| CPC A61K 9/0053 (2013.01) [A61K 9/08 (2013.01); A61K 31/423 (2013.01); A61K 47/02 (2013.01); A61K 47/26 (2013.01); A61K 47/32 (2013.01)] | 16 Claims |
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1. A liquid pharmaceutical formulation, suitable for oral administration, comprising:
an amount of tafamidis of from 0.5 mg/ml to 20 mg/ml;
water;
an amount of an alkaline pH modifier sufficient to yield a concentration of the tafamidis that is dissolved in the water of from 0.5 mg/ml to 19.8 mg/ml; and
each of:
(i) from 5 mg/ml to 50 mg/ml of a polyvinylpyrrolidone (PVP) of, wherein the PVP has a K value of from 10 to 120;
(ii) from 50 mg/ml to 500 mg/ml of a polysorbate 20, a polysorbate 40, a polysorbate 60, a polysorbate 80, or a combination thereof of; and
(iii) an amount of an acidic pH adjuster sufficient to yield, in combination with the alkaline pH modifier, a pH of the formulation of from 6 to 11
wherein the formulation has a pH of from 6 to 11; and
wherein the alkaline pH modifier is sodium carbonate, potassium carbonate, calcium carbonate, magnesium carbonate, ammonium carbonate, sodium bicarbonate, potassium bicarbonate, calcium bicarbonate, magnesium bicarbonate, ammonium bicarbonate, sodium citrate, potassium citrate, calcium citrate, sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide, ammonium hydroxide, sodium phosphate, potassium phosphate, calcium phosphate, magnesium phosphate, sodium oxide, potassium oxide, calcium oxide, magnesium oxide, ammonium phosphate, ammonia, tromethamine, or a combination of at least any two thereof.
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