Claims
- 1. A formed tablet calibration standard-reagent for calibrating Karl Fischer reactions for determining water content in a substance, the tablet having physical, chemical, bioavailability, and structural characteristics, the tablet comprising:
an active ingredient; and at least one excipient configured to enhance at least one of the physical, chemical, bioavailability, and structural characteristics of the tablet.
- 2. The formed tablet of claim 1, wherein the excipient is selected from the group consisting essentially of fillers, binding agents, dyes, film coatings, aqueous coatings, glidants, lubricants, disintegrants, and super disintegrants.
- 3. The formed tablet of claim 1, wherein the excipient is a filler selected from the group consisting essentially of lactose, starch, dibasic calcium phosphate, microcrystalline cellulose (MCC), calcium carbonate, sucrose, mannitol, sorbital, acidisol, alcohol, calcium sulfate, dextrose, and dicalcium phosphate dehydrate (Ditab).
- 4. The formed tablet of claim 1, wherein the excipient is a binding agent selected from the group consisting essentially of acacia gum, gelatin, sucrose, povidone, methylcellulose, carboxymethylcellulose, hydrolyzed starch pastes, and MCC.
- 5. The formed tablet of claim 1, wherein the excipient is a lubricant selected from the group consisting essentially of magnesium stearate, metallic stearates, stearic acid, hydrogenated vegetable oils, talc, polyethylene glycols, lauryl sulfate salts, and calcium stearate.
- 6. The formed tablet of claim 1, wherein the excipient is a dye selected from the group consisting essentially of D & C dye, FD & C dyes and lakes.
- 7. The formed tablet of claim 1, wherein the excipient is a film coating selected from the group consisting essentially of hydroxypropyl methylcellulose, methyl cellulose, hydroxypropylcellulose, carboxymethylcellulose sodium, and mixtures of cellulose acetate phthalate and polyethylene glycols.
- 8. The formed tablet of claim 1, wherein the excipient is an aqueous coating including sugar with insoluble starch/CaCO3/talc/titanium dioxide suspended in acacia/gelatin.
- 9. A calibration standard-reagent for calibrating Karl Fischer reactions for determining water content in a substance, the calibration standard including:
an active ingredient configured to interact with a Karl Fischer reagent; and means for delivering the active component.
- 10. A calibration standard-reagent for calibrating Karl Fischer reactions for determining water content in a substance, the calibration standard including:
a body including an active ingredient configured to interact with a Karl Fischer reagent.
- 11. The calibration standard of claim 10, wherein the body further includes at least one excipient.
- 12. The calibration standard of claim 11, wherein the excipient is selected from the group consisting essentially of a filler, a disintegrant, a super disintegrant, a glidant, a lubricant, a dye, a film coating, and a aqueous coating.
- 13. The calibration standard of claim 11, wherein the excipient is selected from the group consisting essentially of lactose, starch, dibasic calcium phosphate, microcrystalline cellulose (MCC), calcium carbonate, sucrose, mannitol, sorbital, acidisol, alcohol, calcium sulfate, dextrose, dicalcium phosphate dehydrate (Ditab), acacia gum, gelatin, sucrose, povidone, methylcellulose, carboxymethylcellulose, hydrolyzed starch pastes, and MCC, starch, chemically modified starches cellulose, alginic acid, MCC, cross-linked povidone, effervescent mixtures, apple pectin, avicel, croscarmellose sodium, sodium starch glycolate, magnesium stearate, metallic stearates, stearic acid, hydrogenated vegetable oils, talc, polyethylene glycols, lauryl sulfate salts, calcium stearate, D & C dye, FD & C dyes and lakes, sugar with insoluble starch/CaCO3/talc/titanium dioxide suspended in acacia/gelatin, hydroxypropyl methylcellulose, methyl cellulose, hydroxypropylcellulose, carboxymethylcellulose sodium, mixtures of cellulose acetate phthalate and polyethylene glycols.
- 14. The calibration standard of claim 10, wherein the active ingredient is selected from the group consisting essentially of sodium tartrate dihydrate, purified water, certified water standards, aluminum potassium sulfate, ammonium oxalate, citric acid, ferric ammonium sulfate, ferrous ammonium sulfate, lactose, oxalic acid, potassium citrate, potassium sodium tartrate, potassium tartrate, sodium acetate, sodium bitartrate, sodium citrate, and sulfosalicylic acid.
- 15. The calibration standard of claim 10, wherein the body is one of a gelcap, geltab, capsule, caplet, container, pill, lozenge, enclosed vessel, or foil pouch containing the active component in either liquid or solid (i.e., a powder) form
- 16. A calibration standard-reagent for calibrating Karl Fischer reactions for determining water content in a substance, the calibration standard including:
a container enclosing an active ingredient configured to interact with a Karl Fischer reagent.
- 17. The calibration standard of claim 15, wherein the body further includes at least one excipient.
- 18. The calibration standard of claim 16, wherein the excipient is selected from the group consisting essentially of a filler, a disintegrant, a super disintegrant, a glidant, a lubricant, a dye, a film coating, and a aqueous coating.
- 19. The calibration standard of claim 16, wherein the excipient is selected from the group consisting essentially of lactose, starch, dibasic calcium phosphate, microcrystalline cellulose (MCC), calcium carbonate, sucrose, mannitol, sorbital, acidisol, alcohol, calcium sulfate, dextrose, dicalcium phosphate dehydrate (Ditab), acacia gum, gelatin, sucrose, povidone, methylcellulose, carboxymethylcellulose, hydrolyzed starch pastes, and MCC, starch, chemically modified starches cellulose, alginic acid, MCC, cross-linked povidone, effervescent mixtures, apple pectin, avicel, croscarmellose sodium, sodium starch glycolate, magnesium stearate, metallic stearates, stearic acid, hydrogenated vegetable oils, talc, polyethylene glycols, lauryl sulfate salts, calcium stearate, D & C dye, FD & C dyes and lakes, sugar with insoluble starch/CaCO3/talc/titanium dioxide suspended in acacia/gelatin, hydroxypropyl methylcellulose, methyl cellulose, hydroxypropylcellulose, carboxymethylcellulose sodium, mixtures of cellulose acetate phthalate and polyethylene glycols.
- 20. The calibration standard of claim 15, wherein the active ingredient is selected from the group consisting essentially of sodium tartrate dihydrate, purified water, certified water standards, aluminum potassium sulfate, ammonium oxalate, citric acid, ferric ammonium sulfate, ferrous ammonium sulfate, lactose, oxalic acid, potassium citrate, potassium sodium tartrate, potassium tartrate, sodium acetate, sodium bitartrate, sodium citrate, and sulfosalicylic acid.
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation-in-part of U.S. patent application Ser. No. 10/399,117, filed Apr. 14, 2003, which claims priority to PCT/US01/27790, filed Nov. 1, 2001, now published as WO 02/40991, which claims priority to U.S. Provisional Patent Application No. 60/248,487, filed Nov. 14, 2000.
Provisional Applications (1)
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Number |
Date |
Country |
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60248487 |
Nov 2000 |
US |
Continuation in Parts (1)
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Number |
Date |
Country |
Parent |
10399117 |
Apr 2003 |
US |
Child |
10793722 |
Mar 2004 |
US |