Zilpaterol animal premix formulation
A new solid dosage form formulation and manufacturing process incorporating zilpaterol HCl is presented. This formulation is an animal feed premix with improved content uniformity and is manufactured by a simple method that uses a supersaturated solution of zilpaterol that is incorporated into a solid carrier matrix.
1. An animal feed premix comprising
zilpaterol or a salt thereof in the range of 0.5 to 2.0 w/w %;
propylene glycol in range of 5-10 w/w %; and
a solid carrier.
2. The premix of claim 1 , further comprising water in the range of 1-4 w/w %.
3. The premix of claim 1 , wherein the zilpaterol is zilpaterol HCl.
4. The premix of claim 1 , wherein the solid carrier is selected from the group consisting of corn cobs, rice hulls, talc, cellulose or mixtures thereof.
5. The premix of claim 4 , wherein the solid carrier is corn cobs.
6. An animal feed premix comprising
0.5-2.0 w/w % zilpaterol HCl;
5-10 w/w % propylene glycol;
1-4 w/w % water; and
QS milled corn cobs.
7. A process for preparing the animal feed premix of claim 1 comprising
(a) mixing the zilpaterol and propylene glycol;
(b) heating the mixture of step (a) until zilpaterol goes into solution; and
(c) mixing the zilpaterol solution of step (b) with the solid carrier, thereby obtaining an animal feed premix according to claim 1 .
8. The process of claim 7 , further comprising adding water to the zilpaterol, propylene glycol mixture of step a).
9. The process of claim 7 , wherein the zilpaterol solution of step b) is supersaturated with respect to zilpaterol.
10. The process of claim 7 , wherein the mixture of step a) is heated to a temperature in the range of about 40° C. to about 100° C.
11. A method of preparing an animal feed comprising mixing the animal feed premix of claim 1 with grain.
12. The method of claim 11 , wherein the relative standard deviation (RSD) value of the distribution of the zilpaterol in the feed prepared from the premix is less than 15%.
13. The method of claim 12 , wherein the RSD of the distribution of the zilpaterol in the feed is less than 10%.
14. The method of claim 13 , wherein the RSD of the distribution of the zilpaterol in the feed is less than 5%.
15. The method of claim 11 , wherein the concentration of zilpaterol in the feed is 4 ppm or less.
16. A method of preparing an animal feed comprising mixing the animal feed premix of claim 6 with grain.
17. The method of claim 16 , wherein the relative standard deviation (RSD) value of the distribution of the zilpaterol in the feed prepared from the premix is less than 15%.
18. The method of claim 16 , wherein the RSD of the distribution of the zilpaterol in the feed is less than 10%.
19. The method of claim 16 , wherein the RSD of the distribution of the zilpaterol in the feed is less than 5%.
20. The method of claim 16 , wherein the concentration of zilpaterol in the feed is 4 ppm or less.