Use of polyalkylamine polymers in controlled release devices

A controlled release solid dosage form comprising:

• a pharmaceutical composition comprising an amine drug, wherein the amine drug is the free base or salt form of [S-(R,S)]-2-[4-[[(4-methyl)piperazin-1-yl]carbonyl]phenoxy]-3,3-diethyl-N-[1-(3,4-methylenedioxyphenyl)butyl]-4-oxo-1-azetidinecarboxamide) and a polyalkylamine polymer, wherein the polyalkylamine polymer is cross-linked polymeric ammonium salt and comprises groups that link ammonium nitrogen atoms wherein:
• about 25% or more of the groups which link ammonium nitrogen atoms are group Y, wherein each Y is independently —C(R1R2)b—;
• b is an integer of 7 to about 20;
• and each R1 and each R2 is independently alkylene of about 1 to 20 carbon atoms;
• zero to about 75% of the groups which link ammonium nitrogen atoms are group Z wherein Z is a hydrocarbylene radical containing 2 to 50 carbon atoms, the hydrocarbylene radical optionally containing or substituted with one or more hydroxyl, ether, ester, amino, thioether, keto, silyl group or helerocyclic rings;
• about 25% or more of the ammonium nitrogen atoms are secondary ammonium nitrogen atoms;
• and said cross-linked polymeric ammonium salt is insoluble in water;
• a coat surrounding the pharmaceutical composition and comprising a film-forming polymer and plasticizer;
• and
• plural apertures in the coat;
• wherein the amine drug and polyalkylamine polymer are released through the apertures when the dosage form is placed into an aqueous environment of use, and the dosage form provides a controlled release of the amine drug.