Enteric coated multiparticulate compositions with a proteinaceous subcoat

1. A method of treating irritable bowel syndrome, the method comprising:

administering to a patient having irritable bowel syndrome an effective amount of a multiparticulate dosage form including a plurality of individual spheroidal enteric coated cores having a diameter of 0.1 mm to 3 mm;

the individual spheroidal enteric coated cores comprising (a) a core including menthol, (b) a proteinaceous subcoating over the core, and (c) an enteric coating over the proteinaceous subcoating, wherein the proteinaceous subcoating forms a barrier between the core and enteric coating; and

wherein the multiparticulate dosage form is configured to release more of the menthol in a small intestine of the patient than in a stomach and colon of the patient combined; and

wherein the multiparticulate dosage form is configured to gradually release the menthol into the small intestine over 4 to 8 hours from passing a pyloric sphincter of the patient.

2. The method of claim 1 , wherein the multiparticulate dosage form is configured to release 20% or less of the menthol into the stomach of the patient and 20% or less of the menthol into the colon of the patient.

3. The method of claim 1 , wherein the effective amount is effective for relieving symptoms of irritable bowel syndrome including at least one of abdominal pain, cramps, and diarrhea.

4. The method of claim 1 , wherein the individual spheroidal enteric coated cores comprise 10% w/w to 35% w/w menthol, 40% w/w to 75% w/w microcrystalline cellulose, and 2% w/w to 10% w/w methyl cellulose.

5. The method of claim 1 , wherein the subcoating is 3.5% w/w to 25% w/w of the individual spheroidal enteric coated cores and the enteric coating is 2% to 35% w/w of the individual spheroidal enteric coated cores.

6. The method of claim 1 , wherein the proteinaceous subcoating is predominantly a dried gelatin film.

7. A method of treating functional dyspepsia, the method comprising:

administering to a patient having functional dyspepsia an effective amount of a multiparticulate dosage form including a plurality of individual spheroidal enteric coated cores having a diameter of 0.1 mm to 3 mm;

the individual spheroidal enteric coated cores comprising (a) a core including menthol and caraway oil, (b) a proteinaceous subcoating over the core, and (c) an enteric coating over the proteinaceous subcoating, wherein the proteinaceous subcoating forms a barrier between the core and enteric coating; and

wherein the multiparticulate dosage form is configured to release more of the menthol in a duodenum of the patient than in a stomach, jejunum, and ileum of the patient combined; and

wherein the multiparticulate dosage form is configured to gradually release the menthol into the duodenum for 2 hours from passing a pyloric sphincter of the patient.

8. The method of claim 7 , wherein the multiparticulate dosage form is configured to release 20% or less of the menthol into the stomach of the patient and 20% or less of the menthol into the jejunum and ileum of the patient.

9. The method of claim 7 , wherein the individual spheroidal enteric coated cores comprise 10% w/w to 35% w/w menthol, 40% w/w to 75% w/w microcrystalline cellulose, 2% w/w to 10% w/w methyl cellulose, and 0.05% w/w to 20% w/w of croscarmellose sodium.

10. The method of claim 7 , wherein the subcoating is 3.5% w/w to 25% w/w of the individual spheroidal enteric coated cores and the enteric coating is 2% to 35% w/w of the individual spheroidal enteric coated cores.

11. The method of claim 7 , wherein the proteinaceous subcoating is predominantly a dried gelatin film.

12. A method of treating an inflammatory bowel disease, the method comprising:

administering to a patient having an inflammatory bowel disease an effective amount of a multiparticulate dosage form including a plurality of individual spheroidal enteric coated cores having a diameter of 0.1 mm to 3 mm;

the individual spheroidal enteric coated cores comprising (a) a core including menthol, (b) a proteinaceous subcoating over the core, and (c) an enteric coating over the proteinaceous subcoating, wherein the proteinaceous subcoating forms a barrier between the core and enteric coating; and

wherein the multiparticulate dosage form is configured to release more of the menthol in a colon of the patient than a stomach and small intestine of the patient combined; and

wherein the multiparticulate dosage form is configured to gradually release the menthol into the colon for 4 to 6 hours from passing a pyloric sphincter of the patient.

13. The method of claim 12 , wherein the multiparticulate dosage form is configured to release 30% or less of the menthol into the stomach and small intestine of the patient.

14. The method of claim 12 , wherein the individual spheroidal enteric coated cores comprise 10% w/w to 35% w/w menthol, 40% w/w to 75% w/w microcrystalline cellulose, and 2% w/w to 10% w/w methyl cellulose.

15. The method of claim 12 , wherein the subcoating is 3.5% w/w to 25% w/w of the individual spheroidal enteric coated cores and the enteric coating is 2% to 35% w/w of the individual spheroidal enteric coated cores.

16. The method of claim 12 , wherein the proteinaceous subcoating is predominantly a dried gelatin film.