Pharmaceutical composition having reduced abuse potential
View Patent ↗A pharmaceutical paste composition comprising an active ingredient such as an addictive substance, a controlled release agent, and a pharmaceutically suitable aqueous or non-aqueous carrier. The composition may comprise one or more of a clay, or an oily, waxy, or fatty substance. The composition may be filled into a capsule or other dispensing device. The composition may reduce dose dumping of an active ingredient. Methods of making and using the composition are also described.
1. A solid oral dosage form comprising:
a pharmaceutical composition enclosed in a capsule shell, the pharmaceutical composition comprising:
(i) an active pharmaceutical agent selected from the group consisting of an opioid and an opiate; and
(ii) 40-50% by weight of an oil selected form the group consisting of almond oil, canola oil, castor oil, corn oil, cottonseed oil, mineral oil, olive oil, olive-pomace oil, peanut oil, safflower oil, sesame oil, soybean oil, sunflower oil, and mixtures thereof; and
(iii) at least 15% by weight of a controlled-release agent selected from the group consisting of hydroxypropyl methylcellulose (hypromellose), hydroxypropyl cellulose, and polyethylene oxide.
2. The solid oral dosage form of claim 1 , wherein (1) the pharmaceutical composition further comprises a clay mineral and (2) the clay mineral is 0.5-20% by weight of the pharmaceutical composition.
3. The solid oral dosage form of claim 2 , wherein the clay mineral is bentonite.
4. The solid oral dosage form of claim 3 , wherein bentonite is 1.0-2.5% by weight of the pharmaceutical composition.
5. The solid oral dosage form of claim 1 , wherein the pharmaceutical composition further comprises bentonite.
6. The solid oral dosage form of claim 1 , wherein the controlled-release agent is hydroxypropyl methylcellulose (hypromellose).
7. The solid oral dosage form of claim 6 , wherein the hydroxypropyl methylcellulose (hypromellose) is 18-22% by weight of the pharmaceutical composition.
8. The solid oral dosage form of claim 1 , wherein the pharmaceutical composition further comprises a carbomer.
9. The solid oral dosage form of claim 8 , wherein the carbomer is 5-8% by weight of the pharmaceutical composition.
10. The solid oral dosage form of claim 1 , wherein the active pharmaceutical agent is an opioid selected from the group consisting of oxycodone and tramadol.
11. The solid oral dosage form of claim 10 , wherein the opioid is oxycodone.
12. A solid oral dosage form comprising:
a pharmaceutical composition enclosed in a capsule shell, the pharmaceutical composition comprising:
(i) an active pharmaceutical agent selected from the group consisting of an opioid and an opiate; and
(ii) 3-50% by weight of an oil selected form the group consisting of almond oil, canola oil, castor oil, corn oil, cottonseed oil, mineral oil, olive oil, olive-pomace oil, peanut oil, safflower oil, sesame oil, soybean oil, sunflower oil, and mixtures thereof; and
(iii) at least 15% by weight of a controlled-release agent selected from the group consisting of hydroxypropyl methylcellulose (hypromellose), hydroxypropyl cellulose, and polyethylene oxide; and
(iv) a carbomer, wherein the carbomer is at least about 5% by weight of the pharmaceutical composition but less than or equal to 8% by weight of the pharmaceutical composition.
13. The solid oral dosage form of claim 12 , wherein (1) the pharmaceutical composition further comprises a clay mineral and (2) the clay mineral is 0.5-20% by weight of the pharmaceutical composition.
14. The solid oral dosage form of claim 13 , wherein the clay mineral is bentonite.
15. The solid oral dosage form of claim 14 , wherein bentonite is 1.0-2.5% by weight of the pharmaceutical composition.
16. The solid oral dosage form of claim 12 , wherein the pharmaceutical composition further comprises bentonite.
17. The solid oral dosage form of claim 12 , wherein the controlled-release agent is hydroxypropyl methylcellulose (hypromellose).
18. The solid oral dosage form of claim 17 , wherein the hydroxypropyl methylcellulose (hypromellose) is 18-22% by weight of the pharmaceutical composition.
19. The solid oral dosage form of claim 12 , wherein the carbomer is 5-8% by weight of the pharmaceutical composition.
20. The solid oral dosage form of claim 12 , wherein the active pharmaceutical agent is an opioid selected from the group consisting of oxycodone and tramadol.
21. The solid oral dosage form of claim 20 , wherein the opioid is oxycodone.