METHOCARBAMOL COMPOSITIONS AND RELATED METHODS
Stable methocarbamol ready to use compositions for parenteral administration including parenteral infusion are provided. In certain embodiments, said compositions are sterile, isotonic, and particulate-matter-free. Further, said 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 method for minimizing an adverse health effect associated with methocarbamol administration to a subject comprising administering a therapeutically effective amount of a methocarbamol solution to the subject, the methocarbamol solution 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, ethanol, glycerin, sorbitol, propylene glycol, and combinations thereof;
a buffer; and
water,
wherein the methocarbamol solution 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, and
wherein the adverse health effect includes latex sensitivity, extravasation, a pathological renal event, or a combination thereof.
2 . The method of claim 1 , wherein the solution is sufficiently stable to allow at least 95 w/v % of the methocarbamol in the composition to remain undegraded and unprecipitated after storage for at least 3 months at 25° C. and 60% relative humidity.
3 . The method of claim 1 , wherein the solution is sufficiently stable to allow at least 95 w/v % of the methocarbamol in the composition to remain undegraded and unprecipitated after storage for at least 6 months at 25° C. and 60% relative humidity.
4 . The method of claim 1 , wherein the solution is sufficiently stable to allow at least 95 w/v % of the methocarbamol in the composition to remain undegraded and unprecipitated after storage for at least 1 year at 25° C. and 60% relative humidity.
5 . The method of claim 1 , wherein the solution is particulate-matter free.
6 . The method of claim 1 , wherein methocarbamol is present in an amount from about 1 mg/ml to about 7 mg/ml.
7 . The method of claim 1 , wherein methocarbamol is present in an amount from about 3 mg/ml to about 7 mg/ml.
8 . The method of claim 1 , wherein the solution has an osmotic pressure of about 250-350 mOsmol/Kg.
9 . The method of claim 1 , wherein the solution has a pH of from about 3.5 to about 4.5.
10 . The method of claim 1 , wherein the administering comprises intravenously administering the solution at a rate of infusion ranging from about 5 mg/minute to about 100 mg/minute.
11 . The method of claim 10 , wherein the solution is administered from a pharmaceutically acceptable sterile container that has a volume from about 50 mL to about 1000 mL.
12 . The method of claim 1 , wherein the therapeutically effective amount provides from about 1 g to about 6 g methocarbamol per day.
13 . The method of claim 1 , wherein the therapeutically effective amount provides from about 3 g to about 5 g methocarbamol per day.
14 . The method of claim 1 , wherein the therapeutically effective amount is sufficient to induce muscle relaxation.
15 . The method of claim 1 , wherein the adverse health effect is latex sensitivity.
16 . The method of claim 1 , wherein the adverse health effect is extravasation.
17 . The method of claim 1 , wherein the adverse health effect is a pathological renal event.