In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions
First Claim
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1. An in vitro method for evaluating a solid dosage form, comprising:
- (a) dispersing a dosage form in a biorelevant medium, wherein the dosage form comprises at least one poorly water-soluble active agent, and wherein prior to incorporation into the solid dosage form, the active agent has an effective average particle size of greater than 2 microns;
(b) measuring the particle size of the dispersed poorly water-soluble active agent; and
(c) determining if the level of dispersibility is sufficient for in vivo effectiveness of the dosage form, wherein the level of dispersibility is sufficient for in vivo effectiveness of the dosage form if the dosage form disperses such that the particle size of the dispersed active agent particles resembles the particle size of the active agent prior to incorporation into the solid dosage form.
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Abstract
Disclosed are in vitro methods for evaluating the in vivo redispersibility of dosage forms of poorly water-soluble active agents. The methods utilize media representative of in vivo human physiological conditions.
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Citations
18 Claims
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1. An in vitro method for evaluating a solid dosage form, comprising:
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(a) dispersing a dosage form in a biorelevant medium, wherein the dosage form comprises at least one poorly water-soluble active agent, and wherein prior to incorporation into the solid dosage form, the active agent has an effective average particle size of greater than 2 microns; (b) measuring the particle size of the dispersed poorly water-soluble active agent; and (c) determining if the level of dispersibility is sufficient for in vivo effectiveness of the dosage form, wherein the level of dispersibility is sufficient for in vivo effectiveness of the dosage form if the dosage form disperses such that the particle size of the dispersed active agent particles resembles the particle size of the active agent prior to incorporation into the solid dosage form. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. An in vitro method for evaluating a solid dosage form, comprising:
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(a) dispersing a dosage form in a biorelevant medium, wherein the dosage form comprises at least one poorly water-soluble active agent, and wherein prior to incorporation into the solid dosage form, the active agent has an effective average particle size of about 2 microns; (b) measuring the particle size of the dispersed poorly water-soluble active agent; and (c) determining if the level of dispersibility is sufficient for in vivo effectiveness of the dosage form, wherein the level of dispersibility is sufficient for in vivo effectiveness of the dosage form if the dosage form disperses such that the particle size of the dispersed active agent particles resembles the particle size of the active agent prior to incorporation into the solid dosage form. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18)
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Specification