Enteric coated pharmaceutical composition and method of manufacturing
OwnerIsmat Ullah, Gary J. Wileyinventors
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Abstract
A high drug load enteric coated pharmaceutical composition is provided which includes a core comprised of a medicament which is sensitive to a low pH environment of less than 3, such as ddl, which composition is preferably in the form of beadlets having an enteric coating formed of methacrylic acid copolymer, plasticizer and an additional coat comprising an anti-adherent. The so-called beadlets have excellent resistance to disintegration at pH less than 3 but have excellent drug release properties at pH greater than 4.5. A novel method of making said pharmaceutical composition is also disclosed.
Claims48
An enteric coated pharmaceutical composition comprising a core in the form of a beadlet, pellet, granule or particle and an enteric coating for said core, said core comprising an acid labile medicament in an amount within the range from about 50 to about 100% by weight of said composition, a binder in an amount within the range from about 0 to about 10% by weight of said composition, a disintegrant in an amount within the range of from about 0 to about 10% by weight of said composition, and said enteric coating comprising a methacrylic acid copolymer, 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, said pharmaceutical composition also comprising an anti-adherent in an amount within the range of from about 0.1 to about 4.0% by weight.
An enteric coatetddl comprising a core in the form of a beadlet or pellet which includes ddl in an amount within the range of from about 50 to about 100% by weight of said core, and an enteric coating which includes a methacrylic acid copolymer.
A process for the preparation of an enteric-coated pharmaceutical composition comprising the steps of:
- (a) preparing a dry blend comprising a medicament, a binder and a disintegrant, and setting a portion of said dry blend aside;
- (b) forming a wet mass from the remainder of said dry blend not set aside in step (a);
- (c) extruding said wet mass to form an extrudate and spheronizing said extrudate into high-potency beadlets by dusting said wet mass extrudate with said portion of said dry blend set aside in step (a);
- (d) coating said beadlets with an enteric coating polymer and plasticizer in an aqueous-media;
- and
- (e) blending said coated beadlets with an anti-adherent.
Dependencies are inferred from the claim text.