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Degradation Time of Capsule in Vivo

Views:326     Author:Site Editor     Publish Time: 2021-04-09      Origin:Site


Degradation time is an important control index for tablets, capsules and dropping pills. The disintegration time limit is generally checked by the pulverizer. The general functions of powder automatic capsule include preventing the stimulation of esophagus when drugs pass through the esophagus, and preventing the damage of gastric mucosa caused by drugs in the stomach.

 

41-3-soft gel capsule manufacturing machine

 

1. Disintegration Time Limit of Different Capsules

According to the Chinese Pharmacopoeia, different capsules have different disintegration time limit. The main requirements are as follows.

 

(1) Hard Capsule

The disintegration time of hard capsule (made by hard gelatin capsule filling machine or hard capsule machine) was 30 minutes.

 

(2) Soft Capsule

The soft capsule (made by soft gel capsule manufacturing machine or soft gelatin capsule filling machine) needs to be completely decomposed within 1 hour.

 

(3) Enteric Coated Capsules

Enteric coated capsules should be checked in hydrochloric acid solution (9 → 1000) for 2 hours, and the shell of each capsule should not have cracks or disintegration. Then it will be checked in artificial intestinal fluid and completely decomposed within 1 hour.

 

(4) Colon Enteric Coated Capsules

The colon enteric coated capsules should be checked in hydrochloric acid solution (9 → 1000) for 2 hours, and the capsule shell should not be broken or disintegrated. Then it will be checked in phosphate buffer solution (pH 6.8) for 3 hours, and the same requirements should be met. Finally, it should be examined in phosphate buffer solution (pH 7.8) and completely decomposed within 1 hour.

 

 

2. Factors Affecting the Degradation Time of Hard Capsules

(1) Different lubricants or characteristics of lubricants

 

(2) Granulation method

 

(3) The type of pill capsule filler

 

(4) Storage conditions and time

 

In addition, the disintegration of hard capsules is related to packaging materials, preparation technology, pharmaceutical excipients and other factors.

 

 

3. Degradation Principle

The main component of the capsule is gelatin. Gelatin is a degradation product of animal connective tissue, which is widely applied in medicine and is harmless to human body. Capsules generally degrade within 30 minutes in human body. The outer shell of the capsule is not plastic, but a kind of soluble ‘pharmaceutical excipient’. It is usually made of some medicinal gelatin and edible pigment that are mixed into raw materials in proportion, and then compression molded. It can be digested and absorbed by the human body. Capsule machine includes automatic capsule filling machine, small capsule filling machine, etc.

 

Gelatin will slowly absorb water and soften in cold water, while it will quickly dissolve in hot water. If the drug is delivered by hot water, the capsule shell is easy to be damaged, and the drug inside will be released in advance, affecting the effectiveness and safety.

 

Capsule preparation has the characteristic of improving the stability of the drug, protecting the digestive tract and respiratory tract from direct stimulation of capsule filler powder and having sustained-release targeting effect. Once the capsule shell is removed, it may reduce the efficacy and increase the toxic side effects.

 

Capsules are edible and can be completely digested in the human body. There is no fixed time for its degradation. How long will the drug capsule be digested in the human body generally depends on the type of drug capsule. Some capsules are made of starch, which can be digested and absorbed quickly and can be dissolved in about half an hour after entering the stomach. The enteric coated capsules will not dissolve until they enter the intestine.

 

Since the drugs are mainly absorbed by staying in the small intestine, more than 95% of the empty automatic capsule and drugs will be digested and absorbed by the human body in the small intestine.


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