Manufacture of tablet in a die utilizing powder blend containing water-containing material

Patent metadata

Field	Value
Publication number	US-9610224-B2
Application number	US-88755210-A
Country	US
Kind code	B2
Filing date	Sep 22, 2010
Priority date	Sep 24, 2009
Publication date	Apr 4, 2017
Grant date	Apr 4, 2017

Abstract

The present invention features the present invention features a process for making a tablet by compacting a powder blend in a die platen to form a tablet shape, wherein the powder blend includes a pharmaceutically active agent and a water-containing material, and applying energy to the tablet shape for a sufficient period of time to heat the water-containing material within the tablet shape above its dehydration temperature to form the tablet.

First claim

What is claimed is:

1. A process for making a tablet comprising compacting the particles of a powder blend in a die platen to form a tablet shape, wherein said powder blend comprises a pharmaceutically active agent and a water-containing material having a dehydration temperature, and applying radiofrequency energy to said tablet shape within a die platen for a sufficient period of time to heat the water-containing material within said tablet shape above said dehydration temperature to form said tablet, wherein said process comprises the steps of:
(i) introducing said powder blend into a forming cavity within said die platen;
(ii) compacting said particles of said powder blend by introducing at least one forming tool into said die platen with sufficient force such that a tablet shape is formed;
(iii) applying said radiofrequency energy to said tablet shape within said forming cavity to bind said particles in said tablet shape to form said tablet; and
(iv) removing said tablet from said forming cavity.

2. The process of claim 1 , wherein said powder blend further comprises one or more carbohydrates.

3. The process of claim 1 , wherein said powder blend comprises from about 0.01 to about 30 percent, by weight, of said pharmaceutically active agent and from about 1 to about 30 percent, by weight, of said water-containing material.

4. The process of claim 2 , wherein said powder blend comprises from about 0.01 to about 30 percent, by weight, of said pharmaceutically active agent, from about 1 to about 30 percent, by weight, of said water-containing material, and from about 30 to about 95 percent, by weight, of said one or more carbohydrates.

5. The process of claim 1 , wherein said water-containing material is a hydrate salt.

6. The process of claim 2 , wherein said one or more carbohydrates are selected from the group consisting of dextrose monohydrate, mannitol, erythritol, dextrose, lactose, sorbitol, isomalt, sucrose, dextrates and maltodextrins.

7. The process of claim 1 , wherein said powder blend is compacted with a force less than 0.3 kiloNewtons.

8. The process of claim 1 , wherein said radiofrequency energy has a frequency of from about 1 MHz to 100 MHz.

9. The process of claim 1 , wherein said powder blend has an average particle size of less than 500 microns.

10. The process of claim 1 , wherein said tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.

11. The process of claim 1 , wherein said tablet disintegrates rapidly in the oral cavity, with an in vitro disintegration time of approximately 30 seconds or less, when based on the United States Pharmacopeia (USP) disintegration test method for said pharmaceutically active agent.

12. The process of claim 1 , wherein said tablet has a hardness of less than 700 grams as measure using Texture Analyzer TA-XT2i that is fitted with a 7 millimeter diameter flat faced probe.

13. The process of claim 1 , wherein said tablet has a density less than 0.8 g/cc.

14. The process of claim 1 , wherein said process further comprises the step of cooling said tablet in said die prior to removing said tablet from said die platen.

15. The process of claim 1 , wherein at least one said forming tool emits said radiofrequency energy to said tablet shape.

16. The process of claim 1 , wherein said die platen emits said radiofrequency energy to said tablet shape.

17. The process of claim 1 , wherein said powder blend is compacted using an upper forming tool and a lower forming tool, and at least one of said upper forming tool or lower forming tool emits said radiofrequency energy to said tablet shape.

18. The process of claim 1 , wherein the surface of said tablet is further exposed to infrared energy wherein the majority of the wavelength of said infrared energy from about 0.5 to about 5 micrometers.

19. The process of claim 10 , wherein at least one said forming tool emits said radiofrequency energy to said tablet shape.

Assignees

• Bunick Frank J
• Sowden Harry S
• Luber Joseph R
• Kriksunov Leo B
• Szymczak Christopher E
• Johnson & Johnson Consumer Inc

Inventors

• Bunick Frank J
• Sowden Harry S
• Luber Joseph R
• Kriksunov Leo B
• Szymczak Christopher E

Classifications

• A61P37/00

  Drugs for immunological or allergic disorders · CPC title

• A61P25/34

  Tobacco-abuse · CPC title

• A61P29/00

  Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID] · CPC title

• A61P3/00

  Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) · CPC title

• A61K9/2068

  Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/2013) · CPC title