| 摘要 |
A degradable, multi-layered gastroretentive drug formulation for the sustained release of an active agent in the stomach and gastrointestinal tract of a patient, comprising: an internal layer comprising an active agent and a degradable polymer composition which is not instantly soluble in gastric fluid, the internal layer including a first side and an opposing second side; and at least one membrane covering the internal layer, the membrane comprising at least one polymeric combination of a hydrophilic polymer and a polymer, insoluble in gastric media, the membranes being hydratable at a rate greater than the internal layer; the membrane being directly secured to and covering both sides of the internal layer and having a predetermined length greater than 20 mm in a planar orientation, the membrane and internal layer being arranged in an accordion folded orientation sufficiently compact to be placed within a capsule dissolvable within the stomach; the membrane and internal layer developing sufficient mechanical force to unfold from the initial accordion folded orientation to a length of at least 20 mm within 30 minutes of being exposed to gastric medium; the membrane permitting passage of gastric media from the environment to the internal layer and permitting passage of the active agent from the internal layer through the membrane to the environment; wherein the internal layer comprises the active agent and a polymer that are uniformly distributed throughout the internal layer. |
