GB2082910A - Anti-depressant compositions - Google Patents

Abstract

An anti-depressant pharmaceutical composition comprising amitriptyline and L- tryptophan and an inert, physiologically acceptable carrier e.g. in the form of tablets, capsules, syrup or granules.

Description

SPECIFICATION Amitriptyline-containing pharmaceutical compositions This invention is concerned with amitriptylinecontaining pharmaceutical compositions.

Amitriptyline is a well known and widely prescribed anti-depressant drug. It is normally administered orally as the hydrochloride in the form of tablets or capsules containing 10 mg, 25 mg, or 50 mg of the active material. A typical prescribing regime is initially 75 mg,'day in divided doses increasing to 1 50 mg or 200 mg/day in divided doses according to clinical response.

Amitriptyline is known to have undesirable cardiovascular side effects, in particular cardiac arrythmias including tachycardia, with some patients. These side effects can, in some cases, be so severe or potentially dangerous that medication with amitriptyline cannot be continued.

Another known anti-depressant is the naturally occurring aminoacid, L-tryptophan. This is also normally administered orally in the form of tablets or capsules containing 500 mg or 1 g of the active material. A typical prescribing regime is 3-6 g/day in divided doses.

We have now surprisingly found that when L-tryptophan is administered with amitriptyline, it has the effect of reducing or eliminating the side effects of the latter drug and, at the same time, potentiating its activity.

According to the present invention, therefore, there is provided a pharmaceutical composition comprising amitriptyline and L-tryptophan and an inert, physiologically acceptable carrier.

The composition is preferably formulated for oral administration for example as tablets, capsules, syrup or granules pro syrup. Suitable carriers and formulation auxiliaries for such formulations will be well known to those skilled in the art. The two active ingredients are preferably present in the same amounts as they are in formulations containing them singly.

Thus. in the case of dosage unit formulations, i.e. tablets and capsules, each dosage unit preferably contains 10, 25 or 50 mg of amitriptyline and 500 mg or 1 g of L-tryptophan, but other amounts of the active materials can, of course, be used.

It is found that when L-tryptophan is administered together with amitriptyline, patients who show symptoms of undesirable side-effects when treated with amitriptyline alone are either free of such symptoms or evidence them to a reduced extent. Further, a majority of patients show a significantly improved score for depressed mood in the Hamilton rating scale for depression.

1. A pharmaceutical cornposition comprising amitriptyline and L-tryptophan and inert, physiologically acceptable carrier.

2. A composition according to claim 1 , which is in the form of tablets, capsules, syrup or granules pro syrup.

3. A composition according to claim 1 in dosage unit form, each dosage unit containing 10, 25 or 50 mg of amitriptyline and 500 mg or 1 g of tryptophan.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (3)

**WARNING** start of CLMS field may overlap end of DESC **. SPECIFICATION Amitriptyline-containing pharmaceutical compositions This invention is concerned with amitriptylinecontaining pharmaceutical compositions. Amitriptyline is a well known and widely prescribed anti-depressant drug. It is normally administered orally as the hydrochloride in the form of tablets or capsules containing 10 mg, 25 mg, or 50 mg of the active material. A typical prescribing regime is initially 75 mg,'day in divided doses increasing to 1 50 mg or 200 mg/day in divided doses according to clinical response. Amitriptyline is known to have undesirable cardiovascular side effects, in particular cardiac arrythmias including tachycardia, with some patients. These side effects can, in some cases, be so severe or potentially dangerous that medication with amitriptyline cannot be continued. Another known anti-depressant is the naturally occurring aminoacid, L-tryptophan. This is also normally administered orally in the form of tablets or capsules containing 500 mg or 1 g of the active material. A typical prescribing regime is 3-6 g/day in divided doses. We have now surprisingly found that when L-tryptophan is administered with amitriptyline, it has the effect of reducing or eliminating the side effects of the latter drug and, at the same time, potentiating its activity. According to the present invention, therefore, there is provided a pharmaceutical composition comprising amitriptyline and L-tryptophan and an inert, physiologically acceptable carrier. The composition is preferably formulated for oral administration for example as tablets, capsules, syrup or granules pro syrup. Suitable carriers and formulation auxiliaries for such formulations will be well known to those skilled in the art. The two active ingredients are preferably present in the same amounts as they are in formulations containing them singly. Thus. in the case of dosage unit formulations, i.e. tablets and capsules, each dosage unit preferably contains 10, 25 or 50 mg of amitriptyline and 500 mg or 1 g of L-tryptophan, but other amounts of the active materials can, of course, be used. It is found that when L-tryptophan is administered together with amitriptyline, patients who show symptoms of undesirable side-effects when treated with amitriptyline alone are either free of such symptoms or evidence them to a reduced extent. Further, a majority of patients show a significantly improved score for depressed mood in the Hamilton rating scale for depression. CLAIMS

1. A pharmaceutical cornposition comprising amitriptyline and L-tryptophan and inert, physiologically acceptable carrier.

2. A composition according to claim 1 , which is in the form of tablets, capsules, syrup or granules pro syrup.

3. A composition according to claim 1 in dosage unit form, each dosage unit containing 10, 25 or 50 mg of amitriptyline and 500 mg or 1 g of tryptophan.