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Claims for Patent: 6,113,920

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Claims for Patent: 6,113,920

Title: Pharmaceutical compositions
Abstract:A pharmaceutical composition and a method of inhibiting human immunodeficiency virus (HIV) is disclosed which comprises administering to an HIV infected patient a homogenous combination of lamivudine, zidovudine and a pharmaceutical glidant in an amount which achieves antiviral efficacy.
Inventor(s): Maye; Katherine Jeannette (Durham, NC), Goodson; Gary Wayne (Raleigh, NC), Wood; Allen Wayne (Cary, NC)
Assignee: Glaxo Wellcome Inc. (Research Triangle Park, NC)
Application Number:08/955,635
Patent Claims: 1. A pharmaceutical composition comprising a first active pharmaceutical ingredient and a second active pharmaceutical ingredient, and a pharmaceutically acceptable glidant ingredient, wherein:

(i) a first active pharmaceutical ingredient is lamivudine or a pharmaceutically acceptable derivative thereof,

(ii) a second active pharmaceutical ingredient is zidovudine or a pharmaceutically acceptable derivative thereof, and

(iii) silicon dioxide is present as a glidant ingredient in an amount from about 0.05% to about 10% by weight based on the total weight of all ingredients.

2. The composition according to claim 1, further comprising another glidant ingredient selected from the group consisting of: powdered cellulose, microcrystalline cellulose, metallic stearates, sodium aluminosilicate, sodium benzoate, calcium carbonate, and combinations thereof.

3. The composition according to claim 2, wherein the metallic stearates are selected from the group consisting of: calcium stearate, magnesium stearate, zinc stearate, and combinations thereof.

4. The composition according to claim 2, further comprising another glidant ingredient selected from the group consisting of: calcium silicate, corn starch, magnesium carbonate, asbestos free talc, stearowet C, starch, starch 1500, magnesium lauryl sulfate, magnesium oxide, and combinations thereof.

5. A composition according to claim 1, in the form of a tablet.

6. The composition according to claim 5, wherein the lamivudine or a pharmaceutically acceptable derivative thereof is present in an amount from about 15 to about 1500 mg per tablet and the zidovudine or a pharmaceutically acceptable derivative thereof is present in an amount from about 30 to about 1000 mg per tablet.

7. The composition according to claim 6, wherein the amount of lamivudine or pharmaceutically acceptable derivative thereof is from about 100 to about 500 mg per tablet.

8. The composition according to claim 7, wherein the amount of lamivudine or pharmaceutically acceptable derivative thereof is 150 mg per tablet.

9. The composition according to claim 5, wherein the amount of zidovudine or pharmaceutically acceptable derivative thereof is from about 200 to about 500 mg per tablet.

10. The composition according to claim 9, wherein the amount of zidovudine or pharmaceutically acceptable derivative thereof is 300 mg per tablet.

11. The composition according to claim 5, wherein the lamivudine or pharmaceutically acceptable derivative thereof is substantially free of the (+)enantiomer of lamivudine or derivative thereof.

12. The composition according to claim 5, wherein the (+)enantiomer of lamivudine or pharmaceutically acceptable derivative thereof is not more than about 5% w/w of the total amount of lamivudine or derivative thereof.

13. The composition according to claim 12, wherein the (+)enantiomer of lamivudine pharmaceutically acceptable derivative thereof is not more than about 1% w/w of the total amount of lamivudine or derivative thereof.

14. The composition according to claim 5, wherein the tablet is coated with a pharmaceutically acceptable coating.

15. A method for treating, reversing, reducing or inhibiting retroviral infections by administering one or more tablets according to claim 5.

16. The method for treating, reversing, reducing or inhibiting retroviral infections according to claim 15, wherein the retrovirus is an immunodeficiency virus, including HIV.

17. An article of manufacture comprising:

(i) packaging material; and

(ii) one or more tablets according to claim 5 and contained within the packaging material.

18. An article of manufacture according to claim 17, additionally comprising a brochure containing product information.

19. An article of manufacture according to claim 17, wherein the packaging material is unit dose blister packaging.
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