Nano-structured compositions and methods of making and using the same
First Claim
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1. A method for preparing a pharmaceutical dosage form comprising:
- (a) forming an emulsion base by suspending an active pharmaceutical ingredient (API) in a mixture of oil, solvent, stabilizer, and water or buffer to form an emulsion base, wherein;
(i) the active pharmaceutical ingredient is poorly soluble in the oil, solvent, and water, or (ii) the active pharmaceutical ingredient is soluble in either or both of oil and solvent, but is not soluble, or is poorly soluble, in water, (b) homogenizing the emulsion base to form particles of the active pharmaceutical ingredient, droplets comprising solubilized API, or a combination thereof.
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Abstract
The present invention provides a new tri-phasic method for making nanoparticles of poorly soluble active pharmaceutical ingredients.
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20 Claims
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1. A method for preparing a pharmaceutical dosage form comprising:
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(a) forming an emulsion base by suspending an active pharmaceutical ingredient (API) in a mixture of oil, solvent, stabilizer, and water or buffer to form an emulsion base, wherein;
(i) the active pharmaceutical ingredient is poorly soluble in the oil, solvent, and water, or (ii) the active pharmaceutical ingredient is soluble in either or both of oil and solvent, but is not soluble, or is poorly soluble, in water, (b) homogenizing the emulsion base to form particles of the active pharmaceutical ingredient, droplets comprising solubilized API, or a combination thereof. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method for preparing fenofibrate particles comprising
(a) dissolving fenofibrate in N-methyl-pyrrolidinone to form a solution, (b) adding medium chain triglyceride to the fenofibrate solution, (c) adding Pluronic dissolved in water to the solution, and (d) subjecting the solution to high-pressure homogenization to produce fenofibrate particles.
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12. A method of preparing a transdermal dosage form comprising:
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(a) dissolving an active pharmaceutical ingredient (API) in a mixture of (i) at least one oil, (ii) at least one solvent, and (iii) at least one stabilizer to form an emulsion pre-mix, (b) adding water or buffer to the emulsion pre-mix, and (c) homogenizing or vigorously stirring the mixture, whereby the API is precipitated into particles. - View Dependent Claims (13)
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14. A pharmaceutical dosage form comprising:
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(a) at least one active pharmaceutical ingredient, wherein the active pharmaceutical ingredient is in a solid particulate state and in a soluble state, (b) at least one solvent, (c) at least one oil, (d) at least one surfactant, and (e) water. - View Dependent Claims (15, 16, 17, 18, 19, 20)
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Specification