Multiparticulate L-menthol formulations and related methods

A multiparticulate composition comprising a plurality of spheroidal particulates, the particulates comprising:

• a core comprising about 30% to about 70% w/w L-menthol, the L-menthol being supplied to the core as an at least 80% pure L-menthol containing material, the core further comprising about 25% to about 60% w/w microcrystalline cellulose, about 0.5% to about 4% w/w hypromellose, about 1% to about 3% w/w polysorbate 80, about 2% to about 15% w/w colloidal silica, about 4% to about 6% w/w croscarmellose sodium, and about 0.5% to about 4% w/w ascorbic acid;
• a sub-coating comprising hypromellose on the core;
• an enteric coating on the sub-coating;
• and wherein
• the particulates have an average diameter of not more than 3 mm.

A method of making an L-menthol multiparticulate formulation comprising a plurality of particulates having a reduced release under gastric conditions and an elevated release at neutral pH, the method comprising:

• preparing a plurality of cores comprising crystalline L-menthol as an active ingredient;
• drying the cores;
• coating the cores with an enteric coating effective to release at least about 80% of the L-menthol within about two hours of being placed in a substantially neutral pH environment;
• and
• drying the enteric coated cores.