Method for making a capsule-shaped tablet

• US 5,213,738 A
• Filed: 11/04/1991
• Issued: 05/25/1993
• Est. Priority Date: 05/15/1990
• Status: Expired due to Term

• Current Assignee: L. Perrigo Company (Perrigo Company PLC)
• Original Assignee: L. Perrigo Company (Perrigo Company PLC)
• Inventors: Jordan, Maureen L., Tilton, George W., Hampton, Douglas B.
• Primary Examiner(s): THEISEN, MARY LYNN F
• Application Number:
  US07/787,801
• Time in Patent Office: 568 Days
• Field of Search: 264/112, 264/113, 264/129, 425/345, 425/353
• US Class Current: 264/113
• CPC Class Codes: A61J 2205/20 Colour codes
• 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 11/085 for multi-layer articles

Abstract

A method for making a multi-characteristic, bi-layer, capsule-shaped tablet by filling a die with a blend of one or more excipients and one or more active substances, including a first distinguishing ingredient, e.g., a first coloring agent, leveling the first blend and cleaning the die walls above the first blend, adding a second blend including a second distinguishing ingredient, e.g., a second coloring agent, and compressing both blends longitudinally in the die into the shape of a two component capsule. The tablet is coated with a clear coating, such as gelatin, to provide a solid medicament with the appearance of a gelatin capsule.

Claims

1. A method of manufacturing a pharmaceutical tablet comprising:

filling a die cavity partially with a first blend of solid particulate excipients and active substances, and a first coloring agent;

leveling said first blend in said die cavity and clearing the walls of said die cavity above said first blend to define a clear line of demarcation at the upper circumferential edge of said first blend;

filling the unfilled portion of said die cavity with a second blend of solid particulate excipients and active substances, and a second coloring agent;

compressing said first blend and said second blend along the longitudinal axis of said die cavity to form a layered capsule-shaped tablet; and

removing the capsule-shaped tablet from the die cavity.

2. The method of claim 1 which includes coating said tablet with a clear coating.

3. The method of claim 1 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

4. A method of manufacturing a pharmaceutical tablet comprising:

filling a die cavity partially with a first blend of solid particulate excipients and active substances, and a first coloring agent;

rotating the die cavity on a rotary press;

leveling said first blend in said die cavity and clearing the walls of said die cavity above said first blend to define a clear line of demarcation at the upper circumferential edge of said first blend;

rotating said die cavity on said rotary press;

filling the unfilled portion of said die cavity with a second blend of solid particulate excipients and active substances, and a second coloring agent;

rotating said die cavity on said rotary press;

compressing said first blend and said second blend between a lower punch and an upper punch along the longitudinal axis of said die cavity to form a layered capsule-shaped tablet;

rotating said die cavity on said rotary press; and

ejecting the layered capsule-shaped tablet from the rotary press.

5. The method of claim 4 which includes coating the layered capsule-shaped tablet with a clear coating.

6. The method of claim 4 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

7. A method of manufacturing a pharmaceutical tablet comprising:

filling a die cavity partially with a first blend of solid particulate excipients and active substances, including a first distinguishing ingredient;

leveling said first blend in said die cavity and clearing the walls of said die cavity above said first blend to define a clear line of demarcation at the upper circumferential edge of said first blend;

filling the unfilled portion of said die cavity with a second blend of solid particulate excipients and active substances, including a second distinguishing ingredient;

compressing said first blend and said second blend along the longitudinal axis of said die cavity to form a layered capsule-shaped tablet; and

removing the capsule-shaped tablet from the die cavity.

8. The method of claim 7 and further including coating said tablet with a clear coating.

9. The method of claim 7 and further including:

regulating the amount of said first blend in said dei cavity by movably positioning a lower punch in said cavity and forcing said lower punch supporting said first blend up into said die cavity to force excess of said first blend out of the open top of said cavity where it is easily removed;

moving said lower punch to a lower position within said die cavity; and

regulating the amount of said second blend in said die cavity by forcing said lower punch supporting said first blend and said second blend up into said die cavity to force the excess of said second blend out of said open top of said cavity where it is easily removed.

10. The method as defined in claim 7 wherein said excipients and active substances are granules or microgranules.

11. The method as defined in claim 7 wherein said first and second blends are filled into said cavity to substantially equal depths.

12. The method as defined in claim 7 wherein said first and second distinguishing ingredients are different excipients which control the release of said one or more active substances.

13. The method as defined in claim 12 wherein at least one of said first and second blends of excipients retards the release of said one or more active substances.

14. The method as defined in claim 7 wherein said blend of excipients and active substances has a lubricity level sufficient to avoid sidewall sticking in a tablet compression die.

15. The method as defined in claim 7 wherein said sufficient lubricity level is obtained by adding a pharmaceutical grade lubricant to said blend of excipients and active substances.

16. The method of claim 15 wherein said lubricant is selected from one or more of the following ingredients:

starch, talc, microcrystalline cellulose, stearic acid, magnesium stearate, sodium lauryl sulfate and acetylsalicylic acid.

17. The method of claim 15 wherein said lubricant is selected from one or more of the following ingredients:

stearic acid, magnesium stearate, and sodium lauryl sulfate.

18. The tablet as defined in claim 14 wherein said lubricity level is obtained by the natural lubricity of said blend of excipients and active substances.

19. The method of claim 7 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

20. The method of claim 9 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

21. A method of manufacturing a pharmaceutical tablet comprising:

filling a die cavity partially with a first blend of solid particulate excipients and active substances, including a first distinguishing ingredient;

rotating the die cavity on a rotary press;

leveling said first blend in said die cavity and clearing the walls of said die cavity above said first blend to define a clear line of demarcation at the upper circumferential edge of said first blend;

rotating said die cavity on said rotary press;

filling the unfilled portion of said die cavity with a second blend of solid particulate excipients and active substances, including a second distinguishing ingredient;

rotating said die cavity on said rotary press;

compressing said first blend and said second blend between a lower punch and an upper punch along the longitudinal axis of said die cavity to form a layered capsule-shaped tablet;

rotating said die cavity on said rotary press; and

ejecting the layered capsule-shaped tablet from the rotary press.

22. The method of claim 21 and further including coating the layered capsule-shaped tablet with a clear coating.

23. The method of claim 21 and further including:

regulating the amount of said first blend in said dei cavity by movably positioning a lower punch in said cavity and forcing said lower punch supporting said first blend up into said die cavity to force excess of said first blend out of the open top of said cavity where it is easily removed;

moving said lower punch to a lower position within said die cavity; and

regulating the amount of said second blend in said die cavity by forcing said lower punch supporting said first blend and second blend up into said die cavity to force the excess of said second blend out of said open top of said cavity where it is easily removed.

24. The method as defined in claim 21 wherein said excipients and active substances are granules or microgranules.

25. The method as defined in claim 21 wherein said first and second blends are filled into said cavity to substantially equal depths.

26. The method as defined in claim 21 wherein said first and second distinguishing ingredients are different excipients which control the release of said one or more active substances.

27. The method as defined in claim 26 wherein at least one of said first and second blends of excipients retards the release of said one or more active substances.

28. The method as defined in claim 21 wherein said blend of excipients and active substances has a lubricity level sufficient to avoid sidewall sticking in a tablet compression die.

29. The method as defined in claim 28 wherein said sufficient lubricity level is obtained by adding a pharmaceutical grade lubricant to said blend of excipients and active substances.

30. The method of claim 29 wherein said lubricant is selected from one or more of the following ingredients:

starch, talc, microcrystalline cellulose, stearic acid, magnesium stearate, sodium lauryl sulfate and acetylsalicylic acid.

31. The method of claim 29 wherein said lubricant is selected from one or more of the following ingredients:

stearic acid, magnesium stearate, and sodium lauryl sulfate.

32. The tablet as defined in claim 28 wherein said lubricity level is obtained by the natural lubricity of said blend of excipients and active substances.

33. The method of claim 21 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

34. The method of claim 23 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

35. A method of manufacturing a pharmaceutical tablet comprising:

filling a die cavity partially with a first blend of solid particulate excipients and active substances, including a first distinguishing ingredient;

leveling said first blend in said die cavity;

filling the unfilled portion of said die cavity with a second blend of solid particulate excipients and active substances, including a second distinguishing ingredient;

compressing said first blend and said second blend along the longitudinal axis of said die cavity to form a layered capsule-shaped tablet; and

removing the capsule-shaped tablet from the die cavity.

36. The method of claim 35 and further including:

regulating the amount of said first blend in said dei cavity by movably positioning a lower punch in said cavity and forcing said lower punch supporting said first blend up into said die cavity to force excess of said first blend out of the open top of said cavity where it is easily removed;

moving said lower punch to a lower position within said die cavity; and

regulating the amount of said second blend in said die cavity by forcing said lower punch supporting said first blend and said second blend up into said die cavity to force the excess of said second blend out of said open top of said cavity where it is easily removed.

37. The method as defined in claim 36 wherein said excipients and active substances are granules or microgranules.

38. The method as defined in claim 37 wherein said first and second blends are filled into said cavity to substantially equal depths.

39. The method as defined in claim 38 wherein said blend of excipients and active substances has a lubricity level sufficient to avoid sidewall sticking in a tablet compression die.

40. The method as defined in claim 39 wherein said sufficient lubricity level is obtained by adding a pharmaceutical grade lubricant to said blend of excipients and active substances.

41. The method of claim 40 wherein said lubricant is selected from one or more of the following ingredients:

starch, talc, microcrystalline cellulose, stearic acid, magnesium stearate, sodium lauryl sulfate and acetylsalicylic acid.

42. The method of claim 40 wherein said lubricant is selected from one or more of the following ingredients:

stearic acid, magnesium stearate, and sodium lauryl sulfate.

43. The method of claim 35 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.

44. The method of claim 36 in which said step of leveling said first blend in said die cavity comprises making said first blend level at its line of demarcation with said second blend, but rounding said first blend upwardly slightly above said line of demarcation.