Capsule sealing composition and its sealing method thereof

Abstract

Present invention relates to a capsule sealing composition and the method of using said composition for sealing capsules. Said sealing composition contains an acidic or alkaline solute and a volatile solvent; said sealing method uses the characteristics of capillary action ad volatile solvents to dissolve and seal the junction of the capsule cover and capsule body and said capsule then becomes a sealed capsule and the drugs contained in the capsule will not leak easily.

Claims

1. A capsule sealing method, comprising: dilution of a solute with a volatile solvent to a concentration that does not melt a capsule; then gradually increasing the concentration of the solute in the solvent during a process of evaporation by taking advantage of a volatility of the solvent and capillary action, meanwhile, guiding a remaining solution of the solute and the solvent to a top of an angle formed between a capsule body and a capsule cover through capillary action; wherein until evaporation is complete, the concentration of the solute in the solution is sufficient to locally melt a contact surface of the capsule and combine the capsule cover and the capsule body into one piece; and wherein the solute is acidic aqueous solution or alkaline aqueous solution.

2. The capsule sealing method as recited in claim 1, wherein a ratio of the solute and the volatile solvent is between 1:1 and 1:15.

3. The capsule sealing method as recited in claim 2, wherein the ratio of the solute and the volatile solvent is between 1:4 and 1:6.

4. The capsule sealing method as recited in claim 1, wherein the alkaline aqueous solution is an aqueous solution of a metal oxide or alkaline earth metals.

5. The capsule sealing method as recited in claim 4, wherein a metal oxide is potassium hydroxide or sodium hydroxide.

6. The capsule sealing method as recited in claim 4, wherein the concentration of the alkaline aqueous solution is 1 mole/L to a saturation solution.

7. The capsule sealing method as recited in claim 1, wherein the acidic aqueous solution is an aqueous solution of an organic acid or an inorganic acid.

8. The capsule sealing method as recited in claim 7, wherein the aqueous solution of the organic acid is citric acid or acetic acid.

9. The capsule sealing method as recited in claim 7, wherein the aqueous solution of the inorganic acid is hydrochloric acid or sulfuric acid.

10. The capsule sealing method as recited in claim 7, wherein the concentration of the acidic aqueous solution is 1 mole/L to a saturation solution.

11. The capsule sealing method as recited in claim 1, wherein the volatile solvent is methanol, ethanol, 1-propanol, 2-propanol or 1-butanol.

12. The capsule sealing method as recited in claim 1, wherein the solution further contains gelatin, hydroxypropyl methyl cellulose, guar gum, or agar gel, a pharmaceutically acceptable plasticizer and a light blocking agent.

13. The capsule sealing method as recited in claim 12, wherein the plasticizer is selected from the group consisting of the following: glycerin, sorbitol, maltose, glucose, polysaccharides, sucrose, xylitol, mannitol, 1,2-propylene glycol, and polyethylene glycol.

14. The capsule sealing method as recited in claim 12, wherein the light blocking agent is selected from the group consisting of the following: caramel, titanium oxide, and iron oxide.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 shows the diagram of the capsule sealed by using the capsule sealing method of the invention.

(2) FIG. 2 shows another diagram of the capsule sealed by using the capsule sealing method of the invention.

(3) FIG. 3 shows the schematic diagram of the sealing composition of the capsule sealed by using the capsule sealing method of the invention.

(4) FIG. 4 shows the diagram of a sealed capsule produced by using the capsule sealing method of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

(5) All technical and scientific terms used in the invention, unless otherwise specified, have the common meanings that are understood by person skilled in the art. The foregoing detailed description of the invention and the specific examples are provided herein for the purpose of illustration only, and the invention is not limited to the preferred embodiments shown. It should be understood that any changes or modifications within the spirit of the invention shall be included in the scope of present invention.

(6) Present invention provides a capsule sealing composition, said capsule sealing composition comprises of a solute and a carrier, said solute is an acidic solution or an alkaline solution, and said carrier is a volatile solvent.

(7) Present invention also provides a capsule sealing method, said capsule sealing method refers to applying the aforementioned capsule sealing composition to the junction of the capsule cover and the capsule body and allowing the composition to infiltrate into the space between the capsule cover and the capsule body by capillary action so as to dissolve the capsule shell and form a sealing ring.

(8) Regarding the aforementioned method, the size of the capsule is not restricted and the amount of the content is adjusted to between the range of 1 mg and 10 g.

(9) Regarding the aforementioned method, the capillary action refers to the liquid is elevated inside a tiny space due to cohesion and adhesion and against the gravity.

(10) The material of the capsule of present invention is a substance that retains the characteristic of reversible gelling after drying. Said substance is made of HPMC, gelatin, agar, starch, alginic acid or guar gum, and the preferred material for making the capsule is those that contain gelatin or HPMC and a plasticizer. In addition, the capsule material may also contain additives such as a light blocking agent, if required.

(11) Regarding the aforementioned gelatin, which is obtained from collagen hydrolyzed and extracted from animals such as cows or pigs. Also, the aforementioned gelatin with the characteristic of reversible gelling is subjected to alkaline treatment, acidic treatment or chemical modification. Acid-treated gelatin refers to the gelatin that is hydrolyzed with hydrochloric acid or sulfuric acid; alkali-treated gelatin refers to the gelatin that is hydrolyzed with bases such as lime; chemically modified gelatin refers to the gelatin whose amino group is treated with organic acid, e.g. succinic acid or phthalic acid.

(12) According to the invention, the aforementioned plasticizer may contain, but not limited to, glycerol, sorbitol, maltose, glucose, polysaccharides, sucrose, xylitol, mannitol, propylene glycol, polyethylene glycol and the like.

(13) According to the invention, the aforementioned light blocking agent may contain, but not limited to, caramel, titanium oxide, iron oxide and the like.

(14) The form of the capsule filling of present invention is not restricted and may be a liquid, suspension, paste, powder, granule and the like.

(15) The thickness of the hard capsule of present invention is not restricted, but a thickness between 0.01-5 mm is preferred and the preferred thickness is 0.05-1 mm.

(16) The capsule of present invention can be used in pharmaceuticals, quasi-pharmaceuticals, food, cosmetics and other purposes, according to the composition of the filling.

(17) Regarding the aforementioned pharmaceuticals, quasi-pharmaceuticals, food, cosmetics, the pharmaceutical ingredient(s) of the capsule of present invention is not restricted, as long as the ingredient(s) does not damage the capsule's functions. The pharmaceuticals include but not limited to vitamins, antipyretics, analgesics, anti-inflammatory agents, anti-ulcer agents, cardiac stimulant, anti-coagulants, hemostatic agents, anti-resorptive agents, angiogenesis-inhibiting agents, antidepressants, anti-tumor agents, antitussive and expectorant agent, muscle relaxants, antiepileptic agents, antiallergic agent, arrhythmia therapeutic agents, vasodilators, antihypertensive diuretics, diabetes therapeutic agents, antituberculosis agents, hormonal agents, analgesics, anti-bacterial agents, antifungal agents and antiviral agents and the like, but is not limited to the abovementioned pharmacological effects and all of the pharmaceutical ingredients that have relatively poor water solubility are included as the subjects of the hard capsule of present invention. Substances with poor solubility are preferred.

(18) The invention will now be described more specifically with reference to the schematic diagram of FIG. 1 to FIG. 4 by using the examples.

(19) The appearance of the capsule used in present invention for sealing is shown in FIG. 1, but the appearance is not limited to the diagram shown. All capsules with an appearance that can be sealed by using the method of present invention are included in the invention.

(20) The appearance of the capsule used in present invention for sealing is shown in FIG. 1, the outer diameter (b) of the capsule cover (1) needs to be larger than the outer diameter (a) of the capsule body (2), and the diameter (a) of the inner width of the capsule cover is similar to the outer diameter (a) of the capsule body (2), the combination of said capsule body (2) and the capsule cover (1) is shown in FIG. 2, the inner inside of the capsule cover (1) is not completely sealed with the capsule body (2) and a certain filling space (3) exists between the capsule body (2) and the capsule cover (1), said filling space (3) is an angle formed between the capsule body (2) and the capsule cover (1) and the filling space (3) is used for applying or injecting the sealing composition.

EXAMPLE 1

(21) The capsule sealing composition provided in present invention is used for sealing the capsule, said composition comprises of a (A) solute and a (B) volatile solvent. The aforementioned solute may be an acidic solution, e.g. hydrochloric acid, citric acid, acetic acid, sulfuric acid and the like, or may be an alkaline solution, such as sodium hydroxide solution and potassium hydroxide solution and the like, the solute may be replaced by water; the aforementioned volatile solvent may be an alcohol, including methanol, ethanol, 1-propanol, 2-propanol, 1-butanol and the like. The ratio of the solute and the volatile solvent contained in the aforementioned composition is 1:1 to 1:15; the preferred ratio the solute and the volatile solvent contained in the aforementioned composition is 1:3 to 1:10; the preferred ratio the solute and the volatile solvent contained in the aforementioned composition is 1:4 to 1:6; in addition, the concentration of the aforementioned solute is 1 mole/L to a saturated solution. The aforementioned composition may contain gelatin and vegetable gum, such as hydroxypropyl methylcellulose (HPMC), guar gum, or agar gel.

(22) After the capsule cover (1) is fitted with the capsule body (2) (FIG. 2), a filling space (3) is generated, said filling space is between the capsule cover (1) and the capsule body (2), and the sealing composition (4) can be affixed to the overlapping space (FIG. 3) of the inner side of the capsule cover (1) and the outer side of the capsule body (2), the sealing composition (4) is attached to the capsule and the sealed composition (4) can carry the affixed sealing composition (4) to the conjunction of the capsule cover (1) and capsule body (2) on the capsule surface through its capillary action, that is, the region where the capsule cover (1) with the inner diameter of a contacts the outer area of the capsule body with the diameter of a so as to allow the sealing composition (4) stay in the original filling space (3). Moreover, because the sealing composition (4) contains a volatile solvent, said solvent will evaporate from the opening side over time and because the amount of the solvent will decrease while the amount of solute remains the same, the concentration of solute will increase gradually. After the concentration of solute is increased to a certain level that is sufficient to dissolve the contacted capsule surface, a fusion section (5) is formed at the original filling space (3).

(23) After formation of the fusion section (5), the capsule can be sealed. In addition, because only trace amount of solute is left, the sealing composition (4) can be elevated to the top of the filling space (3) through capillary action.

(24) Meanwhile, because only trace amount of the sealing composition (4) is present, the capsule shell of the filling space (3) can be dissolved without deformation which may cause leakage of the drug contained in the capsule and entry of outside air can be blocked to prevent deterioration of the drug due to air exposure.

(25) The foregoing detailed description of the invention and the specific examples are provided herein for the purpose of illustration only, and the invention is not limited to the preferred embodiments shown. It should be understood that any changes or modifications within the spirit of the invention shall be included in the scope of present invention.

(26) In summary, present invention not only provides a novel method, but also discloses a number of improved features of technologies as described above. Therefore, the invention meet the requirements of novelty as well as non-obviousness.