Sealing fluid for sealing capsules

Abstract

The present invention discloses a sealing fluid comprising an organic acid, an alcohol, and optionally water, wherein the organic acid is lactic acid or acetic acid, the alcohol is isopropanol or ethanol, and the sealing fluid is a liquid composition for sealing a hard capsule having partially overlapping, nested body portions.

Description

Background Art

[0001] The present invention discloses a sealed fluid containing an organic acid, an alcohol, and optionally water. The organic acid is lactic acid or acetic acid, the alcohol is isopropanol or ethanol, and the sealed fluid is a liquid composition for sealing a hard capsule in which body portions are partially coaxially overlapped and joined in an nested manner.

[0002] Capsules are well-known dosage forms for pharmaceuticals, nutraceuticals, nutraceutical ingredients, etc. A hard capsule usually consists of a shell filled with one or more substances. The hard capsule shell is composed of two parts, a cap and a body, both of which are cylindrical with one open end and one closed end. The outer diameter of the cylindrical open end of the body fits coaxially into the inner diameter of the cylindrical open end of the cap. When the capsule, i.e., the body, is filled with the contents of the capsule, the capsule is closed. To close the capsule, the open end of the body is coaxially inserted into the open end of the cap. Hard capsules are generally manufactured using a dip molding method, in which a mold pin is immersed in a melt that is a liquid film-forming composition containing a dissolved film-forming polymer. After extraction, a film is formed on the mold pin. The film is peeled off the mold pin. Dip molding is performed separately to manufacture the cap and the body.

[0003] In a closed capsule, the cylindrical opening of the cap partially overlaps with the cylindrical opening of the body. That is, a portion of the inner cylindrical surface of the cap contacts a portion of the outer cylindrical surface of the body. Leakage can occur between these overlapping surfaces of the cap and body because, for various reasons, the fit between the inner diameter of the cap and the outer diameter of the body cannot be precise and tight enough to prevent any leakage. For example, when inserting the body into the cap to close it, each portion of air inside the cap must be released; otherwise, excessive pressure may be generated, preventing a complete closure or even rupturing the capsule. Also, the force required to slide the cap onto the body to avoid damaging the cap or body when closing the capsule should not be too great. Therefore, there is always some tolerance between the cap and the body, resulting in a gap between the overlapping portion of the cap and body.

[0004] When the capsule is closed, the leading edge of this gap between the edge of the cap and the surface of the body becomes visible and accessible.

[0005] In some cases, such as when a capsule is filled with a liquid substance, it is desirable to prevent the contents from leaking out of the capsule. For this purpose, the capsule is sealed. That is, the gap between the cap and the body is closed by sealing. This sealing can also be considered as mutual adhesion or bonding of the cap and body by a sealing fluid. When sealing a capsule, the sealing fluid is applied to the leading edge of this gap between the edge of the cap and the surface of the body. Then, by capillary action, the sealing fluid spreads and is distributed into the interior of the gap. The capsule shell can be made from various film-forming polymers such as gelatin, HPMC, pullulan, or starch. In the case of HPMC, there are mainly two different methods for forming a film on the mold pin in a dip molding process. One is conventional gelation of HPMC at temperatures below the gelation temperature of the HPMC molten material, which requires the presence of a gelling system such as gelulan in the molten material. The other is thermal gelation, which occurs at temperatures above the gelation temperature of the HPMC molten material and does not require the presence of an additional gelling system in the molten material.

[0006] Patent Document 1 discloses Example 6, which contains HPMC E50 / water / lactic acid / propan-2-ol in a ratio of 6 / 25 / 44 / 25 (total 100%). Example 6 has a viscosity that is far too high to be used to seal capsules immediately after filling them in a conventional capsule filling machine at a speed compatible with conventional capsule filling lines. Its viscosity prevents the formation of a spray, preventing the sealing fluid from being present anywhere within the sealing area, which means a high leakage rate.

[0007] The problem to be solved was to provide a sealing fluid that could be used in automated sealing machines for the automatic sealing of capsules. Therefore, it should enable large-scale mass production to reduce manufacturing time and costs, and minimize waste due to product defects. The sealing fluid should allow for capsule sealing immediately after filling at a speed compatible with conventional capsule filling lines. Furthermore, it should be free from clogging and other problems.

[0008] The sealing fluid should provide an effective seal on the filled capsule to prevent leakage of its contents, and therefore a low leakage rate is desirable. The sealing fluid should not adversely affect the shape, dimensions, or stability of the capsule. The sealing fluid should be able to be applied to all types of capsules, particularly capsules having a combination of HPMC as the film-forming polymer and gellan as the gelling system, i.e., capsule shells made of HPMC and gellan as the main or even sole components of the capsule shell.

[0009] This problem is solved by a sealing composition containing organic acids, alcohols, and optionally water.

[0010] Abbreviations and definitions used herein HPMC (Hydroxypropyl Methylcellulose), also known as hypromellose or cellulose, 2-hydroxypropyl methyl ether or cellulose hydroxypropyl methyl ether, CAS 9004-65-3 [Prior art documents] [Patent Documents]

[0011] [Patent Document 1] WO2004 / 103338A1 [Overview of the project]

[0012] The subject of the present invention is a sealing fluid SEALFLU for sealing hard capsules containing an organic acid ORGACID and an alcohol ALC. ORGACID is lactic acid or acetic acid. ALC is isopropanol or ethanol. Here, The amount of ORGACID is at least 32.5% by weight. The amount of ALC is at least 17.5% by weight. The weight percentage is based on the weight of SEALFLU. SEALFLU does not contain HPMC. SEALFLU has a viscosity of 100 mPa*s or less, as measured at 22°C using a rotational viscometer equipped with a cylindrical spindle. [Modes for carrying out the invention]

[0013] In one embodiment, SEALFLU does not contain any polymers conventionally used in capsule preparation, such as gelatin, pullulan, starch, modified starch, or cellulose derivatives such as HPMC.

[0014] More preferably, SEALFLU contains no polymers whatsoever.

[0015] More preferably, SEALFLU contains no gelling agent whatsoever.

[0016] More preferably, SEALFLU does not contain any substances that increase the viscosity of SEALFLU by its addition, and the viscosity of SEALFLU does not particularly exceed 100 mPa*s, which is the viscosity measured at 22°C using a rotational viscometer equipped with a cylindrical spindle.

[0017] Preferably, the amount of ALC is at least 20% by weight, more preferably at least 25% by weight, even more preferably at least 30% by weight, and particularly at least 35% by weight, where the weight percentage is based on the weight of SEALFLU.

[0018] Preferably, the amount of ALC is 55% by weight or less, more preferably 50% by weight or less, and even more preferably 45% by weight or less, where the weight percentage is based on the weight of SEALFLU. The possible amount of ALC can be combined with either the lower limit or the upper limit.

[0019] Preferably, the amount of ORGACID is at least 35% by weight, where the weight percentage is based on the weight of SEALFLU.

[0020] Preferably, the amount of ORGACID is 75% by weight or less, more preferably at least 70% by weight, even more preferably 65% by weight or less, particularly 60% by weight or less, more particularly 55% by weight or less, even more particularly 50% by weight or less, especially 45% by weight or less, and the % by weight is based on the weight of SEALFLU.

[0021] Any of the lower limits and any of the upper limits of the possible amounts of ORGACID can be combined.

[0022] Any of the lower limit or upper limit of the possible amount of ALC can be combined with any of the lower limit or upper limit of the possible amount of ORGACID.

[0023] In one embodiment, SEALFLU consists of ORGACID and ALC. Preferably, ORGACID is acetic acid, or Preferably, ALC is isopropanol. In this case, more preferably, ORGACID is acetic acid and ALC is isopropanol.

[0024] In one embodiment, SEALFLU consists of ORGACID and ALC. ORGACID is acetic acid. The amount of acetic acid is from 47.5 to 80% by weight, and the amount of ALC is from 20 to 52.5% by weight. Preferably, the amount of acetic acid is from 47.5 to 75% by weight, and the amount of ALC is from 25 to 52.5% by weight. The % by weight is based on the weight of SEALFLU. Preferably, ALC is isopropanol.

[0025] In one embodiment, SEALFLU also contains water in addition to ORGACID and ALC. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water, and the weight percentage is based on the weight of SEALFLU.

[0026] Preferably, if SEALFLU also contains water in addition to ORGACID and ALC, the amount of water in SEALFLU is at least 17.5% by weight, where the weight percentage is based on the weight of SEALFLU, and in this case, ORGACID is preferably lactic acid.

[0027] In one embodiment, SEALFLU includes water in addition to ORGACID and ALC. ORGACID is acetic acid. The amount of acetic acid is 40 to 60% by weight. The amount of ALC is 20 to 40% by weight. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably the total amount of ORGACID, ALC, and water is 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water. The weight percentage is based on the weight of SEALFLU. Preferably, ALC is isopropanol.

[0028] In one embodiment, SEALFLU includes water in addition to ORGACID and ALC. ORGACID is acetic acid. The amount of acetic acid is 45 to 55% by weight. The amount of ALC is 25 to 35% by weight. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably the total amount of ORGACID, ALC, and water is 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water. The weight percentage is based on the weight of SEALFLU. Preferably, ALC is isopropanol.

[0029] In one embodiment, SEALFLU includes water in addition to ORGACID and ALC. ORGACID is lactic acid, The amount of lactic acid ranges from 32.5 to 62.5% by weight. The amount of ALC ranges from 17.5 to 47.5% by weight. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably the total amount of ORGACID, ALC, and water is 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water. Preferably, ALC is ethanol, and the amount of ethanol is 25 to 42.5% by weight, more preferably 27.5 to 42.5% by weight. The weight percentage is based on the weight of SEALFLU.

[0030] In one embodiment, SEALFLU includes water in addition to ORGACID and ALC. ORGACID is lactic acid, The amount of lactic acid is 32.5 to 55% by weight. The amount of ALC ranges from 17.5 to 42.5% by weight. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably the total amount of ORGACID, ALC, and water is 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water. Preferably, ALC is ethanol, and the amount of ethanol is 25 to 42.5% by weight, more preferably 27.5 to 42.5% by weight. The weight percentage is based on the weight of SEALFLU.

[0031] In one embodiment, SEALFLU includes water in addition to ORGACID and ALC. ORGACID is lactic acid, and ALC is isopropanol. The amount of lactic acid is 37.5 to 55% by weight. The amount of isopropanol ranges from 17.5 to 42.5% by weight. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably the total amount of ORGACID, ALC, and water is 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water. The weight percentage is based on the weight of SEALFLU.

[0032] In one embodiment, SEALFLU includes water in addition to ORGACID and ALC. ORGACID is lactic acid, and ALC is isopropanol. The amount of lactic acid is 37.5 to 45% by weight. The amount of isopropanol is 35 to 42.5% by weight. The total amount of ORGACID, ALC, and water is at least 97.5% by weight, preferably 98% by weight, more preferably at least 99% by weight, and even more preferably the total amount of ORGACID, ALC, and water is 100% by weight, i.e., SEALFLU consists of ORGACID, ALC, and water. The weight percentage is based on the weight of SEALFLU.

[0033] In one embodiment, SEALFLU consists of ORGACID, ALC, and water. Preferably, ORGACID is lactic acid, or Preferably, ALC is isopropanol. More preferably, ORGACID is lactic acid and ALC is isopropanol.

[0034] In one embodiment, SEALFLU consists of ORGACID, ALC, and water. The amount of ORGACID is 40% by weight. The amount of ALC is 40% by weight. The weight percentage is based on the weight of SEALFLU. Preferably, ORGACID is lactic acid, or Preferably, ALC is isopropanol. More preferably, ORGACID is lactic acid and ALC is isopropanol.

[0035] Any water may be desalinated water.

[0036] SEALFLU may have a viscosity of 100 mPa*s or less, preferably 75 mPa*s or less, more preferably 60 mPa*s or less, even more preferably 50 mPa*s or less, particularly 45 mPa*s or less, and even more particularly 40 mPa*s or less, as measured at 22°C using a rotational viscometer equipped with a cylindrical spindle.

[0037] In one embodiment, SEALFLU has a viscosity equal to or lower than that of pure lactic acid, measured at 22°C using a rotational viscometer equipped with a cylindrical spindle.

[0038] A further subject of the present invention is a method for preparing SEALFLU, in which ORGACID, ALC, and any water are mixed. This specification includes SEALFLU, ORGACID, and ALC as defined herein, as well as all embodiments thereof.

[0039] The mixture of ORGACID, ALC, and water may be in any order.

[0040] A further subject of the present invention is METHSEAL, a method for sealing hard capsules, wherein the capsule shell of the capsule consists of a cap and a body, the body being nested inside the cap, and a gap being provided between the overlapping portions of the cap and the body. Here, sealing is achieved by applying SEALFLU to the gap. SEALFLU, and all embodiments thereof, are also defined herein.

[0041] The capsule is filled and closed before sealing. When the capsule cap is closed, the body is joined in a nested manner. This joining can be done, for example, by inserting the body into the cap, i.e., sliding the body into the cap, or vice versa. The cap and body partially overlap within the closed capsule. This creates a gap between the overlapping portion of the cap and body. When sealing the capsule, the sealing fluid is applied over the gap, i.e., on the leading edge of the gap that is accessible from the outside of the capsule. The leading edge of the gap is located between the edge of the cap and the surface of the body.

[0042] SEALFLU is uniformly distributed around the capsule, thereby coating the gap, or coating only the gap. SEALFLU may be coated over the entire length of the gap, or only over a portion or portion of the length of the gap. It is preferable that it be coated over the entire length of the gap.

[0043] SEALFLU can be applied by spraying it onto gaps, or by spraying it onto capsules, thereby also applying it to gaps.

[0044] When SEALFLU is applied to capsules, i.e., to gaps, it may reach or be at ambient temperature.

[0045] After applying SEALFLU to the gap, the capsule may be dried. This drying can be done, for example, to remove excess SEALFLU. Alternatively, the overlapping surfaces of the cap and body, i.e., the surfaces forming the gap between the cap and body, may be made to ensure proper adhesion.

[0046] A further subject of the present invention is a sealed capsule that can be obtained by the METHSEAL method, using METHSEAL as defined herein, and also using all embodiments thereof.

[0047] Capsules suitable for the hard capsule sealing method of the present invention may have a shell made of a known film-forming polymer such as gelatin, HPMC, pullulan, or starch. The capsule shell may contain further components such as a gelling system, a typical example of which is gellan. In one embodiment, the hard capsule sealing method of the present invention is a method for sealing hard capsules, wherein the film-forming polymer of the capsule shell is gelatin, HPMC, pullulan, or starch, and in one embodiment, the film-forming polymer is HPMC and the capsule shell contains gellan. The amount of gellan in the capsule shell may be 0.01 to 10% by weight, preferably 0.01 to 7% by weight, more preferably 0.1 to 7% by weight, even more preferably 1 to 7% by weight, particularly 3 to 6% by weight, and more particularly 4 to 6% by weight, where the weight percentage is based on the weight of HPMC. [Examples]

[0048] Materials and Abbreviations In the capsule example, DRcaps capsules (DRcaps(R) Capsules) from Capsugel, a subsidiary of Lonza Ltd, currently located in Basel, Switzerland, were used. DRcaps have an HPMC-based formulation containing gellan gum, and the DRcaps capsules have delayed-release properties. The capsules had the same design as Capsugel's Licaps(R) capsules, which are now part of Lonza Ltd, currently located in Basel, Switzerland. CFS capsule filling and sealing The CFS 1200 is currently manufactured by Lonza GmbH, a subsidiary of Lonza GmbH, based in Basel, Switzerland. TM This is a CFS machine for laboratory and pilot plant-scale operation, with an operating speed of approximately 1,200 capsules per hour. The CFS operates in three steps: filling, sealing, and drying. Drying is performed by applying air at a preset temperature. HPMC (Hydroxypropyl Methylcellulose), also known as hypromellose or cellulose, 2-hydroxypropyl methyl ether or cellulose hydroxypropyl methyl ether, CAS 9004-65-3 IPA Aqueous Isopropanol 80% by weight Lactic acid: Approximately 90% of (S)-lactic acid is produced by Merck KGaA, a limited liability company in Darmstadt, Germany. EMPROVE(R) EXPERT Ph Eur,BP,E 270 (excipient for pharmaceutical manufacturing). Technical datasheet for Merck's 90% lactate: 20 to 40 mPa*s at 20°C Lactic acid viscosity (reference): 37 to 39 mPa*s at ambient temperature 21.2 mPa*s at 35℃ LEMS Liquid-Filled Microspray Sealing LEMS 70 LEMS (R) 70 is a LEMS system from Lonza GmbH, currently located in Basel, Switzerland. The CFS machine for production-scale operation has an operating speed of up to 55,000 capsules per hour, and the capsule size range is 000, 00el, 00, 0el, 0, 1.2, 3, 4. rpm (revolutions per minute)

[0049] (A) Sealed fluid: 40 / 40 / 20 (w / w / w) solution of lactic acid / isopropanol / water Sealing fluid (A1) For a 100g sealed fluid solution: Lactic acid 44.44g • IPA 50g • Desalted water 5.56g A sealed fluid solution was prepared by adding three components in the following order: lactic acid, water, and then IPA. The solution was then mixed using a magnetic stirrer. The sealing fluid was used at ambient temperature to seal the capsule.

[0050] (B) General description of sealing Two different sealing machines were used: the CFS1200 and the LEMS70. CFS1200 was used at a rate of approximately 1200 capsules per hour. LEMS was used at a rate of approximately 40,000 capsules per hour. In the embodiment, a size 0 capsule was used.

[0051] (C) Detection of leakage rate The sealed capsules were spread out on white paper on a tray and stored overnight (approximately 12 hours) at ambient temperature and pressure. Next, the tray was placed in a vacuum chamber, where a vacuum of 250 mbar was applied for 20 minutes. Afterward, the tray was removed from the vacuum chamber, and the capsules were visually inspected on a light table to observe the potential for leakage, indicated by oily stains spreading beneath the leaking capsules within the paper. The leakage rate is given as the percentage of leaking capsules out of the total number of capsules tested for leakage. The capsule may have been left on the paper in the tray for a week, and a separate visual inspection may have been performed to determine the leak rate. For laboratory-scale operations such as those using the CFS1200, a leak rate of 0.5% or less is acceptable. For pilot plant / production scale operations such as LEMS, a leakage rate of 0.05% or less is acceptable.

[0052] (D) Viscosity Viscosity measuring device: Brookfield DV-II+ viscometer with SC4-13R chamber and 18-inch cylindrical spindle, manufactured by AMETEK Brookfield, located in Middleborough, Massachusetts, USA. The temperature chamber must be adjusted using a water bath at 22°C ± 0.1°C. To fill half of the viscosity chamber, inject the sealing fluid using a syringe. Next, introduce the spindle and completely fill the chamber with sealing fluid up to 1 mm from the edge. Ensure that no air bubbles are present to prevent errors in viscosity measurement. To obtain the highest possible measurement accuracy, select the viscometer speed to the maximum possible speed. Measure the viscosity after 10 minutes. Viscosity value = average of two measurements Details are shown in Tables 6 and 7.

[0053] [Table 1] [Table 2]

[0054] Example 1 - Sealing using CFS1200 (1a) Filling with oil The capsules were filled with peanut oil inside the CFS1200. Peanut oil has a very low viscosity (74.9 mPa*s at 22°C - Brookfield viscometer) and is particularly prone to leakage, making it a suitable model for detecting leakage rates. The same amount of oil was filled into each capsule. The capsules were then closed and moved inside the CFS1200 and to the sealed position by the CFS1200.

[0055] (1b) Sealing Each capsule was sealed with a CFS1200 using 20 mg of sealing fluid per capsule. The sealing fluid was prepared according to (A1), and the sealing fluid was sprayed around the outward-facing opening end of the gap provided by the overlap of the cap and body of the nested capsules. No problems such as clogging of the sealing machine were observed.

[0056] (1c) Drying The drying temperature for the CFS1200 was 25°C.

[0057] (1d) Result Leakage rate detection was performed according to (C). The results are shown in Table 1. No leaks were detected before the vacuum chamber. [Table 3] The dimensions, shape, and stability of the capsules were not affected by the sealing process.

[0058] Example 2 - Sealing using LEMS70 (2a) Filling with oil The capsules were filled with sunflower oil. Sunflower oil has a very low viscosity (53 mPa*s at 22°C - Brookfield viscometer) and is particularly prone to leakage, making it a suitable model for detecting leakage rates. Each capsule was filled with the same amount of oil. The capsules were then closed.

[0059] (2b) Sealing Each capsule was sealed with LEMS70 using 25 mg of sealing fluid per capsule. The sealing fluid was prepared according to (A1), and the sealing fluid was sprayed onto the capsules, including spraying it around the outward-facing open end of the gap provided by the overlap of the cap and body of the nested capsules. No problems such as clogging of the sealing machine were observed.

[0060] (2c) Drying The drying temperature for the LEMS70 was 35°C.

[0061] (2d) Result Leakage rate detection was performed according to (C). The results are shown in Table 2. No leaks were detected before the vacuum chamber. [Table 4] Seven iterations consistently yielded similar leakage rates within acceptable limits. The dimensions, shape, and stability of the capsules were not affected by the sealing process.

[0062] Example 3 Example 1 was repeated using the details shown in Tables 3 to 5. The sealing fluid was prepared according to (A) using the compositions shown in Tables 3 to 5. Sealing was performed with CFS1200 according to (B), and the leakage rate was detected according to (C). No leakage was observed in front of the vacuum chamber during each run. No problems such as clogging of the sealing machine were observed. All runs show the leakage rate within acceptable limits. The dimensions, shape, and stability of the capsules were not affected by the sealing process.

[0063] [Table 5] [Table 6] [Table 7]

Claims

1. A sealing fluid for use in an automatic sealing machine for the automatic sealing of capsules, comprising an acid (ORGACID) and an alcohol (ALC), for sealing hard capsules; ORGACIDS is lactic acid or acetic acid; ALC is isopropanol or ethanol; Here, The amount of ORGACID is at least 32.5% by weight; The amount of ALC is at least 17.5% by weight; The aforementioned weight percentage is based on the weight of SEALFLU; SEALFLU does not contain HPMC; SEALFLU is a sealing fluid having a viscosity of 100 mPa*s or less, which is measured at 22°C using a rotational viscometer equipped with a cylindrical spindle.

2. SEALFLU is the SEALFLU according to claim 1, comprising ORGACID and ALC.

3. SEALFLU according to claim 2, wherein ORGAACID is acetic acid.

4. SEALFLU according to claim 2 or 3, wherein ALC is isopropanol.

5. The amount of acetic acid is 47.5 to 80% by weight, and the amount of ALC is 20 to 52.5% by weight. The aforementioned weight % is based on the weight of SEALFLU, according to claim 3 or claim 4.

6. SEALFLU contains water in addition to ORGACID and ALC; The total amount of ORGACID, ALC, and water is at least 97.5% by weight, the weight percentage being based on the weight of SEALFLU, according to claim 1.

7. The SEALFLU according to claim 6, wherein the amount of water in the SEALFLU is at least 17.5% by weight, and the weight percentage is based on the weight of the SEALFLU.

8. ORGACID is acetic acid; The amount of acetic acid is 40 to 60% by weight; The amount of ALC is 20 to 40% by weight; The aforementioned weight % is based on the weight of SEALFLU, according to claim 6 or claim 7.

9. SEALFLU according to claim 8, wherein ALC is isopropanol.

10. ORGACID is lactic acid; The amount of lactic acid ranges from 32.5 to 62.5% by weight; The amount of ALC is 17.5 to 47.5% by weight; The aforementioned weight % is based on the weight of SEALFLU, according to claim 6 or claim 7.

11. ALC is ethanol; The amount of ethanol is 25 to 42.5% by weight; The aforementioned weight % is based on the weight of SEALFLU, according to claim 10.

12. ALC is isopropanol; The amount of lactic acid is 37.5 to 55% by weight; The amount of isopropanol ranges from 17.5 to 42.5% by weight; The aforementioned weight % is based on the weight of SEALFLU, according to claim 10.

13. The amount of lactic acid is 37.5 to 45% by weight; The amount of isopropanol is 35 to 42.5% by weight; The SEALFLU according to claim 12, wherein the weight percentage is based on the weight of SEALFLU.

14. SEALFLU is the SEALFLU according to any one of claims 6 to 13, comprising ORGACID, ALC, and water.

15. SEALFLU according to claim 14, wherein ORGACID is lactic acid.

16. SEALFLU according to claim 14 or claim 15, wherein ALC is isopropanol.

17. The amount of ORGACID is 40% by weight; The amount of ALC is 40% by weight; The aforementioned weight % is based on the weight of SEALFLU, according to one or more of claims 14 to 16.

18. A method for preparing SEALFLU; ORGACID, ALC, and any water are mixed together; A method for preparing SEALFLU, comprising SEALFLU, ORGACID, and ALC as defined in any one of claims 1 to 17.

19. A method for sealing a hard capsule, METHSEAL, wherein the capsule shell of the capsule consists of a cap and a body, and the body is nested within the cap It is inserted inside and provides a gap between the overlapping portion of the cap and the body; here, the sealing is achieved by applying SEALFLU to the gap; The SEALFLU is a SEALFLU as defined in any one of claims 1 to 17, Method, METHSEAL.

Images