Size 0 Enteric Coated Capsules

Hubei Kornnac Pharmaceutical Co., Ltd. is one of the most reliable manufacturers and suppliers of size 0 enteric coated capsules in China, also supports customized service and OEM service. Welcome to buy bulk high quality size 0 enteric coated capsules at competitive price from our factory. Contact us for samples.

Enteric Coated Gelatin Capsules is a kind of empty and hard capsule which is made from gelatin for capsules with added auxiliary materials and appropriate enteric materials. In hydrochloric acid pH 1.2 medium, it did not disintegrate and release within 2 hours. The sample was transferred to pH 6.8 phosphate buffer medium and completely disintegrated within 1 hour.

▶Equipped with PTS Production Lines, with intelligent sol-gel system,automatic viscosity adjustment equipment, Automatic Guided Vehicle System, vacuum pipeline for capsule transmission, with fully-automatic control and operation, core process technology for guarantee, traceable for the procedures, with the higher quality;

 

▶Through fully automated control operations, strict indoor cleaning procedure and quality monitoring, and constant temperature and humidity process conditions, ethylene oxide-free sterilization is achieved;

 

▶In enteric coated capsules by our company complies with the standards of the Chinese Pharmacopoeia and has the following quality control items;

Before our enteric-coated empty gelatin capsules and enteric-coated empty HPMC capsules are packaged and put on the market, they must meet the quality standards;

 

▶For enteric-coated empty gelatin capsules, they must be subjected to long-term stability tests to examine their properties, identification, tightness, disintegration time, sulfites, drying loss, ignition residue, heavy metals and other stability indicators;

 

▶For enteric-coated empty HPMC capsules, they must be subjected to accelerated tests to examine their properties, identification, tightness, friability, disintegration time, drying loss, ignition residue, heavy metals, arsenic salts and other stability indicators.

• We strictly comply with international pharmaceutical excipient GMP standards and have earned ISO 9001 Quality Management System Certification. Upholding scientific, standardized, and high-quality production is our core responsibility.

 

• To deliver high-quality, safe, and healthy empty capsules, every stage of production follows rigorous operational procedures and stringent quality controls.

Control

1. Raw material

2. Test raw material

3. Melting

4. Capsule production

5. Printing(be requested)

6. Inspection by machine

7. Counting and packing

8. Product inspection in lab

Our products comply with the standards of the Chinese Pharmacopoeia and have obtained multiple international certifications, including HALAL, Kosher, FDA, ISO 9001, and ISO 22000.

Packaging

● PE bag+Aluminum foil bag+Six surface foam board+5 ply corrugated Carton

● Carton size: 60x73x40cm; volume: 0.18 cubic meters; gross weight is about 15kgs per box.

● 20' Refrigerator Container: 140 cartons empty capsules;

● 40' Refrigerator Container: 345 cartons empty capsules.

 

Storage

● Empty capsules should be stored in the room with the temperature between 10-25 °C and the relative humidity of 35-65%;

● Capsule carton should be kept away from walls and a certain distance from the floor to avoid moisture;

● Avoid direct sunshine,keep away from heat generation and water sources;

 

Available for customization according to the customer's requirements.

The Main Advantages of Enteric-Coated Capsules
1.Protecting Drugs from Being Destroyed by Gastric Acid
Some drugs are prone to inactivation or degradation in the acidic environment of the stomach, which affects their efficacy. The design of enteric-coated capsules ensures that the drugs are not released in the stomach, thus preventing the degradation of drug components in an acidic environment and ensuring the effectiveness of the drugs.
2.Reduce Irritation to the Gastric Mucosa
Some medications (such as aspirin) have a strong irritating effect on the gastric mucosa, which may lead to stomach pain, ulcers and other problems. Enteric-coated capsules release the drugs into the intestine, reducing the direct contact of the drugs with the gastric mucosa and lowering the incidence of gastric discomfort and gastrointestinal adverse reactions.
3.Precise Drug Release
Enteric-coated capsules can release drugs at specific sites in the intestine, thereby enhancing the local therapeutic effect of the drugs. For instance, when treating intestinal diseases, the drugs can directly act on the affected areas, improving the therapeutic outcome.
4.Enhance Drug Stability
The enteric-coated capsule shell protects the drug from the influence of gastric acid, thereby extending the drug's shelf life and ensuring that the drug remains active upon reaching the intestine.
5.Reduce Drug Dosage
Due to more efficient absorption of the drug in the intestine, in some cases, the dosage of the drug can be reduced, thereby reducing the economic burden on patients.

The Specific Application Fields of Enteric-Coated Capsules

The application scope of enteric-coated capsules is very broad and covers multiple medical fields:
1.In the Field of Traditional Chinese Medicine
In traditional Chinese medicine preparations, enteric-coated capsules are often used to encapsulate drugs that are irritating to the stomach or require absorption through the intestines. This design reduces the irritation of traditional Chinese medicine to the stomach lining and improves the patient's medication comfort.

2.Chemical Drug Field
For some chemical drugs, especially those that need to maintain a certain concentration in the intestinal tract or be released under specific conditions, enteric-coated capsules are the ideal carriers.

3.Biochemical Drug Field
Biochemical drugs usually have higher requirements for the environment. Enteric-coated capsules can provide stable protection, ensuring that the drugs remain active and stable in the intestinal tract.

4.Special Disease Treatment
Enteric-coated capsules have played a significant role in the treatment of specific diseases. For instance, budesonide enteric-coated capsules, as a targeted immunomodulator for the intestinal mucosa, are widely used in the treatment of IgA nephropathy. By reducing the production of pathogenic IgA, this drug intervenes in the disease process at its source, significantly reducing proteinuria and protecting renal function.

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