Pharmaceutical Formulation Containing Gelling Agent
Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.
1 - 40 . (canceled)
41 . An abuse deterrent controlled release dosage form comprising:
an extruded mixture comprising an opioid agonist and a gelling agent selected from the group consisting of polyethylene oxide, a cellulosic polymer and a combination thereof; and
the dosage form having a ratio of gelling agent to opioid agonist from about 40:1 to about 1:40;
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
42 . The abuse deterrent controlled release dosage form of claim 41 , wherein the mixture comprises polyethylene and the cellulosic polymer.
43 . The abuse deterrent controlled release dosage form of claim 41 , wherein the cellulosic polymer is hydroxypropylmethylcellulose.
44 . The abuse deterrent controlled release dosage form of claim 43 , wherein the gelling agent further comprises polyethylene glycol.
45 . The abuse deterrent controlled release dosage form of claim 44 , wherein the mixture further comprises alpha-tocopherol.
46 . The abuse deterrent controlled release dosage form of claim 45 , wherein the dosage form is a compressed tablet.
47 . The abuse deterrent controlled release dosage form of claim 46 , further comprising coating the tablet with a film.
48 . The method of claim 45 , wherein the polyethylene oxide has a weight average molecular weight from about 100,000 daltons to about 1,000,000 daltons.
49 . The method of claim 45 , wherein the polyethylene oxide has a weight average molecular weight from about 1,000,000 daltons to about 10,000,000 daltons.
50 . The method of claim 45 , wherein the ratio of gelling agent to opioid agonist is from about 1:1 to about 30:1.
51 . The method of claim 45 , wherein the ratio of gelling agent to opioid agonist is from about 2:1 to about 15:1.
52 . An abuse deterrent controlled release dosage form comprising:
(i) an opioid agonist;
(ii) alpha-tocopherol;
(iii) polyethylene oxide;
(iv) polyethylene glycol; and
(v) hydroxypropylmethylcellulose;
the dosage form providing a therapeutic effect for about 12 hours or longer when orally administered to a human patient.
53 . The abuse deterrent controlled release dosage form of claim 52 , further comprising:
(vi) polyvinyl alcohol; and
(vii) talc.