N-formyl derivatives of paroxetine
AssigneeSynthon BCT Technologies, LLC
InventorsHans J. Hoorn, Theodorus H.A. Peters, Frantisek Picha
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Abstract
A compound or composition comprising N-formyl paroxetine of formula (1) is useful as a pharmaceutical and as a synthetic intermediate. The N-formyl paroxetine can be an impurity in paroxetine substances and methods of assaying for such an impurity are also useful. 1
Claims30
A compound or composition comprising N-formyl paroxetine of formula (1)
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- and 0 to 99.97% of a paroxetine compound, based on the combined weight of said N-formyl paroxetine and said paroxetine compound.
A pharmaceutical composition for treating a selective serotonin reuptake inhibitor-treatable disease or condition, comprising an effective amount of a paroxetine agent and at least one pharmaceutically acceptable excipient, wherein said paroxetine agent consists of an N-formyl paroxetine compound of formula (1) and optionally a paroxetine compound:
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A process which comprises treating an N-formyl paroxetine compound of formula (1)
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- with a de-formylation agent.
A compound having the formula (2):
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A process for determining the stability or purity of a paroxetine substance or composition, which comprises assaying a paroxetine substance or composition for the presence of an N-formyl paroxetine compound of formula (1):
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A process, which comprises
- forming a production lot of paroxetine pharmaceutical solid dosage forms wherein each dosage form comprises paroxetine or a pharmaceutically acceptable salt thereof and at least one pharmaceutically acceptable excipient;
- removing a sample of said paroxetine pharmaceutical solid dosage forms from said production lot;
- assaying said sample for the presence and/or amount of N-formyl paroxetine;
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- selling or releasing said production lot if said sample passes said assay with respect to the presence or amount of N-formyl paroxetine.
Dependencies are inferred from the claim text.