Enteric coated pharmaceutical compositions
First Claim
1. An enteric coated pharmaceutical composition comprising a core in the form of a tablet, beadlet, pellet or particle and an enteric coating for said core, said core comprising an acid labile medicament in an amount within the range of from about 1 to about 60% by weight of the composition, a disintegrant in an amount within the range of from about 1 to about 20% by weight of the composition and a buffering agent in an amount within the range of from about 1 to about 20% by weight of the composition, and said enteric coating comprising a hydroxypropylmethyl cellulose phthalate which is totally neutralized or at least about 80% neutralized, and a plasticizer, said enteric coating imparting protection to said core so that said core is afforded protection in a low pH environment of 3 or less while capable of releasing medicament at a pH of 4.5 or higher.
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Accused Products
Abstract
An enteric coated pharmaceutical composition is provided which includes a medicament which is sensitive to a low pH environment of less than 3, such as pravastatin, which composition is preferably in the form of pellets which includes an enteric coating formed of neutralized hydroxypropylmethyl cellulose phthalate, plasticizer and anti-adherent. The so-coated pellets have good resistance to deterioration at pH less than 3 but have good drug release properties at greater than 3.
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Citations
33 Claims
- 1. An enteric coated pharmaceutical composition comprising a core in the form of a tablet, beadlet, pellet or particle and an enteric coating for said core, said core comprising an acid labile medicament in an amount within the range of from about 1 to about 60% by weight of the composition, a disintegrant in an amount within the range of from about 1 to about 20% by weight of the composition and a buffering agent in an amount within the range of from about 1 to about 20% by weight of the composition, and said enteric coating comprising a hydroxypropylmethyl cellulose phthalate which is totally neutralized or at least about 80% neutralized, and a plasticizer, said enteric coating imparting protection to said core so that said core is afforded protection in a low pH environment of 3 or less while capable of releasing medicament at a pH of 4.5 or higher.
- 31. An enteric coated pravastatin comprising a core in the form of a pellet, beadlet or tablet which includes pravastatin in an amount within the range of from about 1 to about 60% by weight and an enteric coating which includes a neutralized form of hydroxypropylmethyl cellulose phthalate which is totally neutralized or at least about 80% neutralized.
Specification