Progesterone tablet and its manufacturing process

• US 6,086,916 A
• Filed: 03/16/1999
• Issued: 07/11/2000
• Est. Priority Date: 12/19/1997
• Status: Expired due to Term

• Current Assignee: Laboratories Besins Iscovesco
• Original Assignee: Laboratories Besins Iscovesco
• Inventors: Agnus, Benoit, Besins, Antoine
• Primary Examiner(s): Spear, James M.
• Application Number:
  US09/268,351
• Time in Patent Office: 483 Days
• Field of Search: 424/464, 424/465, 424/470
• US Class Current: 424/464
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 9/2077 Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets

Abstract

The invention concerns a progesterone tablet characterised by the fact that its excipient content is at most 45%, preferably at most 40%, and yet more preferably at most 38%, the percentages being expressed in weight relative to the total dry matter of the tablet.

Claims

1. A progesterone tablet containing micronized progesterone, diluents, disintegrating agents, lubricants and binding agents, having:

an excipient content of at most 45%, the percentage being expressed in weight relative to the total dry matter of the tablet,

a dissolution profile such that the level of progesterone released is at least 75% in 15 minutes, and

a hardness between 20 and 120 N,

whereby said tablet shows excellent properties of stability, hardness, disintegration and dissolution.

2. A progesterone tablet according to claim 1, having an excipient content of at most 40%.

3. A progesterone tablet according to claim 2, having an excipient content of at most 38%.

4. A progesterone tablet according to claim 1, having a disintegration time of less than 15 minutes.

5. A progesterone tablet according to claim 4, having a disintegration time of less than 10 minutes.

6. A progesterone tablet according to claim 5, having a disintegration time of less than 5 minutes.

7. A progesterone tablet according to claim 1, having a dissolution profile such that the level of progesterone released is at least 75% in 10 minutes.

8. A progesterone tablet according to claim 7, having a dissolution profile such that the level of progesterone released is at least 75% in 5 minutes.

9. A progesterone tablet according to claim 1, having a hardness between 30 and 110 N.

10. A progesterone tablet according to claim 9, having a hardness between 40 and 100 N.

11. A manufacturing process of a tablet according to claim 1, wherein:

a first mixture of progesterone and diluent is prepared,

a wetting suspension is prepared,

the first mixture is then wetted by the wetting suspension,

the product of the wetting is then granulated in order to obtain a granular product,

disintegrating agents and diluents are added to the granular product in order to obtain a second mixture,

a lubricant is added to the second mixture in order to obtain a third mixture,

this third mixture is compressed in order to obtain tablets.