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SOLIAN (AMISULPRIDE): CLINICAL PHARMACOLOGY

Class: Neuroleptic of the benzamide class.

Pharmacodynamics

Amisulpride binds selectively to the human dopaminergic D2 (Ki 2.8 nM) and D3 (Ki 3.2 nM) receptor subtypes without any affinity for D1, D4 and D5 receptor subtypes (Ki > 1 mM). Unlike classical and atypical neuroleptics, amisulpride displays low affinity for serotonin, alpha-adrenergic, histamine receptor subtypes, muscarinic receptors and sigma sites.

In the rodent, it preferentially blocks post-synaptic D2 receptors located in the limbic structures as compared to those in the striatum as indicated by its reversal of d-amphetamine-induced hyperactivity without affecting stereotypies. In addition, it does not induce catalepsy and it does not produce D2 hypersensitivity after repeated treatment.

Moreover, it preferentially blocks pre-synaptic D2/D3 dopamine receptors, producing dopamine release responsible for its disinhibitory effects.

This atypical pharmacological profile may explain amisulpride's antipsychotic effect at higher doses through post-synaptic dopamine receptor blockade located in the limbic areas and its efficacy against negative symptoms, at lower doses, through presynaptic dopamine receptor blockade. In addition, the reduced tendency of amisulpride to produce extrapyramidal side effects may be related to its preferential limbic activity.


Pharmacokinetics

Absorption

In man, Amisulpride (Solian) shows two absorption peaks: one which is attained rapidly, one hour post-dose and a second between 3 and 4 hours after administration. Corresponding plasma concentrations are 39±3 and 54±4 ng/mL after a 50 mg dose.

Distribution

The volume of distribution is 5.8 L/kg. As plasma protein binding is low (16%), drug interactions due to displacement are unlikely.

The absolute bioavailability of amisulpride tablets is 48%.

Bioequivalence between the solution and the 200 mg tablet has been demonstrated (Cmax mean ratio 0.95, 90% confidence interval 0.81-1.12; AUC mean ratio 0.89, 90% confidence interval 0.81-0.97). However, bioequivalence has not been demonstrated between the solution and the 400 mg tablet (Cmax mean ratio 0.88, 90% confidence interval 0.75-1.04; AUC mean ratio 0.86, 90% confidence interval 0.78-0.94).

Metabolism

Solian (Amisulpride) is weakly metabolised: two inactive metabolites, accounting for approximately 4% of the dose, have been identified. The elimination half-life of amisulpride is approximately 12 hours after an oral dose.

Excretion

Fifty percent of an intravenous dose is excreted via the urine, the majority as unchanged drug. Ninety percent of the intravenous dose is eliminated in the first 24 hours. Renal clearance is in the order of 20 L/h or 330 mL/min.

Following a single intravenous dose, about 20% of the dose was recovered from the faeces, about 70% of which was as unchanged Amisulpride (Solian). Hepatic metabolism has a limited role in healthy patients.

A high-carbohydrate low-fat meal (14 g protein, 8 g fat, 108 g CHO) significantly decreases the AUC, Tmax and Cmax of amisulpride, but no changes were seen after a high fat meal. However, the significance of these findings in routine clinical use is not known.

Renal insufficiency

In patients with renal insufficiency systemic clearance is reduced by a factor of 2.5 to 3. The AUC of amisulpride in mild renal failure increased two-fold and almost tenfold in moderate renal failure. Experience is, however, limited and there is no data with doses greater than 50 mg.

Solian (Amisulpride) is very weakly dialysed.

Limited pharmacokinetic data in elderly subjects ( > 65 years) show that a 10-30% rise occurs in Cmax, T. and AUC after a single oral dose of 50 mg. No data are available after repeat dosing.



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