Methocarbamol compositions and related methods
Stable methocarbamol ready to use compositions for parenteral administration including parenteral infusion are provided. In certain embodiments, the compositions are sterile, isotonic, and particulate-matter-free. Further, the compositions reduce or avoid allergic reactions to latex, reduce or avoid extravasation, and permit administration of methocarbamol to subjects having renal pathology. Methods of manufacture and methods of administration are also provided.
1. A system for administration of an injectable methocarbamol composition comprising:
a methocarbamol composition suitable for intravenous administration comprising:
methocarbamol in an amount from about 1 mg/ml to less than 10 mg/ml,
a tonicity agent; wherein the tonicity agent is selected from the group consisting of sodium chloride, mannitol, sorbitol, dextrose, organic solvents, and combinations thereof,
a buffer, and
water; and
a pharmaceutically acceptable sterile container holding a volume of the methocarbamol composition; and
wherein the methocarbamol composition is isotonic, has a pH of about 3 to about 5, is free of polyethylene glycol (PEG), and contains no more than 2.0% w/w of guaifenesin after storage at ambient temperature for at least 3 months.
2. The system of claim 1 , wherein the pharmaceutically acceptable sterile container comprises polyethylene, polypropylene, or combinations thereof.
3. The system of claim 1 , wherein the pharmaceutically acceptable sterile container is free of dry natural rubber.
4. The system of claim 1 , wherein the pharmaceutically acceptable sterile container holds a volume of the composition from about 50 ml to about 1000 ml.
5. The system of claim 1 , wherein the pharmaceutically acceptable sterile container comprises a single injectable dose of the methocarbamol composition.
6. The system of claim 1 , wherein the pharmaceutically acceptable sterile container comprises a plurality of injectable doses of the methocarbamol composition.
7. The system of claim 1 , wherein the methocarbamol composition is suitable for administration without further dilution.
8. The system of claim 1 , wherein the methocarbamol composition has a viscosity of less than 50 centipoise.
9. The system of claim 1 , wherein the methocarbamol composition is sufficiently stable to allow at least 95 w/v % of the methocarbamol in the methocarbamol composition to remain undegraded and unprecipitated after storage for at least 3 months at 25° C. and 60% relative humidity.
10. The system of claim 1 , wherein the methocarbamol composition is sufficiently stable to allow at least 95 w/v % of the methocarbamol in the methocarbamol composition to remain undegraded and unprecipitated after storage for at least 6 months at 25° C. and 60% relative humidity.
11. The system of claim 1 , wherein the methocarbamol composition is sufficiently stable to allow at least 95 w/v % of the methocarbamol in the methocarbamol composition to remain undegraded and unprecipitated after storage for at least 1 year at 25° C. and 60% relative humidity.
12. The system of claim 1 , wherein the methocarbamol composition has a pH of from about 3.5 to about 4.5.
13. The system of claim 1 , wherein the methocarbamol composition has an osmotic pressure of about 250-350 mOsmol/Kg.
14. The system of claim 1 , wherein the methocarbamol composition is particulate-matter-free.
15. The system of claim 1 , wherein the methocarbamol is present in the methocarbamol composition in an amount from about 1 mg/ml to about 7 mg/ml.
16. The system of claim 1 , wherein methocarbamol is present in the methocarbamol composition in an amount from about 3 mg/ml to about 7 mg/ml.
17. The system of claim 1 , wherein the volume of the methocarbamol composition is from about 50 ml to about 1000 ml.
18. The system of claim 1 , wherein the methocarbamol composition has about 1.0% w/w or less of 1-hydroxy-3-(2-methoxyphenoxy)propan-2-yl carbamate after storage for at least 3 months at 25° C. and 60% relative humidity.
19. The system of claim 1 , wherein the methocarbamol composition has about 1.0% w/w or less of 1-hydroxy-3-(2-methoxyphenoxy)propan-2-yl carbamate after storage for at least 12 months at 25° C. and 60% relative humidity.
20. The system of claim 1 , wherein the methocarbamol composition has about 1.0% w/w or less of 1-hydroxy-3-(2-methoxyphenoxy)propan-2-yl carbamate after storage for at least 24 months at 25° C. and 60% relative humidity.