end of said body.
9. A tool according to claim 8 wherein said legs are of adjustable length.
10. A tool according to claim 7 wherein said angle gage surface is mounted from said body at a distance from said body.
11. A tool according to claim 10 wherein said distance is adjustable.
12. A method for adjusting the position of a pair of support wheels on a floor edger, the method comprising:
providing a floor edger having a rotatable disk with a support surface for supporting a sanding element and a housing supporting a pair of adjustable wheels, the wheels cooperating with the rotatable disk to support the floor edger while the edger is in operation, the rotatable disk having a perimeter and a center;
providing a tool comprising:
a body, the body having a leading end, a mid-portion and a trailing end;
a leading gage surface, the leading gage surface being mounted from the leading end of the body;
an angle gage surface, the angle gage surface being mounted from the body at a location between the leading end of the body and the trailing end of the body; and
a pair of wheel setting surfaces, the wheel setting surfaces being spaced apart from one another and mounted from the trailing end of the body, the leading gage surface and the angle gage surface lying along a support plane, and said pair of wheel setting surfaces lying on a wheel plane, the wheel plane being at wheel support distance to the support plane;
placing the leading gage surface against the support surface of the disk at a location near the perimeter of the disk,
urging the gage angle surface against the support surface of the disk; and
adjusting the wheels by moving the wheels until the wheels are tangent to the wheel setting surfaces.
13. A method according to claim 12 wherein said body comprises a V-shaped frame, said V-shaped frame being defined by a pair of legs joined to one another near a vertex point, each of the legs having a first end and a second end, the first ends of the legs being closest to one another near the vertex point, the vertex point being near the leading end of said body, the second end of said legs defining the trailing end of said body.
14. A method according to claim 13 wherein said legs are of adjustable length.
15. A method according to claim 12 wherein said angle gage surface is mounted from said body at a distance from said body.
16. A method according to claim 15 wherein said distance is adjustable.