Tamper resistant pharmaceutical formulations
Disclosed in certain embodiments is a solid oral dosage form comprising a heat-labile gelling agent; a thermal stabilizer; and a drug susceptible to abuse.
1. A solid oral dosage form comprising a
a heat-labile gelling agent;
a thermal stabilizer;
an opioid agonist, and
a disintegrant, wherein the disintegrant is selected from the group consisting of sodium starch glycolate, crosscarmellose sodium and a mixture thereof.
2. The solid oral dosage form of claim 1 , wherein the heat-labile gelling agent is a polymer.
3. The solid oral dosage form of claim 2 , wherein the polymer is a polysaccharide.
4. The solid oral dosage form of claim 3 , wherein the polysaccharide is a microbial polysaccharide.
5. The solid oral dosage form of claim 4 , wherein the microbial polysaccharide is xanthan gum.
6. The solid oral dosage form of claim 1 , wherein the thermal stabilizer is a gelling agent different than the heat labile gelling agent.
7. The solid oral dosage form of claim 6 , wherein the thermal stabilizer gelling agent is a polymer.
8. The solid oral dosage form of claim 7 , wherein the thermal stabilizer gelling agent polymer is an anionic polymer in a neutral pH aqueous solution.
9. The solid oral dosage form of claim 8 , wherein the anionic polymer is a polyacrylic acid.
10. The solid oral dosage form of claim 9 , wherein the polymer is carbomer homopolymer.
11. The solid oral dosage form of claim 10 , wherein the heat-labile gelling agent is a polysaccharide.
12. The solid oral dosage form of claim 11 , wherein the polysaccharide is a microbial polysaccharide.
13. The solid oral dosage form of claim 1 , wherein the heat-labile gelling agent is xanthan gum and the thermal stabilizer is carbomer homopolymer.
14. The solid oral dosage form of claim 1 , further comprising a pH-modifying agent.
15. The solid oral dosage form of claim 14 , wherein the pH-modifying agent provides a pH of between about 5.5 and 8.5 to a viscous solution obtained when the dosage form is crushed and mixed with 5 mL of distilled water.
16. The solid oral dosage form of claim 15 , wherein the pH-modifying agent provides a pH of between about 6 and 8.
17. The solid oral dosage form of claim 16 , wherein the pH-modifying agent provides a pH of between about 6.5 and 7.5.
18. The solid oral dosage form of claim 14 , wherein the pH-modifying agent is sodium bicarbonate.