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. A method of preparing an oral dosage form comprising:
preparing a mixture comprising:
(i) an opioid agonist; and
(ii) a gelling agent comprising microcrystalline cellulose, a cellulosic polymer and polyvinyl pyrrolidone, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration when the dosage form is subjected to tampering by dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid;
(iii) lactose; and
(vi) magnesium stearate;
compressing the mixture into a tablet; and
coating the tablet with a 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.
2. The method of claim 1 , wherein the cellulosic polymer comprises sodium carboxymethylcellulose.
3. The method of claim 1 , wherein the coating is a seal coat.
4. The method of claim 1 , wherein the aqueous liquid is water.
5. The method of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering by crushing and dissolution in the aqueous liquid.
6. The method of claim 1 , wherein the viscosity is imparted when the dosage form is subjected to tampering by dissolution in the aqueous liquid with heating greater than 45° C.
7. A method of preparing an oral dosage form comprising:
preparing a mixture comprising:
(i) an opioid agonist; and
(ii) a gelling agent comprising microcrystalline cellulose, sodium carboxymethylcellulose and polyvinyl pyrrolidone, the gelling agent in an effective amount to impart a viscosity unsuitable for parenteral administration when the dosage form is subjected to tampering by dissolution in from about 0.5 ml to about 10 ml of an aqueous liquid;
(iii) lactose; and
(iv) magnesium stearate;
compressing the mixture into a tablet; and
coating the tablet with a film 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.