Lyophilized compositions of phenobarbital sodium salt
A composition of, method for producing, and use of an amorphous lyophilized Phenobarbital Sodium having high purity are presented. The amorphous lyophilized Phenobarbital Sodium is storage-stable being essentially void of impurities (e.g., phenylethylacetylurea (PEAU), 2-ethyl-2-phenylmalonamide (2EPMM), and/or alpha-phenylbutyrylguanidine (PBG)) upon reconstitution in water.
1. A storage stable pharmaceutical product, comprising:
a single use dose vial, and
a composition comprising a 65 mg dose, a 100 mg dose, a 130 mg dose, or a 200 mg dose of phenobarbital sodium, in the single use dose vial,
wherein the composition is sterile and lyophilized, and
wherein the composition comprises no less than 98% phenobarbital sodium.
2. The pharmaceutical product of claim 1 , wherein the composition has the property that when the composition is stored at 40° C. for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.1% PEAU.
3. The pharmaceutical product of claim 1 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% PEAU.
4. The pharmaceutical product of claim 1 , wherein the composition has the property that when the composition is stored at 40° C. for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of 2-ethyl-2-phenylmalonamide (2EPMM) or alpha-phenylbutyrylguanidine (PBG).
5. The pharmaceutical product of claim 1 , wherein the composition is amorphous.
6. The pharmaceutical product of claim 1 , wherein the composition has the property that when the composition is stored at room temperature for 24 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains at most 0.1% phenylethylacetylurea (PEAU).
7. A pharmaceutical product, comprising:
a single use dose vial, and
a composition comprising a 65 mg dose, a 100 mg dose, a 130 mg dose, or a 200 mg dose of phenobarbital sodium, in the single use dose vial,
wherein the composition is sterile and lyophilized,
wherein the composition comprises no less than 98% phenobarbital sodium, and
wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.1% phenylethylacetylurea (PEAU).
8. The pharmaceutical product of claim 7 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% PEAU.
9. The pharmaceutical product of claim 7 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of 2-ethyl-2-phenylmalonamide (2EPMM).
10. The pharmaceutical product of claim 7 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of alpha-phenylbutyrylguanidine (PBG).
11. The pharmaceutical product of claim 10 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of 2-ethyl-2-phenylmalonamide (2EPMM).
12. The pharmaceutical product of claim 7 , wherein the composition is amorphous.
13. The pharmaceutical product of claim 12 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of alpha-phenylbutyrylguanidine (PBG).
14. The pharmaceutical product of claim 1 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% PEAU, and wherein the reconstituted composition contains no more than 0.05% of 2-ethyl-2-phenylmalonamide (2EPMM) or alpha-phenylbutyrylguanidine (PBG).
15. The pharmaceutical product of claim 14 , wherein the composition is amorphous.
16. The pharmaceutical product of claim 1 , wherein the product comprises the 100 mg dose in the single use dose vial.
17. The pharmaceutical product of claim 7 , wherein the product comprises the 100 mg dose in the single use dose vial.
18. The pharmaceutical product of claim 8 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of 2-ethyl-2-phenylmalonamide (2EPMM).
19. The pharmaceutical product of claim 8 , wherein the composition has the property that when the composition is stored at room temperature for 6 months and then reconstituted for injection with 10 mL of an aqueous solution to form a reconstituted composition, the reconstituted composition contains no more than 0.05% of alpha-phenylbutyrylguanidine (PBG).
20. The pharmaceutical product of claim 8 , wherein the composition is amorphous.