IP Library › Granted Patent US 8,778,917
Granted Patent B2
US 8,778,917 · App. 14/026,655 · Granted Jul 15, 2014

Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same

Inventors: Robert E. Dudley (Rosemary Beach, FL); Panayiotis P. Constantinides (Gurnee, IL)
Assignee: Clarus Therapeutics, Inc.
A61K31/568A61K9/1075A61K9/4858A61K31/573A61K31/22
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Quick Facts
Patent No.
US 8,778,917
App. No.
14/026,655
Granted
Jul 15, 2014
Kind
B2
Abstract

A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.

Claims (9)

1. An oral pharmaceutical composition consisting essentially of 20% testosterone ester, 39.99% polyoxyethylated apricot kernel oil (Labrafil M1944CS); 13.32% glyceryl palmitostearate (Precirol ATO5) and 26.68% polyoxyethylene (40) hydrogenated castor oil (Cremophor RH40).

2. The pharmaceutical composition of claim 1 wherein the testosterone ester is selected from the group consisting of testosterone enanthate; testosterone undecanoate; testosterone cypionate, and testosterone palmitate.

3. The pharmaceutical composition of claim 2 wherein the testosterone ester is testosterone undecanoate.

4. An oral pharmaceutical composition consisting essentially of 15% testosterone ester, 42.49% polyoxyethylated apricot kernel oil (Labrafil M1944CS); 14.16% glyceryl palmitostearate (Precirol ATO5) and 28.35% polyoxyethylene (40) hydrogenated castor oil (Cremophor RH40).

5. The pharmaceutical composition of claim 4 wherein the testosterone ester is selected from the group consisting of testosterone enanthate; testosterone undecanoate; testosterone cypionate, and testosterone palmitate.

6. The pharmaceutical composition of claim 5 wherein the testosterone ester is testosterone undecanoate.

7. An oral pharmaceutical composition consisting essentially of 10% testosterone ester, 44.99% polyoxyethylated apricot kernel oil (Labrafil M1944CS); 14.99% glyceryl palmitostearate (Precirol ATO5) and 30.02% polyoxyethylene (40) hydrogenated castor oil (Cremophor RH40).

8. The pharmaceutical composition of claim 7 wherein the testosterone ester is selected from the group consisting of testosterone enanthate; testosterone undecanoate; testosterone cypionate, and testosterone palmitate.

9. The pharmaceutical composition of claim 8 wherein the testosterone ester is testosterone undecanoate.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Dec 6, 2022
From: U.S. BANK TRUST COMPANY, NATIONAL ASSOCIATION, AS SUCCESSOR TO U.S. BANK NATIONAL ASSOCIATION
To: CLARUS THERAPEUTICS, INC.
Reel/Frame 062000/0052 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 15, 2022
From: CLARUS THERAPEUTICS, INC.
To: TOLMAR, INC.
Reel/Frame 061774/0516 →
SECURITY INTEREST Recorded Mar 12, 2020
From: CLARUS THERAPEUTICS, INC.
To: U.S. BANK NATIONAL ASSOCIATION
Reel/Frame 052099/0349 →
CORRECTIVE ASSIGNMENT TO CORRECT THE SPELLING OF ASSIGNOR'S NAME AND ASSIGNESS'S NAME PREVIOUSLY RECORDED ON REEL 032285 FRAME 0101. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT OF ASSIGNOR'S INTEREST. Recorded May 21, 2014
From: DUDLEY, ROBERT E.; CONSTANTINIDES, PANAYIOTIS P.
To: CLARUS THERAPEUTICS, INC.
Reel/Frame 032971/0273 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 24, 2014
From: DUDLEY, ROBERT E; CONSTANTINIDES, PANAYIOTIS E
To: CLARUS THERAPUETICS, INC.
Reel/Frame 032285/0101 →
Continuity (5)
Continuation 13553586 · Jul 19, 2012
Continuation 11911446
Provisional Application 60671454 · Apr 15, 2005
Provisional Application 60721971 · Sep 30, 2005
Related Publication 20140011789A1 · Jan 9, 2014