Organisati

 

(57) Abstract:

The invention relates to medicine, in particular to pharmaceutical drugs used for the treatment of acute and chronic diseases of the urinary tract (pyelonephritis, urethritis, cystitis, prostatitis, and other). The inventive organisati containing piperidinol acid as the active component, and the target auxiliary ingredients: sugar, milk, stearic acid or its salts and Aerosil. This pipemidinova acid may be represented in the form of three-hydrate. The technical result consists in the provision of high-tech production of medicines, while ensuring guaranteed raspadaemosti and rapid release of his drug substances using available components. 3 C.p. f-crystals.

The invention relates to medicine, in particular to pharmaceutical drugs used for the treatment of acute and chronic diseases of the urinary tract (pyelonephritis, urethritis, cystitis, prostatitis, etc.)

One of the famous urbanisation is piperidine. This drug is disclosed in U.S. patent 3887557, IPC 07 D 51/42, publication 03.07.1975.

In this PA is acid) and the target auxiliary components (starch, lactose, talc).

The disadvantage of this dosage form can be seen in the fact that due to the high hygroscopicity of starch may clumping encapsulated mass that affects the process of release of the active component - piperidinol acid.

The problem to which the invention is directed, is getting ready medicinal forms of piperidine, all relevant pharmacopoeial requirements, qualitative and quantitative composition which will provide high manufacturability of the drug, while ensuring guaranteed raspadaemosti and rapid release of his drug substances using available components.

The problem is solved due to the fact that organisati containing piperidinol acid as the active component, and the target auxiliary components, according to the invention as target auxiliary components contains milk sugar, stearic acid or its salts and Aerosil, in the following ratio, wt.%:

Pipemidinova acid - 50-70

Milk sugar - 15-50

Aerosil - 0,5-1,5

Stearic acid or its salts - 0,1-enoi form of the medicinal product is a capsule.

In accordance with pharmacopoeial requirements of the dosage form in the form of capsules should contain 0,200 g piperidinol acid.

Selection of components for the claimed dosage form was carried out experimentally. It was found that to provide a satisfactory flowability capsule weight, in the composition of the medicinal product introduced Aerosil. The amount of Aerosil should be not less than 0.5 wt.% and not more than 1.5 wt.%. The introduction of Aerosil in the composition of the dosage form gives it the necessary technological characteristics and contributes to deaggregate encapsulated powder mass and, as a consequence, the rapid release of the active ingredient.

Receiving the claimed medicinal product is as follows. The main active ingredient - acid piperidou mixed in the mixer with the sugar, milk and auxiliary substances: Aerosil and calcium stearinovokisly. The resulting mixture is dosed in capsules dosing machine.

As example can be mentioned the following composition per capsule, g:

Acid pipemedia trihydrate - 0,200

Milk sugar - 0,124

Stearic acid or its salts (calcium simpathize with the stated ratio of the components ensures optimum physico-chemical and technological properties of the dosage form and high bioavailability of the drug.

Received medication broad-spectrum used in acute and chronic urinary tract infections (pyelonephritis, urethritis, cystitis, prostatitis, and other).

1. Organisati containing piperidinol acid as the active component, and the target auxiliary components, wherein the target auxiliary components it contains sugar, milk, stearic acid or its salts and are presented in the following ratio, wt. %:

Pipemidinova acid - 50 - 70

Milk sugar - 15 - 50

Aerosil - 0,5 - 1,5

Stearic acid or its salts - 0,1 - 1,2

2. Organisati under item 1, characterized in that pipemidinova acid presents in the form of three-hydrate.

3. Organisati under item 1 or 2, characterized in that it is made in the form of a capsule.

4. Organisati on PP. 1-3, characterized in that it contains 0,200 g piperidinol acid.

 

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