Pharmaceutical composition based on sumatriptan

 

(57) Abstract:

Usage: in medicine, the pharmaceutical composition exhibits a selective vasoconstrictor activity and is useful in the treatment of conditions associated with headache, particularly migraine. The inventive pharmaceutical composition for oral administration in the form of a solid dosage form with a film coating contains pharmaceutically acceptable carriers or excipients and the active ingredient 3-[2-(dimethylamino)ethyl]-N-1H-indole-5-methanesulfonamide(sumatriptan) or its pharmaceutically acceptable salt or MES in the amount of from 25 to 200 mg 10 C.p. f-crystals.

The invention relates to a pharmaceutical composition comprising as an active ingredient 3-[2-(dimethylamino)ethyl] -N-methyl-1H-indol-5-methanesulfonamide, in particular, the composition for oral administration.

3-[2-(dimethylamino)ethyl]-N-methyl-1H-indol-5-methanesulfonamide (sumatriptan), which can be represented by the formula (I)

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and its physiological acceptable salt and solvate can be detected d Patent description UK N 2162522. The compound of formula (I) exhibits a selective vasoconstrictor activity and sex is the value of pharmaceutical preparations because it is particularly convenient and acceptable to patients. Unfortunately, the oral composition may have some shortcomings in the treatment of conditions that may be associated headaches. For example, such conditions, in particular migraine, associated with gastrointestinal disorders in the form of delay evacuation of gastric contents. This leads to delay and failure of absorption of the drug. Therefore, it is generally accepted that oral drugs for treatment of these conditions should be applied in the form of liquid preparations.

Numerous clinical studies have demonstrated the effectiveness of the compounds of formula (I) for patients with migraine. To date, this medicine is always used as a parenteral injection or in the form of dispersible tablets, which are dispersed in drinking water before ingestion. It was believed that this method of oral administration of the drug reduces to limit possible problems associated with gastrointestinal dysfunction in migraine sufferers patients.

But nevertheless found that the compound of formula (I) has an extremely unpleasant taste. The ingestion of this drug it unpleasant is favourable ready preparative form convenient for oral administration of compounds with formula (I).

According to the invention is provided a pharmaceutical composition for oral administration comprising coated (film) solid dosage form containing 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indol-5-methanesulphonamide or its pharmaceutically acceptable salt or solvate as an active ingredient.

Used here, the term "coated solid dosage form" means a solid core comprising the active ingredient, coated with a film coating.

Compositions of the invention may include, for example, granules, tablets or capsules. Preferably the compositions are tablets, most preferably extruded tablets.

In a preferred aspect the invention provides a coated tablet formulation, comprising a Central core in the form of tablets, containing an effective amount of 3-[2-(dimethylamino)ethyl]-N-methyl-1H-5-methanesulphonamide or its pharmaceutically acceptable salt or solvate as an active ingredient, and a shell at this Central core.

We found that the unpleasant taste during oral giving the shell drug is also easier to apply, and also reduces potentially hazardous dust observed during filling or applying medication. Surprisingly, these advantages are achieved without any significant loss of bioavailability of compounds with formula (I) in comparison with aqueous solutions or dispersible tablets for oral administration to patients suffering from migraine. According to the invention coated tablets, therefore, is surprisingly effective in the treatment of migraine.

Preferably, 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indol-5-methanesulfonamide was used in the invented compositions in the form of physiologically acceptable salts. Such salts may be salts of inorganic or organic acids, for example, chloride, bromide, sulfate, nitrate, phosphate, format, citrate, benzoate, fumarate, maleate, tartrate and succinate. It is most preferable to use 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indol-5-methanesulfonamide in the proposed compositions in the form of its succinate (1:1).

The shell comprises a polymer. Suitable polymers are cellulose ethers, for example, hypromellose, hydroxypropylcellulose and copolymers of methacrylic acid and methylmetacrylate solids shell, used for solid dosage forms, for example, the Central core in the form of tablets, ranging from 2 wt. up to 5 wt. preferably from 3 wt. up to 4 wt. the weight of solid dosage forms.

The shell may optionally include any pharmaceutically acceptable colorants or silencers transparency, including water-soluble dyes, aluminum varnishes based on water-soluble dyes, and inorganic pigments such as titanium dioxide and iron oxide. Suitable dyes or silencers transparency can range from 5 wt. to 65 wt. preferably from 25 wt. up to 50 wt. from the dry weight of the shell.

The shell may also contain one or more plasticizing agents, generally used in polymer membranes, for example, polyethylene glycol, propylene glycol, disutility ether sabatinovka acid, mineral oil, sesame oil, diethylphthalate and triacetin. Suitable plasticizing agents may comprise from 1 wt. up to 40 wt. preferably from 5 wt. up to 20 wt. from the dry weight of the shell.

In addition to the compound of formula (I) or a physiologically acceptable salt or MES invented compositions preferably include a pharmaceutically priemel, polyvinylpyrrolidone or hypromellose); fillers (e.g. lactose, mannitol, corn starch, sucrose, microcrystalline cellulose or acidic calcium phosphate); lubricating agents (for example, stearic acid, polyethylene glycol, magnesium stearate, talc or silica); disintegrating agents (for example, potato starch, glycolate or sodium croscarmellose-sodium); or moisturizing agents (e.g. sodium lauryl sulphate).

For preparation of compositions according to the invention is 3-[2-(dimethylamino)ethyl] -N-methyl-1H-indol-5-methanesulphonamide or its physiologically acceptable salt or MES can be mixed with a suitable filler and optionally granulated. It is preferable to expose the granulation 3-[2-(dimethylamino)ethyl)-N-methyl-1H-indol-5-methanesulfonamide together with any filler prior to mixing it with other ingredients. The most suitable filler is lactose. In bare shell-shaped tablets can be prepared, for example, pressing the powder mixture or granulate using a lubricating agent to facilitate tableting. Preferred tablets prepared by hot pressing.

Solid dosage form then the body. For film coating the most preferred solvent is purified water, but you can use the various classes of organic solvents, usually widely used in this field, such as alcohols, ketones, ethers and chlorinated hydrocarbons, for example, ethanol, acetone, methylene chloride and similar. The solvent does not remain in the final product. The amount of solvent can vary depending on the equipment and process conditions used in the production of aesthetically designed tablets.

The number of 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indol-5-methanesulfonamide preferably in the form of physiologically acceptable salts used in the compositions of the invention, is from about 25 mg to 200 mg, most preferably from 50 mg to 100 mg based on the weight of free base.

According to further aspect the invention provides a method of treating mammals, including humans, suffering from or susceptible to conditions associated with headache, such as migraine, chronic paroxysmal hemicrania; headache associated with vascular disorders; headache associated with some substances which method comprises the oral intake of the pharmaceutical composition in the form of a coated solid dosage form 3-[2-(dimethylamino)ethyl]-N-1H-indole-5-methanesulphonamide or its pharmaceutically acceptable salt or MES as an active ingredient. It should be borne in mind that such treatment also includes both prevention and relief of existing symptoms.

It should be understood that the precise therapeutic dose depends on the age and condition of the patient and the nature of the condition being treated, and ultimately will be scheduled at the discretion of the treating physician.

However, generally, an effective dose for treating conditions associated with headache, for example, for emergency treatment of migraine, are in the range from 10 mg to 500 mg, preferably from 20 mg to 300 mg, most preferably from 25 mg to 200 mg, for example, 50 mg or 100 mg of active ingredient in the standard-dose can be applied in single or divided doses, for example, 1 or 4 times a day.

Example 1.

The core tablet Composition units mg/tabl

Active ingredient/lactose granules 280,0

Microcrystalline cellulose Ph Eur 15,5

Croscarmellose-sodium USNF 3,0

Magnesium stearate Ph Eur 1,25-1,75

Active ingredient/lactose granules

Succinate compounds of formula (I) 140,0**

Lactose Ph Eur 170 mesh 140,0

Purified water Ph Eur as required*

* Water does not remain in the final product. A typical interval number - of 100-140 g per kg of the mixture.


Opaspray white 5,0**

Purified water Ph Eur 100,0*

* Water does not remain in the final product. The maximum theoretical weight solids used for a coating 11 mg per pill.

** Opaspray white suspension for coating, which is available from Colorcon Ltd. UK. Contains hypromellose and titanium dioxide.

The active ingredient and the lactose are mixed and granulated by adding purified water. The granules obtained after mixing, were dried and passed through a sieve, the resulting granules are then mixed with other fillers core tablets. The mixture was pressed into tablets. Tablets were then covered with a shell on the standard equipment used for these purposes.

Example 2. Core tablets were prepared as described in example 1. Tablets were then covered with a shell using the suspension, described below, on standard equipment.

Suspension for shell wt.

Opadry pink 5,3**

Purified water Ph. Eur. To 100.0*

* Water does not remain in the final product. The maximum theoretical weight solids used for a coating 9 mg per pill.

** Opadry pink proprietary material for pleno is, titanium dioxide, red iron oxide, and triacetin.

1. Pharmaceutical composition for oral administration in the form of a solid dosage form with a film coating containing pharmaceutically acceptable carriers or excipients and 3-[2-(dimethylamino)ethyl]-N-methyl-1H-indol-5-methanesulfonamide as the active ingredient or its pharmaceutically acceptable salt, or MES, characterized in that it contains 25 to 200 mg of the indicated active ingredient.

2. The composition according to p. 1, characterized in that it contains 3-[2-(dimethylamino)ethyl] -N-methyl-1H-indol-5-methanesulfonamide in the form succinate (1 1) salt.

3. Composition under item 1 or 2, characterized in that it is a tablet.

4. The composition according to p. 3, characterized in that it represents a pressed tablet.

5. Composition according to any one of paragraphs. 1 to 4, characterized in that the coating consists of a polymer.

6. The composition according to p. 5, characterized in that the polymer is hypromellose.

7. Composition according to any one of paragraphs.1 to 6, characterized in that the film coating is 2 to 5% by weight of solid dosage forms.

8. Composition according to any one of paragraphs.1 7, by dyes or matting agents.

9. The composition according to p. 8, characterized in that the dyes or matting agents is 5 to 65% by weight of dry film coating.

10. Composition according to any one of paragraphs.1 to 9, characterized in that the coating consists of a polymer and one or more pharmaceutically acceptable plasticizing substances.

11. The composition according to p. 10, characterized in that the plasticizing agents comprise 1 to 40% by weight of dry film coating.

 

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