Oral drug delivery system
Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.
1. A method of preparing an oral dosage form, wherein the oral dosage form comprises a formulation comprising:
an opioid;
sucrose acetate isobutyrate (SAIB);
a cellulose acetate butyrate (CAB) having a number average molecular weight ranging from 66,000 Daltons to 83,000 Daltons;
isopropyl myristate (IPM); and
a solvent in which the CAB is soluble,
the method comprising:
combining the SAIB, the CAB, the solvent, and the IPM to form a solution; and
then adding the opioid to the solution to form the formulation.
2. The method of claim 1 , wherein the solvent is triacetin or ethyl lactate.
3. The method of claim 1 , wherein the solvent is triacetin.
4. The method of claim 1 , wherein the solvent comprises propylene carbonate, N-methylpyrrolidone (NMP), glycofurol, alpha-tocopherol, diethyl phthalate, or polyethylene glycol 400 (PEG 400).
5. The oral formulation of claim 1 , wherein the CAB has a butyryl content ranging from about 17% to about 38%.
6. The method of claim 1 , wherein the CAB has an acetyl content ranging from about 13% to about 30%.
7. The method of claim 1 , wherein the CAB has a hydroxyl content ranging from about 0.8% to about 1.7%.
8. The method of claim 1 , wherein the CAB has a butyryl content ranging from about 17% to about 38%, an acetyl content ranging from about 13% to about 30%, and a hydroxyl content ranging from about 0.8% to about 1.7%.
9. The method of claim 1 , wherein the formulation comprises from about 1 to about 8.6 weight percent of the CAB.
10. The method of claim 1 , wherein the formulation comprises from about 20 to about 50 weight percent of the solvent.
11. The method of claim 1 , wherein the formulation comprises from about 1 to about 75 weight percent IPM.
12. The method of claim 1 , wherein the opioid is hydrocodone, oxymorphone or hydromorphone.
13. The method of claim 1 , wherein the opioid is oxycodone.
14. The method of claim 1 , wherein the method comprises:
placing the formulation within an enclosure or a capsule.
15. The method of claim 14 , wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.
16. The method of claim 14 , wherein the capsule is a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.
17. The method of claim 1 , wherein the formulation comprises:
from about 1 to about 8.6 weight percent of the CAB;
from about 20 to about 50 weight percent of the solvent; and
from about 1 to about 75 weight percent IPM.
18. The method of claim 17 , wherein the formulation comprises from 3 to 7.8 weight percent of the CAB.
19. The method of claim 18 , wherein the CAB has a butyryl content ranging from about 17% to about 38%.
20. The oral formulation of claim 18 , wherein the CAB has an acetyl content ranging from about 13% to about 30%.
21. The oral formulation of claim 18 , wherein the CAB has a hydroxyl content ranging from about 0.8% to about 1.7%.
22. The oral formulation of claim 18 , wherein the CAB has a butyryl content ranging from about 17% to about 38%, an acetyl content ranging from about 13% to about 30%, and a hydroxyl content ranging from about 0.8% to about 1.7%.
23. The method of claim 17 , wherein the method comprises:
placing the formulation within an enclosure or a capsule.
24. The method of claim 23 , wherein the capsule comprises gelatin or hydroxyl propylmethyl cellulose.
25. The method of claim 23 , wherein the capsule is a hard capsule comprising gelatin or hydroxyl propylmethyl cellulose.