Sustained-release gel coated compositions

An oral pharmaceutical dosage form comprising active agent and a coating disposed about the active agent, wherein the coating comprises a pharmaceutically acceptable mixture of gelatin and acrylic polymer.

An oral pharmaceutical dosage form comprising a plurality of inert beads, a first layer comprising active agent disposed about the inert beads, and a second layer comprising a pharmaceutically acceptable mixture of gelatin and hydrophobic polymer disposed about the first layer.

The dosage form of claim 35, wherein the opioid antagonist comprises naltrexone or a pharmaceutically acceptable salt thereof.

The dosage form of claim 38, wherein said opioid antagonist is selected from the group consisting of naltrexone, naloxone, nalmephene, cyclazocine, levallorphan, pharmaceutically acceptable salts thereof and mixtures thereof.

An oral pharmaceutical dosage form comprising an inert core, a first layer and a second layer, the first layer being between the core and the second layer, the first layer comprising naltrexone hydrochloride and the second layer comprising a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising an inert core, a first layer, a second layer and a third layer, the first layer being between the core and the second layer, the second layer being between the first layer and the third layer, the first layer comprising naltrexone hydrochloride, the second layer comprising a hydrophobic polymer and the third layer comprising a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising about 10 mg oxycodone hydrochloride, less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising a first component comprising about 10 mg oxycodone hydrochloride, and a second component comprising less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising about 20 mg oxycodone hydrochloride, less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising a first component comprising about 20 mg oxycodone hydrochloride, and a second component comprising less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising about 40 mg oxycodone hydrochloride, less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising a first component comprising about 40 mg oxycodone hydrochloride, and a second component comprising less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising about 5-20 mg hydrocodone bitartrate, less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising a first component comprising about 5-20 mg hydrocodone bitartrate, and a second component comprising less than about 5.0 mg naltrexone hydrochloride and a mixture of gelatin and hydrophobic polymer.

An oral pharmaceutical dosage form comprising a sustained release substrate comprising a matrix comprising an opioid agonist;

• and a coating comprising gelatin disposed about said substrate.

An oral pharmaceutical dosage form comprising a plurality of inert beads, a first layer comprising an active agent selected from the group consisting of an opioid agonist, an opioid antagonist and a mixture thereof, said active agent disposed about the inert beads, a second layer comprising a hydrophobic polymer disposed about the first layer, and a third layer comprising gelatin disposed about the second layer.

An oral pharmaceutical dosage form comprising a plurality of matrices comprising an active agent selected from the group consisting of an opioid agonist, an opioid antagonist and a mixture thereof, said active agent at least partially interdispersed in a hydrophobic polymer;

• and a layer comprising gelatin disposed about said matrices.