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Details for Patent: 9,006,267

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Details for Patent: 9,006,267

Title:Pharmaceutical compositions and dosage forms of thalidomide
Abstract: Pharmaceutical compositions and single unit dosage forms of thalidomide and pharmaceutically acceptable stereoisomers, prodrugs, salts, solvates, hydrates, or clathrates are disclosed. Also disclosed are methods of treating, managing, and preventing diseases and conditions such as, but not limited to, leprosy, chronic graft-vs-host disease, rheumatoid arthritis, sarcoidosis, an inflammatory condition, inflammatory bowel disease, and cancer using the novel dosage forms disclosed herein.
Inventor(s): D'Angio; Paul (Basking Ridge, NJ), McCarty; John (Miami Springs, FL)
Assignee: Celgene Corporation (Summit, NJ)
Filing Date:Mar 21, 2006
Application Number:11/384,381
Claims:1. A pharmaceutical composition consisting of a uniform admixture of 50 mg thalidomide, pregelatinized corn starch, and 1 mg of magnesium stearate, wherein said composition is suitable for administration to a human in a size 4 capsule and said composition is at least bioequivalent to a thalidomide dosage form which consists of 12.5 percent by weight thalidomide, 15.0 percent by weight microcrystalline cellulose, 3.0 percent by weight povidone having a K-value ranging from 81.0 to 96.3, 1.0 percent by weight stearic acid, 0.2 percent by weight colloidal silicon dioxide, 4.0 percent by weight crospovidone, and 64.3 percent by weight anhydrous lactose.

2. A pharmaceutical composition consisting of a uniform admixture of 100 mg thalidomide, pregelatinized corn starch, and 1.25 mg of magnesium stearate, wherein said composition is suitable for administration to a human in a size 2 capsule and said composition is at least bioequivalent to a thalidomide dosage form which consists of 12.5 percent by weight thalidomide, 15.0 percent by weight microcrystalline cellulose, 3.0 percent by weight povidone having a K-value ranging from 81.0 to 96.3, 1.0 percent by weight stearic acid, 0.2 percent by weight colloidal silicon dioxide, 4.0 percent by weight crospovidone, and 64.3 percent by weight anhydrous lactose.

3. A pharmaceutical composition consisting of a uniform admixture of 150 mg thalidomide, pregelatinized corn starch, and 2 mg of magnesium stearate, wherein said composition is suitable for administration to a human in a size 1 capsule and said composition is at least bioequivalent to a thalidomide dosage form which consists of 12.5 percent by weight thalidomide, 15.0 percent by weight microcrystalline cellulose, 3.0 percent by weight povidone having a K-value ranging from 81.0 to 96.3, 1.0 percent by weight stearic acid, 0.2 percent by weight colloidal silicon dioxide, 4.0 percent by weight crospovidone, and 64.3 percent by weight anhydrous lactose.

4. A pharmaceutical composition consisting of a uniform admixture of 200 mg thalidomide, pregelatinized corn starch, and 2.5 mg of magnesium stearate, wherein said composition is suitable for administration to a human in a size 0 capsule and said composition is at least bioequivalent to a thalidomide dosage form which consists of 12.5 percent by weight thalidomide, 15.0 percent by weight microcrystalline cellulose, 3.0 percent by weight povidone having a K-value ranging from 81.0 to 96.3, 1.0 percent by weight stearic acid, 0.2 percent by weight colloidal silicon dioxide, 4.0 percent by weight crospovidone, and 64.3 percent by weight anhydrous lactose.

5. An oral dosage form in the form of a capsule comprising thalidomide and one or more pharmaceutically acceptable excipients, which oral dosage form is at least bioequivalent to a thalidomide dosage form consisting of 12.5 percent by weight thalidomide, 15.0 percent by weight microcrystalline cellulose, 3.0 percent by weight povidone having a K-value ranging from 81.0 to 96.3, 1.0 percent by weight stearic acid, 0.2 percent by weight colloidal silicon dioxide, 4.0 percent by weight crospovidone, and 64.3 percent by weight anhydrous lactose; wherein the amount of thalidomide is about 40 percent by total weight of the content of the dosage form, and wherein the amount of thalidomide is 50, 100, 150 or 200 mg, and wherein the excipient comprises magnesium stearate in an amount of about 1 percent by total weight of the content in the oral dosage form.

6. The oral dosage form of claim 5, wherein the total weight of the content within the dosage form is about 125 mg and which dosage form is a size 4 capsule.

7. The oral dosage form of claim 5, wherein the total weight of the content within the dosage form is about 250 mg and which dosage form is a size 2 capsule.

8. The oral dosage form of claim 5, wherein the total weight of the content within the dosage form is about 375 mg and which dosage form is a size 1 capsule.

9. The oral dosage form of claim 5, wherein the total weight of the content within the dosage form is about 500 mg and which dosage form is a size 0 capsule.

10. The oral dosage form of claim 5, wherein the excipient comprises pregelatinized starch.

11. The oral dosage form of claim 10, wherein the pregelatinized starch is present at an amount of about 60 percent by total weight of the content in the oral dosage form.

12. The oral dosage form of claim 5, wherein the excipients consists essentially of pregelatinized starch.
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