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Claims for Patent: 6,652,880

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Claims for Patent: 6,652,880

Title: Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants
Abstract:This invention is directed to pharmaceutical compositions for oral administration, wherein the drug or active ingredient is known to have stability problems associated with the use of free fatty acids. The compositions of the invention enhance the solubility of such compounds and improve the storage stability thereof and can be advantageously used in soft-gel and hard-shell capsular formulations. The liquid pharmaceutical compositions, according to the present invention, have a drug dissolved in a liquid vehicle. The liquid vehicle comprising a glyceride of a long chain fatty acid and a lypophilic surfactant having an HLB of less than ten. The composition, according to the invention, is also substantially free of free fatty acids.
Inventor(s): Aylwin; Elizabeth Anne (Swindon, GB), Banbury; Susan (Cheltenham, GB), Ferdinando; Josephine Joan Christine (Tadley, GB), de Nijs; Henrik (Oss, NL)
Assignee: R.P. Scherer Technologies, Inc. (Paradise Valley, NV)
Application Number:09/914,576
Patent Claims: 1. A liquid pharmaceutical composition having a drug dissolved in a liquid vehicle, said liquid vehicle consisting essentially of: a) a glyceride of a long chain fatty acid; b) a lipophilic surfactant having an HLB of less than 10; and wherein said liquid vehicle is substantially free from free fatty acid.

2. A liquid pharmaceutical composition according to claim 1, wherein the drug is testosterone undecanoate.

3. The liquid pharmaceutical composition according to claim 1, wherein the glyceride of a long chain fatty acid is present in an amount from about 15% to about 70% by weight in the liquid vehicle, and wherein the lipophilic surfactant is present in an amount from about 30% to about 60% by weight in the liquid vehicle.

4. The liquid pharmaceutical composition according to claim 1, wherein the glyceride is a long chain triglyceride having 14 to 22 carbon atoms.

5. The liquid pharmaceutical composition according to claim 4, wherein the long chain triglyceride is selected from the group consisting of arachis oil, soya bean oil, castor oil, corn oil, safflower oil, olive oil, apricot kernel oil and sesame oil, and combinations thereof.

6. The liquid pharmaceutical composition according to claim 1, wherein the glyceride of a long chain fatty acid is a mono- or diglyceride.

7. The liquid pharmaceutical composition according to claim 6, wherein the glyceride of a long chain fatty acid is the monoglyceride glyceryl mono-oleate.

8. The liquid pharmaceutical composition according to claim 1, wherein the lipophilic surfactant is selected from the group consisting of: mono- and diglycerides of fatty acids; acetic, succinic, lactic and tartaric esters of mono- and di-glycerides of fatty acids; propylene glycol mono- and di-esters of fatty acids; castor oil and hydrogenated castor oil ethoxylates; acid and ester ethoxylates; sorbitan esters of fatty acids; unsaturated polyglycolized glycerides; alcohol ethoxylates; and polyoxyethylene-propylene co-polymers and block co-polymers, and combinations thereof.

9. The liquid pharmaceutical composition according to claim 8, wherein the lipophilic surfactant is a propylene glycol mono-ester of a fatty acid.

10. The liquid pharmaceutical composition according to claim 9, wherein the lipophilic surfactant is lauroglycol.

11. A soft gel capsule containing the liquid pharmaceutical composition according to claim 1.

12. A hard shell capsule containing the liquid pharmaceutical composition according to claim 1.

13. The liquid pharmaceutical composition according to claim 1, further comprising ethanol.

14. The liquid pharmaceutical composition according to claim 13 which contains less than 15% by weight ethanol.

15. A liquid pharmaceutical composition for oral administration having testosterone undecanoate dissolved in a liquid vehicle, said liquid vehicle consisting essentially of: a) a glyceride of a long chain fatty acid having from 14 to 22 carbon atoms; and b) lauroglycol.

16. The liquid pharmaceutical composition according to claim 15, wherein the glyceride of a long chain fatty acid is a triglyceride.

17. A soft gel capsule containing the liquid pharmaceutical composition according to claim 15.

18. A hard shell capsule containing the liquid pharmaceutical composition according to claim 15.
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