Abstract: A hemostatic composition which comprises at least one procoagulant metal ion, such as silver (I) or mercury (II), and at least one procoagulant biopolymer, such as collagen, thrombin, prothrombin, fibrin, fibrinogen, heparinase, Factor VIIa, Factor VIII, Factor IXa, Factor Xa, Factor XII, von Willebrand Factor, a selectin, a procoagulant venom, a plasminogen activator inhibitor, glycoprotein IIb-IIIa, a protease, or plasma. The composition in the form of a paste, dough, glue, liquid, lyophilized powder or foam, may be provided, for application to a wound. A hemostatic device is also described which comprises a hemostatic composition as described above. The device may be in the form of, for example, a plug, bandage, gauze, cloth, tampon, membrane or sponge. Methods are also provided for prophylaxis or treatment of bleeding at a site by application to the site of the composition or device as described.

Abstract: Novel controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The novel compositions are designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained followed by a prolonged and relatively constant plasma concentration of desglymidodrine. The novel compositions may be designed for administration once or twice daily, i.e. a therapeutically effective concentration of desglymidodrine is maintained for a period of at least 10-16 hours followed by a wash out period of about 8-12 hours in order to avoid the well-known midodrine related side effect with respect to supine hypertension. The therapeutically effective concentration of desglymidodrine is regarded as a plasma concentration of desglymidodrine of at least about 3 ng/ml.

Abstract: A transdermal therapeutic system comprising a largely water vapor-impermeable backing layer, at least one active substance-containing matrix layer comprising the active substance tulobuterol, as well as a removable protective layer, is characterized in that said matrix is built-up on the basis of polyacrylate pressure-sensitive adhesives and contains tulobuterol in the form of its salt tulobuterol hydrochloride as active substance.

Abstract: Tablet containing living micro-organisms, produced from a pressed tablet material comprising micro-organisms and oligosaccharides and/or polysaccharides, the tablet material also comprising at least one slime-forming agent. The invention also relates to a process for the production of such a tablet.

Abstract: A dosage form for delivery of a therapeutic agent to a subject is described. The dosage form contains: (a) an outer wall defining an interior compartment; (b) within the interior compartment, a therapeutic agent; (c) at least one exit orifice formed by laser ablation of the outer wall for release of the agent therethrough, and (d) a barrier layer disposed between the outer wall and the interior compartment in at least a region corresponding to the exit orifice. The barrier layer comprises a material that allows the barrier layer to remain intact during laser-formation of the at least one exit orifice in the outer wall. Also disclosed is a method for controlling the depth of laser ablation of a dosage form during laser formation of an exit orifice in an outer wall of the dosage form.

Abstract: A dry powder cubic gel precursor comprising an encapsulating compound, an amphiphile capable of forming a cubic liquid crystalline phase, and optionally a solvent. The encapsulating compound (A), amphiphile (B), and optional solvent (C) are present in mass fractions relative to each other such that 1.0=a+b+c wherein a is the mass fraction of A, b is the mass fraction of B, and c is the mass fraction of C. Further, 1.0>a>0, 1.0>b>0, 1.0>c>0 and a, b, and c do not fall within a cubic liquid crystalline phase region on a phase diagram representing phase behavior of A, B, and C.

Abstract: This invention relates to an implant for treating pathological changes in the spinal column and/or locomotor system. According to one embodiment of the invention, the implant may be provided with an enamel-like or varnish-like coating up to 100 ?m thick and made of a biodegradable polymer such as polylactide. This coating has an osteoinductive effect, which promotes the healing of fractures. Additional osteoinductive materials such as growth factors may be incorporated in the coating. The invention also relates to a method for producing such an implant using the following steps: preparing a dispersion of biodegradable polymers in an organic solvent; applying the dispersion on the surface to be coated; and allowing the solvent to evaporate.

Abstract: Shaped, preferably porous, inorganic bodies are provided which are prepared from a reactive blend. In accordance with one preferred embodiment, the solution is absorbed into a porous sacrificial substrate such as a cellulose sponge. The solution-saturated substrate is heated and an oxidation-reduction reaction occurs thereby forming an inorganic solid. A shaped, inorganic body is formed in situ. Optional, but preferred additional thermal treatment of the shaped, inorganic body removes the organic substrate, leaving an inorganic body that faithfully mimics the porosity, shape, and other physical characteristics of the organic substrate. Inorganic substrates may also be used to good effect. Large varieties of shaped bodies can be prepared in accordance with other embodiments of the invention and such shapes find wide use in surgery, laboratory and industrial processes and otherwise. The invention also provides chemically and morphologically uniform powders, including those having uniformly small sizes.

Abstract: A non-Division 5.1 Oxidizer tablet consisting essentially of a blend of hydrated calcium hypochlorite with magnesium sulfate heptahydrate, wherein the blend contains at least about 17% by weight of water based on the total weight of the blend and the dissolving rate of the tablet is less than 150 grams per day.

Abstract: Methods for preparing products containing moisture-sensitive materials, including biological materials such as proteins, peptides or live cells, comprising at least the steps: (i) providing a coating liquid comprising at least one active, a sugar polymer and a water soluble/miscible solvent; (ii) providing a quantity of microparticles comprising at least water soluble gel forming solid particles; (iii) fluidizing said quantity of microparticles within a processing chamber of a of a suitable apparatus to form a fluidized bed of said microparticles; (iv) spraying said coating liquid onto said fluidized bed from beneath the fluidized bed to coat said microparticles therewith under saturated moisture conditions; and (vi) allowing coated microparticles to dry, are described. Also described are compositions and uses.

Abstract: The invention concerns a method for producing a controlled-release pharmaceutical preparation with a particle-containing coating, the coating being derived from an aqueous dispersion of a film-forming water insoluble polymer and a water soluble pore-forming agent. By suspending, instead of dissolving the pore-forming agent, the resulting coating will contain particles of the pore-formers with a predetermined size that creates, when disintegrated or dissolved in the body fluid, canals or a network of pores through the polymer film. Due to this network, the film will get a good mechanical stability and are left intact after the release of the drug.

Abstract: A non-Division 5.1 Oxidizer tablet consisting essentially of a blend of hydrated calcium hypochlorite with magnesium sulfate heptahydrate, wherein the blend contains at least about 17% by weight of water based on the total weight of the blend; contains from about 0.1% to about 10% of lime based on the total weight of the hydrated calcium hypochlorate and magnesium sulfate heptahydrate and the average dissolving rate of the tablet is less than 150 grams per day.

Abstract: The invention provides controlled-release formulations for oral administration containing a cGMP PDE-5 inhibitor. The formulations are useful, inter alia, in the treatment or prevention of sexual dysfunction.

Abstract: A pharmaceutical composition for slow release of active ingredient in the gastrointestinal tract, comprising a plurality of active ingredient-containing particles coated with a material insoluble in gastric and intestinal juices, where the particles have as core a homogeneous mixture comprising an active pharmaceutical ingredient and a polymer insoluble in gastric and intestinal juices, with an average internal pore diameter not exceeding 35 ?m, makes efficient and pH-independent delaying of release possible even with comparatively small amounts of polymer. It is additionally distinguished by a long shelf life and is particularly suitable also for nonspherical particles.

Abstract: A pharmaceutical composition in the form of tablets or capsules provides a combination of temporal and spatial control of drug delivery to a patient for effective therapeutic results. The pharmaceutical composition comprises a drug, a gas generating component, a swelling agent, a viscolyzing agent, and optionally a gel forming polymer. The swelling agent belongs to a class of compounds known as superdisintegrants (e.g., cross-linked polyvinylpyrrolidone or sodium carboxymethylcellulose). The viscolyzing agent initially and the gel forming polymer thereafter form a hydrated gel matrix which entraps the gas, causing the tablet or capsule to be retained in the stomach or upper part of the small intestine (spatial control). At the same time, the hydrated gel matrix creates a tortuous diffusion path for the drug resulting in sustained release of the drug (temporal control). A preferred once daily ciprofloxacin formulation comprises 69.9% profloxacin base, 0.34% sodium alginate, 1.103% xanthan gum, 13.

Abstract: Modified amino acid compounds useful in the delivery of active agents are provided. Methods of administration and preparation are provided as well.

Abstract: The invention provides a controlled release dissolution and diffusion devices which can deliver an active ingredient at a constant or controlled-variable rate comprising an active ingredient and dissolution modifiers and/or an insoluble matrix. The compressed core is coated, except for at least one exposed face, with a coating containing an insoluble polymer or a mixture of an insoluble polymer and pore-forming elements said pore-forming elements having a dissolution rate slower that the release rate so that the pore formation is completed after release of the active ingredients and the residual inert structures disintegrate.

Abstract: A modified release preparation having one or more coated core elements, each core element including an active ingredient and having a modified release coating, wherein a stabilising coat is provided between each core element and its modified release coating so that, upon in vitro dissolution testing, the amount of active ingredient released at any time on a post-storage dissolution profile is within 40 percentage points of the amount of active ingredient released at any time on a pre-storage dissolution profile.

Abstract: The present invention is directed to a coating composition for coating a solid dosage form of a medicament, where the coating composition controls the release of the medicament, said coating composition comprising (a) at least 50% (w/w) by dry weight of a water insoluble polymer insoluble in both acidic, basic and neutral pH, present in the form of an aqueous latex dispersion, (b) a water soluble non-polymeric component present in a weight ratio of about 5 to about 50% (w/w) by dry weight of the coating, having a molecular weight of less than about 15,000 daltons and water solubility in excess of 5 grams per 100 grams of water at room temperature at 1 atm pressure, said water soluble non-polymeric component being organic and either solid or liquid; said ratio of water insoluble polymer to water soluble non-polymeric component ranging from about 95:5 to about 1:1, the solid content in the coating composition ranges from about 5% to about 25%, said water soluble component being completely dissolved in the aqueo

Abstract: The present invention is directed to novel combinations of anti-epileptic compounds that demonstrate pain alleviating properties, with compounds selected from the group consisting of analgesics, NMDA receptor antagonists, and NSAIDs and pharmaceutical compositions comprising same. It has been discovered that the administration of anti-epileptic compounds that demonstrate pain alleviating properties in these novel combinations results in an improved reduction in the frequency and severity of pain. It is also believed that the incidence of unwanted side effects can be reduced by these novel combinations in comparison to using higher doses of a single agent treatment to achieve a similar therapeutic effect. The present invention is also directed to methods of using effective amounts of the novel pharmaceutical compositions to treat pain in mammals.