Modified-release pharmaceutical drug composition
The present invention provides compositions and methods for a modified-release pharmaceutical drug composition having a first charged active agent and a second charged active agent at least partially surrounded by a rate controlling membrane. The first charged active agent and the second charged active agent interact to form a modified release pharmaceutical complex within the rate controlling membrane and the modified release pharmaceutical complex has a release characteristic different from the release characteristic of the first active agent or the second active agent alone.
1. A controlled release composition, comprising phenylephrine/phenylephrine-HCl and ibuprofen,
wherein the composition further comprises an ion exchange resin equilibrated with the phenylephrine/phenylephrine-HCl and the ion exchange resin equilibrated with the phenylephrine/phenylephrine-HCl is (i) coated with the ibuprofen or (ii) coated with phenylephrine/phenylephrine-HCl and ibuprofen, and
wherein the ion exchange resin equilibrated with the phenylephrine/phenylephrine-HCl and (i) coated with the ibuprofen or (ii) coated with phenylephrine/phenylephrine-HCl and ibuprofen is further coated with a rate controlling membrane,
wherein the composition is suspended in a pharmaceutically acceptable syrup and wherein the syrup further comprises ibuprofen dissolved or suspended therein.
2. The composition of claim 1 , wherein a molar ratio of the phenylephrine/phenylephrine-HCl and the ibuprofen is in a range of about 1:2 to 1:0.75.
3. The composition of claim 1 , wherein a molar ratio of the phenylephrine/phenylephrine-HCl and the ibuprofen is in a range of about 1:1 to 1:0.9.
4. A method of preparing a controlled release active agent-ion exchange resin composition, comprising:
loading an ion exchange resin with phenylephrine or phenylephrine-HCl to result in an active agent-ion exchange resin such that the ion exchange resin is equilibrated with the phenylephrine or phenylephrine-HCl;
coating the active agent-ion exchange resin with ibuprofen;
coating the ion exchange resin loaded with the phenylephrine or phenylephrine-HCl and coated with the ibuprofen with a rate controlling membrane, and
suspending the composition in a pharmaceutically acceptable syrup containing the ibuprofen dissolved or suspended therein.
5. The method of claim 4 ,
wherein the phenylephrine or phenylephrine-HCl is loaded onto the ion exchange resin by equilibration; or
wherein the ion exchange resin is equilibrated with the phenylephrine or phenylephrine-HCl by suspending the ion exchange resin in a solution containing the phenylephrine or phenylephrine-HCl, and wherein the ion exchange resin is then separated from the solution to result in a filtrate and the ion exchange resin equilibrated with the phenylephrine or phenylephrine-HCl; and wherein the remaining phenylephrine or phenylephrine-HCl in the filtrate of the solution is coated back onto the ion exchange resin equilibrated with the phenylephrine or phenylephrine-HCl.
6. The method of claim 5 , wherein the phenylephrine or phenylephrine-HCl in the filtrate is coated onto the ion exchange resin by spray coating.