Abstract: The present invention includes a hot-melt extruded film and method of preparation thereof. The film is made from a precursor composition containing at least a water soluble or water swellable thermoplastic polymer, preferably HPC and/or PEO, and a bioadhesive polymer. The film can also contain a therapeutic agent, preservative, buffering agent, antioxidant, super-disintegrant or absorbent, flavorant, colorant, water insoluble polymer, organic acid, surfactant, film modifier, and/or cross-linking agent. The film does not contain a conventional plasticizer or a material which is generally recognized in the art as a plasticizer for extruded films. The film can be sized and shaped to provide a controlled delivery of a therapeutic agent to the buccal, rectal, uterine, vaginal, abdominal, cranial, ophthalmic, nasal, sinus, or otic cavities. The film can also be used for the treatment of wounds.

Abstract: Bioartificial implants and methods for their manufacture and use are described, particularly bioartificial pancreases. In particular, the implants may be thin sheets which enclose cells, may be completely biocompatible over extended periods of time and may not induce fibrosis. The high-density-cell-containing thin sheets are preferably completely retrievable, and have dimensions allowing maintenance of optimal tissue viability through rapid diffusion of nutrients and oxygen and also allowing rapid changes in the secretion rate of insulin and/or other bioactive agents in response to changing physiology. Implantations of living cells, tissue, drugs, medicines and/or enzymes, contained in the bioartificial implants may be made to treat and/or prevent disease.

Abstract: Process for preparing a solid mixture comprising one or more cyclodextrins and an insoluble active ingredient characterized in that said process comprises a melt-extrusion step, wherein the active ingredient is embedded into the cyclodextrin carrier.

Abstract: Pharmaceutical compositions comprising a macromolecular pharmaceutical agent in micellar form are disclosed. The micelles are formed from an alkali metal alkyl sulfate, and at least one additional micelle-forming compound as described in the specification. An alkali metal salicylate and a pharmaceutically acceptable edetate are also included in the composition. Micelle size ranges between about 1 and 10 nanometers. Methods for making and using the compositions are also disclosed.

Abstract: Use of a composition having an oil phase, an aqueous phase, at least one emulsifier of water-in-oil (W/O) type and at least one emulsifier of oil-in-water (O/W) type, in the form of a reverse latex comprising from 20% to 70% by weight, and preferably from 25% to 40% by weight, of an anionic polyelectrolyte, the anionic polyelectrolyte being based on partially neutralized acrylic acid, which may be branched and/or crosslinked, to prepare a cosmetic, dermopharmaceutical or pharmaceutical composition. Novel lattices, process for their preparation and cosmetic, dermopharmaceutical or pharmaceutical composition incorporating them.

Abstract: The use of a pharmaceutical composition for oral administration comprising a carrier and active ingredient selected from a dopamine agonist, testosterone and mixtures thereof, the composition being in the form of a fast-dispersing dosage form designed to release the active ingredient rapidly in the oral cavity for the manufacture of a medicament for treatment of male erectile dysfunction.

Abstract: A pharmacologically acceptable growth hormone-potentiating composition for ingestion in a mammal, in a pill form. The composition includes a first herbal extract having an element to synthesize a catecholamine for stimulating release of growth hormone and a second herbal extract including a luteinizing agent which prevents the synthesizing agent of the first herbal extract from breaking down. The pill has an outer surface covered by a protective coating operable to retard acidic degradation of the herbal extracts. The combination of herbal extracts and protective coating result in enhanced uptake into the mammalian system of the synthesizing element of the first herbal extract.

Abstract: In one embodiment, this invention relates to a pharmaceutical composition for oral administration consisting essentially of a gelatin at a concentration up to 5% by weight as a carrier, a solvent, and, as an active ingredient, a dopamine agonist. Alternatively, the invention relates to a composition that takes the form of a solid, unitary fast-dispersing dosage form comprised of a network of an active ingredient after and a water-soluble or water dispersible matrix forming agent or carrier which is inert towards the active ingredient after subliming solvent from the composition in the solid state. The dosage is designed to completely disintegrate within 1 to 30 seconds of being placed in the oral cavity. Compositions which further comprise an anti-emetic and/or an opioid antagonist are also provided herein.

Abstract: Compositions for oral use containing at least one zinc compound, at least one amino acid, a source of ascorbic acid which does not appreciably associate with zinc ions, and a base material. The compositions provide for slow release of zinc upon dissolution in the mouth. The amino acid provides the zinc compound(s) with a palatable taste and no aftertaste. The source of ascorbic acid provides Vitamin C without interacting with zinc and forming unpalatable by-products. A method for making such compositions is also described.

Abstract: A novel polyurethane based prepolymer useful in biomedical devices which provides high oxygen permeability and superior physical properties.

Abstract: Transdermal drug delivery compositions comprising pressure sensitive adhesive microspheres that contain a softening agent and/or a drug. Typically the microspheres contain at least 10 wt-% of a softening agent. The drug and/or softening agent can be incorporated into the microspheres during or after their formation.

Abstract: The invention provides a cosmetic hair conditioning composition comprising: (a) an effective amount of a film forming polymer; and (b) a cosmetically acceptable vehicle, in which the composition is in the form of a solid. A cosmetic hair conditioning device and methods of conditioning and styling hair are also provided.

Abstract: A class of water insoluble iodophors comprising complexes of iodine with various nylons such as nylon-4,6, nylon-6, nylon-6,6 or other polyamides is disclosed. These nylons complexed with iodine can be made in various forms such as powders, pellets, molded objects, granules, films, monofilaments, and either non-woven or woven fabrics. These nylon based iodophors and other water insoluble iodophors herein disclosed can find product applications in the fields of air treatment, water treatment, public hygiene and medicine.

Abstract: The invention features an implantable device for the automatic delivery of an active ingredient according to an adjustable delivery profile. The device includes a housing; a reservoir operatively connected to the housing and arranged to store a solid composition including the active ingredient; an actuator arranged within the housing to move the solid composition from the reservoir to a transit area, wherein the solid composition exits the housing at the transit area; a controller that acts on the actuator to adjust movement of the solid composition out of the housing according to the adjustable delivery profile; and a power source arranged to provide energy to the actuator and the controller. The solid composition can be an elongate, solid composition comprising a drug, and up to 90% of a carrier, wherein the composition has a cross-section of less than 0.

Abstract: A stabilized sustained release oral solid dosage form which includes an effective amount of tramadol or a pharmaceutically acceptable salt thereof dispersed in a matrix of a hydrophobic material comprising a wax-like substance which was melted or softened during the preparation of the matrix, is cured at a temperature from about 35° C. to about 65° C. for a time period from about 4 to about 72 hours, such that the formulation, when subjected to in-vitro dissolution after exposure to accelerated storage conditions of at least one month at 40° C./75% RH, releases an amount of tramadol which does not vary at any given dissolution time point by more than about 20% of the total amount of tramadol released when compared to in-vitro dissolution conducted prior to subjecting the dosage form to the accelerated storage conditions.

Abstract: The invention relates to a process for the production of morphologically uniform microcapsules that contain peptides, proteins or other water-soluble biologically active substances as active ingredients as well as microcapsules that are produced according to this process with a degree of concentration of between 3 to 30% by weight and a diameter≦8 &mgr;m. According to the invention, biodegradable polymers are dissolved in a halogen-free solvent or solvent mixture, and the buffered active ingredient solution, which has a pH of between 6.0 to 8.0, is dispersed into this solution. Then, an aqueous solution that contains a surface-active substance (W/O/W-emulsion) is added to this W/O-emulsion, and the solvent is removed. The microcapsules that are produced with this process do not show any tendency toward agglomeration. The encapsulation efficiency of the process is approximately 90 to 95%.

Abstract: Tannate compositions consisting essentially of pyrilamine tannate and phenylephrine tannate which are effective when administered orally for the symptomatic relief of coryza associated with the common cold, sinusitis, allergic rhinitis and upper respiratory tract conditions are disclosed.

Abstract: The present invention relates to a biostimulatinq agent comprising natural minerals having ion-exchanges and sorption properties, and also a biologically active vegetable stock, the natural minerals including a clinoptylolite-heulandite zeolite containing not less than 92 wt % of clinoptylolite, and/or montmorillonite clay containing not less than 92 wt % of montmorillonite, and as the biologically active vegetable stock comprises wheat bran, rye bran, oats, Japanese laminaria, madder, birch fungus, and the like. The biostimulating agent of the present invention normalizes the mineral balance of the body, produces higher therapeutical effect, for example, in using it in case of intestinal tract diseases, aterosclerosis, urinary calculosis, produces an immune-modulating and tonic effect.

Abstract: The invention is directed in part to oral dosage forms comprising a combination of an orally analgesically effective amount of an opioid agonist and an orally active opioid antagonist, the opioid antagonist being included in a ratio to the opioid agonist to provide a combination product which is analgesically effective when the combination is administered orally, but which is aversive in a physically dependent subject. Preferably, the amount of opioid antagonist included in the combination product provides at least a mildly negative, “aversive” experience in physically dependent addicts (e.g., precipitated abstinence syndrome).

Abstract: A method for making a biocompatible medical article, and preferably, a blood compatible medical article, through the use of a copolymer coating. The copolymer coating is synthesized using methacrylate or acrylate monomers with a functional group (primary amino group) for subsequent attachment of heparin. Synthesis of the copolymer coating is carried out using the proper proportion of hydrophobic monomer/hydrophilic monomer/functional monomer in order to optimize the solubility of the copolymer in alcohol, its insolubility in water (before and after heparin coupling), the heparin coupling efficacy and heparin bioactivity. Once the copolymer coating is fashioned, a medical article is coated with it. The coating is thereafter dried and heparin attached. In such a manner the present invention provides for a method for making a biocompatible medical article, and preferably, a blood compatible medical article.