Abstract: The invention relates to a disintegrating oral tablet suitable for active pharmaceutical ingredients comprising a population of particles and at least one flavor ingredient, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting in a burst of the at least one flavor ingredient upon mastication of the tablet.

Abstract: The invention relates to an oral tablet for taste masking of active ingredients, the tablet comprising a population of particles and an active ingredient with off-note taste, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas resulting at least partly in induced taste masking of the active ingredient upon mastication of the tablet.

Abstract: The invention relates to an oral tablet suitable for fast release of active pharmaceutical ingredients comprising a population of particles, the population of particles comprising directly compressible (DC) and non-directly compressible (non-DC) sugar alcohol particles, the non-DC particles providing the tablet with a plurality of discrete non-DC areas, and the non-DC areas promoting fast release of active ingredients upon mastication of the tablet.

Abstract: The invention relates to a method for manufacturing a transdermal patch from a drug-containing web that minimizes waste. The web is a layered composite that includes at least a backing layer and a drug-in-adhesive layer and a first strippable release liner. The web is kiss-cut along intersecting cut lines at least down to the depth of the liner, generally defining the extent of individual transdermal patches. The intersections of the cut lines define small zones that are punched out of the web in a generally star shape. The portions of the web above the liner are peeled away from the liner and transferred to a faster moving second liner so that the patches are now further spaced apart from one another. This second liner is then cut to provide transdermal patches that are mounted to release liners that are substantially broader in extent than the patches themselves.

Abstract: Synthetic composite materials for use, for example, as orthopedic implants are described herein. In one example, a composite material for use as a scaffold includes a thermoplastic polymer forming a porous matrix that has continuous porosity and a plurality of pores. The porosity and the size of the pores are selectively formed during synthesis of the composite material. The example composite material also includes a plurality of a anisometric calcium phosphate particles integrally formed, embedded in, or exposed on a surface of the porous matrix. The calcium phosphate particles provide one or more of reinforcement, bioactivity, or bioresorption.

Abstract: Transdermal delivery systems for the systemic delivery of memantine are described, wherein the system comprises a drug reservoir layer and an adhesive layer, optionally together with one or more intermediate and/or supporting layers, wherein the drug reservoir layer comprises an acrylate polymer or copolymer, a permeation enhancer, a carrier, and memantine base generated in situ by reaction of a memantine salt and an alkaline salt. Compositions and kits comprising the various components, e.g., drug reservoir and/or adhesive compositions are described. Methods relating to treatment of CNS disorders, e.g., Alzheimer's disease and/or dementia, using the aforementioned transdermal delivery devices and/or compositions are also described.

Abstract: Various embodiments disclosed relate to curable calcium phosphate compositions for use with porous structures and methods of using the same. In various embodiments, the present invention provides a curable calcium phosphate composition or a cured product thereof, with the curable calcium phosphate composition including calcium phosphate and a perfusion modifier. In various embodiments, the present invention provides an apparatus comprising a porous structure at least partially in contact with the curable calcium phosphate composition or a cured product thereof. The porous structure can include a porous substrate including a plurality of ligaments that define pores of the porous substrate, and a biocompatible metal coating on the plurality of ligaments of the porous substrate.

Abstract: This invention provides porated cartilage products, methods of producing porated cartilage products, and methods of treating subjects by administering cartilage products. Optionally, the cartilage products are sized, porated, and digested to provide a flexible cartilage product. Optionally, the cartilage products comprise viable chondrocytes, bioactive factors such as chondrogenic factors, and a collagen type II matrix. Optionally, the cartilage products are non-immunogenic.

Abstract: The present invention provides a rocuronium preparation with an excellent stability. The rocuronium preparation contains rocuronium and a buffer solution and having an adjusted pH of 3.5 or less (for example, 2.5 to 3.5). The buffer solution may be a citric acid-sodium hydroxide buffer solution, a tartaric acid-sodium hydroxide buffer solution, a potassium hydrogen phthalate-hydrochloric acid buffer solution, a glycine-hydrochloric acid buffer solution, or the like. Such a rocuronium preparation has, for example, after 6-month storage at 40° C., a generation rate of rocuronium-related substance C of 5% or less.

Abstract: The invention relates to a tamper-resistant tablet comprising (i) a matrix material in an amount of more than one third of the total weight of the tablet; and (ii) a plurality of coated particulates in an amount of less than two thirds of the total weight of the tablet; wherein said particulates comprise a pharmacologically active compound and a physiologically acceptable polymer, preferably a polyalkylene oxide; and form a discontinuous phase within the matrix material; which preferably provides under in vitro conditions immediate release of the pharmacologically active compound in accordance with Ph. Eur.; and method of using said tablet to treat pain and other conditions.

Abstract: The present invention recognizes that medical devices, such as but not limited to contact lenses, can be made having a coating made at least in part using printing technologies to provide drug storage and drug release structures. The coating preferably includes at least one drug reservoir layer and a least one barrier layer, and can include structures, such as but not limited to capillary structures that alone or in combination modulate the release of the drug from the coating. One aspect of the present invention is a medical device that incorporates a drug in at least one coating. A second aspect of the present invention is a method of making a medical device that incorporates a drug in at least one coating. A third aspect of the present invention is a method of using a medical device of the present invention to treat, prevent from having, prevent from developing, control, reduce the severity, or reduce the progression of a disease, disorder or condition of a subject.

Abstract: The present invention relates to a dialysis solution containing bicarbonate, calcium and phosphate, wherein the dialysis solution contains phosphate having a concentration in the range from up to 0.4 mmol/l, preferably in the range from up to 0.375 mmol/l, or in the range from up to 0.25 mmol/l, and particularly preferably in the range from up to 0.2 mmol/l.

Abstract: The present invention provides a transdermal delivery system, which comprises a drug-containing matrix layer comprising: galantamine or its pharmaceutically acceptable salt as an active ingredient; and a styrene-butadiene-styrene copolymer or a styrene-isoprene-styrene copolymer as an adhesive.

Abstract: The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquillizers, stimulants and narcotics.

Abstract: A transdermal drug administration device comprising a drug delivery element (10) defining a contact surface (12) for location, in use, against a patient's skin. The drug delivery element (10) includes a sustained-release pharmaceutical composition. The composition comprises a network of a carrier material having a high mechanical strength and an active pharmaceutical ingredient. The active pharmaceutical ingredient is co-formedly interspersed within pores in the solid, continuous network of the carrier material.

Abstract: The present invention provides a method for preparing a bone protein preparation which contains for example growth factors. The present invention also provides a bone protein preparation obtained by the method and paste, putty, pellet, disc, block, granule, osteogenic device or pharmaceutical composition containing said bone protein preparation.

Abstract: A medical device comprising a composition comprising a therapeutically active amount of active agent, a zinc compound, and an array of microneedles. The zinc compound may be selected from the group consisting of zinc, pharmaceutically acceptable salts of zinc, and mixtures thereof. At least a portion of the composition is present as a coating on at least a portion of the microneedles. Methods of delivering a therapeutically active agent to a mammal using compositions of the disclosure are also included.

Abstract: The present invention recognizes that medical devices, such as but not limited to contact lenses, can be made having a coating made at least in part using printing technologies to provide drug storage and drug release structures. The coating preferably includes at least one drug reservoir layer and a least one barrier layer, and can include structures, such as but not limited to capillary structures that alone or in combination modulate the release of the drug from the coating. One aspect of the present invention is a medical device that incorporates a drug in at least one coating. A second aspect of the present invention is a method of making a medical device that incorporates a drug in at least one coating. A third aspect of the present invention is a method of using a medical device of the present invention to treat, prevent from having, prevent from developing, control, reduce the severity, or reduce the progression of a disease, disorder or condition of a subject.

Abstract: The embodiments relate to an injectable composition for a bone cement material comprising a dry powder component, a liquid component and a modifier configured to modify a Young's modulus of the bone cement material. The modifier is linoleic acid or a derivative thereof and is present in a concentration of 0.1 to 12 v/v of the liquid component.

Abstract: A comestible dosage form article for administration to a target subject, the dosage form comprising: an outer capsule comprising a first cap telescopically engageable with a first body; and an inner capsule, within the outer capsule, comprising a second cap telescopically engageable with a second body, wherein the inner capsule is inverted with respect to the outer capsule such that, in an assembled state, the second cap is proximal to the first body and distal to the first cap.