Capsule raw materials have been manufactured from animal gelatin for many years. However, the disadvantages of animal raw material capsules are poor stability, high storage environment requirements, people’s psychological difficulty in accepting animal source capsules when foot-and-mouth disease and mad cow disease occur, and inability to enter Islamic countries. Many countries attach great importance to the quality and safety indicators of capsules, and the inspection of related indicators of capsules is extremely strict when importing capsule preparations.
my country is a big exporter of preparations, but every year, some medicines and health foods lose export opportunities because the safety indicators of capsules do not meet the requirements of importing countries. Empty pullulan capsules can overcome the above disadvantages.
Empty pullulan capsules are exopolysaccharides produced by Aureobacidium pullulans. The raw materials are mainly sucrose, glucose, starch hydrolyzate, and other sugary materials. The production process is microbial fermentation and biochemical extraction. It is a non-animal-derived macromolecular polysaccharide. Due to the approval of the International Muslim, Jewish, and Vegetarian Association, empty pullulan capsules have become a green channel for the export of domestic medicines and health products.
Gelatin is a heterogeneous polypeptide mixture formed by partial hydrolysis and degradation of animal (cattle, horse, pig, fish, donkey) skin, bone, tendon, scale, and other collagen-containing tissues after a series of chemical treatments. The disadvantages are poor stability, high storage environment requirements, people not psychologically accepting capsules of animal origin when foot-and-mouth disease and mad cow disease occur, and cannot to enter Islamic countries.
The oxygen transmission rate (25°C, 1atm, 24h (ml/m2)) of empty pullulan capsules is 0.5, which is one-thousandth of that of gelatin. It has unique advantages for traditional Chinese medicine, health care products, and hydrophilic drugs that are easy to absorb moisture.
Empty pullulan capsules are natural water-soluble polysaccharides, which are fermented from corn and are widely used as additives in food, pharmaceuticals, and consumer products. They are a source of soluble fiber and have no risk of cross-linking reaction of amino acids in gelatin (after cross-linking easily leads to disintegration or reduced dissolution), the drug release rate is relatively stable, and individual differences are small.
In terms of storage conditions, according to tests, empty pullulan capsules are almost not brittle in a low-humidity environment, and the properties of the capsule shell are still stable at high temperatures. Empty hard gelatin capsules are prone to dehydration hardening or brittleness under high temperature and low humidity conditions and are highly dependent on the temperature, humidity, and packaging materials of the storage environment. For the situation of large temperature differences, transportation, and retail terminal storage conditions, empty pullulan capsules undoubtedly provide a solution for some pharmaceutical and health care products companies.