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Claims for Patent: 6,056,941

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Claims for Patent: 6,056,941

Title: Kit for the preparation of technetium TC 99m teboroxime myocardial perfusion agent
Abstract:A kit containing a solution of boronic acid adducts of technetium-99 m dioxime complexes; and hydroxypropyl gamma cyclodextrin to maintain the solution free of particulate matter originating from the formulation.
Inventor(s): Schramm; Ernest (North Brunswick, NJ), Newborn; Margaret (Hamilton, NJ), Zodda; Julius P. (Mercerville, NJ), Katona; Thomas (Mercerville, NJ), Monteferrante; Jo Anna (Flemington, NJ)
Assignee: Bracco Research USA (Princeton, NJ)
Application Number:09/363,132
Patent Claims: 1. In an improved kit for myocardial diagnosis of a patient with suspected coronary artery diseases using rest and stress techniques, said kit having

(a) a first container containing lyophilized ingredients; and

(b) a second container containing technetium TC-99 m;

wherein

said first container contains

5 to 15 mg sodium chloride, or sodium bromide;

1 to 3 mg of boronic acid derivative, or compounds which can react in situ to form a boronic acid derivative, having the formula ##STR5## or a pharmaceutically acceptable salt thereof, wherein R.sub.3 is hydroxy, alkyl, alkenyl, cycloalkyl, cycloalkenyl, aloxy, carboxyalkyl, carboxyalkenyl, hydroxyalkyl, hydroxalkenyl, alkoxyalkyl, aloxy-alkenyl, haloalkyl, haloalkenyl, aryl, arylalkyl, or R.sub.4 R.sub.5 N-alkyl and R.sub.4 and R.sub.5 are each independently hydrogen, alkyl, or arylalkyl, or R.sub.4 and R.sub.5 when taken together with nitrogen atom to which they are attached form a 5 or 6-membered nitrogen containing heterocycle, and R.sub.7 is hydrogen, alkyl or aryl;

1 to 3 mg of a dioxime having the formula ##STR6## or a pharmaceutically acceptable salt thereof, wherein R.sub.1 and R.sub.2 are each independently hydrogen, halogen, alkyl, aryl, amino or a 5 or 6-membered nitrogen or oxygen containing heterocycle, or together R.sub.2 and R.sub.3 are --(CH.sub.2 R.sub.9)-- wherein n is 3, 4, 5, or 6 and R.sub.8 and R.sub.9 are each independently hydrogen or alkyl;

0.03 to 0.06 mg stannous chloride;

1 to 3 mg pentetic acid; and

8 to 10 mg citric acid;

and said second container contains

1 to 3 ml of technetium Tc-99 m in physiological saline containing 10 to 100 mCi;

wherein the improvement comprises:

30 to 50 mg hydroxypropyl gamma cyclodextrin added to said first container.

2. The kit for myocardial diagnosis of a patient according to claim 1, wherein said dioxime is selected from the group consisting of:

dimethyl glyoxime,

1,2-cyclohexanedione dioxime,

1,2-ethanedione dioxime,

.alpha.-furyldioxime,

1, 2-cyclopentanedione dioxime and

3-methyl-1, 2-cyclopentanedione dioxime.

3. The kit for myocardial diagnosis of a patient according to claim 1, wherein said boronic acid derivative is selected from the group consisting of:

B-alkyl,

B-alkoxy,

B-benzyl and

B-cycloalkyl.

4. The kit for myocardial diagnosis of a patient according to claim 1 wherein when said technetium Tc-99 m is added to the first container forms a complex with the content thereof, said complex selected from the group consisting of:

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 methoxy boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 hydroxy boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 ethoxy boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 propyloxy boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 hexyloxy boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 1-methylpropyl boron;

.sup.99m Tc (bromine) (dimethyl glyoxime).sub.3 butyl boron;

.sup.99m Tc (iodine) (dimethyl glyoxime).sub.3 butyl boron;

.sup.99m Tc (fluorine) (dimethyl glyoxime).sub.3 butyl boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 3-(4-morpholinyl)propyl boron;

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 2-phenylethyl boron;

.sup.99m Tc (chlorine) (1,2-cyclohexanedione dioxime).sub.3 methyl boron; and

.sup.99m Tc (chlorine) (dimethyl glyoxime).sub.3 4-formylphenyl boron.

5. In an improved kit for myocardial diagnosis of a patient with suspected coronary artery diseases using rest and stress techniques said kit; having

a) a first container containing lyophilized ingredients containing

1 to 3 mg cyclohexanedione dioxime;

1 to 3 mg methyl boronic acid;

8 to 10 mg citric acid;

5 to 10 mg sodium chloride;

and

0.030 to 0.060 mg stannous chloride (SnCl.sub.2); and

b) a second container containing

1 to 3 ml technetium Tc-99 m in physiological saline;

wherein the improvement comprises:

30 to 50 mg hydroxypropyl gamma cyclodextrin added to said first container.
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