Multiparticulate L-Carnitine Compositions and Related Methods
AssigneeZx Pharma, LLC
InventorsSyed M. Shah, Noreen Hassan
Life of this patent
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Abstract
An oral controlled-release multiparticulate dosage form comprises a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach. The individual particulates contain (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating. The dosage form may be used to treat conditions associated with a reduction of the amount of L-carnitine in the body.
Claims26
An oral controlled-release multiparticulate dosage form comprising a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in a patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach, the individual particulates comprising (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating.
An oral controlled-release multiparticulate dosage form comprising a plurality of independently dispersible particulates, the independently dispersible particulates comprising:
- a spheroidal core comprising an L-carnitine, microcrystalline cellulose, and hydroxypropyl methylcellulose;
- a sub-coat over the spheroidal core, the subcoat comprising hydroxypropyl methylcellulose;
- and
- an enteric coat on the sub-coated spheroidal core;
- wherein the average diameter of the independently dispersible particulates is about 0.1-3 mm.
A method of treating a physiological condition associated with a reduction of endogenous L-carnitine in the body, the method comprising:
- administering to a patient in need thereof an effective oral multiparticulate dosage form comprising a plurality of individually enteric coated particulates containing an L-carnitine that independently disperse in the patient's stomach after oral ingestion and travel through the stomach and past the pyloric sphincter without substantially releasing the L-carnitine in the stomach, the individual particulates comprising (a) a solid core containing the L-carnitine, (b) a subcoating containing a cellulosic water soluble polymer over the core, and (c) an enteric coating over the subcoating.
Dependencies are inferred from the claim text.