DEVELOPMENT AND TREND OF DOMESTIC CAPSULE INDUSTRY FROM THE NUMBER OF CDE HOLLOW CAPSULES REGISTERED

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As the carrier of oral preparation, hollow capsule is used more than 200 billion capsules every year. It is one of the important pharmaceutical excipients for oral solid preparation. According to the general principles of capsules in Pharmacopoeia, hollow capsules for oral capsule preparations are made of film-forming materials and corresponding auxiliary materials. The film-forming materials and their auxiliary materials used shall meet the medicinal or edible requirements. Hollow capsules usually include two parts (capsule cap and capsule body), both of which are cylindrical.

According to the preliminary statistics of the registration information publicity of pharmaceutical excipients by CDE, as of April 21, 2020, there were 328 hollow capsules and 148 enterprises, of which 143 were domestic enterprises. Among all kinds of medicinal excipients, the registration information and the number of manufacturers of hollow capsules rank first. Among the domestic hollow capsule manufacturers, Shanxi Guangsheng, Huangshan capsule, Qingdao Yiqing, Jiangsu Lifan, Hubei Renfu, Shanghai guangdeli, Yili capsule, Tianlong capsule, Huaguang capsule, Antai capsule and Honghui capsule are in the leading position in the hollow capsule production facilities, quantity and variety. Among them, Qingdao Yiqing hollow capsule intelligent digital workshop was recognized by Qingdao Bureau of industry and information technology in 2017. Huangshan capsule hollow capsule intelligent manufacturing new mode project won the special intelligent manufacturing project of made in China 2025 of the Ministry of industry and information technology in 2017 to realize the whole process visual capsule intelligent factory with visualization of production process, predictable and optimized production process and traceable product quality.

According to the source of film-forming materials, it can be divided into animal derived hollow capsules and non animal derived hollow capsules

The hollow capsule film-forming material of animal origin is mainly gelatin, mainly from bovine bone, cow leather or pig skin. Auxiliary materials generally include moisturizing agent, surfactant, colorant and shading agent when necessary.

Comparison of different formulations of animal derived hollow capsules in application

Among the domestic enterprises providing medicinal gelatin, Rousselot, Dongbao biology, Amin biology, Qinghai gelatin and other enterprises are in the leading position in the industry in terms of production conditions and scale. Among them, Rousselot uses suppliers with the qualification of animal epidemic prevention condition certificate for raw materials, suppliers with food additive production license and hygiene license for auxiliary materials, and suppliers with CDE registration number for inner packaging materials. Ensure the quality of medicinal gelatin from raw materials, auxiliary materials and packaging.

Comparison of different film-forming materials in application

According to the purpose, according to the content released by the hollow capsule in specific parts of the human body, it can be divided into stomach coated hollow capsule and intestinal coated hollow capsule. Intestinal coated hollow capsule can include colon coated hollow capsule, etc. in CDE registration number, in addition to the above purposes, there are hollow capsules for inhalation. The enterprises that can provide include Suzhou capsule, ACG and qualicaps. In China, respiratory diseases have become the third leading cause of death after cardiovascular diseases and tumors, among which asthma and chronic obstructive pulmonary disease (COPD) are the most common chronic respiratory diseases. At present, the drugs mainly used for the treatment of respiratory diseases in China mainly rely on traditional injection and oral preparations, which greatly increases the drug safety of patients and reduces the treatment effect. The effective inhaled drugs available on the market are highly dependent on foreign imports. Hollow capsule for inhalation is an important part of single dose capsule inhaler, and it is also a trend of hollow capsule development in the future. In addition, hollow capsules have the following two development trends:

Trend 1 - New applicability (diversified filling combinations)

At present, the main fillers of hollow capsules on the market are particles, including ordinary pellets, rapid-release pellets, sustained-release pellets, controlled-release pellets or enteric coated pellets, which can be filled alone or mixed. In fact, they can also be filled with tablets, liquid and semi-solid contents.

Trend 2 - expanded application of hollow capsules of non animal origin

In 1997, Pfizer took the lead in launching hydroxypropyl methylcellulose hollow capsule vcapstm and pullulan polysaccharide in the U.S. market. Since then, Japan, Austria and South Korea have successfully developed plant capsules with seaweed and corn starch as raw materials. As a large producer and consumer of traditional Chinese medicine and health care products, China is a big demand country for capsule products from a global perspective. In terms of categories, especially the market prospect of hydroxypropyl methylcellulose and pullulan polysaccharide plant capsules will be good. For pharmaceutical and functional food enterprises, the entry of plant capsules into China's drug and functional food market can not only enhance the brand value of products in China, but also accelerate the internationalization of domestic preparations.

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