Orally administrable nifedipine solution in a solid light resistant dosage form

摘要

A solid dosage form having a fill composition encased in a shell composition; the fill composition comprising (a) 5-60 mg of nifedipine; (b) a 5-7 membered cyclic pharmaceutically acceptable ingestible carbonate of the formula I where A is an alpha,omega-C2-C4 alkylene which is unsubstituted or substituted by at least one C1-C4 alkyl; and (c) a pharmaceutically acceptable ingestible surfactant having a total of d ring members and being of the formula II wherein B is a C1-4-alpha,omega-alkylene; n is an integer from 0 up to d-1; m is an integer from 0 up to (d-n-1); each R is independently H or a C1-4alkyl which is unsubstituted or substituted by at least one R'; each R' is independently a hydroxy which is free, etherified by R2, or esterified by R3; each R2 is a C2-4 straight or branched oxyalkylene or a poly (C2-4 straight or branched oxyalkylene), the terminal oxygen of which is bound to hydrogen or R3; and each R3 is independently an acyl of a C2-24 alkanoic acid or a C4-24 alkeneoic acid; provided that there is at least one free hydroxy group, at least one R3 group, and at least 5 now cyclic etherified oxygen atoms per molecule of formula II; (b) and (c) being present in amounts sufficient to dissolve the nifedipine therein; the shell composition comprising at least gelatin and a dye.