1. A composition for radiolabeling diethylenetriaminepentaacetic Acid (DTPA)-dextran with Technetium-99m, compromising:
(a) a DTPA-dextran with a concentration of up to 0.50 mgvial;
(b) a sugar selected from the group of non-reducing disaccharides with a concentration up to 2% (wv);
(c) a non-sulfhydryl anti-oxidant wherein the concentration is in the range of about 0.5 mgvial;
(d) a stannous salt wherein the concentration of the dihydrate form of the stannous salt is up to 75 microgramsvial;
(e) a pH buffer selected from a group of pH buffers in the concentration range of up to about 0.5 mgvial; and
(f) a water for injection (WFI), wherein the water is degassed and deaerated with an inert gas.
2. The composition of claim 1, wherein the DTPA-dextran contains multiple DTPA groups conjugated to dextran in the molar range of about 2:1 to 12:1.
3. The composition of claim 1, wherein the DTPA-dextran contains dextran in the average molecular weight range of about 5,000 to 20,000 Daltons.
4. The composition of claim 1, wherein the DTPA-dextran is DTPA-mannosyl-dextran containing a molar ratio range of about 2:1 to 12:1 conjugated Mannose groups to DTPA-dextran.
5. The composition of claim 1, wherein the non-reducing disaccharide is \u03b1,\u03b1-Trehalose Dihydrate.
6. The composition of claim 1, wherein the non-sulfhydryl anti-oxidant is L(+)-Ascorbic Acid Sodium salt.
7. The composition of claim 1, wherein the stannous salt is Stannous Chloride Dihydrate.
8. The composition of claim 1, wherein the pH buffer and transchelator is Glycine.
9. The composition of claim 1, wherein the inert gas used to deaerated WFI is nitrogen.
10. A method for stabilizing a DTPA-dextran cold kit for long-term storage, compromising the steps of:
(a) adding an aqueous composition, compromising;
(i) a sugar selected from the group of non-reducing disaccharides with a concentration up to 2% (wv);
(ii) a pH buffer selected from a group of pH buffers in the concentration range of up to about 0.5 mgvial;
\u2003to a vessel containing about 90% of its target volume of degassed and deaerated water for injection;
(b) adding a non-sulfhydryl anti-oxidant wherein the concentration is in the range of about 0.5 mgvial;
(c) adjusting the solution pH to a target pH of 3.2\xb10.2 with 6 N hydrochloric acid, while maintaining an inert gas sparge;
(d) adding a stannous salt wherein the concentration of the dihydrate form of the stannous salt is up to 75 microgramsvial;
(e) adding a DTPA-dextran with a concentration of up to 0.50 mgvial;
(f) adjusting the solution pH to a target pH of 3.2\xb10.2 with 6 N hydrochloric acid, while maintaining an inert gas sparge;
(g) adjusting the volume of the formulation to 100% of its target volume with degassed and deaerated water for injection;
(h) filtering the aqueous composition through a 0.22 micron filter and filling the aqueous composition into glass vials with 1.0 mL\xb110% and placing stoppers in the neck of the vials;
(i) removing the majority of the water content of the product, decreasing the residual moisture to about less than 1% water content by lyophilization in step a;
(j) backfilling the lyophilized product with an inert gas to about 11.5 p.s.i. prior to stoppering the vials in step b
(k) crimping the lyophilized product vials with aluminum seals in step c; and
(l) storing the crimped-sealed lyophilized product vials in step d at either 2\xb0 to 8\xb0 C., or 25\xb0 C.
11. The method of claim 10, wherein the non-reducing disaccharide is \u03b1,\u03b1-Trehalose Dihydrate.
12. The method of claim 10, wherein the pH buffer and transchelator is Glycine.
13. The method of claim 10, wherein the non-sulfhydryl anti-oxidant is L(+)-Ascorbic Acid Sodium salt.
14. The method of claim 10, wherein the stannous salt is Stannous Chloride Dihydrate.
15. The method of claim 10, wherein the DTPA-dextran contains multiple DTPA groups conjugated to dextran in a molar ratio range of about 2:1 to 12:1.
16. The method of claim 10, wherein the DTPA-dextran contains dextran in the average molecular weight range of about 5,000 to 20,000 Daltons.
17. The method of claim 10, wherein the DTPA-mannosyl-dextran containing a molar ratio range of about 2:1 to 12:1 conjugated mannose groups to DTPA-dextran.
18. A method for radiolabeling a DTPA-dextran cold kit with a Sodium 99mTc-Pertechnetate solution and a diluent for use as a diagnostic radiopharmaceutical and for adjusting the final solution pH for patient comfort, compromising the steps of:
(a) adding an aqueous Sodium Pertechnetate (Tc99m) composition, compromising;
(i) greater than about 100 Curies of Sodium Pertechnetatemmol DTPA-dextran in a volume of 0.7 mL;
(ii) allowing for a Tc99m dose range from about 0.3 to 5.0 millicuries Tc99m in a 0.2 mL dose in a final volume of 1.0 mL;
(b) adding an aqueous buffered saline diluent composition in a volume of 0.3 ml, compromising;
(i) 0.5% (wv) Sodium Chloride, USP;
(ii) 0.107% Sodium Phosphate Heptahydrate;
(iii) 0.036% Potassium Phosphate;
(iv) 0.4% Phenol;
(v) adding water for injection (wfi) to q.s. to a final volume; and
(vi) adding concentrated Sodium Hydroxide or Hydrochloric Acid, as needed to adjust ph to about ph 7.0.
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 composition polymerizable in response to radiation being incident thereupon, said composition comprising:
only one silane bis vinyl ether, wherein the silane bis vinyl ether is bis(divinyloxymethyl)tetramethyldisiloxane;
an initiator component responsive to said radiation to produce an acid in response thereto; and
a base in an amount that reduces unwanted acid production,
wherein said bis(divinyloxymethyl)tetramethyldisiloxane is reactive to said acid and polymerizes in response thereto, and
wherein the composition is operable to form a pattern on a substrate using imprint lithography employing dark-field polymerization.
2. A composition polymerizable in response to radiation being incident thereupon, said composition comprising:
only one silane bis vinyl ether, wherein the silane bis vinyl ether is bis(divinyloxymethyl)tetramethyldisiloxane;
an initiator component including triphenylsulphonium salts or diphenyliodonium salts; and
a base in an amount that reduces unwanted acid production,
wherein the composition is operable to form a pattern on a substrate using imprint lithography employing dark-field polymerization.
3. A composition polymerizable in response to radiation being incident thereupon, said composition comprising:
only one silane bis vinyl ether, wherein the silane bis vinyl ether is bis(vinyloxymethyl)dimethysilane; and
an initiator component responsive to said radiation to produce an acid in response thereto,
wherein said bis(vinyloxymethyl)dimethysilane is reactive to said acid and polymerizes in response thereto,
wherein the composition is operable to form a pattern on a substrate using imprint lithography employing dark-field polymerization.
4. The composition as recited in claim 1 wherein said initiator component includes triphenylsulphonium salts or diphenyliodonium salts, the salts having a counter ion selected from the group consisting of antimony hexafluoride; phosphorus hexafluoride; boron tetrafluoride; and tris (trifluoromethylsulphonyl) methide.
5. The composition as recited in claim 3 further including an acrylate monomer.
6. The composition as recited in claim 3 wherein said bis(vinyloxymethyl)dimethysilane is approximately 98% of said composition by weight and said initiator component is approximately 2% of said composition by weight.
7. The composition as recited in claim 3 further including an acrylate monomer, and a base in an amount that reduces unwanted acid production.
8. The composition as recited in claim 3 wherein the initiator component includes a diaryliodonium salt, and the composition further includes a mixture of an ethylene glycol divinyl ether and a base in an amount that reduces unwanted acid production.
9. The composition as recited in claim 3 wherein said initiator component includes a diaryliodonium salt and the composition further includes ethylene glycol divinyl ether.
10. A polymerized product of the composition of claim 3 obtained by exposure to radiation.
11. A composition polymerizable in response to radiation being incident thereon, said composition comprising:
only one silane bis vinyl ether, wherein the silane bis vinyl ether is bis(vinyloxymethyl)dimethylsilane; and
an initiator component including triphenylsulphonium salts or diphenyliodonium salts,
wherein the composition is operable to form a pattern on a substrate using imprint lithography employing dark-field polymerization.
12. The composition as recited in claim 11 wherein said composition further includes an acrylate monomer.
13. The composition as recited in claim 12 wherein said composition further includes a base in an amount that reduces unwanted acid production.
14. The composition as recited in claim 11 wherein said silane bis vinyl component is approximately 98% of said composition by weight and said initiator component is approximately 2% of said composition by weight.
15. The composition as recited in claim 11 wherein said initiator component includes a diphenyliodonium salt, and the composition further includes a mixture of an ethylene glycol divinyl ether and a base in an amount that reduces unwanted acid production.
16. A composition polymerization in response to radiation being incident thereupon, said composition comprising:
exactly two silane bis vinyl ethers, wherein the two silane bis vinyl ethers are bis(vinyloxymethyl)dimethysilane and bis(divinyloxymethyl)tetramethyldisiloxane; and
an initiator component responsive to said radiation to produce an acid in response thereto, wherein said bis vinyl ethers are reactive to said acid and polymerize in response thereto,
wherein the composition is operable to form a pattern on a substrate using imprint lithography employing dark-field polymerization.