Pharmaceutical compositions and related methods of delivery
The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.
1. An oral dosage form, comprising:
a composition comprising a suspension which comprises an admixture of a hydrophobic medium and a solid form,
wherein the solid form comprises: a therapeutically effective amount of octreotide and a medium chain fatty acid salt, wherein the composition comprises 12% to 21% by weight of the medium chain fatty acid salt, and at least 3% by weight of a matrix forming polymer.
2. The oral dosage form of claim 1 , wherein the medium chain fatty acid salt is sodium hexanoate, sodium heptanoate, sodium octanoate, sodium nonanoate, sodium decanoate, sodium undecanoate, sodium dodecanoate, sodium tridecanoate or sodium tetradecanoate, or a corresponding potassium or lithium or ammonium salt or a combination thereof.
3. The oral dosage form of claim 1 , wherein the medium chain fatty acid salt is sodium octanoate.
4. The oral dosage form of claim 1 , wherein the composition comprises 12% to 18% by weight of the medium chain fatty acid salt.
5. The oral dosage form of claim 1 , wherein the matrix forming polymer is dextran, polyvinylpyrrolidone (PVP), alginic acid, alginates, hydroxypropylmethyl cellulose, polyvinyl alcohol, polyacrylic acid, or poly methacrylic acid, or a combination thereof.
6. The oral dosage form of claim 1 , wherein the matrix forming polymer comprises PVP.
7. The oral dosage form of claim 6 , wherein the PVP has a molecular weight of about 2500 Da to about 3000 Da.
8. The oral dosage form of claim 1 , wherein the composition comprises 3% to 20% by weight of the matrix forming polymer.
9. The oral dosage form of claim 1 , wherein the composition comprises 5% to 15% by weight of the matrix forming polymer.
10. The oral dosage form of claim 1 , wherein the composition comprises 3% to 20% by weight of the matrix forming polymer and 12% to 18% by weight of the medium chain fatty acid salt.
11. The oral dosage form of claim 1 , wherein the composition comprises 5% to 15% by weight of the matrix forming polymer and 12% to 18% by weight of the medium chain fatty acid salt.
12. The oral dosage form of claim 1 , wherein the hydrophobic medium comprises a mineral oil, a paraffin, a fatty acid, a monoglyceride, a diglyceride, a triglyceride, an ether or an ester, or a combination thereof.
13. The oral dosage form of claim 1 , wherein the hydrophobic medium comprises glyceryl tricaprylate or castor oil.
14. The oral dosage form of claim 1 , wherein hydrophobic medium comprises a surfactant.
15. The oral dosage form of claim 14 , wherein the surfactant is lecithin, sorbitan monopalmitate, glyceryl monocaprylate or polyoxyethylene sorbitan monooleate, or a combination thereof.
16. The oral dosage form of claim 1 , wherein the composition comprises about 3-10% by weight of a surfactant.
17. The oral dosage form of claim 1 , wherein the oral dosage form is a capsule.
18. The oral dosage form of claim 1 , wherein the oral dosage form is enterically coated.