Solid medicinal formulation for treatment of arterial hypertension and method for its preparing

FIELD: medicine, chemical-pharmaceutical industry, pharmacy.

SUBSTANCE: invention relates to a solid medicinal formulation eliciting an antihypertensive, anti-anginal, vasodilating, antioxidant and antiproliferative effect. The solid medicinal formulation comprises the following components: carvedilol, disaccharide, magnesium stearate, starch, calcium phosphate, hydroxypropylmethylcellulose, aerosil and carboxymethylcellulose sodium salt. Also, invention discloses a method for preparing this formulation. Invention provides preparing the formulation eliciting high rate and fullness in releasing an active substance in the human body, stability of quality indices for all fitness period and allowing the effective usage in manufacturing the medicinal agent. Invention can be used in treatment hypertension, stenocardia, myocardium ischemia and chronic cardiac insufficiency.

EFFECT: improved preparing method, valuable medicinal properties of formulation.

5 cl, 1 tbl, 4 ex

 

The invention relates to chemical-pharmaceutical industry, in particular to a solid dosage form, based on carvedilola with antihypertensive, antianginalnam, vasodilator, antioxidant and antiproliferative action, and will be used for the treatment of hypertension, angina pectoris, myocardial ischemia, chronic heart failure.

In the mid 80-ies in the global pharmaceutical market appeared carvedilol new drug for the treatment of hypertension. The results of numerous studies indicate that this drug when used in therapeutic doses acts as a nonselective blocker β- and α-adrenergic receptors.

Carvedilol is available in solid form, which usually contains 12.5 or 25 mg carvedilola as an active ingredient and pharmaceutically acceptable excipients.

Closest to the proposed solid dosage form for the treatment of hypertension is disclosed in patent RU 2214243. This form contains carvedilol and pharmaceutically acceptable excipients, which are used starch, saccharide (mannitol or lactose), stearic acid and/or its salt (calcium stearate or magnesium), in the following ratio, wt.%:

Carvedilol - 1,-25,0

Starch - 0,1-3,5

Saccharide - 70,0-96,9

Stearic acid and/or its salt is from 0.6 to 1.5

The way to obtain this form includes wet granulation of a mixture of active ingredient with lactose and, optionally, starch, drying, introduction of other ingredients and forming the final mixture.

The resulting dosage form based on carvedilola meets the requirements of the current Gosfarmakapei (GF XI) for the medicinal product, and it is stable during storage, provides therapeutic dosage and dissolves easily, which allows to achieve a high speed of release of the active substance and, accordingly, to quickly obtain the desired concentration of drug in the blood.

The disadvantages of this dosage form is that it contains a significant amount of lactose tablets have insufficient mechanical strength, which may cause a decrease in quality. In addition, generated during production of the mixture components does not have enough good flowability, which affects the uniformity of distribution of the active component.

The technical result of the invention is to improve the uniformity of distribution of the active component while increasing pressuemosti and increase the strength of the tablets, as well as the reduction of sugar content./p>

This technical result is achieved by the fact that the solid dosage form for the treatment of hypertension, comprising as active ingredient carvedilol and as pharmaceutically acceptable excipients magnesium stearinovokisly and starch, in accordance with the invention as pharmaceutically acceptable excipients further comprises a disaccharide, calcium phosphate, hypromellose, Aerosil and sodium salt of carboxy-methylcellulose in the following ratio, wt.%:

Carvedilol4,0-16,0
Sugar20,0-56,0
Magnesium stearinovokisly0,1-2,0
Starch5,0-12,0
Calcium phosphate20,0-45,0
Hydroxypropylcellulose0,1-1,0
Aerosil0,2-3,0
Sodium salt of carboxymethylcellulose2,0-10,0

In private embodiments of the invention the problem is solved in that the solid dosage form as starch contains potato starch, and the disaccharide is sucrose.

Solid dosage form may be made in the form of tablets.

At asany the technical result is also achieved by a method of manufacturing a dosage form of the drug for the treatment of hypertension, namely, that mixed powders carvedilola and starch, hydrate mixture, damp granulation and drying, then optivault by adding magnesium stearinovokisly, the mixture is stirred and tabletirujut, according to the invention the mixing carvedilola and starch is carried out by adding sucrose, calcium phosphate and parts of Aerosil, exercise hydration solution hydroxypropylmethylcellulose, after drying, carry out dry granulation, and when dusting also add the remainder of Aerosil and sodium carboxymethyl cellulose.

Preferably the drying be carried out at 50-55°and the dry granulation is carried out after cooling of the granulate at room temperature.

The essence of the proposed invention is that the introduction in the form as pharmaceutically acceptable excipients calcium phosphate, hydroxypropylmethylcellulose, Aerosil and sodium salt of carboxymethyl cellulose can improve the processing properties of the tablet mixture, to reduce the pressing force in forming tablets, to increase the mechanical strength of the tablets and to improve their appearance.

The introduction of the tablets of calcium phosphate and Aerosil allows to obtain dry mass with high uniformity of distribution of active component that allows you to reduce R sbros content of the active ingredient in the tablets. Strength tablet and good compressibility of the mixture attach included in the hypromellose and sucrose. Good release carvedilola due to the presence of the sodium salt of carboxymethylcellulose, and the optimal value of other auxiliary components. The use of sucrose can reduce the amount of sugar in the composition due to its better binding properties.

Use in the method of operation of the dry granulation reduces the spread of tablets by weight.

While the finished product fully complies with the requirements of the State Pharmacopoeia, has high bioavailability (released 95-98% carvedilola for 45 min), the uniformity of distribution of the active substance. In addition, the use of the disaccharide, in particular sucrose, improving the absorption of medicinal substance enables you to get a drug that has a great therapeutic effect and storage stability.

The invention is illustrated by examples 1-3.

Example 1. Pre-sifted 838 g (33 wt.%) calcium phosphate, 20 g (0.8 wt.%) Aerosil and 963 g (38 wt.%) sugar are thoroughly mixed. To the mixture was added 250 g (10 wt.%) sifted carvedilola and 202 grams (8 wt.%) the starch. Then, thoroughly mixed, the resulting mixture was added 300 g (of 0.28 wt.%) 2.3% of RA the creators of hydroxypropylmethylcellulose, was stirred until uniform wetting and held wet granulation.

The wet granules were dried at a temperature of 50-55°to a residual moisture of 1±0,5%.

The dried granules were cooled to room temperature and held dry granulation, then dry granulate outrival by adding 50 g (2 wt.%) magnesium stearinovokisly, the remaining part of 20 g (0.8 wt.%) Aerosil and 150 g (6 wt.%) sodium salt of carboxymethyl cellulose, and the mixture was stirred and alloy preformed.

Received tablets weighing 0.25, the Composition of the tablets are shown in table 1 (columns 2 and 3).

Example 2. Received the tablet with a weight of 0.125 g, and content carvedilola 5%. The production process was carried out in accordance with the procedures described in example 1. The composition of the tablets are shown in table 1 (columns 4-5).

Example 3. Received the tablet with a weight of 0.08 g and the content carvedilola 16%. The production process was carried out in accordance with the procedures described in example 1. The composition of the tablets are shown in table 1 (columns 4-5).

Example 4. Received the tablet with a mass of 0.25 g and the content carvedilola 12%. The production process was carried out in accordance with the procedures described in example 1. The composition of the tablets is the following: carvedilol 0.03 g (12%), magnesium stearinovokisly 0.00025 grams (0.1%), potato starch 0.03 g (12%), calcium phosphate 0,106 g (42.8 per cent), hypromellose 000025 g (0.1%), sucrose 0.05 g (20%), Aerosil 0.0075 g (3%), sodium carboxymethyl cellulose 0.025 g (10%).

All the tablets carvedilola satisfy the requirements of the pharmaceutical agent. Within 45 minutes of the tablet is released and passes into solution 95-98% active substance content carvedilola corresponds necessary to form the uniformity of dosing (content of active ingredient in each tablet) is required nominal with tolerances (is ±6% if the required State pharmacy ±15%).

1. Solid dosage form for the treatment of hypertension, comprising as active ingredient carvedilol, as pharmaceutically acceptable excipients magnesium stearinovokisly and starch, characterized in that as pharmaceutically acceptable auxiliary substances it further comprises sucrose, calcium phosphate, hydroxypropylcellulose, Aerosil and sodium carboxymethyl cellulose in the following content, wt.%:

Carvedilol4,0-16,0
Sucrose20,0-56,0
Magnesium stearinovokisly0,1-2,0
KRA is small 5,0-12,0
Calcium phosphate20,0-45,0
The hypromellose0,1-1,0
Aerosil0,2-3,0
Sodium salt of carboxymethylcellulose2,0-10,0

2. Solid dosage form according to claim 1, characterized in that it contains as starch and potato starch.

3. Solid dosage form according to claim 1, characterized in that it is made in tablet form.

4. A method of manufacturing a dosage form of the drug for the treatment of hypertension, namely, that mixed powders carvedilola and starch, hydrate mixture, damp granulation and drying, then optivault by adding magnesium stearinovokisly, the mixture is stirred and tabletirujut, characterized in that the mixing carvedilola and starch is carried out by adding sucrose, calcium phosphate and parts of Aerosil, exercise hydration solution hydroxypropylmethylcellulose, after drying, carry out dry granulation, and when dusting also add the remainder of Aerosil and sodium carboxymethyl cellulose.

5. The method according to claim 4, characterized in that the drying is carried out at 50-55°and the dry granulation is carried out after cooling of the granulate at room temperature.



 

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