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 oral dosage form comprising:
a compressed mixture comprising: (i) an opioid agonist; and (ii) a gelling agent selected from the group consisting of microcrystalline cellulose, a cellulosic polymer and a combination thereof;
the oral dosage form having a ratio of gelling agent to opioid agonist from about 40:1 to about 1:40;
the oral dosage form providing an immediate release when orally administered to a human patient.
42 . The oral dosage form of claim 41 , wherein the cellulosic polymer comprises sodium carboxymethylcellulose.
43 . The oral dosage form of claim 41 , wherein the gelling agent comprises microcrystalline cellulose and the cellulosic polymer.
44 . The oral dosage form of claim 43 , wherein the cellulosic polymer comprises sodium carboxymethylcellulose.
45 . The oral dosage form of claim 41 , wherein the gelling agent further comprises polyvinyl pyrrolidone.
46 . The oral dosage form of claim 42 , wherein the gelling agent comprises microcrystalline cellulose, sodium carboxymethylcellulose and polyvinyl pyrrolidone.
47 . The oral dosage form of claim 46 , wherein the compressed mixture further comprises lactose.
48 . The oral dosage form of claim 46 , wherein the compressed mixture further comprises magnesium stearate.
49 . The oral dosage form of claim 46 , wherein the compressed mixture further comprises lactose and magnesium stearate.
50 . The oral dosage form of claim 46 , wherein the oral dosage form is a compressed tablet.
51 . The oral dosage form of claim 50 , wherein the compressed tablet is coated with a film.
52 . The oral dosage form of claim 51 , wherein the film is a seal coat.
53 . The oral dosage form of claim 51 , wherein the film comprises polyethylene glycol.
54 . The oral dosage form of claim 51 , wherein the film comprises polyvinyl alcohol.
55 . The oral dosage form of claim 51 , wherein the film comprises talc.
56 . The oral dosage form of claim 44 , wherein the ratio of gelling agent to opioid agonist is from about 30:1 to about 1:30.
57 . The oral dosage form of claim 44 , wherein the ratio of gelling agent to opioid agonist is from about 15:1 to about 1:15.
58 . The oral dosage form of claim 44 , wherein the ratio of gelling agent to opioid agonist is from about 8:1 to about 1:8.
59 . An oral dosage form comprising:
a compressed tablet comprising: (i) an opioid agonist; (ii) a gelling agent comprising microcrystalline cellulose, sodium carboxymethylcellulose and polyvinyl pyrrolidine; (iii) lactose; and (iv) magnesium stearate; and
a coating over the compressed tablet, the coating comprising polyvinyl alcohol, polyethylene glycol and talc;
the oral dosage form having a ratio of gelling agent to opioid agonist from about 8:1 to about 1:8;
the oral dosage form providing an immediate release when orally administered to a human patient.