Mirtazapine

Mirtazapine is an antidepressant that is not chemically related to any other class of antidepressants. Mirtazapine belongs to a unique class known as piperazinoazepines and is a tetracyclic compound. Mirtazapine possesses an anxiolytic effect that may be useful in depressed patients who have a coexisting anxiety disorder. Mirtazapine may also improve sleep patterns associated with depression. Mirtazapine is associated with fewer ADRs than tricyclic antidepressants and is better tolerated. Selective blockade of specific serotonin receptors by mirtazapine is thought to help to minimize certain side effects (e.g., sexual dysfunction and weight gain) typical of other antidepressants.

Mirtazapine’s innovator is Schering-Plough-Global and appears world-wide under the brand names Remeron and Remeron Soltab.

The primary mechanism of action of mirtazapine is antagonism at central pre-synaptic alpha2-receptors. Normally, these receptors are involved in a negative feedback loop and activation causes inhibition of further norepinephrine (NE) release. By blocking pre-synaptic alpha2-receptors, mirtazapine defeats negative feedback to the presynaptic nerve and causes an increase in NE release. Antagonism at central alpha2-receptors is 10-fold higher than at peripheral alpha2-receptors which results in a reduced incidence of peripheral adverse effects. Mirtazapine also antagonizes several subtypes of serotonin (5-HT) receptors. The drug is a weak antagonist at 5-HT1 receptors and a potent antagonist at 5-HT2 (particularly subtypes 2A and 2C) and 5-HT3 receptors. Blockade of these receptors may result in a lower incidence of certain adverse effects such as anxiety, insomnia, and nausea that occur with other agents like the selective serotonin reuptake inhibitors (SSRIs). Serotonergic neurons also contain alpha2-receptors, called heteroreceptors and blockade of heteroreceptors results in enhanced release of 5-HT. The increased amount of 5-HT released interacts with 5-HT1 receptors which may be relevant to the antidepressant and anxiolytic effects of mirtazapine. Mirtazapine has no effects on the reuptake of either NE or 5-HT. Mirtazapine has minimal activity at dopaminergic and muscarinic receptors.

Mirtazapine appears in the following formulation and dosage:
Tablets: 7.5 mg, 15 mg, 30 mg and 45 mg
Tablets Disintegrating: 15 mg, 30 mg and 45 mg

General data on Mirtazapine Active Pharmaceutical Ingredient

CAS Registry: 61337-67-5
ATC: N06AX11
Molecular Formula: C17H19N3
Molecular Weight: 265.4
Pharmacopoeias: In US.

USP 30: Mirtazapine is anhydrous or contains one-half molecule of water of hydration. Mirtazapine is a white to creamy white, crystalline powder. Mirtazapine is practically insoluble in water; soluble in solvent ether; sparingly soluble in n-hexane; freely soluble in methyl alcohol and in toluene.

TAPI's Mirtazapine Pharmaceutical Ingredient

TAPI's Mirtazapine Active Pharmaceutical Ingredient is produced in Assia Chemical Industries Limited - Teva Tech site in Beer Sheva, Israel.

Mirtazapine is produced by TAPI by Organic synthesis and considered to be medium volume Active Pharmaceutical Ingredient.

2008 Available DMF: U.S. DMF, EU CTD and CEP.

TAPI provide full service on Mirtazapine and other APIs in our portfolio. Our local sales offices provide full information on our product, regulatory compliance and documentation on Mirtazapine. Contact us today for further inquiries and samples and kilograms availability information for TAPI's Mirtazapine.

Other products, in the group of CNS PREPARATIONS - Antidepressant - Others available on TAPI's portfolio are:  Nefazodone Hydrochloride and Trazodone Hydrochloride. Contact us today for information on these products.

Legal Note

Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law. In USA Products  that  Currently on Patent are available for R&D Use in Accordance with 35 USC §271 (e) (1).

*TAPI stands for Teva's Active Pharmaceutical Ingredients