ВЕНКАТЕШ Голи М. (US),ПЕРРЕТТ Стивен (US),ТИРОФФ-ЭКЕРДТ Рут (US),ЭФТИМИОПОУЛОС Константино (CH)
申请号:
RU2012113253/15
公开号:
RU2012113253A
申请日:
2010.09.17
申请国别(地区):
RU
年份:
2013
代理人:
摘要:
1. The composition of digestive enzymes from multiple particles (multi-particulate), containing enteric coated granules containing the digestive enzyme, and uncoated granules containing the digestive enzyme, where: enteric coated granules containing the digestive enzyme contain a core and enteric coating located on the core, where the core contains a therapeutically effective amount of lipase, and the enteric coating contains an enteric polymer; uncoated pellets containing a digestive enzyme contain a therapeutically effective amount of a protease and are substantially free of enteric polymer coating; where the lipase activity of the coated granules is in the range of about 1000 USP (US Pharmacopeia) units to about 10,000 USP units, and the protease activity is Uncoated granules range from about 65,000 USP units to about 34,000 USP units. 2. The multiple-particle digestive enzyme composition of claim 1, wherein the lipase activity of the coated granules is in the range of about 1000 USP units to about 5000 USP units. The multiple-particle digestive enzyme composition of claim 1, wherein the lipase activity of the coated granules is in the range of from about 2000 USP units to about 4000 USP units. The multi-particle digestive enzyme composition according to claim 1, wherein: each of the enteric coated and uncoated granules containing the digestive enzyme contains a lipase and a protease and has substantially the same protease and lipase a1. Композиция пищеварительных ферментов из множества частиц (multi-particulate), содержащая покрытые энтеросолюбильной оболочкой гранулы, содержащие пищеварительный фермент, и непокрытые оболочкой гранулы, содержащие пищеварительный фермент, где:покрытые энтеросолюбильной оболочкой гранулы, содержащие пищеварительный фермент, содержат ядро и энтеросолюбильную оболочку, расположенную на ядре, где ядро содержит терапевтически эффективное количество липазы, и энтеросолюбильная оболочка содержит энтеросолюбильный полимер; инепокрытые об