Duloxetine formulation

Abstract

A duloxetine pellet formulation comprises: (i) a core including a desired amount of duloxetine; (ii) an enteric coating comprising hydroxypropylmethylcellulose phthalate (HPMCP) as an enteric polymer;and, optionally, (iii) a separating layer located between the core and the enteric coating, the separating layer including polyvinyl alcohol and a low molecular weight hydroxypropylmethylcellulose (HPMC).

Description

technical field [0001] The invention relates to an active substance duloxetine pharmaceutical preparation and a preparation process thereof. Background technique [0002] Duloxetine: (+)-(S)-N-methyl-y-(1-naphthyloxy)-2-thienylamine hydrochloride is an SSNRI (selective serotonin and norepinephrine reuptake inhibitor ) is a well-known drug in the class of compounds, which can be used in the treatment of depression MDD, diabetic peripheral neuralgia and incontinence, especially stress urinary incontinence (SUI). The hydrochloride salt is commonly used, and the term "duloxetine" is used hereinafter to refer generally to duloxetine free base, but is also used to refer to duloxetine salts and other duloxetine compounds, But generally refers to its hydrochloride. [0003] Duloxetine is known to be unstable in acidic media. Therefore, there is a need to protect the active substance thereof from the acidic environment of the stomach and to allow its release in the gastrointestina...

AI Technical Summary

Problems solved by technology

[0004] However, duloxetine is also known to react with many known enteric coatings, forming a slowly dissolving or even insoluble coating, reducing the bioavailability of the active substance

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