KR100514590B1 - A pharmaceutical composition comprising pravastatin sodium and copolyvidone as a stabilizer - Google Patents

Abstract

A pharmaceutical composition containing pravastatin sodium and a copolyvidone as a stabilizer with a pharmaceutically acceptable carrier and a method for preparing the same, the copolyvidone effectively stabilizes the pravastatin sodium.

Description

Pharmaceutical composition containing sodium pravastatin and copolyvidone as a stabilizing agent {A PHARMACEUTICAL COMPOSITION COMPRISING PRAVASTATIN SODIUM AND COPOLYVIDONE AS A STABILIZER}

The present invention relates to pharmaceutical compositions containing sodium pravastatin and copolyvidone as a stabilizer. More specifically, the present invention relates to a pharmaceutical composition containing sodium pravastatin and copolyvidone as a stabilizer, containing from 10 to 5000 parts by weight of copolyvidone with respect to 100 parts by weight of pravastatin sodium.

Pravastatin sodium represented by the following formula is a compound which inhibits the action of hydroxymethylglutaryl Co-A (HMG-CoA) enzyme and inhibits the production of cholesterol, and is commercially available as a treatment for hyperlipidemia.

Pravastatin sodium is unstable because of the excessive substitution of hydroxy groups and the presence of double bonds and thus lactones and other degradation products, as well as unsaturated aromatic compounds conjugated to neutral, acidic or acidic compounds that are readily removed, isomerized or oxidized To form. In addition, such degradation is accelerated by hygroscopicity as well as heat and light sensitivity. Degradation of such active ingredients does not provide sufficient desired pharmacological effects, and there is a problem that requirements for formulation and storage are added (see European Patent Publication No. 1984 0114027).

Korean Patent No. 0142435 discloses a composition in which pravastatin sodium is stabilized with at least one basic agent selected from alkali metal hydroxides, alkaline earth metal hydroxides, ammonium hydroxide, aluminum hydroxide, magaldrate, magnesium oxide or aluminum oxide.

Korean Patent No. 281521 discloses a composition comprising stabilizing sodium pravastatin by containing β-cyclodextrin.

Despite these pravastatin sodium stabilization techniques, the stabilization of pravastatin sodium is not sufficient, and there is still a need for a technique for stabilizing pravastatin sodium.

Accordingly, the present inventors have conducted a long study to develop a stable oral dosage form that can be prepared by a general preparation process and prevents decomposition due to hygroscopic absorption of pravastatin sodium, and when copolyvidone is contained as a stabilizer of pravastatin sodium, The present invention has been accomplished by discovering that vidon can block the hygroscopicity of pravastatin sodium to stabilize the pravastatin sodium, resulting in better pharmacological effects.

In a first aspect of the present invention, the present invention provides pharmaceutical compositions containing sodium pravastatin and copolyvidone as a stabilizer with a pharmaceutically acceptable carrier.

Copolyvidone represented by the following structural formula is a random copolymer composed of a vinyl acetate and vinylpyrrolidone in a ratio of 6: 4, and is used as a pharmaceutical excipient in the British Pharmacopoeia (BP), and is commonly used as a binder and plasmon It is commercially available as Plasdone S 630 (International Specialty Products).

The present inventors have long researched a method for stabilizing pravastatin sodium, and surprisingly found that copolyvidone stabilizes pravastatin sodium. The exact mechanism by which copolyvidone stabilizes pravastatin sodium has not been demonstrated, but the vinylacetate group of copolyvidone is hydrophobic, increasing the stability of pravastatin sodium by preventing the pravastatin sodium from absorbing moisture from the environment. It is estimated.

Since copolyvidone is usually used as a binder in the manufacture of tablets, the binder may not be used separately or the amount of the binder may be used when preparing a pharmaceutical composition according to the present invention.

Copolyvidone is preferably contained in a ratio of 10 to 5000 parts by weight, more preferably 50 to 3000 parts by weight of copolyvidone, relative to 100 parts by weight of the pravastatin sodium. If the copolyvidone content is less than 10 parts by weight, it does not play a sufficient role of blocking moisture, and if it exceeds 5000 parts by weight, it is difficult to formulate such as difficulty in filling and tableting.

In the pharmaceutical composition according to the present invention, pravastatin sodium is preferably included in the range of 1 to 60% by weight based on the total weight of the pharmaceutical composition. If the content of pravastatin sodium is less than 1% by weight, the compliance of the patient dose is reduced due to the increase in tablet weight, and if the content exceeds 60% by weight, it is difficult to control the dosage according to the patient.

Pharmaceutical compositions according to the present invention include pharmaceutically acceptable carriers, which include excipients, binders, disintegrants, glidants, colorants and the like.

Excipients that can be included in the pharmaceutical composition are conventional excipients, preferably lactose, microcrystalline cellulose, low substituted hydroxypropyl cellulose, corn starch, potato starch, wheat starch, white sugar, glucose, fructose, di-mannitol, precipitated calcium carbonate , Dextrin and methylcellulose, and combinations thereof. Excipients are preferably included in an amount of 3 to 80% by weight relative to the total weight of the pharmaceutical composition.

The binder which may be included in the pharmaceutical composition is a conventional binder, preferably polyvinylpyrrolidone, hydroxypropyl cellulose, microcrystalline cellulose, hydroxypropyl methyl cellulose, dextrin, gelatin, methyl cellulose, hydroxy cellulose, hydroxymethyl Cellulose and polyvinyl alcohol, and combinations thereof. The binder is preferably included in an amount of 2 to 40% by weight relative to the total weight of the pharmaceutical composition.

Disintegrants that may be included in the pharmaceutical composition are conventional disintegrants, preferably starch glycolate sodium, crospovidone, croscarmellose sodium, low-substituted hydroxypropyl cellulose, hydroxypropyl methyl cellulose, polyvinylpyrrolidone and Ethylcellulose, and combinations thereof. Disintegrants are preferably included in amounts of 0.1-30% by weight relative to the total weight of the pharmaceutical composition.

Glidants that may be included in the pharmaceutical compositions are conventional glidants, preferably selected from the group consisting of magnesium stearate, talc, stearic acid and light silicic anhydride, and combinations thereof. Glidants are preferably included in amounts of 0.1-20% by weight relative to the total weight of the pharmaceutical composition.

Moreover, although a coloring agent can be included in a pharmaceutical composition as needed, it is 1 or more types chosen from blue No. 1 aluminum lake, red No. 40 aluminum lake, etc., and it adds a suitable quantity with respect to the whole pharmaceutical composition.

The pharmaceutical composition according to the present invention may be preferably formulated into solid preparations for oral administration such as tablets, capsules, granules, powders, pills, dry syrups and the like.

In addition, during oral administration, in order to prevent the drug from being degraded by gastric acid, an antacid may be used in combination, or may be administered by formulating a formulation coated with tablets and granules with enteric skin.

The route of administration of the pharmaceutical composition according to the invention is preferably oral administration in the form of tablets or capsules.

The human dose of the active ingredient according to the present invention is appropriately selected depending on the absorption rate, inactivation rate, excretion rate, age, sex and condition of the patient, the severity of the disease in the body, but generally 1 day 1 adult It is preferred to administer 10-40 mg twice a night or before bedtime.

In a second aspect of the present invention, the present invention provides a method for preparing a pravastatin sodium-containing medicament, characterized by adding copolyvidone as a stabilizer to a medicament containing pravastatin sodium.

In the method for preparing a pravastatin sodium-containing drug according to the present invention, the copolyvidone is contained in a ratio of 10 to 5000 parts by weight, more preferably 50 to 3000 parts by weight, relative to 100 parts by weight of pravastatin sodium.

In the process for preparing a pravastatin sodium-containing drug according to the present invention, pravastatin sodium is preferably included in an amount of 1 to 60% by weight based on the total weight of the pharmaceutical composition.

In the method for preparing a pravastatin sodium-containing pharmaceutical agent according to the present invention, a pharmaceutically acceptable conventional carrier as mentioned above is included.

In the preparation method, pravastatin sodium-containing medicament is prepared by a method known in the art by mixing pravastatin sodium, copolyvidone, and a pharmaceutically acceptable conventional carrier using a conventional mixer.

       Hereinafter, the present invention will be described in more detail with reference to Examples. However, this does not limit the scope of the invention.

Example

Example 1

A pharmaceutical composition having the following composition was prepared by the following method.

Content (% by weight)

    Pravastatin Sodium 10.0

    Copolyvidone 7.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 51.0

    Microcrystalline cellulose 10.0

    Magnesium Stearate 2.0

    Total 100

All of the above components except magnesium stearate were mixed and compressed and granulated using a roller compressor. The assembly was sieved using a # 12 to # 16 mesh screen. The resulting granules were mixed with magnesium stearate and compressed using a conventional tablet machine.

Example 2

A pharmaceutical composition having the following composition was prepared by the following method.

     Content (% by weight)

    Pravastatin Sodium 10.0

    Copolyvidone 7.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 50.9

    Microcrystalline cellulose 10.0

    Magnesium Stearate 2.0

    Blue No. 1 Aluminum Lake 0.02

    Red No. 40 Aluminum Lake 0.08

    Total 100

The blue No. 1 aluminum lake and the red No. 40 aluminum lake were well dispersed and mixed with lactose, and then the remaining ingredients except magnesium stearate were added and compressed and granulated using a roller compressor. The assembly was sieved using a # 12 to # 16 mesh screen. The resulting granules were mixed with magnesium stearate and compressed using a conventional tablet machine.

Example 3

A pharmaceutical composition having the following composition was prepared by the following method.

         Content (% by weight)

    Pravastatin Sodium 10.0

    Copolyvidone 7.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 49.93

    Microcrystalline cellulose 10.0

    Hydroxypropylcellulose 1.07

    Magnesium Stearate 2.0

    Total 100

The hydroxypropyl cellulose was dissolved in ethanol, and then added to a mixture of all components except magnesium stearate, followed by granulation and drying. The dry was sieved using a # 12 to # 16 mesh screen. The resulting granules were mixed with magnesium stearate and compressed using a conventional tablet machine.

Example 4

A pharmaceutical composition having the following composition was prepared by the following method.

      Content (% by weight)

    Pravastatin Sodium 10.0

    Copolyvidone 7.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 49.83

    Microcrystalline cellulose 10.0

    Hydroxypropylcellulose 1.07

    Magnesium Stearate 2.0

    Blue No. 1 Aluminum Lake 0.02

    Red No. 40 Aluminum Lake 0.08

    Total 100

Hydroxypropyl cellulose, blue No. 1 aluminum lake and red No. 40 aluminum lake were dissolved in ethanol, and then granulated and dried by adding all components except magnesium stearate to the mixture. The dry was sieved using a # 12 to # 16 mesh screen. The resulting granules were mixed with magnesium stearate and compressed using a conventional tablet machine.

Example 5

A pharmaceutical composition having the following composition was prepared by the following method.

        Content (% by weight)

    Pravastatin Sodium 10.0

    Copolyvidone 7.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 52.0

    Microcrystalline cellulose 10.0

    Magnesium Stearate 1.0

     Total 100

All of the above components were mixed and compression granulated using a roller compressor. The resulting granules were charged using a conventional capsule charger.

Comparative Example 1

A tablet having the following composition was prepared by the method described in Example 1.

Content (% by weight)

    Pravastatin Sodium 10.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 58.0

    Microcrystalline cellulose 10.0

    Magnesium Stearate 2.0

    Total 100

Comparative Example 2

A tablet having the following composition was prepared by the method described in Example 1.

     Content (% by weight)

    Pravastatin Sodium 10.0

    Plasdon K-29 / 32 ™ * 7.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 51.0

    Microcrystalline cellulose 10.0

    Magnesium Stearate 2.0

    Total 100

^* Commercial products from ISP (International Specialty Products)

Comparative Example 3

A tablet having the following composition was prepared by the method described in Example 3.

        Content (% by weight)

    Pravastatin Sodium 10.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 49.93

    Microcrystalline cellulose 10.0

    Bentonite 7.0

    Hydroxypropylcellulose 1.07

    Magnesium Stearate 2.0

    Total 100

Comparative Example 4

A tablet having the following composition was prepared by the method described in Example 3.

Content (% by weight)

    Pravastatin Sodium 10.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 54.93

    Microcrystalline cellulose 10.0

    Butylhydroxytoluene 1.0

    Butylhydroxyanisole 1.0

    Hydroxypropylcellulose 1.07

    Magnesium Stearate 2.0

    Total 100

Comparative Example 5

A tablet having the following composition was prepared by the method described in Example 3.

       Content (% by weight)

    Pravastatin Sodium 10.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 49.93

    Microcrystalline cellulose 10.0

    Silicon Dioxide 7.0

    Hydroxypropylcellulose 1.07

    Magnesium Stearate 2.0

    Total 100

Comparative Example 6

A pharmaceutical composition having the following composition was prepared by the following method.

      Content (% by weight)

    Pravastatin 6.7

    Lactose 70.8

    Microcrystalline cellulose 15.0

    Croscarmellose Sodium 2.0

    Magnesium Stearate 1.0

    Magnesium oxide 3.3

    Red No. 3 Aluminum Lake 0.2

    Polyvinylpyrrolidone 1.0

    Total 100

Pravastatin was dissolved in a warmed aqueous solution of polyvinylpyrrolidone. A red No. 3 aluminum lake was incorporated into a mixture of lactose, magnesium oxide, microcrystalline cellulose and some of croscarmellose sodium and granulated using the solution. The granules were passed through # 4 to # 10 mesh screens and then dry granulated in a dish drying oven. Dry granules were passed through # 12 to # 20 mesh screens. The remaining croscarmellose sodium was added to the dry granules and mixed for 2 to 10 minutes. Thereafter, magnesium stearate was added and mixing continued for 1 to 5 minutes. The resulting granules were compressed into tablets.

Comparative Example 7

A pharmaceutical composition having the following composition was prepared by the following method.

        Content (% by weight)

    Pravastatin Sodium 10.0

    Low Substituted Hydroxypropyl Cellulose 20.0

    Lactose 59.0

    Microcrystalline cellulose 10.0

    Magnesium Stearate 1.0

     Total 100

All of the above components were mixed and compression granulated using a roller compressor. The resulting granules were charged using a conventional capsule charger.

Test Example 1

       Experimental Changes in Water Absorption and Content with or without Copolyvidone

20 tablets according to Example 1 and Comparative Example 1 were subjected to an accelerated test in accordance with the stability test standard of Notice No. 2000-7 of the Korea Food and Drug Administration and measured the water absorption and the content of pravastatin sodium in the following manner. However, in order to make the initial conditions of each composition constant, experiments were performed after leaving them in a vacuum desiccator having a condition of 22 ° C. and a relative humidity of 5% for one day.

 1) Content test

    Take 20 tablets of pravastatin sodium tablets and weigh them accurately to make a fine powder, which is tested according to the Quantitative Method of Pravastatin Sodium Tablet No. 98-127.

Operation condition

    Detector: UV absorbance photometer (wavelength: 238 nm)

Column: Capcell-pak C ₁₈ UG120 (4.6mm x 5cm), 5um (shiseido)

    Column temperature: 40 ℃

    Mobile phase: Water, methanol, glacial acetic acid, triethylamine mixture (500: 500: 1: 1)

    Flow rate: 1 ml / min

2) moisture absorption

20 tablets of pravastatin sodium tablets are powdered and tested according to the water quantitative method (Karl-Fischer method) of the Korean Pharmacopoeia General Test Methods.

Average values of water absorption and content are shown in Table 1 below.

Table 1

        Experimental Results of Water Absorption and Content Change with or without Copolyvidone

Example 1 Comparative Example 1 Retention period (days) 0 15 30 0 15 30 Water absorption (%) 0 0.15 0.15 0 0.17 0.37 Retention period (days) 0 30 60 0 30 60 content (%) 100.06 99.96  100.01 100.33 98.62 98.04 60% content loss compared to 0 days 0.05 2.29

As can be seen from Table 1, when the storage period is 30 days, the tablet of Example 1 with the copolyvidone is added 2 compared to the tablet of Comparative Example 1 without the copolyvidone in the formulation of Example 1 More than twice the amount of water absorption could be blocked. In addition, it can be seen that the tablet according to Example 1 is superior to the tablet according to Comparative Example 1 in terms of content stability.

Test Example 2

Experimental Changes of Pravastatin Sodium Content with and Without Colorant in Granule Preparation

The content was measured in the same manner as described in Test Example 1 on 20 tablets according to Example 2. For comparison, the experimental results together with the content data of the tablets according to Example 1 measured in Test Example 1 are shown in Table 2 below.

TABLE 2

Experimental Results of Pravastatin Sodium Content with or Without Colorant

Example 1 Example 2 Retention period (days) 0 30 60 0 30 60 content (%) 100.06 99.96  100.01 99.98 100.17 99.96 60% content loss compared to 0 days 0.05 0.02

As can be seen in Table 2, the tablet according to Example 2, the colorant was added to the composition of Example 1 was confirmed that there is no difference in content change compared to the tablet according to Example 1.

Test Example 3

Experimental Changes of Pravastatin Sodium with and without Solvents

The content of 20 tablets according to Example 3 was measured in the same manner as described in Test Example 1. For comparison, the experimental results together with the content data of the tablets according to Example 1 measured in Test Example 1 are shown in Table 3 below.

TABLE 3

Experimental Results of Pravastatin Sodium Content with and without Solvent

Example 1 Example 3 Retention period (days) 0 30 60 0 30 60 content (%) 100.06 99.96  100.01 99.99 100.04 99.96 60% content loss compared to 0 days 0.05 0.03

As can be seen in Table 3, the tablet according to Example 3 using a solvent when preparing the granules was confirmed that there is no difference in the content change compared to the tablet according to Example 1 when the solvent is not used. Therefore, it was confirmed that dry and wet granule manufacturing methods can be used at the time of granule preparation.

Test Example 4

Experimental Changes of Pravastatin Sodium Content with or Without Solvents and Colorants

The content was measured in the same manner as described in Test Example 1 on 20 tablets according to Example 4. For comparison, the experimental results together with the content data of the tablets according to Example 1 measured in Test Example 1 are shown in Table 4 below.

Table 4

Experimental Results of Pravastatin Sodium Content with Addition of Solvent and Coloring Agent

Example 1 Example 4 Retention period (days) 0 30 60 0 30 60 content (%) 100.06 99.96  100.01 100.02 99.96 99.97 60% content loss compared to 0 days 0.05 0.07

As shown in Table 4, it was confirmed that the addition of a solvent and a colorant to prepare granules did not affect the stabilization of pravastatin sodium by copolyvidone.

Test Example 5

Experimental Changes of Water Absorption (%) and Content with or without Copolyvidone in Capsules

Water absorption and content were measured in the same manner as described in Test Example 1 for 20 capsules according to Example 5 and Comparative Example 7. The experimental results are shown in Table 5 below.

Table 5

Experimental Results of Water Absorption and Content with and without Copolyvidone in Capsules

Example 5 Comparative Example 7 Retention period (days) 0 15 30 0 15 30 Water absorption (%) 0 0.07 0.23 0 0.12 0.44 Retention period (days) 0 30 60 0 30 60 content (%) 100.01 99.81 99.85 100.02 99.89 99.53 60% content loss compared to 0 days 0.16 0.49

As shown in Table 5, the capsule of Example 5 containing copolyvidone had a water absorption of 2 or more times lower than the capsule of Comparative Example 7, which did not contain copolyvidone, and the content change was also lower than that of Comparative Example 7. It was about three times lower.

Comparative Test Example 1

Comparative experiment of water absorption between copolyvidone and Plasdon K-29 / 32 ™

Containing 20 tablets according to Example 1 and Plasdon K-29 / 32 ™ as stabilizers For 20 tablets according to Comparative Example 2, the water absorption was measured in the same manner as described in Test Example 1 under closed conditions of 31%, 52% and 75% relative humidity. The experimental results are shown in Table 6 below.

Table 6

Experimental results of water absorption of copolyvidone and Plasdon K-29 / 32 ™

Relative Humidity (%) Water absorption (%) Example 1 Comparative Example 2 31 0.05 0.04 52 0.07 0.28 75 0.149 0.327

As can be seen from Table 6, the tablet according to Example 1 containing copolyvidone according to the present invention is a tablet according to Comparative Example 2 containing copolyvidone and the same type of Plasdon K-29 / 32 ™. Water absorption was much lower. Thus, it can be seen that only copolyvidone can specifically increase the stability of pravastatin sodium.

Comparative Test Example 2

Comparative experiment of stabilizing effect of copolyvidone and bentonite

The content was measured by the same method as described in Test Example 1 for 20 tablets according to Comparative Example 3 containing bentonite as stabilizer. For comparison, the experimental results together with the content data of the tablets according to Example 3 measured in Test Example 3 are shown in Table 7 below.

TABLE 7

Experimental Results of Copolyvidone and Bentonite Content

Example 3 Comparative Example 3 Retention period (days) 0 30 60 0 30 60 content (%) 99.99 100.04 99.96 99.80 97.04 97.20 60% content loss compared to 0 days 0.03 2.6

As can be seen in Table 7, it was found that the tablet according to Example 3 containing copolyvidone as a stabilizer was significantly superior in content stability compared to the tablet according to Comparative Example 3 containing bentonite as a stabilizer.

Comparative Test Example 3

Comparative experiment of stabilizing effect of copolyvidone, butylhydroxyanisole and butylhydroxytoluene

The content was measured by the same method as described in Test Example 1 for 20 tablets according to Comparative Example 4 containing butylhydroxyanisole and butylhydroxytoluene as stabilizers. For comparison, the experimental results together with the content data of the tablets according to Example 3 measured in Test Example 3 are shown in Table 8 below.

Table 8

Experimental Results of Copolyvidone, Butylhydroxyanisole and Butylhydroxytoluene Contents

Example 3 Comparative Example 4 Retention period (days) 0 30 60 0 30 60 content (%) 99.99 100.04 99.96 100.18 97.01 95.70 60% content loss compared to 0 days 0.03 4.48

As can be seen from Table 8, the tablet according to Example 3 containing copolyvidone as a stabilizer was significantly better in content stability than the tablet according to Comparative Example 4 containing butylhydroxyanisole and butylhydroxytoluene as stabilizers. It was excellent.

Comparative Test Example 4

Comparative experiment of stabilizing effect of copolyvidone and silicon dioxide

The content was measured by the same method as described in Test Example 1 for 20 tablets according to Comparative Example 5 containing silicon dioxide as a stabilizer. For comparison, the experimental results together with the content data of the tablets according to Example 3 measured in Test Example 3 are shown in Table 9 below.

Table 9

Experimental Results of Copolyvidone and Silicon Dioxide Contents

Example 3 Comparative Example 5 Retention period (days) 0 30 60 0 30 60 content (%) 99.99 100.04 99.96 99.84 96.09 95.40 60% content loss compared to 0 days 0.03 4.44

As can be seen in Table 9, the tablet according to Example 3 containing copolyvidone as a stabilizer has a content stability compared to the tablet according to Comparative Example 5 containing silicon dioxide, which serves to contain and stabilize the active ingredient. I could see that it was excellent.

Comparative Test Example 5

Experimental Changes of Water Absorption and Content of Copolyvidone and Magnesium Oxide

According to the prior art Korean Patent No. 0142435, water absorption and content were measured by the same method as described in Test Example 1 for 20 tablets according to Comparative Example 6 containing magnesium oxide as a stabilizer. For comparison, the experimental results together with the content data of the tablets according to Example 3 measured in Test Example 3 are shown in Table 10 below.

Table 10

Experimental results of water absorption and content of copolyvidone and magnesium oxide

Example 3 Comparative Example 6 Retention period (days) 0 15 30 0 15 30 Water absorption (%) 0 0.15 0.15 0 0.22 0.34 Retention period (days) 0 30 60 0 30 60 content (%) 99.99 100.04 99.96 100.02 99.89 99.98 60% content loss compared to 0 days 0.03 0.04

As can be seen in Table 10, the tablet according to Example 3 containing copolyvidone as a stabilizer can block more than twice the water absorption (%) compared to the tablet according to Comparative Example 6 containing magnesium oxide as a stabilizer. And, it was confirmed that the content stability is almost similar.

Therefore, the pharmaceutical composition containing sodium pravastatin and copolyvidone as a stabilizer together with a pharmaceutically acceptable carrier can stabilize the pravastatin sodium as an active ingredient, thereby sufficiently performing the pharmacological action of pravastatin sodium. As a copolyvidone is also used as a binder, there is also an economic advantage that does not need to administer a separate binder when preparing a tablet.

Claims (6)

A pharmaceutical composition with excellent stability containing sodium pravastatin, copolyvidone as a stabilizer, and a pharmaceutically acceptable carrier. The pharmaceutical composition according to claim 1, which contains 10 to 5000 parts by weight of copolyvidone with respect to 100 parts by weight of the pravastatin sodium. The pharmaceutical composition of claim 1, wherein the pharmaceutically acceptable carrier is an excipient, a binder, a disintegrant, a lubricant and a colorant. The pharmaceutical composition of claim 1, wherein the pravastatin sodium is included in an amount of 1 to 60 wt% based on the total weight of the pharmaceutical composition. delete delete