Formoterol tartrate process and polymorph
A method of preparation of a highly pure salt of R,R-formoterol L-tartrate is disclosed. The process provides the most thermodynamically stable polymorph by recrystallization of a novel polymorph.
1. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a highly pure (R,R)-formoterol L-tartrate comprising less than 0.5% by weight of chemical impurities other than formoterol L-tartrate, said chemical impurities including less than 0.1% by weight (based on total crystalline solid) of a compound of formula 8:
wherein said composition is obtained by combining (R,R)-formoterol L-tartrate polymorph A and the pharmaceutically acceptable carrier.
2. An aerosol pharmaceutical composition according to claim 1 .
3. An oral pharmaceutical composition according to claim 1 .
4. An oral pharmaceutical composition according to claim 3 in the form of a tablet, capsule or syrup.
5. A dry powder pharmaceutical composition for inhalation according to claim 1 .
6. The pharmaceutical composition of claim 1 , wherein the highly pure (R,R)-formoterol L-tartrate comprises less than about 0.4% by weight of chemical impurities other than formoterol L-tartrate.
7. A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a highly pure (R,R)-formoterol L-tartrate comprising less than 0.5% by weight of chemical impurities other than formoterol L-tartrate, said chemical impurities including less than 0.1% by weight (based on total crystalline solid) of a compound of formula 8:
wherein said composition is obtained by combining solid (R,R)-formoterol L-tartrate having a differential scanning calorimetry pattern as shown in FIG. 8 and the pharmaceutically acceptable carrier.
8. An aerosol pharmaceutical composition according to claim 7 .
9. An oral pharmaceutical composition according to claim 7 .
10. An oral pharmaceutical composition according to claim 9 in the form of a tablet, capsule or syrup.
11. A dry powder pharmaceutical composition for inhalation according to claim 7 .
12. The pharmaceutical composition of claim 7 , wherein the highly pure (R,R)-formoterol L-tartrate comprises less than about 0.4% by weight of chemical impurities other than formoterol L-tartrate.