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Claims for Patent: 8,715,724

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Claims for Patent: 8,715,724

Title:Tabletting process
Abstract: A process for producing a compressed solid dosage form containing an active ingredient. The process includes a step of preparing core elements containing the active ingredient. Optionally the core elements are coated with a pharmaceutically acceptable coating layer to form coated pellets. The core elements or pellets are treated with an anti-static agent and compressed with suitable excipients to form the compressed solid dosage form. Preferred anti static agents are starch, microcrystalline cellulose, kaolin, bentonite, silicates, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate and glyceryl behenate.
Inventor(s): Lukas; Stefan (Manningham, AU)
Assignee: Mayne Pharma International Pty Ltd (Melbourne, Victoria, AU)
Application Number:11/666,354
Patent Claims: 1. A process for producing a tablet containing an active ingredient, the process comprising: providing core elements containing the active ingredient; coating the core elements with a pharmaceutically acceptable coating layer; drying the coated core elements; dusting the dried coated core elements with a powdered anti-static agent selected from the group consisting of kaolin, magnesium trisilicate, starch, microcrystalline cellulose, bentonite, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate, and glycerol behenate, the group not including talc, to form dusted pellets; and then compressing the dusted pellets with tabletting excipients to form the tablet, wherein amount of the anti-static agent is about 0.5% (by weight) of the dusted pellets, and amount of the dusted pellets in each tablet is in the range of 20 to 50% by weight of the total tablet weight.

2. The process according to claim 1, wherein the step of dusting the dried coated core elements with an anti-static agent to reduces accumulated static charge, or prevents or reduces the accumulation of static charge.

3. The process according to claim 1, wherein the drying step is carried out in a fluid bed dryer.

4. The process according to claim 1, wherein the anti-static agent is selected from the group including starch, microcrystalline cellulose, magnesium trisilicate and kaolin.

5. The process according to claim 1, wherein the anti-static agent is starch.

6. The process according to claim 1, wherein the compression force at which the tablet is formed is less than 40 kiloNewtons.

7. The process according to claim 1, wherein the strength of the tablet is about 5 to about 15 kiloponds.

8. The process according to claim 1, wherein the active ingredient is a pharmaceutically active ingredient.

9. The process according to claim 8, wherein the pharmaceutically active ingredient is selected from the group consisting of doxycycline, tetracycline, oxytetracycline, minocycline, chlortetracycline, demeclocycline, and pharmaceutically acceptable salts thereof.

10. The process according to claim 1, wherein the active ingredient is present in the core element in an amount from 5 to 95% by weight, based on the total weight of the core element.

11. The process according to claim 1, wherein the percentage of coated pellets in each tablet is in the range of 25 to 35% by weight of the total tablet weight.

12. The process according to claim 1, wherein the percentage of coated pellets in each tablet is about 30% by weight of the total tablet weight.

13. The process according to claim 1, wherein the tabletting excipients are present in an amount of 50 to 80% by weight of the total tablet weight.

14. A tablet that is formed according to the process of claim 1.

15. The tablet according to claim 14, wherein the anti-static agent is selected from the group including starch, microcrystalline cellulose, magnesium trisilicate and kaolin.

16. The tablet according to claim 14, wherein the anti-static agent is starch.

17. The tablet according to claim 14, wherein the strength of the tablet is about 5 to about 15 kiloponds.

18. The tablet according to claim 14, wherein the active ingredient is a pharmaceutically active ingredient.

19. The tablet according to claim 18, wherein the pharmaceutically active ingredient is selected from the group consisting of doxycycline, tetracycline, oxytetracycline, minocycline, chlortetracycline, demeclocycline, and pharmaceutically acceptable salts thereof.

20. The tablet according to claim 14, wherein the active ingredient is present in the core element in an amount from 5 to 95% by weight, based on the total weight of the core element.

21. The tablet according to claim 14, wherein the percentage of coated pellets in each tablet is in the range of 25 to 35% by weight of the total tablet weight.

22. The tablet according to claim 14, wherein the percentage of coated pellets in each tablet is about 30% by weight of the total tablet weight.

23. The tablet according to claim 14, wherein the tabletting excipients are present in an amount of 50 to 80% by weight of the total tablet weight.
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