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Claims for Patent: 6,004,968

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Claims for Patent: 6,004,968

Title: Pharmaceutical compositions containing lamivudine
Abstract:The present invention relates to pharmaceutical formulations containing (2R, cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2 -one (-)-2',3'-dideoxy,3'-thiacytidine, lamivudine, that are substantially free of ethanol and ethylenediamine-tetraacitic acid, and their use in medical therapy.
Inventor(s): Casey; Warren Michael (Knightdale, NC), Nguyen; Ngoc-Anh Thi (Durham, NC)
Assignee: Glaxo Wellcome Inc. (Research Triangle Park, NC)
Application Number:09/044,896
Patent Claims: 1. A pharmaceutical composition, substantially free of ethanol and ethylenediaminetetraacetic acid, comprising lamivudine or a pharmaceutically acceptable derivative thereof, and a preservative system.

2. A pharmaceutical composition comprising lamivudine, said composition being substantially free of ethanol and ethylenediaminetetraacetic acid and exhibiting antimicrobial preservative efficacy.

3. A pharmaceutical composition as claimed in claim 2, further comprising parabens, said composition having a pH greater than 5.5.

4. A pharmaceutical composition, substantially free of ethanol and ethylenediaminetetraacetic acid, comprising lamivudine or a pharmaceutically acceptable derivative thereof, methyl paraben, and propyl paraben, said composition having a pH greater than 5.5.

5. A pharmaceutical composition according to claim 4 wherein the concentration of methyl paraben is 0.96 mg/mL to 2 mg/mL and the concentration of propyl paraben is 0.1 mg/mL to 0.2 mg/mL.

6. A pharmaceutical composition according to claim 4 wherein the pH is in the range 5.56-7.4.

7. A pharmaceutical composition according to claim 6 wherein the pH is 6.0.

8. A pharmaceutical composition as claimed in claim 4 wherein the amount of lamivudine is in the range of 0.1-100 mg/mL.

9. A pharmaceutical composition as claimed in claim 8 wherein the amount of lamivudine is in the range of 5-20 mg/mL.

10. A pharmaceutical composition as claimed in claim 4 further comprising a second therapeutic agent.

11. A pharmaceutical composition as claimed in claim 4 for oral administration.

12. A method of treatment of viral infections by administering a pharmaceutically safe and effective amount of a pharmaceutical composition according to claim 4.
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