KR100580577B1 - Drug composition with antiphlogistic-analgestic activity using oral-microemulsuion drug delivery system - Google Patents

Abstract

The present invention relates to a drug composition using a self-emulsifying drug delivery system, wherein the drug composition comprises 1 to 40% by weight of the active ingredient of the anti-inflammatory analgesic; 5 to 50 wt% surfactant; 10-50 wt. 10 to 50 weight percent of cosurfactant; 0.1-5% by weight of pH adjuster; And a nanoemulsion concentrate comprising 1 to 5% by weight of an antioxidant.

The core of the present invention is a method of expressing a rapid drug and minimizing side effects by applying dexibuprofen, an anti-inflammatory analgesic, to a self-emulsifying drug delivery system, in addition to acquiring a number of industrial property rights, independence of domestic technology and accumulation of new technology. It is expected to lead to technology exports.

Dexibuprofen, nanoemulsion concentrates, solubilizers, surfactants, cosurfactants, self-emulsifying drug delivery systems, soft capsules, pH regulators, antioxidants.

Description

Pharmaceutical composition having anti-inflammatory analgesic activity using a self-emulsifying drug delivery system {DRUG COMPOSITION WITH ANTIPHLOGISTIC-ANALGESTIC ACTIVITY USING ORAL-MICROEMULSUION DRUG DELIVERY SYSTEM}

1 is a graph measuring the size distribution of the emulsion by diluting the dexibufurophene nanoemulsion concentrate prepared according to Example 1 of the present invention in artificial gastric juice by dynamic light scattering method.

Figure 2 is a graph measuring the size distribution of the emulsion by dilution of the dexibuprofen nano emulsion concentrate prepared according to Example 6 of the present invention in artificial gastric juice by dynamic light scattering method.

Figure 3 is a graph showing the concentration change in vitro release test 300 mg of dexibuprofen soft capsule prepared according to Example 1 of the present invention.

Figure 4 is a graph evaluating the stability of the drug by measuring the content of the drug in order to evaluate the stability of the formulation prepared according to Example 1 of the present invention.

Figure 5 is a graph showing a nanoemulsion forming area when the preparation according to the present invention in contact with the water phase.

[Industrial use]

The present invention relates to a pharmaceutical composition having an anti-inflammatory analgesic activity using a self-emulsifying drug delivery system, and more particularly, to a self-microemulsifying drug delivery system expressing an medicinal effect rapidly, that is, a fast-acting anti-inflammatory analgesic effect without side effects. The present invention relates to a pharmaceutical composition having anti-inflammatory analgesic activity.

[Prior art]

Ibuprofen is one of the effective and stable propionic acid nonsteroidal anti-inflammatory drugs. It reversibly inhibits cyclooxygenase, an enzyme involved in the synthesis of prostaglandin in arachidonic acid, and inhibits the biosynthesis of prostaglandins. It is effective in inflammatory, antipyretic and analgesic effects and is widely used in rheumatoid arthritis and related diseases. This drug is usually formulated in the form of a tablet and administered by oral administration of a dose of 100 to 800 mg.

It was found that ibuprofen exists as two isomers of S- and R-forms, while R-ibuprofen is converted into S-ibuprofen in the human body and shows efficacy, but S-ibuprofen is the main agent that shows the efficacy of racemic ibuprofen. It is known. Therefore, if a formulation containing only S-Ibuprofen instead of ibuprofen of racemic body is used, the dosage is reduced by half, the size of the formulation is reduced, and side effects are also reduced. Therefore, much attention has been paid to the preparation using S-Ibuprofen recently. It has been concentrated.

As such, the preparation using ibuprofen is an anti-inflammatory analgesic that minimizes side effects such as gastrointestinal disorders, hepatotoxicity and nephrotoxicity of the conventional anti-inflammatory anti-inflammatory drugs. However, R-S ibuprofen is difficult to formulate due to its poor water solubility and low melting point. In addition, there is a problem that is not dissolved at all in the gastric juice and dissolved in the intestine so that the drug is only expressed after 1 to 2 hours after administration.

Therefore, studies have been conducted to compensate for the difficulty of formulating due to poor water solubility and low melting point, and also to reduce drug expression time. For example, Korean Patent Publication No. 2003-33587 discloses 10 to 80 wt% of ibuprofen with 1.0 to 20 wt% of polyvinylpyrrolidone, alcohols selected from co-solvents such as ethanol and isopropanol, acetone, methylene chloride, chloroform, ether, It is dissolved in 20 to 85% by weight of at least one organic solvent selected from propylene glycol and glycerin, and then lyophilized, reduced pressure or spray dried to prepare a ibuprofen coprecipitation mixture, and the coprecipitation mixture 10 to 90 wt% and the sweetener 1.0 to 20.0 wt% A fast dissolving ibuprofen-containing diffusion tablet composition prepared by mixing 1.0 to 60.0 wt% excipient, 1.0 to 30 wt% powder binder, 0.1 to 5.0 wt% lubricant, and 0.1 to 25 wt% disintegrant is described.

In addition, Korean Patent Publication No. 2002-85047 discloses a fast-acting soft capsule containing a high concentration transparent liquid ibuprofen solution, wherein the transparent liquid ibuprofen solution is ibuprofen and caprylocaproyl macroglyceride, polyoxyethylene sorbitan fatty acid ester or polyoxy 40 A transparent liquid ibuprofen solution comprising at least one surfactant selected from hardened castor oil and at least one amine selected from ethylenediamine, monoethanolamine, diethanolamine or triethanolamine, and a soft capsule containing the same It is.

In addition, Korean Patent Publication No. 2002-20284 relates to the purification of an anti-inflammatory analgesic agent comprising S (+)-ibuprofen as an active ingredient, after dissolving S (+)-ibuprofen in a small amount of solvent and adsorbing it to an adsorbent. Disclosed is the preparation of S (+)-ibuprofen tablets or coated tablets including fast disintegrating agents.

U.S. Patent No. 5,560,926 is a drug tableted with S-Ibuprofen and prepared by the addition of various excipients and binders. U. S. Patent No. 5,753, 264 uses vitamin E and sunscreen as active ingredients as a system comprising a chitosan microcapsule and an oil / water emulsion. U. S. Patent No. 5,993, 858 discloses a self-microemulsifying drug composition comprising a poorly water soluble drug and a surfactant, a cosurfactant and a solvent to increase bioavailability.

However, there is still a problem that the above-described patent cannot sufficiently reduce the drug expression time, and research on this continues.

It is an object of the present invention to provide a pharmaceutical composition having anti-inflammatory analgesic activity using a self-emulsifying drug delivery system expressing a fast-acting anti-inflammatory analgesic effect capable of rapidly expressing medicinal effects.

Another object of the present invention is to provide a pharmaceutical composition having anti-inflammatory analgesic activity using a micro-emulsified drug delivery system that expresses a fast-acting anti-inflammatory analgesic effect without side effects.

In order to achieve the above object, the present invention comprises 1 to 40% by weight of an anti-inflammatory analgesic as an active ingredient; 5 to 50 wt% surfactant; 10-50 wt. 10 to 50 weight percent of cosurfactant; 0.1-5% by weight of pH adjuster; And it provides a pharmaceutical composition having anti-inflammatory analgesic activity using a self-emulsifying drug delivery system comprising a nano-emulsion comprising 1 to 5% by weight antioxidant.

Hereinafter, the present invention will be described in more detail.

The present invention is useful as an anti-inflammatory analgesic agent that minimizes side effects such as gastrointestinal disorders, liver toxicity, and nephrotoxicity of the conventional anti-inflammatory anti-inflammatory drugs, but it is difficult to formulate due to its poor water solubility and low melting point, and also does not dissolve in gastric juice. Instead of dissolving and absorbing in the intestine and solubilizing ibuprofen, which has a problem of expressing the drug too late, a self micro emulsifying drug delivery system (SMEDDS) was developed and completed.

The pharmaceutical composition having anti-inflammatory analgesic activity of the present invention utilizes the above self-emulsifying drug delivery system. As described above, the pharmaceutical composition of the present invention using the self-emulsifying system can disintegrate when administered to the human body as a liquid and have a very short time for dissolving the drug. That is, the highest concentration can be reached in about 30 minutes. As such, the present invention is a pharmaceutical composition that focuses on fastness rather than sustaining drug efficacy.

The pharmaceutical composition of the present invention comprises 1 to 40% by weight of the active ingredient of the anti-inflammatory analgesic agent, 5 to 50% by weight surfactant, 10 to 50% by weight solubilizer; 10 to 50 weight percent of cosurfactant; nanoemulsion concentrate comprising 0.1 to 5% by weight of pH adjusting agent and 1 to 5% by weight of antioxidant.

In the present invention, the active ingredient is preferably ibuprofen or dexibuprofen (S-ibuprofen) as the active ingredient of the nonsteroidal anti-inflammatory analgesic agent, and dexibuprofen is most preferred.

The content of the active ingredient in the pharmaceutical composition of the present invention is preferably 1 to 40% by weight, more preferably 25 to 40% by weight of the total content of the nanoemulsion concentrate. When the content of the active ingredient is less than 1% by weight, it is impossible to formulate due to a large amount of excipients, there is a problem in that the dosage is increased, and when it exceeds 40% by weight, it is difficult to dissolve the drug and the size of the particles is increased. There is a problem that the absorption rate is reduced in the body.

The nonsteroidal anti-inflammatory analgesic active ingredient, ibuprofen or dexibuprofen, has poor solubility in water and thus has a poor absorption rate. In order to improve solubilization and solubility of such drugs, the pharmaceutical composition of the present invention may include a surfactant, Solubilizers, pH adjusters and cosurfactants. In addition, antioxidants are included to increase the stability of the formulation.

In the present invention, the pharmaceutically acceptable surfactant used to improve the bioabsorption and bioefficiency of the active ingredient is mainly ionic and non-ionic because it is highly irritating and toxic. The surfactant serves as a dissolving agent that dissolves poorly soluble drugs, prevents drug recrystallization in the gastrointestinal tract, and stably disperses the drug regardless of pH and temperature to enable stable emulsion formation. It can be useful for the system. The HLB (Hydrophilic Lipophilic Balance) value of the surfactant used in the self-emulsifying drug delivery system preferably has a water solubility of 7 or more, and more preferably, the HLB value is 10 to 15.

The nonionic surfactants include castor oils such as polyoxylated castor oil, substituted caster oils such as cremophores or hydrogenated cremophors, tweens, spans, It is preferred to be selected from the group consisting of lavorasol and brij, with polyoxyl 35 castor oil being more preferred.

Polyoxyl 35 castor oil is a substance used in the preparation of fat soluble vitamin preparations with an HLB value of about 14, which is desirable for achieving a stable oil-in-water emulsion. In addition, polyoxyl 35 castor oil has 83% hydrophobic polyethyleneglycol ricinoleate and 17% fatty acid portion of hydrophilic polyethyleneglycol, which is very soluble in water and strongly hydrophobic in addition to chloroform, toluene and xylene It also mixes well with strong organic solvents such as, and has very good solubility in other alcoholic solvents, castor oil, olive oil and natural and synthetic oils such as fatty acids and fatty alcohols. The polyoxyl 35 castor oil has a viscosity of 650 to 800 mPas and a critical micelle concentration of 0.009%, which can form micelles even in very small amounts.

The amount of the surfactant used is preferably 5 to 50% by weight, more preferably 20 to 40% by weight of the total content constituting the nanoemulsion concentrate. If the content thereof is less than 5% by weight, the drug is absorbed into the human body to prevent stable emulsion formation. If the content exceeds 50% by weight, it may cause disorders of the gastrointestinal tract, and the formed nanoemulsion may coalesce to precipitate. There may be a phenomenon.

In addition, the solubilizing agent is ibuprofen or dexibuprofen used as an active ingredient in the present invention is used to improve the absorption rate of these effective drugs, and to reduce the dosage, as a strong hydrophobicity, fatty acid ester, vegetable oil, purified fish oil, Strong hydrophobic pharmaceutically acceptable solubilizers and the like can be used.

Examples of the fatty acid esters include propylene glycol mono or di, such as glycofurol, diethylene glycol monoethyl ether, propylene glycol monocaprylate, polyglycolide glycerides of oleic acid and linoleic acid, and prolene glycol monolaurate. Fatty acid ester derivatives, polyglyceryl di fatty acid esters such as propylene glycol, polyglyceryl dioleate, macrogol glycerols such as alpicot canal oil, and the like, and more preferably macrogoles such as alpicot kennel oil Glycerol based alpicoat canal oil may be used.

The vegetable oil may be selected from oils containing coconut oil, olive oil, corn oil, castor oil, maca dominia nut oil, apricot oil, and other unsaturated fatty acids such as fatty acids, or vegetable oils derived from polyethylene glycol in these vegetable oils. Although it may be preferably used, vegetable oils derived from polyethylene glycol in vegetable oils are more preferable since they can improve the solubility of the active ingredient of the present invention. Preferred examples of vegetable oils derived from polyethylene glycol in vegetable oils are alpicoat canal oil polyethylene glycol esters.

The amount of the solubilizer used is preferably 10 to 50% by weight, more preferably 10 to 25% by weight of the total content of the nanoemulsion concentrate. If the content thereof is less than 10% by weight, there is a problem that the drug is not completely dissolved, and if it exceeds 50% by weight, a problem of unstable stable emulsion formation occurs.

In the present invention, co-surfactants used to improve the dissolution and stability of the nanoemulsion concentrate are polyethylene glycol, propylene glycol, dimethylisosorbide, diethylene glycol monoethyl ether (transcutol), alpicoat canal oil, propylene glycol Substituted polyhydric alcohols, such as a monolaurate and tetraglycol, can be used.

The content of the co-surfactant is preferably 10 to 50% by weight, more preferably 15 to 30% by weight of the total content constituting the nanoemulsion concentrate. If the content of the co-surfactant is less than 10% by weight, there is a problem in dissolving. If the content of the co-surfactant exceeds 50% by weight, a problem occurs that crystals are precipitated when the nanoemulsion concentrate is diluted in an aqueous phase.

In the present invention, the antioxidant is used to increase the stability of the nonsteroidal anti-inflammatory analgesic active ingredient and prevent oxidation, and such an antioxidant inhibits the reaction to free radicals, and prevents heart disease, cancer or other It is a substance that suppresses various reactions to aging. By using such antioxidants, the drug content can be made constant. Representative examples of the antioxidant include tocopherol acetate. Tocopherol acetate is a fat-soluble vitamin, a large amount in fat tissues, liver muscles, platelets, adrenal glands, pituitary gland, testes, ovaries, etc. are stored in small amounts, mainly antioxidants in the biological membranes by inhibiting the oxidation of the biofilms lung cancer, stomach cancer It has been known to be effective in prolonging the survival of various adult diseases and red blood cells, cancers such as bladder cancer, strengthening of blood vessel walls and inhibiting platelet adhesion.

The amount of the antioxidant in the pharmaceutical composition of the present invention is preferably 1 to 5% by weight of the total weight of the nanoemulsion concentrate. When the content of the antioxidant exceeds 5% by weight, the size of the formulation to be prepared is increased too much, and when the content of the antioxidant is present in the above range, the emulsion size is stable and it is preferable because it can function as an antioxidant. .

The pH adjusting agent is a substance that serves to enhance stability and solubility, and examples thereof include ethanolamine such as monoethanolamine, diethanolamine or triethanolamine. The content of the pH adjuster is preferably 0.1 to 5% by weight of the total weight of the nanoemulsion concentrate. If the content of the pH regulator is less than 0.1% by weight, it does not function as a pH regulator, and if it exceeds 5% by weight, there is a disadvantage in that coagulation of the nanoconcentrate phase occurs.

A water soluble polymer such as polyvinylpyrrolidone may be further added to the composition of the present invention having such a configuration in order to increase the viscosity, dispersibility and water absorption. The addition amount of the water-soluble polymer may be suitably adjusted to an amount usable in the pharmaceutical composition, and does not need to be particularly limited. It is also possible to further add anionic surfactants such as sodium lauryl sulfate. The anionic surfactant serves to increase the solubility of the drug to improve the absorption rate. In the case of using the anionic surfactant, since the substance is toxic, it should be used in an amount of not more than 2 parts by weight based on 100 parts by weight of the total composition.

A soft capsule may be prepared by administering the pharmaceutical composition of the present invention to a soft capsule in a conventional manner, and when the soft capsule is administered to a human body, the microcapsule self-emulsifying drug delivery system may be emulsified in a fast time by itself in the gastrointestinal tract. The drug can be formulated in a form that maximizes the bioavailability by causing the absorption in the body within a few minutes and by enhancing the absorption.

As such, the composition according to the present invention uses ibuprofen, an active ingredient of steroidal anti-inflammatory analgesic, as an active ingredient, and a surfactant to improve the bioabsorption and bioefficiency of the drug, a dissolving agent and a ball to improve the absorption rate of the drug. Nonsteroidal anti-inflammatory analgesic drugs that allow the drug to be absorbed into the human body using a self-emulsifying drug delivery system prepared by adding an antioxidant and a nanoemulsion concentrate, and a pH adjusting agent to enhance the stability of the surfactant and the drug. A composition can be obtained.

Hereinafter, preferred examples and comparative examples of the present invention are described. However, the following examples are only one preferred embodiment of the present invention and the present invention is not limited to the following examples.

(Examples 1 to 4)

Next, a soft capsule was prepared by the composition as shown in Table 1 and the following method. Dexibuprofen, a non-steroidal anti-inflammatory analgesic active ingredient, was dissolved in glycofurol and alpicoat canal oil, and then the surfactant polyoxy hydrogenated oil (cremophore ELP) and antioxidant tocopherol acetate were used at room temperature. A nanoemulsion concentrate was prepared by adding and uniformly mixing triethanol amine as a pH regulator. This concentrate was poured into a soft capsule maker as it was prepared in a conventional manner.

(Examples 5 to 10)

Next, a soft capsule was prepared by the composition as shown in Table 1 and the following method. Dexibuprofen, a nonsteroidal anti-inflammatory analgesic active ingredient, is dissolved using glycofurol and polyethylene glycol, propylene glycol monolaurate, and dimethylisosorbide cosurfactant, respectively, and then cooled at room temperature to form a surfactant cremophor ELP. Tocopherol acetate and a pH adjusting agent were added and mixed uniformly to prepare a nanoemulsion concentrate. To the nanoemulsion concentrate, a pharmaceutically acceptable additive commonly used in the preparation of soft capsules was added to the soft capsule preparation machine, and prepared in a conventional manner.

division Ingredient (% by weight) drug Surfactants Solvent Cosurfactant Antioxidant pH regulator Dexibuprofen Cremophor ELP Glycofurol Propylene Glycol Monolaurate Alpicoat Canal Oil Dimethylisosorbide Polyethylene glycol Tocopherol Acetate Triethanolamine Example One 35.8 25 21.5 - 15.3 - - 2 0.4 2 35.8 25 20.5 - 15.3 - - 3 0.4 3 35.8 25 18.5 - 15.3 - - 5 0.4 4 35.8 25 18.5 - 13.3 - - 7 0.4 5 35.8 25 21.5 15.3 - - - 2 0.4 6 35.8 25 20.5 15.3 - - - 3 0.4 7 35.8 25 21.5 - - - 15.3 2 0.4 8 35.8 25 20.5 - - - 14.3 3 0.4 9 35.8 25 21.5 - - 15.3 - 2 0.4 10 35.8 25 20.5 - - 14.3 - 3 0.4

(Example 11)

To the nanoemulsion concentrate prepared in Example 1, polyvinyl pyrrolidone, which is a water-soluble polymer, was added according to the composition of Table 2 and poured into a soft capsule maker, thereby preparing in a conventional manner.

Components (% by weight) division Dexibuprofen Cremophor ELP Glycofurol Alpicoat Canal Oil Tocopherol Acetate Triethanolamine Polyvinyl pyrrolidone Example 11 35.8 25 21.5 15.3 1.5 0.4 0.5

(Test Example 1)

The Examples 1 to 11 observed the size of the emulsion formed when it meets the water phase and the results are shown in Table 3. The uniformity and size distribution of the relics were measured using the ELS-8000 (Otsuka Electronics) instrument using dynamic light scattering and the average size and distribution according to the laser intensity. In general, the smaller the emulsion size, the more stable and the absorption of the drug means that the improved, the pharmaceutical composition of Examples 1 to 11 was found to form a small emulsion of less than micro as shown in the results of Table 3.

division Average size (distribution) (nm) Dilute 1/10 in distilled water Dilute 1/10 in artificial gastric juice Example One 24.1 / (22.8-30) 24.8 / (24.6-26.9) 2 35 / (33-41.3) 45.9 / (41.4-50.4) 3 55.8 / (51.1-59.5) 60 / (58.1-166.9) 4 80 / (76-100) 85 / (74-124) 5 75.3 / (72.2-77.3) 80.3 / (79.9-45.7) 6 58.8 / (40.2-80.4) 60.8 / (55.1-65.4) 7 120.8 / (102.8-160) 134 / (117.2-152) 8 135.9 / (128.4-164) 138.2 / (118.5-197) 9 203.8 / (178-264) 210.5 / (204-267) 10 257.8 / (230.7-302) 257.4 / (203-320) 11 135 / (104-182.2) 147.5 / (118.2-195.7)

In addition, the dilution of the nanoemulsion concentrate prepared in Example 1 and Example 2 in artificial intestine in the measured by the dynamic light scattering method according to Test Example 1 is shown in Figs. 1 and 2, respectively. 1 and 2, the x-axis represents the size of the emulsion, the y-axis represents the distribution of the emulsion having the same size (for example, about 12 emulsions having about 17.3 nm is distributed), It was also found that the size of the emulsion is small and stable and the absorption of the drug is improved.

(Test Example 2)

In vitro release experiments were conducted to determine whether the rate of release of the drug was increased compared to that of normal tablets. The nanoemulsion concentrate was added to 500 ml of artificial gastric juice, gastric juice was taken for a predetermined time, and the amount of drug released by HPLC was determined.

As can be seen in Test Examples 1 and 2, the nanoemulsion concentrate according to the present invention was found to have a high release rate because the emulsion formed in contact with an aqueous phase was small in size and stable and fast in absorption of drugs. Therefore, when the Examples 2 to 11 also having an emulsion size similar to that of Example 1 can be expected to improve the bioabsorption rate of the drug.

(Test Example 3)

While keeping the soft capsule self-emulsifying drug prepared in Example 1 for two months at an accelerated condition of 40 ° C. and 75% relative humidity, the formation of precipitates, changes in turbidity, color changes, phase separation, and the like were observed. It was. The result was a stable phase with no visible changes.

While storing the drug in the above conditions, the area ratio (that is, the content of dexibuprofen) obtained by HPLC dissolved in acetonitrile for each day was measured and the results are shown in FIG. 4. As a result of confirming the content change of dexibuprofen with time through FIG. 4, it was 105% at the time of the first measurement, and the content after 120 days was maintained at 101.8%. Exceeding 100% in the experimental results is an error that can generally occur experimentally, and this error does not impede the reliability of the experimental results. Calculation of the dexibuprofen degradation rate is estimated to 16 months up to 90% of the US pharmacopoeia. It was determined that the designed drug is very stable. After two months, there was only a slight decrease in the drug content and no significant change, so the formulation of the designed drug was able to confirm that the drug was kept stable. It was confirmed.

(Test Example 4)

In order to check the stability of the self-emulsifying microemulsion type microemulsion and the distribution of particle size through FIG. It confirmed and shown by the dot in FIG.

As described above, the pharmaceutical composition having an anti-inflammatory analgesic activity of the present invention by using a self-emulsifying drug delivery system, by delivering the drug to the human body, the drug efficacy time and absorption of the poorly soluble drug is improved compared to the prior art of the drug There is an effect of reducing the cost and stability due to the reduced dose.

Claims (10)

1-40% anti-inflammatory analgesic active ingredient; 20 to 40 wt% surfactant; 10 to 50% by weight solubilizer selected from glycofurol or alpito canal oil; 10 to 50 weight percent of a cosurfactant selected from Alpicoat canal oil or diethylene glycol monoethyl ether; 0.1-5% by weight of pH adjuster; And 1 to 5 weight percent antioxidant A fast-acting anti-inflammatory analgesic comprising a nanoemulsion consisting of, using a self-emulsifying drug delivery system. The fast-acting anti-inflammatory analgesic according to claim 1, wherein the anti-inflammatory analgesic active ingredient is ibuprofen or dexibuprofen. The fast-acting anti-inflammatory analgesic according to claim 1, wherein the surfactant is a nonionic surfactant selected from the group consisting of caster oils, substituted caster oils, twins, spans, lavorasol and bridges. delete delete The fast-acting anti-inflammatory analgesic according to claim 1, further comprising a pharmaceutically acceptable additive.  The fast-acting anti-inflammatory analgesic according to claim 1, further comprising sodium lauryl sulfate. The fast-acting anti-inflammatory analgesic according to claim 1, further comprising polyvinylpyrrolidone. The fast-acting anti-inflammatory analgesic of claim 1, wherein the pH adjusting agent is selected from the group consisting of monoethanolamine, diethanolamine, and triethanolamine. A soft capsule comprising the fast-acting anti-inflammatory analgesic according to any one of claims 1 to 3 and 6 to 9 as an active ingredient.

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