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|Title:||Ibuprofen compositions and methods of making same|
|Abstract:||The present invention provides an improved ibuprofen lysine pharmaceutical composition and a process for preparing the same.|
|Inventor(s):||Krishna; Aravind (Skillman, NJ)|
|Assignee:||Recordati Rare Diseases Inc. (Lebanon, NJ)|
1. A pharmaceutical composition comprising: a) an alkylammonium salt of ibuprofen selected from the group consisting of R ibuprofen, S-Ibuprofen and R,S-ibuprofen; b) an
aqueous, or a non-aqueous solvent; c) optionally an absence of preservative- and d) optionally the presence of an excipient; wherein: the composition is in a unit dosage form in a vial, ampoule, blister pack or prefillable delivery system, said vial,
ampoule, blister pack or prefillable delivery system comprises glass having a silicon dioxide coating or polymer coating disposed on the inner wall.
2. The pharmaceutical composition of claim 1, wherein the composition can be administered parenterally.
3. The pharmaceutical composition of claim 1, wherein there is an absence of preservative.
4. The pharmaceutical composition of 1, wherein there is a presence of excipient.
5. The pharmaceutical composition of claim 1, where in the environment for keeping is inert such that the pharmaceutical composition has less than about 5 .mu.g/L of ibuprofen aluminum salt precipitate.
6. A pharmaceutical composition of claim 1, wherein the composition is in a vial and the polymer coating is comprised of Teflon.RTM..
7. The pharmaceutical composition of claim 1, wherein the composition is in a vial and the coating is comprised of silicon dioxide.
8. The pharmaceutical composition of claim 1, wherein the liquid unit dosage form is a mixture selected from the group consisting of a solution, suspension, dispersion and emulsion.
9. The pharmaceutical composition of claim 1, wherein the alkylammonium salt is selected from a group consisting of d,l-lysine, l-lysine, d-lysine, tromethamine, and meglumine.
10. The pharmaceutical composition of claim 1, wherein the alkylammonium salt is selected from the group consisting of d,l-lysine, l-lysine and d-lysine.
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