Production of covered tablets

• US 5,897,910 A
• Filed: 06/20/1997
• Issued: 04/27/1999
• Est. Priority Date: 12/23/1994
• Status: Expired due to Term

• Current Assignee: Abbvie Deutschland GmbH & Company KG (Abbvie Incorporated)
• Original Assignee: BASF AG (BASF SE)
• Inventors: Breitenbach, Jorg, Rosenberg, Joerg, Maier, Werner, Grabowski, Sven
• Primary Examiner(s): DUDASH, DIANA L
• Application Number:
  US08/860,016
• Time in Patent Office: 676 Days
• Field of Search: 427/2.14, 427/2.23, 427/2.22, 427/2.21, 427/358, 427/364, 427/365, 427/375, 427/366
• US Class Current: 427/2.14
• CPC Class Codes: A61J 1/035 Blister-type containers blisters in general B65D75/36
• CPC Class Codes: A61J 2200/20 Extrusion means, e.g. for producing pharmaceutical forms
• CPC Class Codes: A61J 3/005 Coating of tablets or the like coating of sweetmeats or confectionery A23G3/20; coating of granules in general B01J2/006
• CPC Class Codes: A61J 3/10 into the form of compressed tablets tablet presses B30B11/00
• CPC Class Codes: A61K 9/2072 characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms A61K9/0004, A61K9/0056, A61K9/0065 take precedence
• CPC Class Codes: B30B 11/16 using pocketed rollers, e.g. two co-operating pocketed rollers
• CPC Class Codes: B30B 11/34 for coating articles, e.g. tablets
• CPC Class Codes: B65B 9/04 one or both webs being formed with pockets for the reception of the articles, or of the quantities of material

Abstract

The present invention is a process for the production of covered tablets by melt calendering in which the melt containing active ingredient is introduced between two sheets of the covering material into the molding rolls.

Claims

1. A process for the production of covered tablets by

i) mixing one or more pharmaceutically active ingredients and one or more conventional ancillary substances to give a pharmaceutical mixture,

ii) melting the pharmaceutical mixture to give a melted tablet composition, and

iii) molding the melted tablet composition in a calender with counter-rotating molding rolls at least one of which molding rolls has on its surface depressions for receiving and molding the melted tablet composition,

which process comprises

a) introducing the melted tablet composition into the calender between two sheets of covering material, which covering material comprises a polymer selected from the group consisting of polyvinyl alcohol, alkylcellulose, hydroxy alkylcellulose, cellulose ester, carboxymethylcellulose, cellulose phthalate, polyvinyl pyrrolidone, polyvinyl ester, acrylic resins, and mixtures thereof,

b) applying the covering material to the melted tablet composition simultaneously to the molding of the tablet composition into the required tablet shape,

c) cutting out of the two sheets of covering material the parts forming the cover of the tablet simultaneously to the molding of the tablet composition into the required tablet shape,

whereby the tablets are enveloped singly by the coating material to give a tablet completely and uniformly coated by the covering material.

2. The process of claim 1, wherein the coating material further comprises an active ingredient.

3. The process of claim 1, wherein the covering material provides an enteric coating or a coating for modified release of active ingredient.

4. The process of claim 1, wherein the molding rolls of the calender have different depressions.

5. The process of claim 1, wherein the calender has one molding roll with depressions and one smooth molding roll.

6. The process of claim 1, wherein the calender has at least one molding roll having depressions which are divided by at least one bar which extends essentially to the surface of the molding roll and forms a score to give divisible tablets.

7. The process of claim 1, wherein the calender has molding rolls which are coated with a mold release agent.

8. The process of claim 1, further comprising that the covered tablets are cooled for hardening.

9. The process of claim 1, wherein the different sheets of covering material differ from one another in their material or in their thickness.

10. The process of claim 1, wherein the coating material further comprises colored pigments or masking flavors or a release agent.

11. A process for the production of covered tablets by

i) mixing one or more pharmaceutically active ingredients and one or more conventional ancillary substances to give a pharmaceutical mixture,

ii) melting the pharmaceutical mixture to give a melted tablet composition, and

iii) molding the melted tablet composition in a calender with counter-rotating molding rolls at least one of which molding rolls has on its surface depressions for receiving and molding the melted tablet composition,

which process comprises

a) introducing the melted tablet composition into the calender between two sheets of covering material, which covering material comprises polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polystyrene, aluminum or coated aluminum,

b) applying the covering material to the melted tablet composition simultaneously to the molding of the tablet composition into the required tablet shape,

whereby the tablets are enveloped singly by the coating material to give tablets sealed in a blister pack.

12. The process of claim 11, wherein the different sheets of covering material differ from one another in their material or in their thickness.

13. The process of claim 11, wherein the coating material further comprises colored pigments or masking flavors or a release agent.

14. The process of claim 11, wherein the molding rolls of the calender have different depressions.

15. The process of claim 11, wherein the calender has one molding roll with depressions and one smooth molding roll.

16. The process of claim 11, wherein the calender has molding rolls which are coated with a mold release agent.

17. A process for the production of covered tablets by

i) mixing one or more pharmaceutically active ingredients and one or more conventional ancillary substances to give a pharmaceutical mixture,

ii) melting the pharmaceutical mixture to give a melted tablet composition, and

iii) molding the melted tablet composition in a calender with counter-rotating molding rolls at least one of which molding rolls has on its surface depressions for receiving and molding the melted tablet composition,

which process comprises

a) introducing the melted tablet composition into the calender between two sets of two sheets of covering material,

the inner set of sheets directly facing the melted tablet composition consisting of a covering material which comprises a polymer selected from the group consisting of polyvinyl alcohol, alkylcellulose, hydroxy alkylcellulose, cellulose ester, carboxymethylcellulose, cellulose phthalate, polyvinyl pyrrolidone, polyvinyl ester, acrylic resins, and mixtures thereof, and

the outer set of sheets consisting of a covering material which comprises polyethylene, polypropylene, polyvinyl chloride, polyethylene terephthalate, polystyrene, aluminum or coated aluminum,

b) applying the covering material of the inner set of sheets and the outer set of sheets to the melted tablet composition simultaneously to the molding of the tablet composition into the required tablet shape,

c) cutting out of the two inner sheets of covering material the parts forming the cover of the tablet simultaneously to the molding of the tablet composition into the required tablet shape, whereby the tablets are enveloped singly by the coating material to give a tablet completely and uniformly coated by the covering material of the inner set of sheets, and

d) applying the covering material of the outer set of sheets to the coated melted tablet composition simultaneously to the molding of the tablet composition into the required tablet shape, whereby the tablets are enveloped singly by the coating material of the outer set of sheets to give tablets sealed in a blister pack.

18. The process of claim 17, wherein the different sheets of covering material differ from one another in their material or in their thickness.

19. The process of claim 17, wherein the molding rolls of the calender have different depressions.

20. The process of claim 17, wherein the calender has one molding roll with depressions and one smooth molding roll.