US 7,320,800 B2
Vaginally administrable progesterone-containing tablets and method for preparing same
Azariah Jossifoff, Ramat Gan (Israel)
Assigned to Ferring B.V., Hoofddorp (Netherlands)
Filed on Jan. 12, 2005, as Appl. No. 11/39,062.
Application 11/039062 is a continuation of application No. 10/832742, filed on Apr. 26, 2004.
Application 10/832742 is a continuation of application No. 09/856417, filed on Aug. 08, 2001.
Application 09/856417 is a continuation of application No. PCT/IL99/00619, filed on Nov. 17, 1999.
Claims priority of application No. 127129 (IL), filed on Nov. 18, 1998.
Prior Publication US 2005/0181045 A1, Aug. 18, 2005
Int. Cl. A61K 13/00 (2006.01); A61K 9/02 (2006.01)
U.S. Cl. 424—433  [424/434; 424/436] 6 Claims
 
1. A method of delivering progesterone to a female patient, comprising placing in the vagina of said patient a tablet consisting of natural progesterone, pharmaceutically acceptable excipients, and an effervescent, wherein said tablet is prepared by the steps of:
(i) mixing water with natural progesterone to obtain wetted natural progesterone in the absence of pharmaceutically acceptable excipients; and drying said wetted natural progesterone to form dry progesterone;
(ii) mixing said dry natural progesterone with
(a) pharmaceutically acceptable excipients and
(b) an effervescent to form a mixture; and
(iii) forming said tablet in dry form by direct compaction of said mixture, and retaining said tablet in said vagina until the tablet dissolves, wherein the tablet provides a Tmax from 3.05 hours to 9.75 hours after said tablet is placed in the vagina.