Abstract: The invention concerns a storage stable pharmaceutical formulation comprising preferably two active compounds in a non-swellable diffusion matrix, whereby the compounds are released from the matrix in a sustained, invariant and, if several compounds are present, independent manner and the matrix is determined with respect to its substantial release characteristics by ethylcellulose and at least one fatty alcohol. The invention also concerns methods for producing such pharmaceutical formulations.

Abstract: The present disclosure relates to a biocompatible polymer composition for an article comprising a surface intended to contact blood, tissue, skin, epithelial layers, wounds, cells in culture fluids, body fluids, dialysis fluids, therapeutic fluids, or mixtures thereof for removal or infusion. The invention also relates to a method for the preparation of an article comprising the biocompatible polymer composition and a use thereof.

Abstract: Silane-functionalized hydrophobic ?(1?4)glucopyranose polymers and polymeric matrices are described. Biodegradable matrices can be formed from hydrophobic ?(1?4)glucopyranose polymers with reactive pendent silyl ether groups. Reaction of the silyl ether groups provides improved matrix formation through bonding to a device surface of a device, polymer-polymer crosslinking, or both. Biodegradable matrices can be used for the preparation of implantable and injectable medical devices, including those that release a bioactive agent.

Abstract: An implant for insertion into a punctum of a patient comprises a body. The body has a distal end, a proximal end, and an axis therebetween. The distal end of the body is insertable distally through the punctum into the canalicular lumen. The body comprises a therapeutic agent included within an agent matrix drug core. Exposure of the agent matrix to the tear fluid effects an effective therapeutic agent release into the tear fluid over a sustained period. The body has a sheath disposed over the agent matrix to inhibit release of the agent away from the proximal end. The body also has an outer surface configured to engage luminal wall tissues so as to inhibit expulsion when disposed therein. In specific embodiments, the agent matrix comprises a non-bioabsorbable polymer, for example silicone in a non-homogenous mixture with the agent.

Abstract: Disclosed is a novel device for the vacuum infusion of a porous medical implant contained therein with one or more pharmaceutical substances and a method for the device's use. The device is deformable, and capable of adjusting to the outer contour of a porous medical implant to facilitate packaging, shipping and storage of the implant contained within the device. In addition, the device is unbreakable, easily disposed of after use, maintains the implant in a sterile condition before and after infusion and minimizes the quantity of pharmaceutical substance needed for infusion. Use of the device provides for rapid and complete infusion of a variety of pharmaceutical substances into a porous implant prior to surgery.

Abstract: The invention comprises a transdermal dosage form comprising an active agent component comprising an active agent and an adverse agent component comprising an adverse agent, wherein the active agent component defines at least one channel extending substantially there through.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, the coatings including block-polymers comprising at least one poly(hydroxyacid) or poly(hydroxy-alkanoate) block, at least one block of a biologically compatible polymer and at least one type of linking moiety.

Abstract: Medical devices may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. In addition, various polymer combinations may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Abstract: Hyaluronic acid (HA) conjugates or crosslinked HAs compositions for coating an implantable device are provided. The implantable device can be used for treating a disorder such as atherosclerosis, thrombosis, restenosis, high cholesterol, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, and combinations thereof.

Abstract: Methods are disclosed for controlling the morphology and the release-rate of active agent from a coating layer for medical devices comprising a polymer matrix and one or more active agents. The methods comprise exposing a wet or dry coating to a freeze-thaw cycle. The coating layer can be used for controlled delivery of an active agent or a combination of active agents.

Abstract: An implantable medical device for releasing therapeutic agent having a medical device body and a plurality of reservoir-defining structures disposed on a surface of the body. A reservoir can be defined by the reservoir-defining structures and therapeutic agent may be located in the reservoir. A cover may extend over the reservoir so that the therapeutic agent is released from the reservoir when the medical device implanted. Methods for making the medical device may also include providing a medical device body, positioning a plurality of reservoir-defining structures on a surface of the body to form a reservoir, loading therapeutic agent into the reservoir, and covering the reservoir so that the therapeutic agent may release when the medical device is implanted. Alternatively, the reservoir may be covered with a cover and an opening formed in the cover so that the therapeutic agent may release when the medical device is implanted.

Abstract: Implantable medical devices (IMDS) having anti-infective properties are described. Anti-infective agents are disposed in, on, or about at least a portion of a surface of the medical device. The anti-infective agents are disposed in or on a vehicle, which may be in the form of a coating layer or covering. The vehicle may be biodegradable so that, over time, the anti-infective agent is removed from a tissue location into which the device is implanted, reducing the likelihood that microorganisms resistant to the anti-infective agent will develop. IMDs having an anti-infective agent and an anti-activity agent disposed therein, thereabout, or thereon are also described. The anti-activity agent interferes with the activity of the anti-infective agent, may be released from a surface at the IMD at a time when activity of the anti-infective agent is no longer desired, and may reduce the likelihood that microorganisms resistant to the anti-infective agent will develop.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, and the coatings comprise biologically absorbable poly(ester amides).

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Also, the devices may be modified to promote endothelialization. Medical devices include stents, grafts, anastomotic devices, perivascular wraps, sutures and staples.

Abstract: The present invention provides a ceramide dispersion which includes (1) ceramide-containing particles which contains a ceramide, which are dispersed in an aqueous phase as an oil-phase component, and which have a volume average particle diameter from 1 nm to 100 nm; and (2) a fatty acid component which is at least one of a fatty acid having a melting temperature not higher than 30° C. or a fatty acid salt; the amount of nonionic surfactant being 0 or not more than 0.1 times the total mass of the ceramide; the amount of an ionic surfactant other than the fatty acid component being 0 or less than 0.05 times the total mass of the ceramide; and the pH being from 6 to 8.

Abstract: The invention relates to a bilayer pharmaceutical tablet comprising a first layer containing 3 to 50 wt. % of telmisartan dispersed in a dissolving tablet matrix and a second layer containing a diuretic in a disintegrating tablet matrix as well as a processes for producing same.

Abstract: At least three component, body-implantable, absorbable, biocompatible, putty, and non-putty pain-relieving compositions for use in surgery comprising in intimate admixture: an analgesic having local pain-relieving activity for internal relief of pain, a finely powdered bulking material, preferably less than 50 microns, e.g. the metal salts of fatty acid, hydroxyapatite, DBM, polyglycolide, polylactide, polycaprolactones, absorbable glasses, gelatin, collagens, mono, and polysaccharides starches. An organic liquid capable of solubilizing, dispensing or suspending the analgesic, such as esters of monohydric alcohols with aliphatic monocarboxylic acids; C2-C18 monohydric alcohols with polycarboxylic acids; C8-C30 monohydric alcohols; tocopherol and esters thereof with mono or polycarboxylic acids; free carboxylic acids such as oleic, capric, and lauric; dialkyl ethers and ketones; polyhydroxy compounds and esters and ethers thereof; random or block copolymers of ethylene oxide and propylene oxide.

Abstract: Coatings for an implantable medical device and a method of fabricating thereof are disclosed, the coatings include block-polymers comprising at least one poly(hydroxyacid) or poly(hydroxy-alkanoate) block, at least one block of a biologically compatible polymer and at least one type of linking moiety.

Abstract: An object of the present invention is to provide a peptide derivative for determining ?-glucan or endotoxin which allows high sensitivity measurement, and a method for determining ?-glucan and/or endotoxin using the same.

Abstract: This invention provides for biocompatible, biodegradable eye drop pharmaceutical formulations useful for the treatment of ocular indications. In particular, tocopherols and their esters of low water solubility, notably ?-tocopheryl acetate, are exceptional vehicles for biocompatible, nonirritating topical eye drop formulations that provide sustained release of active agents.