Combined hypotensive drug

FIELD: medicine, pharmaceutics.

SUBSTANCE: invention refers to medicine, namely to combined drugs, and can be used for treating arterial hypertension. The drug is prepared by direct compression. A preparation with low residual humidity is more storage stable, shows high processibility and biological availability. The combined hypotensive drug contains a combination of enalapril maleate and hydrochlorthiazide as an agent, and lactose anhydride, microcrystalline cellulose, povidone, colloidal silicon dioxide, croscarmellose sodium and stearic acid salt as excipients. The optimum proportions of the components makes, wt %: The agent 11.0-18.0; Lactose anhydride 56.0-78.0; Microcrystalline cellulose 5.0-15.0; Povidone 2.0-4.0; Colloidal silicon dioxide 0.5-1.0; Magnesium stearate 0.5-1.0; Croscarmellose sodium 3.0-5.0.

EFFECT: making the drug preparation for treating arterial hypertension.

12 cl, 1 tbl

 

The invention relates to medicine, specifically to compound medicines, and can be used for the treatment of hypertension.

In accordance with the recommendations of the world health organization and International society of hypertension one of the main directions in the treatment of hypertension is the use of combinations of antihypertensive drugs. The advantage of combination therapy is the potentiation of antihypertensive action and fewer side effects that may occur when you use rational combinations of antihypertensive drugs based on ACE inhibitors.

When administered orally, the drug passes through the mucosal lining of the stomach, liver, etc. and only part of it gets into the blood system. The effect of the drug depends largely on how big this part. This indicator characterizes the bioavailability of the drug. The bioavailability of a drug is influenced not only by the route of administration of the drug, but biopharmaceutical factors (dosage form, its composition, characteristics of the production technology of the drug).

Among the drugs from the group of ACE inhibitors is important enalapril maleate (or (S)-1-[N-[1-(etoxycarbonyl)-3-f is ylpropyl]-L-alanyl]-L-Proline maleate (1:1)), using which produced the famous solid dosage forms, for example ENAP H containing 10 mg of enalapril and 25 mg of hydrochlorothiazide, or ENAP HL, containing 10 mg of enalapril and 12.5 mg of hydrochlorothiazide [Mashkovsky PPM Medicines, vol. 1, ed. 14-e, M.: Publishing house New Wave, 2001, s].

therapeutic action of enalapril maleate is because he is absorbed in the gastro-intestinal tract and as a result of deesterification during the hydrolysis in the body become active metabolite enalaprilat, which leads to the suppression of the formation of angiotensin II is a powerful vasoconstrictor agent. The result is lower blood pressure and thus does not increase the heart rate. The presence of these effects was a prerequisite widespread use of enalapril maleate in medical practice as an antihypertensive. Among the many various pharmaceuticals on the basis of enalapril maleate is the most convenient and simple are solid dosage forms for oral administration, which comprise one or more pharmaceutically active ingredients and auxiliary inert substances, including solvents, fillers, diluents, preservatives and stabilizers, binders and sliding substances, taste obuvki, which determine the rate of release of pharmaceutically active compounds, the speed and completeness of their absorption, as well as the stability and strength of the dosage form.

To enhance therapeutic action is preferable to make use of enalapril maleate in combination with other antihypertensive agents, preferably diuretics. Thus, the literature describes the use for the treatment of severe forms of hypertension remedy contains a combination of enalapril maleate and diuretic - hydrochlorothiazide [Mashkovsky PPM, s].

In European patent No. 12401, 1980, described antihypertensive composition containing as active principle a combination of enalapril and hydrochlorothiazide is used as auxiliary substances Pregelatinised starch, microcrystalline cellulose and magnesium stearate. However, the known composition is characterized by low stability and, accordingly, a small shelf life.

Known drug (patent No. 2266751 EN, publ. 27.12.2005, containing as active principle a combination of enalapril maleate and hydrochlorothiazide is used as excipients sodium bicarbonate, starch, milk sugar, iron oxide and salt of stearic acid. The selection of the components of the composition due to the fact that the mixture of enalapril maleate and hydrochlorothiazide is not FPIC is bsearch to direct pressing, in addition, enalapril maleate unstable and incompatible with many auxiliaries. This song is performed by wet or dry granulation or by combining the above methods. Thus, in the manufacture of medicinal components of the mixture, including enalapril maleate, exposed to moisture, high temperature, pressure and prolonged contact with the working surfaces of equipment. These factors negatively affect the stability and, consequently, the shelf life of the composition, make a long, exhausting and time-consuming process of obtaining a mixture.

The technical objective of the proposed solution is the creation of a stable combined antihypertensive drugs with a long shelf life.

The technical result of the application of the new decision is to ensure the possibility of manufacturing a stable drug with a long shelf life, received by way of direct pressing with a low content of residual moisture, more stable during storage, with high technological and biological availability.

This technical result is achieved due to the fact that the claimed combination anti-hypertensive agent contains as the effective beginning of the combination of enalapril maleate and hydrochlorothiazide is used as excipients lactose anhydride, cellulose microcrystalline, povidone, colloidal silicon dioxide, croscarmellose sodium salt of stearic acid.

The optimum mixing ratio of wt.%:

The active principle11,0-18,0
Lactose anhydride56,0-78,0
Microcrystalline cellulose5,0-15,0
Povidone2,0-4,0
Colloidal silicon dioxide0,5-1,0
Magnesium stearate0,5-1,0
Croscarmellose sodium3,0-5,0

Combined anti-hypertensive agent is produced by direct pressing, contains a small amount of residual moisture less than 2%, has a shelf life of over 3 years, it has high biological availability. Obtaining the claimed composition is simple, economical way, and it does not require granulation components.

The claimed ratio of ingredients determined experimentally and allows you to retrieve the specified technical result.

the active beginning of the proposed drug is the combination of enalapril maleate and hydrochlorothiazide (chemical name 7-sulfamoyl-6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-1,1-dioxide). Enalapril reduces the amount of angiotensin II in blood serum and hydrochlorothiazide causes a diuretic effect, with enalapril maleate and hydrochlorothiazide reinforce the hypotensive effect of each other. The preferred mass ratio of enalapril maleate and hydrochlorothiazide is about 1:1.25 or 1:2,5, or 2:1,25.

Additional substances used in the present compositions, are:

- lactose anhydride and microcrystalline cellulose are used as fillers;

- povidone is used as a binder;

- croscarmellose sodium is used as disintegrant;

- colloidal silicon dioxide and magnesium stearate are used as anti-friction substance.

The goal, namely the stability of the dosage form, and accordingly increase the shelf life is achieved at the stated interval content of the active agent and additional components.

The proposed pharmaceutical composition is in the form of solid dosage forms, preferably in the form of tablets that allows for maximum adaptability subsequent packaging and precision dosing of the active agent.

Obtaining the claimed composition is in accordance with known technologically and processes. Weighted enalapril maleate, hydrochlorothiazide, colloidal silicon dioxide are mixed in a centrifugal impeller mixer, then calibrate. The resulting concentrate is mixed in the mixer-obogrevateli with lactose anhydride, microcrystalline cellulose, povidone and croscarmellose sodium, then optivault a stearate. The resulting mixture is calibrated for vertical granulator. Standardized quantitative content of the mixture tabletirujut on the presses of the rotary type. Get tablets white or white with a beige shade with an average weight of 200 mg, which are Packed in blisters or in plastic container.

Variants of the formulation of the claimed composition (see table).

IngredientsContent, wt.%
Examples
123
The active principle, includingof 17.5at 11.2516,25
the enalapril maleate(5,0(5,0(10,0
- hydroch artisid 12,5)6,25)6,25)
Lactose anhydride63,569,7564,75
Microcrystalline cellulose10,010,010,0
Povidone3,03,03,0
Colloidal silicon dioxide1,01,01,0
Magnesium stearate1,01,01,0
Croscarmellose sodium4,04,04,0
Only100,0100,0100,0

1. Combined antihypertensive agent containing as active principle a combination of enalapril maleate and hydrochlorothiazide is used as excipients lactose anhydride, microcrystalline cellulose, povidone, criminialized colloid, magnesium stearate, croscarmellose sodium in the following ratio of ingredients, wt.%:

The active principle11,0-18,0
Lactose anhydride56,0-78,0
Microcrystalline cellulose5,0-15,0
Povidone2,0-4,0
Colloidal silicon dioxide0,5-1,0
Magnesium stearate0,5-1,0
Croscarmellose sodium3,0-5,0

2. The tool according to claim 1, characterized in that it contains enalapril maleate and hydrochlorothiazide in the ratio of 1:2,5.

3. The tool according to claim 1, characterized in that it contains enalapril maleate and hydrochlorothiazide in the ratio of 1:1,25.

4. The tool according to claim 1, characterized in that it contains enalapril maleate and hydrochlorothiazide in the ratio 2:1,25.

5. The tool according to claim 1, characterized in that it contains lactose anhydride as filler.

6. The tool according to claim 1, characterized in that it contains microcrystalline cellulose as filler.

7. The tool according to claim 1, characterized in that it contains povidone in image quality is as binder.

8. The tool according to claim 1, characterized in that it contains colloidal silicon dioxide as an anti-friction substance.

9. The tool according to claim 1, characterized in that it contains magnesium stearate as a lubricating substance.

10. The tool according to claim 1, characterized in that it contains croscarmellose sodium as disintegrant.

11. A tool according to any one of claims 1 to 10, characterized in that it is made in the form of solid dosage forms.

12. The tool according claim 11, characterized in that it is made in the form of tablets.



 

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