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DUODART (DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE): PHARMACOKINETICS

Bioequivalence was demonstrated between Duodart (Dutasteride, Tamsulosin Hydrochloride) capsules and concomitant dosing with separate dutasteride and tamsulosin capsules.

The Tamsulosin HCl component of Duodart consists of a multi-unit pelletised preparation which has modified release properties. The individual pellets consist of a drug core and an outer coating layer which reduces the rate of dissolution of the drug.

The single dose bioequivalence study was performed in both the fasted and fed states. A 30% reduction in Cmax was observed for the tamsulosin component of dutasteridetamsulosin in the fed state compared to the fasted state. Food had no effect on AUC of tamsulosin.

Absorption

Dutasteride

Dutasteride is administered orally in solution as a soft gelatin capsule. Following administration of a single 0.5 mg dose, peak serum concentrations of dutasteride occur within 1 to 3 hours. Absolute bioavailability in man is approximately 60% relative to a 2 hour I.V. infusion. The bioavailability of dutasteride is not affected by food.

Tamsulosin

Tamsulosin Hydrochloride is absorbed from the intestine and is almost completely bioavailable. Tamsulosin HCl exhibits linear kinetics, following single and multiple dosing, with achievement of steady state concentrations by the fifth day of once-aday dosing. The rate of absorption of tamsulosin hydrochloride is reduced by a recent meal. Uniformity of absorption can be promoted by the patient always taking tamsulosin hydrochloride approximately 30 minutes after the same meal each day.

Distribution

Dutasteride

Pharmacokinetic data following single and repeat oral doses show that dutasteride has a large volume of distribution (300 to 500 L). Dutasteride is highly bound to plasma proteins (greater than 99.5%).

Following daily dosing, dutasteride serum concentrations achieve 65% of steady state concentration after one month and approximately 90% after three months. Steady state serum concentrations (Css) of approximately 40 ng/mL are achieved after six months of dosing 0.5 mg once a day. Similarly to serum, dutasteride concentrations in semen achieved steady state at six months. After 52 weeks of therapy, semen dutasteride concentrations averaged 3.4 ng/mL (range 0.4 to 14 ng/mL). Dutasteride partitioning from serum into semen averaged 11.5%.

Tamsulosin

The mean steady-state apparent volume of distribution of tamsulosin hydrochloride after intravenous administration to ten healthy male adults was 16 L, which is suggestive of distribution into extracellular fluids in the body.

Tamsulosin Hydrochloride is extensively bound to human plasma proteins (94% to 99%), primarily alpha-1 acid glycoprotein (AAG), with linear binding over a wide concentration range (20 to 600 ng/mL).

Metabolism

Dutasteride

Dutasteride is extensively metabolised in humans. While not all metabolic pathways have been identified, in vitro studies show that dutasteride is metabolised by the CYP3A4 isoenzyme to 2 minor mono-hydroxylated metabolites. Dutasteride is not metabolised in vitro by human cytochrome P450 isoenzymes CYP1A2, CYP2C9, CYP2C19, and CYP2D6.

In human serum, following dosing to steady state, unchanged dutasteride, 3 major metabolites (4'-hydroxydutasteride, 1,2-dihydrodutasteride and 6-hydroxydutasteride), and 2 minor metabolites (6,4'-dihydroxydutasteride and 15-hydroxydutasteride), have been detected. In vitro, 4'-hydroxydutasteride and 1,2-dihydrodutasteride metabolites are much less potent than dutasteride against both isoforms of human 5alpha-reductase. The activity of 6-beta-hydroxydutasteride is comparable to that of dutasteride.

Tamsulosin

There is no enantiomeric bioconversion from tamsulosin hydrochloride [R(-) isomer] to the S(+) isomer in humans. Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes in the liver and less than 10% of the dose is excreted in urine unchanged. However, the pharmacokinetic profile of the metabolites in humans has not been established. In vitro results indicate that CYP3A4 and CYP2D6 are involved in metabolism of tamsulosin as well as some minor participation of other CYP isoenzymes. Inhibition of hepatic drug metabolizing enzymes may lead to increased exposure to tamsulosin. The metabolites of tamsulosin hydrochloride undergo extensive conjugation to glucuronide or sulfate prior to renal excretion.

Elimination

Dutasteride

Dutasteride is extensively metabolized. Following oral dosing of dutasteride 0.5 mg/day to steady state in humans, 1.0% to 15.4% (mean of 5.4%) of the administered dose is excreted as dutasteride in the faeces. The remainder is excreted in the faeces as 4 major metabolites comprising 39%, 21%, 7%, and 7% each of drug-related material and 6 minor metabolites (less than 5% each). Only trace amounts of unchanged dutasteride (less than 0.1% of the dose) are detected in human urine.

At low serum concentrations (less than 3 ng/mL), dutasteride is cleared rapidly by both the concentration-dependent and concentration-independent elimination pathways. Single doses of 5 mg or less showed evidence of rapid clearance and a short half-life of 3 to 9 days.

At serum concentrations greater than 3 ng/mL, dutasteride is cleared slowly (0.35 to 0.58 L/h) primarily by linear, non-saturable elimination with terminal half-life of 3 to 5 weeks. At therapeutic concentrations, the terminal half-life of dutasteride is 3 to 5 weeks, and following repeat dosing of 0.5 mg/day, the slower clearance dominates and the total clearance is linear and concentration-independent. Serum concentrations remain detectable (greater than 0.1 ng/mL) for up to 4 to 6 months after discontinuation of treatment.

Tamsulosin

Tamsulosin half-life is 5 to 7 hours following intravenous administration. Following the administration of Duodart, the tamsulosin half-life was reported to be 12 to 14 hours. Approximately 10% is excreted unchanged in urine.


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