The status quo of Chinese medical empty capsules

Due to the impact of the “poison capsule” incident, the market structure of China’s medicinal empty capsules has accelerated restructuring. However, from the overall point of view, most enterprises in the capsule industry still have the stage characteristics of individual dispersion, small production scale and inconsistent product standards. Therefore, the capsule industry presents a prominent contradiction between structural supply and demand, and the competition in the low-end products market is fierce; the industry differentiation is becoming more and more obvious, and the industrial concentration still needs to be improved.

China’s pharmaceutical capsule manufacturers are in a state of grouping, and the products of workshop-style enterprises are concentrated in the low-end market. These enterprises rely on low-cost competition strategies for production and sales; automation enterprises rely on their own scale advantages and brand advantages to compete in the high-end market. There are structural supply and demand contradictions in the industry as a whole: on the one hand, the supply of low-end pharmaceutical empty capsules is relatively abundant. Under the cost pressure brought by low-price competition, Enterprises reduce investment in quality management systems, causing hidden dangers to the safety and stability of pharmaceutical production and distribution systems; on the other hand, with the improvement of the public’s living standards, the residents’ health awareness is enhanced, the consumption concept changes, the consumption of health care products is improved, and the demand for medicinal empty capsules in the field of health care products is increasing year by year. Maintaining a 10% to 15% share of the demand for the empty capsule industry, the supply of high-quality medicinal empty capsules is obviously insufficient, and the price increases.

In fact, the Chinese pharmaceutical empty capsule industry is showing a differentiation trend. Enterprises with large production scale and strong marketing strength in the industry occupy the high-end market and have obtained most of the profits of the industry. According to statistics, the total installed capacity of 32 members of the China Pharmaceutical Packaging Association empty Capsule Professional Committee is about 320 production lines, with an annual production capacity of about 120 billion, accounting for about two-thirds of the total production capacity of the industry. Up to now, there are 130 capsule manufacturers approved in China, so at least 100 companies compete in the low-end products market, and the industry’s production capacity is partially over-supplied. Most of the company’s profits are further diluted.

According to the data of China Daily Chemicals Association Gelatin Branch, from January to November this year, China’s gelatin production is about 41,000 to 43,000 tons, mainly including bone gelatin and skin gelatin. Among them, the output of bone gelatin is about 20,000 tons, and the output of skin gelatin is about 21,000 to 22,000 tons. About 50% to 55% of bone gelatin is medicinal gelatin, and about 10% of skin gelatin is medicinal gelatin. On the whole, medicinal gelatin accounts for about 30% of the total gelatin production, so the output of medicinal gelatin is about 12,000 tons. Assuming that the structure of the medicinal empty capsule product is unchanged, each ton of gelatin can produce 10 million to 12 million medicinal empty capsules. From this, it can be inferred that the annual output of Chinese medicinal empty capsules is about 120 billion to 144 billion. At the same time, the data of the China Pharmaceutical Packaging Association empty Capsule Professional Committee shows that the total output of the top four companies in terms of production scale and sales amount is about 50% of the industry’s output, while the sum of the output of the world’s top five capsule manufacturers accounts for more than 70% of the industry’s output. Therefore, China’s high-quality medicinal empty capsule industry still has a large integration space.

In the future, with the transformation and upgrading of the pharmaceutical industry and structural adjustment, the national drug regulatory authorities will further improve the pharmaceutical excipient management system, and the standardized, specialized and large-scale pharmaceutical empty capsule enterprises will occupy the dominant position. In addition, due to the dietary preferences from consumers and the special needs of modern pharmaceutical research and development, the development of new medicinal empty capsules such as plant capsules and other non-animal capsules will continue to accelerate.

Problems That May be Encountered During Capsule Filling

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Pure hand-filled capsules are time-consuming and labor-intensive, so most people now use manual capsule fillers to make capsule products. For customers with large filling requirements (medical, nutrition industry), an automatic or semi-automatic capsule filling machine will be purchased to fill the capsules. However, these machines do not fully ensure that each capsule produced is intact.

The difference in loading is overrun.

Excessive difference in capsule loading is one of the problems that are prone to occur. Studies have shown that the size of the empty capsules, the characteristics of the materials, the differences in manual operations, the rotational speed of the automatic capsule filling machine, etc. all affect the stability of the load. (Specifically refer to factors affecting the difference in capsule loading) To solve this problem, it is necessary to analyze according to the actual situation. For example, the fluidity of the powder can be improved by adding suitable excipients or made into granules to make the filling accurate; the speed of the capsule machine is increased, and the filling is performed at the same time. The equipment should be repaired and maintained in time to ensure normal operation.

Moisture absorption

Moisture absorption is a relatively common problem encountered in the preparation of capsule products. The contents tend to become soft, agglomerate, and even mildew after moisture absorption; the capsule shells become soft and deformed after moisture absorption, thereby affecting the quality and efficacy of the drug. The solution includes the following three methods: First, strictly control the ambient temperature and humidity in the production process of empty capsule storage, material processing, material filling, etc. Second, improve the preparation process (such as granulation, moisture-proof coating, etc.). Third, adapt bottle, double aluminum foil packaging or aluminum plastic packaging.

How to Deal with Capsule Softening & Adhesion Problem

Capsule drugs are used frequently in life. However, in actual production, the problem of softening of the capsule is often encountered, which is usually happened in spring and summer. The main reason is that the gel cap is not properly stored, which is affected by the temperature or adsorbs moisture in the air.

After the capsule is softened, it is not only easy to break down by bacteria, but also causes deformation or adhesion, which makes it difficult to fill the empty capsules and take the finished capsules. If you find that the gelatin capsules you bought are stuck together, you can do so by the following methods.

First, find out the cause of the capsule adhesion. If the capsule softens due to moisture, it can be solved by the principle that the desiccant adsorbs moisture. The desiccant is placed in a dry glass dryer and the capsules to be treated are placed. Then, tighten the dryer cover. The drying time can be determined according to the degree of softening of the capsule. Pay attention to the drying time when using this method. Excessive drying can easily cause the capsule to become brittle or damage the rupture.

If the storage environment temperature is too high due to overheating, it can be solved by cooling. The softened empty capsules/ finished caps are sealed in the refrigerator for a while and then gently shaken. Most of the capsules can be dispersed during the shaking process. In addition, placing a small amount of edible powder such as corn starch, flour in a pill box for storing capsules also helps to eliminate the problem of capsule adhesion. Powder coatings help to reduce the stickiness of the capsule.

Of course, in order to properly store the capsule and ensure its medicinal properties, it is important to understand the capsule storage.

3 External Factors Affecting Stability of Drugs in Capsules

Air (oxygen)
Oxygen in the atmosphere can cause oxidation of the drug contained in the capsule. On the one hand, during the filling and fitting process, a small amount of oxygen in the atmosphere will remain in the interior of the capsule along with the air, so that some of the medicine is oxidized. On the other hand, during the storage of the capsule, since the part is not completely sealed, the air will enter and exit the capsule as the temperature changes, so that the internal oxygen is continuously increased, making the medicine further oxidized. Therefore, when filling the easily oxidizable drug, the air should be removed as much as possible, and the capsule should be sealed storage after the filling is completed to improve the stability of the drug.

Humidity and moisture
After the solid drug absorbs moisture, a liquid film is formed on the surface. Some drugs accelerate hydrolysis and oxidation under the influence of trace amounts of water. Excessive moisture can also cause the capsule to deform. Therefore, when filling and storing highly absorbent and unstable drugs, care should be taken to avoid contact with moisture. For example, the capsule drug cannot be stored in a damp place in the bathroom or kitchen.
Packaging materials
The choice of packaging material has an impact on the stability of the finished capsule after filling. If the capsule is stored directly in a room temperature environment, it will be affected by heat, light, moisture, air, and the like. Therefore, a properly sealed package design can greatly reduce drug instability and ensure the quality of volatile drugs.

特色

Common Pharmaceutical Excipients Used in Capsules

The main excipients for capsules are diluents, lubricants, glidants, disintegrants, wetting agents, adhesives, etc. The correct excipients enable the capsule to achieve the desired pharmacokinetic properties and reduce manufacturing costs. It simplifies the manufacture of pharmaceutical products and ultimately promotes the physiological absorption of the drug.

(1) Diluents: Improve the physical properties of the contents and increase the volume, and they often have a certain compressibility. Commonly used diluents are mannitol, microcrystalline cellulose, lactose, pregelatinized starch 1500, corn starch and the like.

(2) Lubricants: Prevent the adhesion of powder to metal materials. Common materials include magnesium stearate, glyceryl monostearate, stearic acid, talc, and the like.

(3) Glidants: Improve the fluidity of the contents. Commonly used glidants are micro-silica gel and talcum powder.

(4) Disintegrants: Ensure the disintegration of the contents. Common disintegrants include crosslinked cellulose, corn starch, crospovidone, pregelatinized starch 1500, and the like.

(5) Wetting agents: Increase the wettability of the drug and the dissolution medium to ensure the efficacy of the preparation. Polysorbate 80, sodium lauryl sulfate, and the like are common.

(6) Adhesives: The adhesive binds the drug powder together at the time of granulation, such as starch slurry, CMC-Na, HPC, and so on.

Tips on Taking Capsule Pills

Some people often have difficulty swallowing when we take capsules. They always feel sticky on the esophagus when capsule swallowed into the throat. It is unpleasant and even suffocating. This is caused by a certain viscosity of the mucosa because the capsule shell is made of gelatin and other ingredients. So how can you easily eat capsules more conveniently?

First you need to overcome psychological barriers. Strengthen the idea that taking capsules will not get into the trachea or cause suffocation. In fact, sometimes the capsule has been swallowed, but the psychology of the user giving you a feeling of disgust and uncomfortable.

Second, you need to pay attention to the posture of taking the capsule. It is best not to swallow with your head raised, because the density of the capsule is smaller than that of water (there is mostly air inside, and the density of the capsule shell is also very small). When it is soaked in water, it will dissolve a part. At this time, it will be very sticky and will stick to the esophagus. If the capsule is really stuck in the esophagus, swallow a lot of water to flush it into the stomach. When taking capsules, it is best to use a bowed posture. When the capsule is suspended in the soft palate, the water is swallowed and the capsule is naturally carried along with the water.

When taking capsule pills, it can be served with cold water and warm water. One thing that should be noted more than the water temperature is the amount of water. Many people take only a sip of water when they take medicine or even swallow without water. This makes it possible to stick to the esophagus. In fact, you should drink more water to ensure that the drug reaches the stomach smoothly, and it can also reduce the stimulation of certain drugs on the esophagus.

Source: www.capsulcn.com

Ways to identify plant capsules and gelatin capsules:

At present, the capsule products on the market are mainly gelatin. However, the unique structural characteristics of gelatin molecules make them have obvious defects in their applications. For example, it is easy to cross-link with drugs containing aldehydes, reducing sugar-based compounds and vitamin C, so that the gelatin shell is degraded in water solubility, resulting in disintegration of the hollow capsules and delay in dissolution of the capsule contents. Therefore, plant capsules have begun to receive widespread attention.

Vegetarian capsules are hollow glues made from plant cellulosic materials. The plant capsule retains the advantages of traditional gelatin capsules: it is convenient to take, effectively masks the taste and smell, and the contents are transparent and visible. Moreover, compared with gelatin capsules, plant capsules have a tight molecular structure, strong sealing, effectively avoiding the oxidation reaction of the drug in contact with air. Plant capsules are all made of botanical ingredients, which are harmless to the body and have nutrients. They are also effective for diabetes and high blood pressure. As a new technology, the production of plant capsules uses internationally accepted standards. Here are two easy ways to distinguish between plant capsules and gelatin capsules:

1. Observe the dissolution of cold water:

As the two capsules were placed in cold water at 25 degrees Celsius, and the gelatin capsules gradually enlarged and did not dissolve; the plant capsules gradually dissolved.

2. Observe the burning phenomenon:

As the two capsules are separately burned, the plant capsules produce the smell of burning cotton, and the gelatin capsules produce a smell of burning protein (similar to the smell of burning hair).

Precautions:

Do not touch the hand when using the burning method, pay attention to protect the eyes and skin to avoid splashing Mars.

Empty Capsules

Empty capsules are made from a variety of different materials. For example, gelatin capsules are composed of a cap and a body capsule made of medicinal gelatin plus auxiliary materials. The capsule is mainly used for holding solid drugs, and can be used for self-made powders, health products, medicines, etc., and solves the problem of difficult entrance and poor mouthfeel for the user, greatly reducing the bitterness of the user when taking the powder. . Today’s hollow capsules are becoming more and more popular for a variety of reasons. First of all, the shape of the capsule is slender and easy to swallow. It is the most popular dosage form for consumers; in addition, it can effectively mask the unpleasant taste and smell of the built-in powder. Capsules come in a variety of sizes, including length 00 and capsule size 5. In addition, the capsules can be printed with text, logos and graphics to create a unique custom look.