TWM511327U - Positive pressure capsule - Google Patents

Description

Positive pressure capsule

The present invention relates to a positive pressure capsule which can accelerate the breakage of the capsule to form a break and accelerate the release of the drug. The capsule is characterized in that the sealed capsule contains gas and the internal pressure is positive pressure.

Capsule is a rapidly developing pharmaceutical dosage form with a thickness of about 0.1-0.7 mm. It is widely used in medicines, health foods and other internal medicines. It has the advantages of convenient storage, accurate dosage, controlled drug release, and can mask the adverse effects of active pharmaceutical ingredients. Odor, maintain drug activity, and therefore easy for the user to accept.

The capsule dosage form can seal the medicine inside the capsule. Due to its sealing characteristics, the medicine in the capsule can prevent the activity from being weakened by contact with the outside air and moisture, and thus maintain long-term stability.

Certain pharmaceutically active substances may have biopharmaceutical or physicochemical properties that make them difficult to formulate into commercially acceptable formulations. However, such materials can be administered in the form of a liquid carrier medium. The potential of 1,2-propanediol and dimethylisosorbide as solvents for such carrier media is great. The composition of the carrier medium allows it to form an emulsion in the stomach, thereby promoting absorption of the pharmaceutically active substance. The carrier medium must be prepared accurately so that it does not affect the pharmaceutical composition and does not destroy its beneficial nature. The solubilizing nature of the drug carrier may alter the nature of the active substance to precipitate it, resulting in insufficient patient dosage. The emulsifying properties of the pharmaceutical carrier may also vary, and emulsions may not form in the stomach upon administration, and the pharmaceutically active substance will not be properly absorbed.

This liquid formulation encapsulation in a capsule provides a very convenient method of administration for such pharmaceutically active substances. However, commercially acceptable capsule fillings are also accompanied by difficulties limiting the availability of this route.

Capsules for medicine can be divided into two types: hard capsules and soft capsules. Hard capsules (hereinafter referred to as hard capsules) can be filled with solid medicines such as medicine powder or fine-particle medicine, and soft capsules (hereinafter referred to as soft capsules) can be filled with liquid medicines such as medicines. .

The capsule material may be gelatin, sorbital, hydroxypropyl methylcellulose (abbreviated as HPMC), and opaque food coloring or other additives.

The traditional capsule manufacturing material is gelatin, which is a protein or peptide extracted from the epidermis, bone or connective tissue of the animal, and contains collagen. After boiling in water, a hydrophilic yellowish protein layer can be obtained. gelatin.

Another commonly used capsule material can be hydroxypropyl methylcellulose, or simplified as hydroxypropyl methylcellulose (HPMC), which is a viscous polymer that often acts as an oral drug. An alternative to excipients, emulsifiers, thickeners, suspending agents or gelatin. After the cellulose is treated with a base, the alkoxy anion formed by deprotonation of the hydroxyl group may be added to propylene oxide to form a hydroxypropyl cellulose ether; or may be condensed with methyl chloride to form a methyl cellulose ether. Hydroxypropyl methylcellulose is produced when both reactions are carried out simultaneously.

There are also a variety of alternatives to capsule materials, including extracts of seaweed, ie, polysaccharide colloids. In order to replace the raw materials, the vegetable raw materials can avoid the cross-linking reaction with the animal protein contained in the capsule, and the strength of the capsule capsule can be maintained, and since the popularity of the American mad cow disease has gradually increased in recent years, the improved soft capsule raw materials have been paid more and more attention. Other alternative raw materials, such as agar gum, water-soluble etherified starch derivatives, HPMC, ie carrageenan, also gradually have a market share.

One of the purposes of capsule improvement is to improve the bioavailability of pharmaceutical agents. The active ingredient can be quickly released in liquid form as the capsule ruptures. Unlike the tablet composition, the active ingredient is made to be absorbable and does not require the capsule to completely disintegrate. At the same time, the insoluble active ingredient can be dispersed in the liquid carrier to provide faster absorption, such as a solution of a hydrophobic drug in a hydrophilic solvent; in the digestion, the capsule will rupture in the stomach, and Hydrophobic drugs can be dispersed in gastric juice.

However, it is a common problem that the capsule is sluggish in the process of disintegration. It is considered that the disintegration of the capsule is mainly caused by the cross-linking reaction of gelatin. Since the amino acid in the gelatin molecule is easily oxidized to form an aldehyde group, the formed aldehyde group can crosslink with the surrounding amino acid to form a three-dimensional network structure in/between molecules, resulting in gelatin molecular weight, structural stability, and water solubility. The decline in sex causes the disintegration of the capsule to be slow. For the problem of capsule disintegration, the main solutions are: 1. Adding antioxidants, 2. Adjusting the capsule formula and changing the proportion of ingredients such as water and plasticizer, 3. Using raw materials that are less susceptible to oxidation.

In order to solve the shortcomings of the above-mentioned capsules which are not easy to disintegrate and affect the bioavailability of the drug in the gastric juice, the novel creator has deliberately developed the novel creation content.

For the purpose of the foregoing, the present invention provides a positive pressure capsule which utilizes the characteristic of the internal pressure of the capsule as a positive pressure, and accelerates the speed of destruction and disintegration of the capsule in the stomach after administration, thereby adding The release of the drug is facilitated by the drug and is used by the organism.

Wherein, the capsule can be a sealed capsule.

Wherein, the internal pressure of the capsule must be a positive pressure and greater than one atmosphere.

Wherein, the capsule contains gas inside, and the gas may be oxygen, helium, nitrogen, or carbon dioxide or a mixed gas of the above gases.

Wherein, the capsule raw material may be gelatin, that is, a hydrolyzate produced from animal collagen.

Wherein, the capsule raw material may be hydroxypropyl methylcellulose (HPMC).

Wherein, the capsule raw material may further comprise agar, starch, alginic acid, guar gum, and additives such as pharmaceutically acceptable sunscreens, plasticizers and the like.

The gelatin may be alkali-treated gelatin, acid-treated gelatin, or chemically modified gelatin.

Wherein, the plasticizer may be selected from the group consisting of glycerin, sorbitol, maltose, glucose, polysaccharide, sucrose, xylitol, mannitol, propylene glycol, polyethylene glycol.

Wherein, the opacifier may be selected from the group consisting of caramel, titanium oxide, and iron oxide.

The filler of the capsule may be in the form of a liquid, a suspension, a paste, a powder, or a granule.

For the foregoing purposes, the present invention provides a positive pressure capsule which can be manufactured by filling a capsule under a positive pressure environment and then sealing the capsule, wherein the capsule is retained in the capsule, and the capsule is finished in a capsule. Positive pressure capsules under atmospheric pressure.

In order to achieve the aforementioned purpose, the present invention provides another positive pressure capsule which can be borrowed It is manufactured by filling in a low temperature environment, the above low temperature environment is lower than 25 ° C, and sealing the capsule, wherein a bubble is retained in the capsule, and the capsule is a positive pressure capsule under normal temperature environment.

1‧‧‧ capsule capsule

2‧‧‧The capsule contains positive pressure gas or bubbles

3‧‧‧Capsule capsule bonding line

4‧‧‧Capsule capsule junction

5‧‧‧Capsules filled with capsules

The first picture is a schematic diagram of the positive pressure capsule of the present creation.

Figure 2 is another schematic view of the positive pressure capsule of the present invention.

Figure 3A is a schematic diagram of the positive pressure capsule of the present invention, which has not been digested in the stomach after administration.

Figure 3B is a schematic diagram of the positive pressure capsule of the present invention in the digestion of the stomach after administration.

All of the technical and scientific terms described in this specification, unless otherwise defined, are intended to be common to those of ordinary skill in the art. This creation is exemplified by the following examples, but the present creation is not limited by the following examples. The materials used in this creation are commercially available and readily available. The following are just examples of the available pipelines.

The purpose of the novel creation is to provide a positive pressure capsule, which can be made by the following method, comprising the following steps: Step 1: placing the environment filling the capsule in a positive pressure environment or a low temperature environment; Step 2, filling the medicine Place the capsule inside and keep the space with bubbles inside; Step 3, seal the capsule body so that there is no opening on the surface to avoid gas leakage.

With respect to the aforementioned positive pressure environment, it refers to an environment greater than one atmosphere, and one atmosphere is equivalent to the International System of Units of 1 atm, 1013 hPa, or 76 cm-Hg.

Regarding the aforementioned bubble, the bubble is based on the principle that the dosage is not affected, and the bubble size is not particularly limited; the gas may be a gas that does not affect the drug or the content.

Regarding the aforementioned low temperature environment, it is lower than 25 °C.

The positive pressure capsule may be in the form of a spherical shape, an elliptical shape, a long elliptical shape, a test tube type, an angle type or the like; and the size thereof is not particularly limited, and the content can be adjusted to a range of about 1 mg to 10 g. Just fine.

The capsule material of the present invention is a substance which has the property of reversible gelling even after drying. The substance is formed, for example, from an intra-gel material such as HPMC, gelatin, agar, starch, alginic acid, guar gum, etc., and is a raw material containing gelatin or HPMC and a plasticizer as a capsule. good. Further, the capsule raw material may contain an additive such as an opacifier as needed.

The gelatin may be obtained by using an animal such as a cow or a pig, and extracting the collagen by hydrolysis to obtain gelatin. Further, as the gelatin having the reversible gel property described above, it includes alkali treatment, acid treatment, or chemical modification gelatin. The acid-treated gelatin is a hydrolyzing agent using an acid such as hydrochloric acid or sulfuric acid; the alkali-treated gelatin is a hydrolyzing agent using an alkali such as lime; and the chemically modified gelatin is an amine group of gelatin and succinic acid or phthalic acid. (phthalic acid) and other organic acid reaction.

With regard to the aforementioned plasticizer, it may include, but is not limited to, glycerin, sorbitol, maltose, glucose, polysaccharide, sucrose, xylitol, mannitol, propylene glycol, polyethylene glycol, and the like.

The sunscreen agent may include, but is not limited to, caramel, titanium oxide, iron oxide, and the like.

The shape of the capsule filling is not limited, and it can be liquid or suspended. The thickness of the hard capsule of the present invention is only required to function as a capsule, and is not particularly limited, but is preferably 0.01 to 5 mm (mm), preferably 0.05 to 1 mm.

The capsule of the present invention can be used for pharmaceuticals, quasi-drugs, foods, cosmetics, etc., and can be determined according to the composition of the filler.

Regarding the above-mentioned pharmaceuticals and quasi-drugs, the medicinal ingredients filled in the capsules of the present invention are not particularly limited as long as they do not impair the capsule function. Drugs include, but are not limited to, the following listed vitamins, antipyretics, analgesics, anti-inflammatory agents, anti-ulcer agents, cardiotonic agents, anticoagulants, hemostatic agents, anti-bone resorbants, anti-angiogenic agents, anti-depressants, anti-drugs Oncology agent, antitussive and expectorant, anti-aging agent, anti-epileptic agent, anti-allergic agent, arrhythmia therapeutic agent, vasodilator, antihypertensive diuretic, diabetes therapeutic agent, anti-tuberculosis agent, hormone preparation, analgesic, anti-bacterial Agents, antifungal agents, antiviral agents, etc., but are not limited to the aforementioned pharmacological action group, and all the medicinal ingredients containing relatively poor solubility to water are the objects of the present hard capsule. It should be an active substance that is difficult to dissolve.

The preferred embodiment of the present invention is described in detail below with reference to the schematic diagrams of the positive pressure capsules of Figures 1 and 2:

Embodiment 1

The positive pressure capsule manufacturing method provided by the present invention comprises the following steps: Step 1: placing the filled capsule environment under positive pressure conditions, the positive pressure condition needs to be greater than 1 atmosphere; Step 2: under positive pressure environment, The drug (5) is filled inside the capsule; Step 3: sealing the capsule capsule (1) so that there is no opening on the surface to avoid gas leakage, but retaining bubbles (2) therein; Step 4: Return the finished capsule to a normal environment, that is, under one atmosphere, and the inside of the capsule can be greater than one atmosphere, and become a positive pressure capsule.

In the foregoing positive pressure capsule, before or after sealing the capsule body (1), another gas may be injected, and the gas chamber is injected into the gas (2), and then sealed, thereby becoming the positive content of the prior art. Press the capsule.

The positive pressure capsule, after being taken by the user, enters the stomach for digestion, and when the capsule disintegrates to a certain extent, wherein the positive pressure is sufficient to break through the capsule to form a break, the purpose of releasing the drug (5) can be achieved (3A) Figure, Figure 3B).

Embodiment 2

The positive pressure capsule manufacturing method provided by the present invention comprises the following steps: Step 1: placing the filled capsule environment under low temperature conditions, the low temperature condition is lower than 25 ° C; Step 2: placing the medicine under low temperature environment ( 5) Filled inside the capsule; Step 3: Seal the capsule capsule (1) so that there is no opening on the surface to avoid gas leakage, but retain bubbles (2) therein; Step 4: Return the finished capsule to the normal environment Under the temperature, the inside of the capsule can be more than one atmosphere, and it becomes a positive pressure capsule.

In the positive pressure capsule, when the capsule capsule (1) is sealed, a gas can be additionally injected, and the gas chamber is injected into the gas (2), and then sealed, thereby becoming a positive pressure capsule of the present invention.

The positive pressure capsule is further pressurized by the body temperature after being taken by the user, and the pressure in the capsule is further pressurized due to the body temperature. When the capsule collapses to a certain extent, when the positive pressure is enough to break through the capsule formation, the pressure can be reached. The purpose of releasing the drug (5) (Fig. 3A, Fig. 3B).

The capsule is a sealed capsule, and the capsule must be a close-packed capsule (1). The capsule can be joined by the capsule capsule bonding wire (3) shown in FIG. 1 or the capsule shown in FIG. The capsule junction region (4), the junction region is partially melted to form a tight region, but the implementation of the present invention is not limited to the manner of bonding into a sealed capsule, and the schematic is only for explaining the positive pressure capsule of the present invention. Must be a closed capsule.

The detailed description above is for the specific description of the possible embodiments of the present invention, but the embodiment is not intended to limit the scope of the patents of the present invention, and equivalent implementations or changes that are not departing from the spirit of the present invention should be included in the present case. In the scope of patents.

The above-mentioned multiple functions are the statutory creative elements that fully meet the novelty and progressiveness. If you apply in accordance with the law, you are requested to approve the application for the creation of this article to encourage creation.

1‧‧‧ capsule capsule

2‧‧‧The capsule contains positive pressure gas or bubbles

3‧‧‧Capsule capsule bonding line

5‧‧‧Capsules filled with capsules

Claims (9)

A positive pressure capsule comprising a body, the system is hollow; a filling is filled in the body; and a bubble is disposed in the body, and the air pressure of the bubble is greater than one atmosphere. For example, the positive pressure capsule of claim 1 can be a spherical type, an elliptical type, a long elliptical type, a test tube type, or an angular type. For example, in the positive pressure capsule of claim 1, the gas of the bubble may be oxygen, helium, nitrogen, or carbon dioxide, or a gas that does not react with the contents. For example, the positive pressure capsule of the first application of the patent scope is gelatin or hydroxypropyl methylcellulose (HPMC). The positive pressure capsule of claim 1 of the patent scope may further comprise an agar, a starch, an alginic acid, a guar gum, and an additive such as a pharmaceutically acceptable plasticizer, an opacifier or the like. For example, the positive pressure capsule of claim 3, the gelatin may be alkali treated gelatin, acid treated gelatin, or chemically modified gelatin. The positive pressure capsule according to item 4 of the patent application, the plasticizer may be selected from the group consisting of glycerin, sorbitol, maltose, glucose, polysaccharide, sucrose, xylitol, mannitol, propylene glycol, Polyethylene glycol. The positive pressure capsule of claim 4, the opacifier may be selected from the group consisting of caramel, titanium oxide, and iron oxide. For example, the positive pressure capsule of the first aspect of the patent application may be a pharmaceutical composition or a health food product in the form of a liquid, a suspension, a paste, a powder, or a granule.