VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
dosage form, wherein the unit dosage form consists essentially of:
a) from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
b) 10 mM acetate buffer; and
c) water,wherein:
the unit dosage form has a pH of 3.8;
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof
per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.
VITAMIN B12 NASAL SPRAY AND METHOD OF USE
Par Pharmaceutical, Inc.,...
A) a composition for nasal administration of a cobalamin compound, the composition comprising an aqueous solution containing
about 0.02% w/w to about 1% w/w of a cobalamin compound and a pharmaceutically acceptable buffer, wherein the composition
is sterile, wherein the composition is free of preservatives, wherein the composition has a pH of about 4 to about 6.5, and
wherein the cobalamin compound is cyanocobalamin or hydroxocobalamin; and
B) a container equipped with a pump adapted to deliver the composition into a patient's nostril, wherein the container is
configured such that the dose of the cobalamin compound delivered with each administration is from about 5 ?g to about 45
?g.
EPINEPHRINE FORMULATIONS
Par Pharmaceutical, Inc.,...
in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of about 2.8 to 3.8 mg/mL of a pH raising agent,
in the range of about 0.1 to 1.1 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and
in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent;
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite, and
wherein the condition is selected from the group consisting of anaphylaxis, bronchospasm, sensitivity reactions, cardiac arrhythmias,
GI and renal hemorrhage, superficial bleeding, premature labor, hypoglycemia, and cardiogenic, hemorrhagic, and traumatic
shock.
EPINEPHRINE FORMULATIONS
PAR PHARMACEUTICAL, INC.,...
in the range of about 0.5 to 1.5 mg/mL of epinephrine and/or salts thereof,
in the range of about 6 to 8 mg/mL of a tonicity regulating agent,
in the range of about 2.8 to 3.8 mg/mL of a pH raising agent,
in the range of about 0.1 to 1.1 mg/mL of an antioxidant,
in the range of about 0.001 to 0.010 mL/mL of a pH lowering agent, and
in the range of about 0.01 to 0.4 mg/mL of a transition metal complexing agent,
wherein the antioxidant comprises sodium bisulfite and/or sodium metabisulfite.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
a) providing a pharmaceutical composition for intravenous administration comprising: i) from about 0.01 mg/mL to about 0.07
mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) acetic acid; and iii) water,
wherein the pharmaceutical composition has a pH of 3.8;
b) storing the pharmaceutical composition at 2-8° C. for at least 4 weeks; and
c) intravenously administering the pharmaceutical composition to the human,
wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt
thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the human is hypotensive,
wherein the pharmaceutical composition exhibits less than about 5% degradation after storage at 2-8° C. for about four weeks.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
storing the unit dosage form for at least about 24 hours at a concentration from about 0.1 ?g/ml to about 2 ?g/mI vasopressin or a pharmaceutically-acceptable salt thereof; and
after the storing, intravenously administering the unit dosage form to the human;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.:2 are present in the unit dosage form at a ratio of about 1000: about 1 to about 30: about 1,
wherein the unit dosage form that is administered to the human comprises from about 0.1?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
a) providing a pharmaceutical composition for intravenous administration consisting of, in a unit dosage form: i) from about
0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically-acceptable salt thereof; ii) optionally chlorobutanol;
iii) acetic acid, acetate, or a combination thereof; iv) 0-2% vasopressin degradation products; and v) water;
b) diluting the unit dosage form in a diluent to provide a concentration from about 0.1 units/mL to about 1 unit/mL of vasopressin
or the pharmaceutically-acceptable salt thereof; and
c) administering the diluted unit dosage form to the human by intravenous administration;
wherein:
the unit dosage form has a pH of 3.5 to 4.1;
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof
per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
Par Pharmaceutical, Inc.,...
wherein the unit dosage form has a pH of 3.6 to 3.9;
the unit dosage form further comprises impurities that are present in an amount of 0.9%-1.7%, wherein the impurities have from about 85% to about 100% sequence homology to SEQ ID NO.: 1, dextrose, and from about 1 mM to about 10 mM acetate buffer;
storing the unit dosage form for at least about 24 hours at from about 0.1 units/ml to about 1 unit/ml vasopressin or a pharmaceutically-acceptable salt thereof;
after the storing, intravenously administering the unit dosage form to the human;
wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the unit dosage form that is administered to the human comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
Par Pharmaceutical, Inc.,...
storing the unit dosage form for at least about 24 hours at a concentration of from about 0.1 ug/ml to about 2 ?g/ml of vasopressin or a pharmaceutically-acceptable salt thereof; and
after the storing, intravenously administering the unit dosage form to the human;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the vasopressin or the pharmaceutically-acceptable salt thereof and SEQ ID NO.:3 are present in the unit dosage form at a ratio of about 1000:about 1 to about 90:about 1,
wherein the unit dosage form that is administered to the human comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
storing the unit dosage form for at least about 24 hours at a concentration of from about 0.1 ?g/ml to about 2 ?g/ml of vasopressin or a pharmaceutically-acceptable salt thereof; and
after the storing, intravenously administering the unit dosage form to the human;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute,
wherein the unit dosage form that is administered to the human comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof; and
the human is hypotensive.
CYANOCOBALAMIN LOW VISCOSITY AQUEOUS FORMULATIONS FOR INTRANASAL DELIVERY
PAR PHARMACEUTICAL, INC.,...
comprising:
administering an aqueous solution of cyanocobalamin to the subject having vitamin B12 deficiency associated with gastric surgery,
wherein the aqueous solution of cyanocobalamin comprises:
cyanocobalamin;
water;
a buffer selected from the group consisting of citric acid, sodium citrate, monopotassium phosphate, disodium phosphate, potassium
biphthalate, sodium hydroxide, sodium acetate, acetic acid, and combinations thereof;
optionally, a humectant selected from the group consisting of sorbitol, propylene glycol, and glycerin, and combinations thereof;
and
optionally, a preservative selected from the group consisting of benzyl alcohol, parabens thimerosal, chlorobutanol, benzethonium
chloride, and benzalkonium chloride, and combinations thereof;
wherein the aqueous solution of cyanocobalamin is suitable for intranasal administration, has a viscosity of less than about
1000 cPs, and a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular
injection of cyanocobalamin.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
Par Pharmaceutical, Inc.,...
i) from about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
ii) from about 1 mM to about 10 mM acetate buffer;
iii) 0-2% vasopressin degradation products;
iv) sodium chloride; and
v) water; and
b) storing the unit dosage form for at least about 24 hours at from about 0.1 units/ml to about 1 unit/ml of vasopressin or a pharmaceutically-acceptable salt thereof; and
c) after the storing, administering the unit dosage form to the human by intravenous administration, wherein the unit dosage form that is administered to the human comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; wherein:
the unit dosage form has a pH of 3.4 to 3.8; the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
c) intravenously administering the portion of the pharmaceutical composition to the human,wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute,wherein the human is hypotensive;d) puncturing the dispensing region of the container a second time and drawing from the container a second portion of the pharmaceutical composition,wherein the second time that the dispensing region of the container is punctured occurs at least 48hours after the first time that the dispensing region of the container is punctured;e) intravenously administering the second portion of the pharmaceutical composition to the human,wherein the administration of the second portion of the pharmaceutical composition provides to the human from about 0.01 units of vasopressin or the pharmaceutically acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically acceptable salt thereof per minute.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
i) from about 0.1 units/mL to about 1 unit/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
ii) from about 1 mM to about 10 mM acetate buffer;
iii) no more than about 0-2% vasopressin degradation products;
iv) about 5% dextrose; and
v) water; and
b) administering the unit dosage form to the human by intravenous administration, wherein the unit dosage form comprises from about 0.1 units/mL to about 1 unit/mL of vasopressin or the pharmaceutically-acceptable salt thereof; wherein:
the unit dosage form has a pH of 3.6 to 3.9; the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
Par Pharmaceutical, Inc.,...
b) storing intravenously the unit dosage form at 2-8° C. for at least about 24 hours; and
c) after the storing, administering the unit dosage form to the human, wherein the unit dosage form comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically-acceptable salt thereof;
wherein:
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
dosage form, wherein the unit dosage form comprises from about 0.01 mg/mL to about 0.07 mg/mL of vasopressin or a pharmaceutically
acceptable salt thereof, wherein:
the unit dosage form has a pH of 3.7-3.9;
the unit dosage form further comprises impurities that are present in an amount of 0.9% - 1.7%, wherein the impurities have
from about 85% to about 100% sequence homology to SEQ ID NO.: 1;
the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof
per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.

VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or a pharmaceutically-acceptable salt thereof;
impurities that are present in an amount of 0.9% to 1.7%, wherein the impurities have from about 85% to about 100% sequence
homology to SEQ ID NO.: 1;
about 5% dextrose;
and from about 1 mM to about 10 mM acetate buffer, and wherein the unit dosage form has a pH of 3.6 to 3.9;
and wherein the unit dosage form is suitable for administration at a concentration of from about 0.1 ?g/ml to about 2 ?g/ml
of vasopressin or the pharmaceutically acceptable salt thereof.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
or a pharmaceutically-acceptable salt thereof, wherein the unit dosage form further comprises impurities that are present
in an amount of 0.9% to 1.7%, wherein the impurities have from about 85% to about 100% sequence homology to SEQ ID NO.: 1,
and wherein the unit dosage form has a pH of 3.7-3.9.
EPINEPHRINE FORMULATIONS
PAR PHARMACEUTICAL, INC.,...
an antioxidant present at a concentration of in the range of about 0.1 to 0.9 mg/mL,
a buffer system, the buffer system comprising tartaric acid,
sodium chloride as a tonicity regulating agent at a concentration of in the range of about 6 to 7.5 mg/mL,
a preservative, and
disodium edetate dihydrate as a transition metal complexing agent at a concentration of in the range of about 0.01 to 0.4 mg/mL,
wherein the buffer system provides a resistance to a pH change such that the composition has a pH of in the range of about 3.5 and 4.0 after 18 months of shelf life, and wherein after 18 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.
VASOPRESSIN FORMULATIONS FOR USE IN TREATMENT OF HYPOTENSION
PAR PHARMACEUTICAL, INC.,...
wherein the pharmaceutical composition exhibits no more than about 1% degradation of vasopressin or the pharmaceutically-acceptable salt thereof after the storage at 5° C. for about one month; and
b) administering to the human the pharmaceutical composition, wherein the pharmaceutical composition comprises from about 0.1 ?g/mL to about 2 ?g/mL of vasopressin or the pharmaceutically acceptable salt thereof;
wherein the administration provides to the human from about 0.01 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute to about 0.1 units of vasopressin or the pharmaceutically-acceptable salt thereof per minute; and
the human is hypotensive.
EPINEPHRINE FORMULATIONS
PAR PHARMACEUTICAL, INC.,...
an antioxidant present at a concentration of in the range of about 0.1 to 0.9 mg/mL,
a buffer system, the buffer system comprising tartaric acid,
sodium chloride as a tonicity regulating agent at a concentration of in the range of about 6 to 7.5 mg/mL,
a preservative, and
disodium edetate dihydrate as a transition metal complexing agent at a concentration of in the range of about 0.01 to 0.4 mg/mL,
wherein the buffer system provides a resistance to a pH change such that the composition has a pH of in the range of about 3.5 and 4.0 after 18 months of shelf life, and wherein after 18 months of storage at between 23° C. and 32° C. and between 55% RH and 70% RH, the composition comprises about 3% or less of D-Epinephrine.
METHOD TO TREAT HYPOTENSION USING VASOPRESSIN IN CERTAIN GENOTYPES
PAR PHARMACEUTICAL, INC.,...