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|Abstract:||Stable pharmaceutical formulations of a therapeutic agent, a low molecular weight alcohol and a glycol derivative are disclosed. Preferred formulations include 19-nor-1.alpha.,3.beta.,25-trihydroxy-9,10-secoergosta-5,7(E),22(E)-triene .|
|Inventor(s):||Li; Lukchiu (Vernon Hills, IL), Pec; Edward Anthony (Brookfield, IL), Robinson; Daniel H. (Lake Bluff, IL), Stephens; Dennis A. (Mt. Prospect, IL), Jantzi; Kathee (Madison, WI), May; Thomas Barton (Grayslake, IL), Oberdier; John Paul (Gurnee, IL)|
|Assignee:||Abbott Laboratories (Abbott Park, IL)|
1. A sterilized, self-preserved, aqueous pharmaceutical composition for parenteral administration consisting essentially of a therapeutically effective amount of a vitamin D compound,
about 50% (v/v) of an organic solvent selected from the group consisting of low molecular weight alcohols in the range of about 15% to about 30% (v/v) and glycol derivatives in the range of about 20% to about 35% (v/v), and about 50% (v/v) water.
2. The composition of claim 1 wherein the low molecular weight alcohol is ethanol.
3. The composition of claim 1 wherein the glycol derivative is selected from the group consisting of glycerin and propylene glycol.
4. The composition of claim 3 wherein the glycol derivative is propylene glycol.
5. The composition of claim 1 wherein the vitamin D compound is selected from the group consisting of parecelcitol and calcitriol.
6. The composition of claim 1 wherein the low molecular weight alcohol is ethanol and the glycol derivative is propylene glycol.
7. The composition of claim 6 wherein the vitamin D compound is paracalcitol or calcitriol.
8. The composition of claim 7 wherein the vitamin D compound is present between about 2 .mu.g/ml and about 10 .mu.g/ml.
9. The composition of claim 8 wherein the vitamin D compound is present at about 5 .mu.g/ml.
10. The formulation of claim 1 wherein sterilization is terminal sterilization.
11. The formulation of claim 1 wherein the sterilization is aseptic fill.
12. A sterilized, self-preserved pharmaceutical formulation for parenteral administration consisting essentially of:
2-10 micrograms/milliliter of a paracalcitol;
20% (v/v) ethanol;
30% (v/v) propylene glycol; and
50% (v/v) water.
13. A process for preparing a pharmaceutical formulation comprising a therapeutically effective amount of paracalcitol comprising the steps of:
a) preparing a mixture of water and propylene glycol;
b) preparing a mixture of paracalcitol and ethanol;
c) combining the mixtures from steps (a) and (b) to prepare a uniform mixture; and
d) filtering said uniform mixture.
14. A unit dose of a sterile, self-preserved pharmaceutical formulation for parenteral administration consisting essentially of:
2-10 micrograms/milliliter of paracalcitol;
20% (v/v) ethanol;
30% (v/v) propylene glyco; and
50% (v/v) water.
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