Pharmaceutical formulations
AssigneeAbbott Laboratories
InventorsYi Gao, Tzuchi R. Ju, Dennis Y. Lee, Nicole Nguyen, Huailiang Wu
Life of this patent
Estimating the term…
Abstract
The present invention provides a modified release formulation comprising an active agent in a hydrophilic polymer matrix wherein the active agent is a salt of fenofibric acid wherein the release rate of the formulation in an in vitro dissolution is substantially independent of the ionic strength of the dissolution media.
Claims19
1-13. (canceled)
A method of treating hyperlipidemia, hypercholesterolemia, or hypertriglyceridemia comprising the step of orally administering a pharmaceutical composition to a human subject in need thereof, wherein the pharmaceutical composition comprises:
- (a) a salt of fenofibric acid, wherein the process for selecting said salt of fenofibric acid comprises the steps of:
- (i) creating a modified-release oral dosage form comprising:
- (1) a salt of fenofibric acid;
- (2) a hydrophilic polymer;
- and
- (3) optionally, one or more pharmaceutically acceptable excipients;
- and
- (ii) choosing a dosage form of step (i) having at least one of the following properties:
- (1) the release rate of fenofibric acid from the dosage form is substantially independent of the ionic strength of the dissolution media;
- (2) the difference between the amount of fenofibric acid salt dissolved at 0.5, 1, 2, 4, 6, or 8 hours in (A) 900 mL of 0.05 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C. and (B) 900 mL of 0.3 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C., is not greater than about 25%;
- or
- (3) the difference between disintegration times in (A) 900 mL of 0.05 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C. and (B) 900 mL of 0.3 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C., is less than about 475 minutes;
- and
- (b) a hydrophilic polymer.
A method of treating hyperlipidemia, hypercholesterolemia, or hypertriglyceridemia comprising the steps of:
- (a) creating a modified-release pharmaceutical dosage form suitable for oral administration to a human subject comprising:
- (i) a salt of fenofibric acid;
- (ii) a hydrophilic polymer;
- and
- (iii) optionally, other pharmaceutically acceptable excipients;
- and wherein the pharmaceutical dosage form has at least one of the following properties:
- (1) the release rate of fenofibric acid from the dosage form is substantially independent of the ionic strength of the dissolution media;
- (2) the difference between the amount of fenofibric acid salt dissolved at 0.5, 1, 2, 4, 6, or 8 hours in (A) 900 mL of 0.05 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C. and (B) 900 mL of 0.3 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C., is not greater than about 25%;
- or
- (3) the difference between disintegration times in (A) 900 mL of 0.05 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C. and (B) 900 mL of 0.3 M potassium phosphate buffer at a pH of 6.0 and a temperature of 37° C., is less than about 475 minutes;
- and (b) orally administering the pharmaceutical dosage form to a human subject in need thereof.
Dependencies are inferred from the claim text.