Enteric coating for pharmaceutical dosage forms
AssigneeFMC Corporation
InventorsEmanuel J. McGinley, Domingo C. Tuason, Jr.
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Abstract
The application discloses a process for making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms and also a process for using the powder for its intended purpose.
Claims22
A process of making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms, comprising providing a freshly prepared aqueous dispersion of a water-insoluble enteric polymer, adding to said dispersion an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%, said acetylated monoglyceride being added in an amount of between about 6% and about 18% based upon the weight of the dry insoluble solids contained in the dispersion, thoroughly mixing to distribute the acetylated monoglyceride throughout the dispersion, and homogenizing and spray drying to form the powder.
A process of making a polymeric powder which is readily dispersible in water to provide a composition useful for forming an enteric coating on pharmaceutical dosage forms, comprising providing a freshly prepared aqueous dispersion of cellulose acetate phthalate, adding to said dispersion an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%, said acetylated monoglyceride being added in an amount of between about 6% and about 18% based upon the weight of the dry insoluble solids contained in the dispersion, thoroughly mixing to distribute the acetylated monoglyceride throughout the dispersion, and homogenizing and spray drying to form the powder.
A polymeric powder capable of being readily dispersed in water to provide with the addition of a plasticizer a composition useful for forming an enteric coating on pharmaceutical dosage forms, said powder consisting essentially of a water-insoluble enteric polymer in the form of spherical polymer particles held together in aggregates and impregnated by an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%.
A polymeric powder capable of being readily dispersed in water to provide with the addition of a plasticizer a composition useful for forming an enteric coating on pharmaceutical dosage forms, said powder consisting essentially of substantially spherical particles of cellulose acetate phthalate held together in aggregates and impregnated by an acetylated monoglyceride characterized by being liquid at room temperature and having a degree of acetylation of at least about 96%.
Dependencies are inferred from the claim text.