Multiparticulate L-menthol formulations and related methods
A pharmaceutical dosage form includes an effective amount of L-menthol for treating a gastrointestinal disorder. The L-menthol is within a plurality of particulates having a core including crystalline L-menthol dissolved in a terpene-based essential oil. A proteinaceous coating of a continuous film of proteinaceous material is over the core.
1. A pharmaceutical dosage form comprising an effective amount of L-menthol for treating a gastrointestinal disorder, the L-menthol being within a plurality of particulates having:
(a) a core including crystalline L-menthol dissolved in a terpene-based essential oil, a hydrophobic phase, and a hydrophilic phase; the crystalline L-menthol dissolved in the terpene-based essential oil being in the hydrophobic phase;
(b) a proteinaceous coating of a continuous film of proteinaceous material over the core, forming a proteinaceous material coated core; and
(c) an enteric coating over the proteinaceous material coated core.
2. The pharmaceutical dosage form of claim 1 , wherein the plurality of particulates are in a capsule or packet-type dosage form for oral delivery.
3. The pharmaceutical dosage form of claim 1 , wherein the effective amount is about 10 mg to about 200 mg of L-menthol.
4. The pharmaceutical dosage form of claim 1 , wherein the terpene-based essential oil is peppermint oil.
5. The pharmaceutical dosage form of claim 1 , wherein the terpene-based essential oil is caraway oil.
6. The pharmaceutical dosage form of claim 1 , wherein the proteinaceous material includes gelatin.
7. The pharmaceutical dosage form of claim 1 , wherein the proteinaceous material includes acid bone gelatin.
8. The pharmaceutical dosage form of claim 1 , wherein the proteinaceous coating is a gelatin film.
9. The pharmaceutical dosage form of claim 1 , wherein the core also includes both of methylcellulose and microcrystalline cellulose.
10. The pharmaceutical dosage form of claim 1 , wherein:
the terpene-based essential oil is peppermint oil;
the proteinaceous coating is a continuous coating of gelatin; and
the enteric coating is a methacrylic acid based polymer coating over the proteinaceous material coated core.
11. The pharmaceutical dosage form of claim 1 , wherein:
the terpene-based essential oil is caraway oil;
the proteinaceous coating is a continuous coating of gelatin; and
the enteric coating is a methacrylic acid based polymer coating over the proteinaceous material coated core.
12. The pharmaceutical dosage form of claim 1 , wherein the proteinaceous coating is effective to substantially prevent L-menthol in the core from leaving the core when stored at a temperature of 40 degrees C. and 75% relative humidity for between 1 day to 30 days.
13. The pharmaceutical dosage form of claim 1 , wherein the core is a solid spheroid.
14. The pharmaceutical dosage form of claim 1 , wherein the hydrophilic phase includes a hydrogel polymer matrix and the hydrophobic phase includes a hydrophobic polymer matrix.