METHOD FOR DETERMINING EFFECT OF PREFORMULATION FORMS ON THEIR DISSOLUTION RATES
First Claim
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1. A method of determining how the solubility of a solid compound-of-interest is affected by its form which comprises:
- (a) preparing an array of samples, each comprising a controlled amount of the compound-of-interest, wherein the form of the compound-of-interest in at least two of the samples is different;
(b) forming a liquid portion of each sample by adding a solvent to each sample; and
(c) determining how much compound-of-interest dissolved in the liquid portion of each sample.
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Abstract
Preformulation analysis and optimization comprising dissolution strudies.
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Citations
7 Claims
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1. A method of determining how the solubility of a solid compound-of-interest is affected by its form which comprises:
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(a) preparing an array of samples, each comprising a controlled amount of the compound-of-interest, wherein the form of the compound-of-interest in at least two of the samples is different;
(b) forming a liquid portion of each sample by adding a solvent to each sample; and
(c) determining how much compound-of-interest dissolved in the liquid portion of each sample. - View Dependent Claims (2)
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3. A method of determining how the dissolution of a solid compound-of-interest is affected by its form, which comprises:
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(a) preparing an array of samples, each comprising a controlled amount of the compound-of-interest, wherein the form of the compound-of-interest in at least two of the samples is different;
(b) forming a liquid portion of each sample by adding a solvent to each sample; and
(c) determining how much compound-of-interest dissolved in the liquid portion of each sample as a function of time. - View Dependent Claims (4)
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5. A method of determining how the stability of a solid compound-of-interest is affected by its form, which comprises:
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(a) preparing an array of samples, each comprising a controlled amount of the compound-of-interest, wherein the form of the compound-of-interest in at least two of the samples is different;
(b) exposing the compound-of-interest in each sample to a condition that may affect the stability of the compound-of-interest; and
(c) determining whether the form or chemical composition of the compound-of-interest in each sample changed. - View Dependent Claims (6)
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7-23. -23. (canceled)
Specification