Enteric coated multiparticulate controlled release peppermint oil composition and related methods

1. A multiparticulate composition comprising a plurality of individual enteric coated cores, the cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel.

2. The multiparticulate composition of claim 1 , further comprising a continuous proteinaceous subcoating layer covering the individual cores and separating the individual cores from their respective enteric coatings.

3. The multiparticulate composition of claim 2 , wherein the continuous proteinaceous subcoating comprises a gelatin film adhered to the core.

4. The multiparticulate composition of claim 2 , wherein the continuous proteinaceous subcoating comprises a dried proteinaceous gel.

5. The multiparticulate composition of claim 2 , wherein the continuous proteinaceous subcoating is adapted to prevent the peppermint oil from mixing with the enteric coating.

6. The multiparticulate composition of claim 2 , wherein the enteric coating has a glass transition temperature higher than a standard boiling point of the peppermint oil.

7. The multiparticulate composition of claim 1 , wherein the enteric coated cores release no more than about 20% of the peppermint oil within about two hours of being placed in a 0.1 N HCl solution and, subsequently, no less than about 85% of the peppermint oil within about eight hours of being placed in a substantially neutral pH environment.

8. The multiparticulate composition of claim 1 , wherein the enteric coated cores are spheroidal and not more than 3 mm in diameter.

9. A multiparticulate composition comprising a plurality of individual enteric coated cores containing about 15% w/w to about 40% w/w peppermint oil, about 35% w/w to about 75% w/w microcrystalline cellulose, and about 2% w/w to about 15% w/w methylcellulose, wherein the % w/w is the % w/w of the enteric coated cores.

10. The multiparticulate composition of claim 9 , further comprising a continuous proteinaceous subcoating layer covering the cores and separating the cores from their respective enteric coatings.

11. The multiparticulate composition of claim 10 , wherein the continuous proteinaceous subcoating comprises a gelatin film adhered to the core.

12. The multiparticulate composition of claim 10 , wherein the continuous proteinaceous subcoating comprises a dried proteinaceous gel.

13. The multiparticulate composition of claim 10 , wherein the continuous proteinaceous subcoating is adapted to prevent the peppermint oil from mixing with the enteric coating.

14. The multiparticulate composition of claim 10 , wherein the enteric coating has a glass transition temperature higher than a standard boiling point of the peppermint oil.

15. The multiparticulate composition of claim 10 , wherein the enteric coated cores release no more than about 20% of the peppermint oil within about two hours of being placed in a 0.1 N HCl solution and, subsequently, no less than about 85% of the peppermint oil within about eight hours of being placed in a substantially neutral pH environment.

16. The multiparticulate composition of claim 9 , wherein the enteric coated cores are spheroidal and not more than 3 mm in diameter.

17. A method of making a multiparticulate composition, the method comprising:

blending peppermint oil, microcrystalline cellulose, a hydrogel forming polymer, and water to form a wet mass including a hydrophobic phase containing the peppermint oil dispersed in a microcrystalline cellulose gel and a hydrophilic phase containing the hydrogel forming polymer and water;

extruding the wet mass to form an extrudate;

dividing the extrudate into individual wet cores;

removing water from the hydrophilic phase in the wet cores to form dried cores; and

applying an enteric coating to the dried cores.

18. The method of claim 17 , further comprising coating the dried cores with a liquid proteinaceous material and drying the liquid proteinaceous material to form sub-coated cores prior to applying the enteric coating.

19. The method of claim 18 , wherein the liquid proteinaceous material comprises gelatin.

20. The method of claim 18 , wherein the liquid proteinaceous material is a solution containing at least about 50% gelatin.

21. The method of claim 18 , wherein coating the dried cores with a liquid proteinaceous material comprises spraying the liquid proteinaceous material onto the dried cores.

22. The method of claim 17 , wherein the enteric coated core is spheroidal and not more than 3 mm in diameter.

23. The method of claim 17 , wherein removing water from the hydrophilic phase in the wet cores to form dried cores is achieved without substantially removing peppermint oil.

24. A method of treating a gastrointestinal disorder in a subject, the method comprising administering to the subject a multiparticulate composition comprising a plurality of individual enteric coated cores, the cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and hydrophilic phase containing a hydrogel.

25. The method of claim 24 , wherein administering is performed enterally.

26. The method of claim 24 , wherein the multiparticulate composition is blended with an acidic vehicle prior to being administered.