Dosage forms containing cholylsarcosine active ingredient
2005
The present invention provides a dosage form containing cholylsarcosine active ingredient in the form of active ingredient-containing pellets having a gastric juice of polymer coating 50 to 80 wt% of cholylsarcosine active ingredient and one or more of the pharmaceutically the excipients customary containing 50 to 20 wt% as a binder, in which at least 90 wt% of the excipients that are contained is water-soluble, and the active ingredient-containing pellets until at least 80% have a size in the range of 800~2500Myuemu, this time, the granules containing the active ingredient is coated with an anionic film-forming polymer coating, the coating agent is sodium phosphate buffer of 0.07M It was dissolved in dissolution rate of at least 10mg / min × g for submerged pH 5.5, and the dissolution rate of the less sodium phosphate buffer pH6.0 in 0.07M Also a 200 mg / min × g, and this time, relates to a dosage form, wherein the polymer coating is 5 to 15% by weight relative to the pellets mass. The present invention further relates to a method of manufacturing a dosage form.
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