Coated capsules and tablets of a fatty acid oil mixture

摘要

Compositions comprising a fatty acid oil mixture and at least one free fatty acid in a coated capsule or a coated tablet form suitable for oral administration, and methods of use thereof, are disclosed. Further disclosed are preconcentrates comprising a fatty acid oil mixture, at least one surfactant, and optionally at least one free fatty acid, in a coated capsule or a coated tablet form, and methods of use thereof. The preconcentrates are capable of forming a self-nanoemulsifying drug delivery system (SNEDDS), a self-microemulsifying drug delivery system (SMEDDS), or self-emulsifying drug delivery systems (SEDDS) in an aqueous solution.

主权项

1. A preconcentrate in a gelatin capsule or a tablet form comprising:
a fatty acid oil mixture comprising from about 45% to about 55% by weight, relative to the weight of the preconcentrate, wherein the fatty acid oil mixture comprises from about 80% to about 88% eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) by weight of the fatty acid oil mixture, and the EPA and DHA are in ethyl ester form; and at least one free fatty acid comprising from about 10% to about 15% by weight, relative to the weight of the preconcentrate, of the at least one free fatty acid, wherein the at least one free fatty acid comprises from about 80% to about 88% EPA and DHA, by weight of the at least one free fatty acid, and the EPA and DHA are in free fatty acid form; and at least one nonionic surfactant comprising from about 15% to about 35% by weight, relative to the weight of the preconcentrate, wherein the at least one nonionic surfactant is chosen from comprises polysorbate 20;wherein the gelatin capsule or the tablet comprises at least one coating; andfurther wherein the preconcentrate, the gelatin capsule, and the at least one coating do not comprise an additional active pharmaceutical ingredient other than the fatty acid oil mixture.