Multiparticulate L-menthol formulations and related methods
A multiparticulate dosage form includes a plurality of individual spheroidal enteric coated particulates having (a) a diameter of 0.1 to 2.5 mm; (b) a solid core containing an effective amount of a combination of an L-menthol source and a terpene-based essential oil; (c) a continuous proteinaceous subcoating over the core; and (d) an enteric coating over the subcoating. The multiparticulate dosage form can be used to treat gastrointestinal disorders.
1. A multiparticulate dosage form comprising a plurality of individual spheroidal enteric coated particulates having (a) a diameter of 0.1 to 2.5 mm; (b) a solid core containing an effective amount of a combination of an L-menthol source and a terpene-based essential oil; (c) a continuous proteinaceous subcoating over the core; and (d) an enteric coating over the subcoating.
2. The multiparticulate dosage form of claim 1 , wherein the effective amount is an amount effective for treating a gastrointestinal disorder.
3. The multiparticulate dosage form of claim 1 , wherein the L-menthol source is at least 80% pure L-menthol.
4. The multiparticulate dosage form of claim 3 , wherein the L-menthol source is crystalline L-menthol.
5. The multiparticulate dosage form of claim 4 , wherein the crystalline L-menthol is dissolved in the terpene-based essential oil.
6. The multiparticulate dosage form of claim 5 , wherein the terpene-based essential oil is peppermint oil.
7. The multiparticulate dosage form of claim 5 , wherein the terpene-based essential oil is caraway oil.
8. The multiparticulate dosage form of claim 3 , wherein the terpene-based essential oil is peppermint oil.
9. The multiparticulate dosage form of claim 3 , wherein the terpene-based essential oil is caraway oil.
10. The multiparticulate dosage form of claim 1 , wherein the proteinaceous subcoating is a dried proteinaceous gel.
11. The multiparticulate dosage form of claim 1 , wherein the proteinaceous subcoating is a gelatin film.
12. The multiparticulate dosage form of claim 1 , wherein the proteinaceous subcoating is a continuous coating of gelatin substantially surrounding the core.
13. The multiparticulate dosage form of claim 1 , wherein:
the L-menthol source is crystalline L-menthol, the terpene-based essential oil is peppermint oil, and the L-menthol is dissolved in the peppermint oil;
the proteinaceous subcoating is a continuous coating of gelatin substantially surrounding the core; and
the enteric coating is a methacrylic acid based polymer material.
14. The multiparticulate dosage form of claim 1 , wherein:
the L-menthol source is crystalline L-menthol, the terpene-based essential oil is caraway oil, and the crystalline L-menthol is dissolved in the caraway oil;
the proteinaceous subcoating is a continuous coating of gelatin substantially surrounding the core; and
the enteric coating is a methacrylic acid based polymer material.
15. A multiparticulate dosage form comprising a plurality of individual spheroidal enteric coated particulates having (a) a diameter of 0.1 to 2.5 mm; (b) a solid core containing an effective amount of a combination of an L-menthol source and EGCG; (c) a continuous proteinaceous subcoating over the core, and (d) an enteric coating over the subcoating.
16. The multiparticulate dosage form of claim 15 , wherein the proteinaceous subcoating is a dried proteinaceous gel.
17. The multiparticulate dosage form of claim 15 , wherein the proteinaceous subcoating is a gelatin film.
18. The multiparticulate dosage form of claim 15 , wherein the proteinaceous subcoating is a continuous coating of gelatin substantially surrounding the core.
19. The multiparticulate dosage form of claim 15 , wherein the L-menthol source is crystalline L-menthol.
20. The multiparticulate dosage form of claim 15 , wherein the L-menthol source is at least 80% pure L-menthol.
21. The multiparticulate dosage form of claim 15 , wherein:
the L-menthol source is crystalline L-menthol;
the proteinaceous subcoating is a continuous coating of gelatin substantially surrounding the core; and
the enteric coating is a methacrylic acid based polymer material.