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AssigneeAndrx Pharmaceuticals, Inc.
InventorsChih-Ming Chen, Xiu Xiu Cheng
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A once-a-day controlled release formulation of a water soluble drug is described which includes: (a) from 20 to 50% by weight of enteric polymeric membrane coated pellets comprising a polymer membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of a water soluble drug and a binder; and a second layer which comprises a membrane comprising a pH dependent polymeric material; and (b) from 50% to 80% by weight of delayed pulse polymeric membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of a water soluble drug and a binder and a second layer which comprises a polymeric membrane and a alkaline earth metal stearate which will substantially maintain its integrity in the varying pH conditions of the gastrointestinal tract but is permeable to said water soluble drug; and (c) a unit dose containment system.
A once-a-day controlled release formulation of a water soluble drug which comprises:
A delayed pulse bead formulation of a water soluble drug which comprises membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of a water soluble drug and a polymeric binder polymer and a second layer which comprises a polymeric membrane, an alkaline earth metal stearate and talc said second layer being capable of substantially maintaining its integrity in the varying pH conditions of the gastrointestinal tract and being permeable to said water soluble drug and which resists any substantial release of said water soluble drug for 12 hours in a USP dissolution Type II apparatus at 37° C., 100 rpm in hydrochloric acid at pH 1.0.
A once-a-day controlled release formulation of diltiazem which comprises:
A delayed pulse diltiazem bead formulation which comprises membrane coated pellets comprising a polymeric membrane coated core which comprises a biologically inert core which is coated with a first layer which consists essentially of diltiazem and a polymeric binder polymer and a second layer which comprises a polymeric membrane, an alkaline earth metal stearate and talc, said second layer being capable of substantially maintaining its integrity in the varying pH conditions of the gastrointestinal tract and being permeable to diltiazem and which resists any substantial release of diltiazem for 12 hours in a USP dissolution Type II apparatus at 37° C., 100 rpm in hydrochloric acid at pH 1.0.
Dependencies are inferred from the claim text.