A dosage form comprising a composition comprising a drug surrounded by an interior and an exterior wall with an exit for administering the drug to a patient; and a method of using the dosage form are disclosed for an indicated therapy.
An enteric coated pharmaceutical extended releasedosage form of a H+, K+-ATPase inhibitor giving an extended plasma concentration profile of a H+, K+-ATPase inhibitor. The extended plasma profile is obtained by a pharmaceutical composition which comprises a core material of a hydrophilic or hydrophobic matrix, and the H+, K+-ATPase inhibitor and optionally pharmaceutically acceptable excipients. The dosage form may be administered once daily.
A membrane system comprising an interior wall, a fluid-permeable exterior wall surrounding the interior wall and an internal compartment defined by the membrane system, wherein fluid permeability of the interior wall is responsive to osmolarity of an osmotic core within the internal compartment are disclosed. A controlled releasedosage form comprising the membrane system and a process for delivering an osmotically active formulation from an osmotic pump over an extended period of time are also disclosed.
A membrane system comprising an interior wall, a fluid-permeable exterior wall surrounding the interior wall and an internal compartment defined by the membrane system, wherein fluid permeability of the interior wall is responsive to osmolarity of an osmotic core within the internal compartment are disclosed. A controlled releasedosage form comprising the membrane system and a process for delivering an osmotically active formulation from an osmotic pump over an extended period of time are also disclosed.
A unit dosage form, such as a capsule or the like for delivering drugs into the body in a sustained release fashion similar to that produced by INDERAL® LA indicated for the treatment of cardiovascular diseases, comprises two populations of propranolol-containing particles (beads, pellets, granules, etc.). Each bead population exhibits a pre-designed rapid release profile (i.e., substantially complete release within 60 minutes) or sustained release profile over a period of 24 hours. Such a cardiovascular drugdelivery system is designed by combining immediate release (IR) beads and sustained release (SR) beads. SR beads may be obtained by membrane coating IR beads with a water-insoluble polymer such as ethylcellulose or a mixture of a water insolublepolymer and a water-soluble polymer such as hydroxypropylcellulose at a ratio of from about 65 / 35 to 95 / 5.
There is described a prolonged release pharmaceutical dosage form comprising a plurality of coated beads, each of the coated beads comprising: (a) a granule; (b) a first layer coated on the granule, the first layer comprising: (i) hydromorphone or a pharmaceutically acceptable salt thereof, (ii) naloxone or a pharmaceutically acceptable salt thereof, (iii) an antioxidant compound, and (iii) a chelating compound; and (c) a second layer coated on the first layer, the second layer comprising a prolonged release agent. The dosage form has improved stability and dissolution properties. Another aspect of the invention relates to use of a combination of an antioxidant (such as sodium metabisulfite) and a chelating agent (such as ethylenedinitrotetraacetic acid disodium salt dihydrate) to improve the stability and / or dissolution properties of a prolonged releasedosage form comprising (i) hydromorphone or a pharmaceutically acceptable salt thereof and (ii) naloxone or a pharmaceutically acceptable salt thereof.