Blister package for topiramate tablets

• US 20040104142A1
• Filed: 05/30/2003
• Published: 06/03/2004
• Est. Priority Date: 05/25/2000
• Status: Abandoned Application

• Current Assignee: Dieter Bachmann, Monika Dobler, Pedro Lorca, Stefan Merkle
• Original Assignee: Dieter Bachmann, Monika Dobler, Pedro Lorca, Stefan Merkle
• Inventors: Bachmann, Dieter, Lorca, Pedro, Dobler, Monika, Merkle, Stefan
• Application Number:
  US10/258,006
• Publication Number:
  US 20040104142A1
• Time in Patent Office: Days
• US Class Current: 206/531
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61P 25/08 Antiepileptics; Anticonvulsants
• CPC Class Codes: B65D 75/327 and forming several compartments

Abstract

The present invention provides a blister package for topiramate tablets comprising a pan sheet having preformed cavities containing topiramate tablets dried to a free water content of between about 0.4% to about 1.4% and a cover sheet sealed to the pan sheet. The present invention further provides a process for blister packaging dried topiramate tablets into a blister package with improved shelf-life and stability performance.

Claims

1. A blister package for topiramate tablets comprising a pan sheet having preformed cavities containing topiramate tablets, and a cover sheet sealed to the pan sheet;

wherein the topiramate tablets have a free water content of between about 0.4% to about 1.4% at the time the cover sheet is sealed to the pan sheet and wherein the blister package thus formed contains no desiccant.

2. The blister package of claim 1 wherein the pan sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a single plastic layer, multiple plastic layers, and a composite metal and plastic layer.

3. The blister package of claim 2 wherein the cover sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a composite metal and plastic layer, a composite metal and paper layer, and a composite metal, plastic and paper layer.

4. The blister package of claim 3, wherein the pan sheet is a composite metal and plastic layer and the cover sheet is a metal layer.

5. The blister package of claim 4 wherein the pan sheet is a composite metal and plastic layer of ortho-polyamide/aluminum foil/polyvinylchloride and the cover sheet is a single aluminum foil layer.

6. The blister package of claim 5 wherein the pan sheet is a 25 μ

m ortho-polyamide/45 μ

m aluminum foil/60 μ

m polyvinylchloride sheet and the cover sheet is a 20 μ

m aluminum foil sheet.

7. The blister package of claim 1 wherein the topiramate tablets have between about 0.7% to about 1.2% free water.

8. The blister package of claim 7 wherein the topiramate tablets have between about 0.8% to about 1.0% free water.

9. The blister package of claim 1 wherein the topiramate tablets are dried by a method selected from the group consisting of microwave drying, vacuum drying, hot air drying, infrared drying, drying using very dry air either statically or dynamically, and drying by placing a desiccant in a storage drum of bulk product for a period of time.

10. The blister package of claim 0 wherein the topiramate tablets are dried using hot air.

11. A process for making a blister package containing topiramate tablets comprising the steps of:

(a) drying a plurality of topiramate tablets to a free water content of between about 0.4% to about 1.4%;

(b) placing the dried topiramate tablets from step (a) into a pan sheet having a plurality of cavities; and

(c) sealing a cover sheet to the pan sheet from step (b) to form the blister package, provided that the dried topiramate tablets have a free water content of less than about 1.4% at the time the cover sheet is sealed to the pan sheet and wherein the blister package contains no desiccant.

12. The process of claim 11 wherein the pan sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a single plastic layer, multiple plastic layers and a composite metal and plastic layer.

13. The process of claim 12 wherein the cover sheet is a sheet selected from the group consisting of a single metal layer, multiple metal layers, a composite metal and plastic layer, a composite metal, and paper layer and a composite metal, plastic and paper layer.

14. The process of claim 13, wherein the pan sheet is a composite metal and plastic layer and the cover sheet is a metal layer.

15. The process of claim 14 wherein the pan sheet is a composite metal and plastic layer of ortho-polyamide/aluminum foil/polyvinylchloride and the cover sheet is a single aluminum foil layer.

16. The process of claim 15 wherein the pan sheet is a 25 μ

m ortho-polyamide/45 μ

m aluminum foil/60 μ

m polyvinylchloride sheet and the cover sheet is a 20 μ

m aluminum foil sheet.

17. The process of claim 11 wherein the topiramate tablets are dried to a free water content of between about 0.7% to about 1.2%.

18. The process of claim 17 wherein the topiramate tablets are dried to a free water content of between about 0.8% to about 1.0%.

19. The process of claim 11 wherein the topiramate tablets are dried by a method selected from the group consisting of microwave drying, vacuum drying, hot air drying, infrared drying, drying using very dry air either statically or dynamically, and drying by placing a desiccant in a storage drum of bulk product for a period of time.

20. The process of claim 19 wherein the topiramate tablets are dried using hot air in a coater at a temperature from about 60°

C. to about 70°

C.

21. A blister package made by the process of claim 11.