(Molindone Hydrochloride Tablets, USP)
MOBAN (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes.
MOBAN is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4 (5 H)-one hydrochloride. It is a white to off-white crystalline powder, freely soluble in water and alcohol.
MOBAN Tablets contain the following inactive ingredients:
Calcium sulfate, lactose, magnesium stearate, microcrystalline cellulose and povidone.
The 5 mg strength also contains alginic acid, colloidal silicon dioxide and FD&C Yellow 6. The 10 mg strength also contains alginic acid, colloidal silicon dioxide, FD&C Blue 2 and FD&C Red 40. The 25 mg strength also contains alginic acid, colloidal silicon dioxide, D&C Yellow 10, FD&C Blue 2, and FD&C Yellow 6. The 50 mg strength also contains FD&C Blue 2 and sodium starch glycolate.
Molindone Hydrochloride is represented by the following structural formula:
The empirical formula is C16H24N2O2• HCl representing a molecular weight of 312.83.
MOBAN has a pharmacological profile in laboratory animals which predominantly resembles that of other antipsychotic agents causing reduction of spontaneous locomotion and aggressiveness, suppression of a conditioned response and antagonism of the bizarre stereotyped behavior and hyperactivity induced by amphetamines. In addition, MOBAN antagonizes the depression caused by the tranquilizing agent tetrabenazine.
In human clinical studies an antipsychotic effect is achieved in the absence of muscle relaxing or incoordinating effects. Based on EEG studies, MOBAN exerts its effect on the ascending reticular activating system.
Human metabolic studies show MOBAN to be rapidly absorbed and metabolized when given orally. Unmetabolized drug reached a peak blood level at 1.5 hours.
Pharmacological effect from a single oral dose persists for 24-36 hours. There are 36 recognized metabolites with less than 2-3% unmetabolized MOBAN being excreted in urine and feces.