Enteric-coated hypromellose capsules and delayed-release hypromellose capsules are on the market, bringing new value-added to capsules

Introduction to 1.

Capsules are mainly divided into gastric-soluble capsules and enteric-soluble capsules according to their dissolution and release characteristics. Among them, enteric-coated capsules are generally prepared by filling drugs with enteric-coated hollow capsules, which can be located in the small intestine or large intestine of the human body and release drugs, and have the advantages of protecting drugs from the destruction of gastric enzymes or gastric acid, avoiding strong stimulation of drugs to gastric mucosa, and the like. In recent years, the pharmaceutical industry at home and abroad has developed rapidly, and the research and development of new dosage forms and varieties of pharmaceutical preparations are particularly important. This plays an important role in improving the efficacy of drugs, reducing drug side effects, increasing drug bioavailability and improving patient compliance. The research and development of enteric-coated targeted drug delivery system has great clinical value.

2. process classification

Enteric-coated hollow capsules and delayed-release hollow capsules are prepared from film-forming materials and enteric-coated materials under the corresponding process conditions. According to the preparation process, it can be divided into coating process (multiple dipping coating) and non-coating process (one molding). At present, there are two kinds of hollow capsules, enteric gelatin and enteric hypromellose, on the market. The former is usually made by formaldehyde crosslinking or surface coating with enteric coating materials (such as cellulose acetate phthalate (CAP), hypromellose phthalate (HPMCP), hypromellose acetate succinate (HPMCAS), etc.), while the latter is also made by wrapping a layer of enteric coating outside the capsule shell, and the process mostly uses enteric coating materials for secondary coating preparation. Because a large number of organic solvents (such as ethanol, acetone, etc.) are used to dissolve enteric-coated materials in the coating process, there are great safety risks for operators and production workshops, and the coating preparation process is complicated and the product cost is high. At the same time, a large number of organic solvents volatilize in the production environment, which also has great risks to the occupational health of operators, making the use of enteric-coated capsules subject to many restrictions, europe and the United States is banned the use of enteric coated capsules.

Dissolution Test of 3. Enteric-coated Hollow Capsules and Delayed-release Hollow Capsules

Lifan capsules are currently available in enteric-coated hypromellose hollow capsules H-caps®-Enteric and delayed-release hypromellose hollow capsule H-caps®-DR, two kinds of capsules do not use organic solvents, using a molding process (non coating), to avoid the production, storage process of fire safety and employee occupational health risks.

1H-caps of Enteric-coated Hypromellose Hollow Capsules®-Enteric

H-caps of Hollow Enteric-Coated Hypromellose Capsules®-Enteric dissolution test, take 0.25g cefradine and fill it into the H-caps of enteric-coated hypromellose hollow capsules.®-In the Enteric, the dissolution data of the film-forming drug capsules in the environment of gastric juice and intestinal juice were tested respectively according to the requirements of the "Pharmacopoeia of the People's Republic of China" 2020 Edition II Cefradine Capsules. The results showed that the enteric coated hydroxypropyl methylcellulose hollow capsule H-caps®-Enteric does not dissolve in the gastric juice environment within 2 hours, meets the requirements of enteric-coated preparations in ChP, USP and EP, and can protect acid-sensitive drugs from acidic environment and gastric mucosa from irritating drugs.

2Delayed Release Hypromellose Hollow Capsules H-caps®-DR

H-caps of delayed-release hypromellose hollow capsules®-DR for dissolution test, take 0.25g cefradine filling into delayed release hypromellose hollow capsule H-caps®-In DR, the dissolution data of film-forming drug capsules in the gastric juice environment are tested according to the requirements of the Chinese Pharmacopoeia 2020 Edition II Cefradine Capsules. The results showed that the delayed-release hypromellose hollow capsules H-caps®-DR is not easy to dissolve in acidic medium, and is not easy to be brittle under dry conditions. It is suitable for substances that will reduce the effectiveness of ingredients in acidic medium, and also suitable for substances that have strong stimulation to gastric mucosa.

4. application

According to the relevant requirements of enteric-coated capsules in the 2020 edition of Chinese Pharmacopoeia, the enteric-coated capsules protect the contents of the capsules within 120 minutes in the medium of simulated gastric juice. H-caps of Enteric-Coated Hypromellose Hollow Capsules of Lifan Capsules®-Enteric and delayed-release hypromellose hollow capsule H-caps®-DR not only has the characteristics of protecting acid-sensitive drugs from acidic environment, but also has the advantage of low water content of hypromellose capsules. It is more suitable for filling proton pump inhibitors (PPIs) drugs that are sensitive to humidity and unstable and degrade under acidic conditions, such as omeprazole, esomeprazole, dexlansoprazole, rabeprazole, pantoprazole, etc.



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