Drug formulations having inert sealed cores
AssigneeMylan Pharmaceuticals Inc.
InventorBoyong Li
Life of this patent
Estimating the term…
Abstract
A drug composition comprising a coated bead is used in the manufacture of immediate release and/or controlled release drug compositions. In a specific embodiment, the bead includes an inert core of a water-soluble or water-swellable material, which has been coated with a seal layer formed from a non-polymeric hydrophobic material. The immediate and/or controlled release beads may be used to form tablets or capsules. A method of making the beads by sequential deposition of multiple layers on the inert cores is also described.
Claims50
1) A controlled release drug composition comprising a bead, said bead comprising:
- an inert core;
- a seal layer positioned on said core layer, said seal layer containing a non-polymeric hydrophobic material;
- a layer containing at least one active ingredient positioned on said seal layer;
- and
- a layer of at least one release-controlling polymer positioned on said layer containing at least one active ingredient.
18a) The controlled release drug composition of claim 17, wherein the water soluble or water mobile pore forming agent is hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methylcellulose, carboxymethylcellulose, polyethylene glycol, polyvinylpyrrolidone, polyvinyl alcohol, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, cellulose acetate trimellitate, polymethacrylates, an ammonium salt of a copolymer of methacrylic acid and methacrylic acid alkyl ester, sucrose, lactose, maltose, mannitol, maltodextrin, NaCl, or a mixture thereof.
24) A controlled release dosage form comprising a plurality of beads, each of said beads comprising:
- an inert water-soluble or water-swellable core;
- a seal layer positioned on said core layer, said seal layer containing a non-polymeric hydrophobic material;
- a layer containing at least one active ingredient positioned on said seal layer;
- and
- a layer of at least one release-controlling polymer positioned on said layer containing at least one active ingredient.
32) A method of making a controlled release drug-containing bead, said method comprising the steps of:
- depositing a seal layer on an inert core, said seal layer containing a non-polymeric hydrophobic material;
- depositing a layer containing at least one active ingredient on said seal layer;
- and
- depositing a layer of at least one release-controlling polymer on said layer containing at least one active ingredient.
44) A controlled release drug composition comprising a bead, said bead comprising:
- an inert water-soluble or water-swellable core;
- a water-insoluble seal layer positioned on said core layer, said seal layer being formed from a C12-C20 fatty alcohol or a C12-C20 fatty carboxylic acid;
- a layer containing at least one active ingredient positioned on said seal layer, said active ingredient being tolterodine tartrate;
- and
- a layer of a release-controlling polymer positioned on said layer containing at least one active ingredient.
48) A dosage form comprising a plurality of controlled release beads and a plurality of immediate release beads, each of said controlled release beads including:
- an inert water-soluble or water-swellable core;
- a seal layer positioned on said core layer, said seal layer containing a non-polymeric hydrophobic material;
- a layer containing at least one active ingredient positioned on said seal layer;
- and
- a layer of a release-controlling polymer positioned on said layer containing at least one active ingredient.
Dependencies are inferred from the claim text.