INTRAVAGINAL FORMULATIONS COMPRISING GnRH
An intravaginal formulation is provided, comprising a carboxylic acid in a n amount of 10-20% w/w of said formulation, an oleaginous base, having melting temperature between 30° C. and 38° C., GnRH or an analog thereof, in an amount equivalent to GnRH amount of between 10 μg and 600 μg. A method of inducing ovulation in a ruminant using the formulation is also provided.
1 . An intravaginal formulation comprising:
a) 10-20% (w/w) of carboxylic acid;
b) an oleaginous base having a Tm between about 30° C. and 38° C.; and
c) a GnRH or GnRH analog in an amount equivalent to a GnRH amount of between 10 μg and 600 μg.
2 . The intravaginal formulation of claim 1 , wherein said GnRH or GnRH analog is present in an amount equivalent to a GnRH amount of:
a) between 140 and 550 μg; or
b) between 140 and 500 μg; or
c) between 140 and 300 μg; or
d) between 140 and 200 μg; or
e) between 200 and 500 μg; or
f) between 200 and 400 μg; or
g) between 200 and 300 μg; or
h) between 280 and 550 μg; or
i) between 280 and 500 μg.
3 - 10 . (canceled)
11 . The intravaginal formulation of claim 1 , wherein said GnRH or the analog thereof is present in the amount of between 140% and 250% of ED70 of said GnRH or the analog thereof when administered intramuscularly to a female ruminant.
12 . The intravaginal formulation of claim 11 , wherein the female ruminant is a bovine, an ovine or a caprine.
13 . The intravaginal formulation of claim 12 , wherein the female ruminant is a bovine.
14 . The intravaginal formulation of claim 1 , wherein said GnRH or the analog thereof is present at a dose of ED70 or greater when administered intravaginally.
15 . The intravaginal formulation of claim 1 , wherein the carboxylic acid is selected from the group consisting of citric acid, succinic acid, tartaric acid, glycolic acid, ascorbic acid, lactic acid, aspartic acid, dipotassium edetate, or a combination thereof.
16 . The intravaginal formulation of claim 15 , wherein said carboxylic acid is citric acid.
17 . The intravaginal formulation of claim 1 , wherein said carboxylic acid is present in the amount of 12-15% w/w of said formulation.
18 . The intravavinal formulation of claim 1 , wherein said oleaginous base has OHV below 30.
19 . The intravaginal formulation of claim 1 , wherein said oleaginous formulation has OHV between 1 and 20.
20 . The intravaginal formulation of claim 1 , wherein said oleaginous formulation has OHV between 5 and 15.
21 . A method of inducing ovulation in a female ruminant, comprising administering said female ruminant the intravaginal formulation of claim 1 .
22 . The method of claim 21 , wherein the ruminant is a bovine.
23 . A method of producing the intravaginal formulation according to claim 1 , comprising:
a) admixing the GnRH or GnRH analog with the carboxylic acid;
b) grinding the GnRH or GnRH analog and the carboxylic acid;
c) dispersing said ground GnRH or GnRH analog and said ground carboxylic acid in the oleaginous base.
24 . An intravaginal formulation produced according to the method of claim 23 .