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US 6,761,903 B2Granted
Clear oil-containing pharmaceutical compositions containing a therapeutic agent
AssigneeLipocine Inc.
InventorsFeng-Jing Chen, Mahesh V. Patel, David T. Fikstad
Life of this patent
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Abstract
The present invention relates to pharmaceutical compositions and methods for improved solubilization of triglycerides and improved delivery of therapeutic agents. Compositions of the present invention include a carrier, where the carrier is formed from a combination of a triglyceride and at least two surfactants, at least one of which is hydrophilic. Upon dilution with an aqueous medium, the carrier forms a clear, aqueous dispersion of the triglyceride and surfactants.
Claims122
A pharmaceutical composition comprising:
- (a) a carrier comprising a triglyceride and at least two surfactants, at least one of the surfactants being hydrophilic;
- and
- (b) a therapeutically effective amount of a polysaccharide drug, wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm.
A pharmaceutical composition comprising:
- (a) a carrier comprising a triglyceride and at least two surfactants, at least one of the surfactants being hydrophilic;
- and
- (b) a therapeutically effective amount of a polysaccharide drug, wherein the triglyceride and the surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms an aqueous dispersion having an average particle size less than about 200 nm.
A pharmaceutical composition comprising:
- (a) a carrier comprising a triglyceride, at least one hydrophilic surfactant, and at least one hydrophobic surfactant;
- and
- (b) a therapeutically effective amount of a polysaccharide drug, wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm.
A pharmaceutical composition comprising:
- (a) a therapeutically effective amount of a polysaccharide drug;
- and
- (b) a carrier comprising a triglyceride and at least two surfactants, at least one of the surfactants being hydrophilic, wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, and wherein the triglyceride is present in an amount greater than the amount of the triglyceride that remains solubilized in an aqueous dispersion of the triglyceride and a carrier having only one surfactant, the surfactant being hydrophilic, and having the same total surfactant concentration.
A pharmaceutical composition comprising:
- (a) a therapeutically effective amount of a polysaccharide drug;
- and
- (b) a carrier comprising a triglyceride, at least one hydrophilic surfactant, and at least one hydrophobic surfactant, wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm, and wherein the triglyceride is present in an amount greater than the amount of the triglyceride that remains solubilized in an aqueous dispersion of the triglyceride and one surfactant, the surfactant being hydrophilic, and having the same total surfactant concentration.
A method of treating a mammalian patient with a polysaccharide drug, the method comprising:
- (a) providing an initial dosage form of a pharmaceutical composition having a carrier comprising a triglyceride and at least two surfactants, at least one of the surfactants being hydrophilic wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm.
- (b) providing a polysaccharide drug;
- and
- (c) administering said dosage form to said animal.
1 more element
A method of treating a mammalian patient with a polysaccharide drug, the method comprising:
- (a) providing a dosage form of a pharmaceutical composition having a carrier comprising a triglyceride and at least two surfactants, at least one of the surfactants being hydrophilic, wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to carrier ratio of about 100:1 by weight, the carrier forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm;
- and
- (b) administering the dosage form to the mammalian patient.
A method for increasing the loading capacity of a pharmaceutical composition comprising the steps of:
- providing a pharmaceutical composition comprised of
- (a) a carrier comprising a triglyceride and a first surfactant, and
- (b) a therapeutically effective amount of a polysaccharide drug;
- and
- adding an absorption-enhancing amount of a second surfactant to the pharmaceutical composition, the second surfactant comprising a hydrophobic surfactant, wherein said aborption-enhancing amount is effective to increase the loading capacity of the pharmaceutical composition, wherein the triglyceride and the combined surfactants are present in amounts such that upon mixing with an aqueous medium in an aqueous medium to triglyceride and surfactants ratio of about 100:1 by weight, the triglyceride and surfactants form a clear aqueous dispersion.
2 more elements
Dependencies are inferred from the claim text.