Clear oil-containing pharmaceutical compositions
AssigneeLipocine Inc.
InventorsFeng-Jing Chen, Mahesh V. Patel
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 triglyceride and a carrier, where the carrier is formed from a combination of at least two surfactants, at least one of which is hydrophilic. Upon dilution with an aqueous solvent, the composition forms a clear, aqueous dispersion of the triglyceride and surfactants. An optional therapeutic agent can be incorporated into the composition, or can be co-administered with the composition. The invention also provides methods of enhancing triglyceride solubility and methods of treatment with therapeutic agents using these compositions.
Claims184
A pharmaceutical composition comprising:
- (a) a triglyceride;
- (b) a carrier comprising at least two surfactants, at least one of the surfactants being hydrophilic;
- and
- (c) a therapeutic agent which is capable of being solubilized in the triglyceride, the carrier, or both the triglyceride and the carrier,
- wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous solution in an aqueous solution to composition ratio of about 100:1 by weight, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm.
A pharmaceutical composition comprising:
- (a) a triglyceride;
- (b) a carrier comprising at least one hydrophilic surfactant and at least one hydrophobic surfactant;
- and
- (c) a therapeutic agent which is capable of being solubilized in the triglyceride, the carrier, or both the triglyceride and the carrier, wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous solution in an aqueous solution to composition ratio of about 100:1 by weight the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm.
A pharmaceutical composition comprising:
- (a) a triglyceride;
- (b) a carrier comprising 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 solution in an aqueous solution to composition ratio of about 100:1 by weight, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm;
- (c) a first amount of a therapeutic agent, said first amount being solubilized in the triglyceride, the carrier, or both the triglyceride and the carrier;
- and
- (d) a second amount of a therapeutic agent, said second amount not solubilized in the triglyceride or the carrier.
A pharmaceutical composition comprising:
- (a) a triglyceride;
- and
- (b) a carrier comprising 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 solution in an aqueous solution to composition ratio of about 100:1 by weight, the composition 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 method of treating an animal with a therapeutic agent, the method comprising:
- (a) providing a dosage form of a pharmaceutical composition comprising:
- (i) a triglyceride;
- and
- (ii) a carrier comprising 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 solution in an aqueous solution to composition ratio of about 100:1 by weight, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm;
- (b) providing a therapeutic agent;
- and
- (c) administering said dosage form to said animal.
A method of increasing the amount of a triglyceride that can be solubilized in a clear aqueous dispersion, the method comprising:
- (a) providing a composition comprising a triglyceride and a carrier, the carrier comprising at least two surfactants, at least one of the surfactants being hydrophilic;
- and
- (b) dispersing the composition in an aqueous solution,
- wherein the triglyceride and surfactants are present in amounts such that upon mixing with an aqueous solution in an aqueous solution to composition ratio of about 100:1 by weight, the composition 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 and having the same total surfactant concentration.
A method of treating an animal with a therapeutic agent, the method comprising:
- (a) providing a dosage form of a pharmaceutical composition comprising:
- (i) an effective amount of a triglyceride;
- and
- (ii) a carrier comprising 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 solution in an aqueous solution to composition ratio of about 100:1 by weight, the composition forms a clear aqueous dispersion having an absorbance of less than about 0.3 at 400 nm;
- and
- (b) administering said dosage form to said animal.
The dosage form of clairm 65, comprising a capsule.
Dependencies are inferred from the claim text.