Drug formulations
The invention provides derivatives of decitabine with superior chemical stability and shelf life, with similar physiological activity. The derivatives are provided in a non-aqueous formulation, which further stabilizes the derivatives. Methods of treating one or more myelodysplastic syndromes, leukemia, or solid tumours using the formulations are described.
1. A composition comprising, in a solution:
a) about 45% to about 85% propylene glycol (w/w);
b) about 5% to about 45% glycerin (w/w); and
c) about 1% to about 30% ethanol (w/w),
wherein the solution is substantially anhydrous.
2. The composition of claim 1 , wherein the composition comprises about 60% to about 70% propylene glycol (w/w).
3. The composition of claim 1 , wherein the composition comprises about 20% to about 30% glycerin (w/w).
4. The composition of claim 1 , wherein the composition comprises about 5% to about 15% ethanol (w/w).
5. The composition of claim 1 , wherein the composition comprises about 65% propylene glycol (w/w).
6. The composition of claim 1 , wherein the composition comprises about 25% glycerin (w/w).
7. The composition of claim 1 , wherein the composition comprises about 10% ethanol (w/w).
8. The composition of claim 1 , wherein the composition is about 65% propylene glycol; about 25% glycerin; and about 10% ethanol (w/w/w).
9. The composition of claim 1 , wherein the composition is 65% propylene glycol; 25% glycerin; and 10% ethanol (w/w/w).
10. The composition of claim 1 , wherein the composition is formulated as part of a pharmaceutical formulation, wherein the pharmaceutical formulation comprises a dinucleotide compound or a pharmaceutically acceptable salt thereof.
11. The composition of claim 10 , wherein the dinucleotide compound or pharmaceutically acceptable salt thereof is present in the pharmaceutical formulation at a concentration of about 80 mg/mL to about 110 mg/mL.
12. The composition of claim 10 , wherein the pharmaceutical formulation further comprises DMSO.