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Hydrogel-driven drug dosage formRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Tablets, Lozenges, Or Pills, Sustained Or Differential Release Type, Layered Unitary Dosage FormsHydrogel-driven drug dosage form description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070087057, Hydrogel-driven drug dosage form. Brief Patent Description - Full Patent Description - Patent Application Claims
BACKGROUND OF THE INVENTION [0001] The present invention relates to a dosage form that provides a controlled release of a low-solubility beneficial agent, or drug, to an environment of use. [0002] Osmotic and hydrogel-driven drug delivery devices for the release of a drug have been known in the art for some time. Exemplary dosage forms have included a tablet comprising a semipermeable wall surrounding a compartment containing the drug and a layer of swellable hydrogel, with the drug being delivered through a passageway in the semipermeable wall by swelling of the hydrogel, as described in U.S. Pat. No. 4,327,725; another tablet comprising a wall permeable to an exterior fluid but impermeable to the drug, the wall surrounding a compartment containing two osmotic agents, two expandable polymers and the drug, as described in U.S. Pat. No. 4,612,008; drug dispersed in a swellable hydrogel matrix core that releases the drug by diffusion into the environment of use, as described in U.S. Pat. No. 4,624,848; a hydrogel reservoir containing a multiplicity of tiny pills wherein each tiny pill consists of a wall surrounding a drug core, as described in U.S. Pat. No. 4,851,232; and a two-layered tablet wherein one layer is drug mixed with a hydrogel and the other layer is a hydrogel, as described in U.S. Pat. No. 5,516,527. [0003] While the conventional dosage forms described above are functional, nonetheless such dosage forms suffer from a variety of drawbacks. A controlled release dosage form should ideally deliver substantially all of the drug from the dosage form to the environment of use. However, a common problem encountered by osmotic and hydrogel-driven dosage forms, particularly when the drug has low aqueous solubility, is that residual drug is left in the tablet interior after the hydrogel or other swellable material has completely swelled. This residual drug is not available for absorption and, accordingly, such dosage forms require increased amounts of drug to compensate for the failure of the system to release all of the drug into the environment of use. [0004] In addition, the controlled release dosage form must operate within certain size constraints, and yet be capable of delivering most or all of the drug to the environment of use. Dosage forms, particulary for humans, are limited in size, and are usually less than 1 gram, more preferably less than 700 mg in weight. However, for some types of drugs, the dose amount may make up to half or even more of the weight of the dosage form. The water-swellable materials that provide the delivery of the drug must in instances where the dose is high be capable of providing a highly efficient delivery of the drug, since very little of the dosage form may be available for the swellable material or other excipients. [0005] In addition, it is often desired that the dosage form begin extruding drug relatively quickly upon entering the use environment. However, many delivery systems exhibit a time lag before extruding drug. This is particularly a problem when the drug has low aqueous solubility or is hydrophobic. Several techniques have been proposed to reduce the time lag, but each has its own drawback. One technique has been to provide high-permeabilitiy coatings by utilizing thin coatings around the dosage form. While this technique provides a quicker uptake of fluid, the thin coating lacks strength and often bursts in use or provides insufficient protection to the dosage form which becomes susceptible to damage during handling. Yet another technique has involved providing pores or one or more passageways that communicate with the water-swellable materials, but this often leads to unacceptable amounts of residual drug. Another technique involves coating the dosage form with an immediate release drug formulation, but this requires additional processing steps and provides a dosage form with two different release rates, which may be undesirable. [0006] Yet another problem encountered with conventional osmotic and hydrogel-driven drug delivery systems is that such dosage forms often require the presence of osmagents. Osmagents are selected such that they generate an osmotic pressure gradient across the barrier of the surrounding coating. The osmotic pressure gradient drives the permeation of water into the tablet and the resulting buildup of sufficient hydrostatic pressure, which forces the drug through the delivery port. These osmagents increase the weight of the dosage form, thus limiting the amount of drug which may be contained in the dosage form. In addition, the presence of additional ingredients in the dosage form, such as osmagents, increases the costs of manufacture due to the need to insure uniform concentrations of the ingredients throughout the dosage form, and may have other drawbacks such as adverse effects on compression properties and on drug stability. [0007] Accordingly, there is still a need in the art for a controlled release dosage form that results in a highly efficient delivery of drug to an environment of use with very little residual drug, that allows large drug loading so as to minimize the dosage size, that begins releasing drug soon after entering the environment of use, and that limits the number of necessary ingredients. These needs and others which will become apparent to one skilled in the art are met by the present invention, which is summarized and described in detail below. BRIEF SUMMARY OF THE INVENTION [0008] The various aspects of the invention each provide a controlled release drug dosage form having a core comprising a drug-containing composition and a water-swellable composition. The drug-containing composition and the water-swellable composition occupy separate regions within the core. The drug-containing composition comprises a low-solubility drug and a drug-entraining agent. A coating around the core is water-permeable, water-insoluble and has at least one delivery port therethrough. [0009] In a first aspect of the invention, the drug-containing composition further includes a swelling agent having a swelling ratio of at least 3.5, and the drug-entraining agent comprises at least 15 wt % of the drug-containing composition. [0010] In a second aspect of the invention, the mass ratio of the drug-containing composition to the water-swellable composition has a value of at least 1.5, and the water-swellable composition comprises a water-swellable agent and a tableting aid, the water-swellable composition having a swelling ratio of at least 3.5, and a strength of at least 3 Kp/cm.sup.2 (where Kp is Kiloponds). [0011] In a third aspect of the invention, the water-swellable composition comprises a swelling agent. The coating around the core has a minimum durability of 1 Kp/cm.sup.2, and a minimum water flux (40/75) of at least 1.0.times.10.sup.-3 gm/cm.sup.2-hr. [0012] In a fourth aspect of the invention, the coating is porous and is formed from a substantially homogeneous solution comprising a solvent, a hydrophilic cellulosic polymer, and a non-solvent. [0013] In a fifth aspect of the invention, the drug-containing composition further comprises a fluidizing agent. Following introduction into an environment of use, the dosage form releases at least about 70 wt % of the low-solubility drug to the use environment within about 12 hours. [0014] In a sixth aspect of the invention, the drug-containing composition further comprises a solubilizer. When the drug is a basic drug, the solubilizer may be an organic acid. [0015] In a seventh aspect of the invention, the low-solubility drug is in the form of an amorphous dispersion. [0016] In an eighth aspect of the invention, a method is provided for treating a patient in need of a drug by administering a therapeutically effective amount of the drug in a dosage form of the invention. [0017] In one embodiment, the dosage form includes a concentration-enhancing polymer. [0018] The various aspects of the present invention have one or more of the following advantages. The dosage forms of the present invention are capable of delivering greater amounts of drug to the desired environment of use with greater efficiency using smaller amounts of swelling materials, and also result in lower amounts of residual drug than do conventional compositions. The compositions are also capable of higher drug loading compared with conventional compositions. In addition, the compositions begin delivering drug to the environment of use more quickly than do conventional osmotic controlled release dosage forms. The dosage forms are capable of rapidly delivering a low-solubility drug without the coating failing due to rupture as a result of excessive pressure within the core when the dosage form is introduced into an environment of use. The dosage forms are also capable of delivering a low-solubility drug in a solubilized form. [0019] The foregoing and other objectives, features, and advantages of the invention will be more readily understood upon consideration of the following detailed description of the invention, taken in conjunction with the accompanying drawing. BRIEF DESCRIPTION OF THE DRAWING [0020] FIG. 1 is a schematic drawing of a cross section of an exemplary embodiment of a dosage form of the present invention. DETAILED DESCRIPTION OF THE INVENTION Continue reading about Hydrogel-driven drug dosage form... Full patent description for Hydrogel-driven drug dosage form Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Hydrogel-driven drug dosage form patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. 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