ABUSE DETERRENT COMPOSITIONS AND METHODS OF USE

1 . A method of treating, preventing, reducing the occurrence of, decreasing the severity or degree of, and/or reducing the signs and/or symptoms of a disease or condition in a subject in need thereof,

wherein the disease or condition is selected from the group consisting of: pain, sleep disorders, anxiety, attention deficit hyperactivity disorder, narcolepsy, and depression in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising at least one drug, at least one pH-dependent agent, and at least one pH-independent agent;

wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid and kept in sustained contact with at least one other unit dosage of the composition for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics: (1) a weight gain of 0 to 25%; (2) an increase in thickness of 0 to 25%; and (3) an increase in mucoadhesive strength of 0 to 25%.

2 . The method of claim 1 , wherein the disease or condition is selected from the group consisting of: chronic pain or acute pain.

3 . The method of claim 1 , wherein the disease or condition is pain associated with, secondary to, or caused by osteoarthritis, rheumatoid arthritis, fibromyalgia, migraine or other headache, back-related disorder, shingles, stiffened joints, physical trauma, cardiovascular condition, cancer, sciatica, kidney stones, appendicitis, neuralgia, pancreatitis, gout, endometriosis, stomach ulcers, Crohn's Disease, or post-operative condition.

4 . The method of claim 1 , wherein the pharmaceutical composition comprises a central nervous stimulant or central nervous depressant.

5 . The method of claim 1 , wherein the drug is selected from the group consisting of: opioids, benzodiazepines, barbiturates, and amphetamines.

6 . The method of claim 1 , wherein the drug is selected from the group consisting of: fentanyl, sufentanil, carfentanil, lofentanil, alfentanil, hydromorphone, oxycodone, morphine, hydroxycodone, propoxyphene, pentazocine, methadone, tilidine, butorphanol, buprenorphine, levorphanol, codeine, oxymorphone, meperidine, and dihydrocodeinone and pharmaceutically acceptable salts thereof.

7 . The method of claim 1 , wherein the drug is selected from the group consisting of: oxycodone, hydrocodone, codeine, morphine, oxymorphone and hydromorphone, and pharmaceutically acceptable salts and esters thereof.

8 . A pharmaceutical composition comprising at least one drug, at least one pH-dependent agent, and at least one pH-independent agent;

wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid and kept in sustained contact with at least one other unit dosage of the composition for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics: (1) a weight gain of 0 to 25%; (2) an increase in thickness of 0 to 25%; and (3) an increase in mucoadhesive strength of 0 to 25%.

9 . The pharmaceutical composition of claim 8 , wherein the at least one drug is selected from the group consisting of: central nervous stimulants, opioids, barbiturates, benzodiazepines, and sedatives.

10 . The pharmaceutical composition of claim 8 , wherein the drug is selected from the group consisting of alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, desomorphine, dextromoramide, dezocine, diampromide, diamorphone, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, levophenacylmorphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, nalbuphene, normorphine, norpipanone, opium, oxycodone, oxymorphone, papavereturn, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propoxyphene, sufentanil, tilidine, and tramadol.

11 . The pharmaceutical composition of claim 8 , wherein the drug is morphine.

12 . The pharmaceutical composition of claim 8 , wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid and kept in sustained contact with at least one other unit dosage of the composition for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics:

(1) a weight gain of 0 to 15%; (2) an increase in thickness of 0 to 15%; and (3) an increase in mucoadhesive strength of 0 to 15%.

13 . The pharmaceutical composition of claim 8 , wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid and kept in sustained contact with at least one other unit dosage of the composition for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics:

(1) a weight gain of 0 to 10%; (2) an increase in thickness of 0 to 10%; and (3) an increase in mucoadhesive strength of 0 to 10%.

14 . The pharmaceutical composition of claim 8 , wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid and kept in sustained contact with at least one other unit dosage of the composition for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics:

(1) a weight gain of 0 to 5%; (2) an increase in thickness of 0 to 5%; and (3) an increase in mucoadhesive strength of 0 to 5%.

15 . A method of treating, preventing, reducing the occurrence of, decreasing the severity or degree of, and/or reducing the signs and/or symptoms of a disease or condition in a subject in need thereof,

wherein the disease or condition is selected from the group consisting of: pain, sleep disorders, anxiety, attention deficit hyperactivity disorder, narcolepsy, and depression in a subject in need thereof, comprising administering to the subject a pharmaceutical composition comprising at least one drug, at least one pH-dependent agent, and at least one pH-independent agent;

wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics: (1) a weight gain of 0 to 25%; (2) an increase in thickness of 0 to 25%; and (3) an increase in mucoadhesive strength of 0 to 25%.

16 . The method of claim 15 , wherein the disease or condition is selected from the group consisting of: chronic pain or acute pain.

17 . The method of claim 15 , wherein the disease or condition is pain associated with, secondary to, or caused by osteoarthritis, rheumatoid arthritis, fibromyalgia, migraine or other headache, back-related disorder, shingles, stiffened joints, physical trauma, cardiovascular condition, cancer, sciatica, kidney stones, appendicitis, neuralgia, pancreatitis, gout, endometriosis, stomach ulcers, Crohn's Disease, or post-operative condition.

18 . The method of claim 15 , wherein the pharmaceutical composition comprises a central nervous stimulant or central nervous depressant.

19 . The method of claim 15 , wherein the drug is selected from the group consisting of: opioids, benzodiazepines, barbiturates, and amphetamines.

20 . The method of claim 15 , wherein the drug is selected from the group consisting of: fentanyl, sufentanil, carfentanil, lofentanil, alfentanil, hydromorphone, oxycodone, morphine, hydroxycodone, propoxyphene, pentazocine, methadone, tilidine, butorphanol, buprenorphine, levorphanol, codeine, oxymorphone, meperidine, and dihydrocodeinone and pharmaceutically acceptable salts thereof.

21 . The method of claim 15 , wherein the drug is selected from the group consisting of: oxycodone, hydrocodone, codeine, morphine, oxymorphone and hydromorphone, and pharmaceutically acceptable salts and esters thereof.

22 . A pharmaceutical composition comprising at least one drug, at least one pH-dependent agent, and at least one pH-independent agent;

wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics: (1) a weight gain of 0 to 25%; (2) an increase in thickness of 0 to 25%; and (3) an increase in mucoadhesive strength of 0 to 25%.

23 . The pharmaceutical composition of claim 22 , wherein the at least one drug is selected from the group consisting of: central nervous stimulants, opioids, barbiturates, benzodiazepines, and sedatives.

24 . The pharmaceutical composition of claim 22 , wherein the drug is selected from the group consisting of alfentanil, allylprodine, alphaprodine, anileridine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, desomorphine, dextromoramide, dezocine, diampromide, diamorphone, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone, eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine, etonitazene, hydrocodone, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levorphanol, levophenacylmorphan, lofentanil, meperidine, meptazinol, metazocine, methadone, metopon, morphine, myrophine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, nalbuphene, normorphine, norpipanone, opium, oxycodone, oxymorphone, papavereturn, pentazocine, phenadoxone, phenomorphan, phenazocine, phenoperidine, piminodine, piritramide, propheptazine, promedol, properidine, propoxyphene, sufentanil, tilidine, and tramadol.

25 . The pharmaceutical composition of claim 22 , wherein the drug is morphine.

26 . The pharmaceutical composition of claim 22 , wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics:

(1) a weight gain of 0 to 15%; (2) an increase in thickness of 0 to 15%; and (3) an increase in mucoadhesive strength of 0 to 15%.

27 . The pharmaceutical composition of claim 22 , wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics:

(1) a weight gain of 0 to 10%; (2) an increase in thickness of 0 to 10%; and (3) an increase in mucoadhesive strength of 0 to 10%.

28 . The pharmaceutical composition of claim 22 , wherein the composition is configured such that when a unit dosage of the composition is submerged in water and/or Simulated Gastric Fluid for a time period selected from 15 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours, the unit dosage has at least one of the following characteristics:

(1) a weight gain of 0 to 5%; (2) an increase in thickness of 0 to 5%; and (3) an increase in mucoadhesive strength of 0 to 5%.