Sodium Chloride → Formoterol

HRID 1452609

Reaction equation

HRID 1452609 reaction equation
O.C(O)(=O)CC(CC(O)=O)(C(O)=O)O.O.O.C([O-])(=O)CC(CC([O-])=O)(C([O-])=O)O.[Na+].[Na+].[Na+].[Cl-].[Na+].[CH3:35][CH:36]([NH:46][CH2:47][CH:48]([OH:59])[C:49]1[CH:50]=[CH:51][C:52]([OH:58])=[C:53]([NH:55][CH:56]=[O:57])[CH:54]=1)[CH2:37][C:38]1[CH:39]=[CH:40][C:41]([O:44][CH3:45])=[CH:42][CH:43]=1.C(/C(O)=O)=C\C(O)=O.O.O>O>[CH3:35][CH:36]([NH:46][CH2:47][CH:48]([OH:59])[C:49]1[CH:50]=[CH:51][C:52]([OH:58])=[C:53]([NH:55][CH:56]=[O:57])[CH:54]=1)[CH2:37][C:38]1[CH:39]=[CH:40][C:41]([O:44][CH3:45])=[CH:42][CH:43]=1

Participants

6

Reactant 4

HCID 5234Sodium ChlorideHCID 222302-Hydroxy-1,2,3-propanetricarboxylic acid hydrate (1:1)HCID 71474Sodium Citrate DihydrateHCID 11954385HCID 11954385, compound

Product 1

HCID 3410Formoterol

Reagents, catalysts & solvents 1

HCID 962WaterSolvent2×

Procedure

In a clean stainless steel (SS) tank fitted with bottom drain, 75% of the required amount of purified water is added. Samples are taken for pH, conductivity, and microbiological testing. Citric acid monohydrate, sodium citrate dihydrate and sodium chloride are added to the tank and mixed for 15 minutes to dissolve. A sample is taken at this point to check pH. Formoterol fumarate dihydrate is added at this point and mixed for about 75 minutes to dissolve all active raw material. Purified water is used to adjust to final volume. The formulation is mixed for an additional 30 minutes and samples for pH and assay are taken based on which the formulation is released for filling. The bulk solution is filled into low density polyethylene (LDPE) vials (2 mL fill) in a form-fill-seal (FFS) machine. The released drug product solution is transferred from the formulation tank through sanitary delivery lines into the FFS machine. The individual vials are overwrapped with a suitable foil laminate.

Workup

  1. additionis added
  2. additionmixed for 15 minutes
  3. dissolutionto dissolve
  4. additionmixed for about 75 minutes
  5. dissolutionto dissolve all active raw material
  6. additionThe formulation is mixed for an additional 30 minutes
  7. customa form-fill-seal (FFS) machine

Sources & evidence

ORD record
ord-5e60e3c0f5fe4b97bd4fa2486622a01e
Source dataset
uspto-grants-2009_01
Patent number
US07473710B2

Linked notes

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