Abstract: A topical ear composition that uses penetration enhancers to diffuse the therapeutic agents through the tympanic membrane into the middle and inner ear for the purpose of reducing the inflammation of ear tissues, providing pain relief, and introducing agents with antimicrobial activity to combat infection. The composition reduces swelling of the lining membranes of the middle and inner ear, prevent the destructive effects of inflamation, inhibit the production of prostaglandins, reduce symptoms of tinnitus and vertigo, improve and prevent paralysis of the facial nerve, relieve labyrinthitis, and prevent hearing loss.

Abstract: A stable solution cream, salve, or spray composition containing activated stabilized chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the prevention and treatment of abnormal conditions of the epithelium of bodily orifices. Examples of such abnormal conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices include bacterial infections, such as Actinobacillus actinomycetemcomitans and Porphyromonoas gingivalis, and fungal infections, such as Candida, and leukoplakia. The preferred concentration ranges are between about 0.005%-2.0% chlorine dioxide, and between about 0.02%-3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.

Abstract: A water soluble biodegradable ABA-type block copolymer made up of a major amount of hydrophobic poly(lactide-co-glycolide) copolymer A-blocks and a minor amount of a hydrophilic polyethylene glycol polymer B-block, having an overall average molecular weight of between about 3100 and 4500, possesses reverse thermal gelation properties. Effective concentrations of the block copolymer and a drug may be uniformly contained in an aqueous phase to form a drug delivery composition. At temperatures below the gelation temperature of the copolymer the composition is a liquid and at temperatures at or above the gelation temperature the composition is a gel or semi-solid. The gelation temperature is preferably at or below body temperature of a warm-blooded animal. The composition may be administered to a warm-blooded animal as a liquid by parenteral, ocular, topical, transdermal, vaginal, transurethral, rectal, nasal, oral, or aural delivery means and is a gel at body temperature.

Abstract: (Meth)acrylic acid/maleic acid copolymers for improving mucosal permeability and pharmaceutical compositions containing them are described.

Abstract: The invention is directed to an improved system for controlled release of biologically active materials and to a liquid composition for its formation. The liquid composition is composed of a thermoplastic polymer, rate modifying agent, bioactive material and organic solvent. The liquid composition is capable of forming a biodegradable and/or bioerodible microporous, solid polymer matrix. The matrix is useful as an implant in patients (humans and animals) for delivery of biologically active substances to tissues or organs.

Abstract: A formulation and methods for inducing sustained regional local anesthesia in a patient comprising a substrate comprising a local anesthetic and an effective amount of a biocompatible, biodegradable, controlled release material prolonging the release of the local anesthetic from the substrate to obtain a reversible local anesthesia when implanted or injected in a patient, and a pharmaceutically acceptable, i.e., non-toxic, non-glucocorticoid augmenting agent effective to prolong the duration of the local anesthesia for a time period longer than that obtainable from the substrate without the augmenting agent.

Abstract: A stable solution, cream, salve, or spray composition containing activated chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the treatment of vaginitis and endometriosis by reducing any of Candida, Actinobacillus actinomycetemcomitans, Pseudomonades, and Porphyromonas gingivalis present in the vagina or the uterus. The preferred concentration ranges are in the range of about 0.005% to about 2.0% of chlorine dioxide, and in the range of about 0.02% to about 3.0% of phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.4, at which pH chlorine dioxide becomes activated and releases sufficient chlorine dioxide to reduce motility and become lethal to the involved micro-organisms.

Abstract: An improved method or process and device for treating and healing a bone void is disclosed, and in particular a method employing a surfactant for efficiently incorporating a biologically active agent into the interstices (voids or pares) of a porous hydrophobic biodegradable material wherein the biologically active agent is deposited on the internal surfaces defining the voids or pores of the biodegradable material. The biodegradable body or device, now containing surfactant and a biologically active agent in the body itself as well as on the external surfaces and the internal surfaces defining the voids or pores, is than applied into the bone void or cavity.

Abstract: A stable solution, cream, salve, or spray composition containing chlorine dioxide and a phosphate, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the prevention and treatment of abnormal conditions of the epithelium of bodily orifices. Examples of such abnormal conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices brought about by any of leukoplakia, hairy leukoplakia, vaginitis, endometriosis, Candida Albicans, Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Pseudomonades, Candida species, and leukoplakia vulvae. The preferred concentration ranges are between about 0.005%-2.0% chlorine dioxide, and between about 0.02%-3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.

Abstract: A method of forming an implantable and retrievable immunoisolatory vehicles is disclosed, the method comprising the steps of first forming a core comprising a volume of at least 1 .mu.l and at least 10.sup.4 cells capable of providing a biologically active product or metabolic or immunologic function, said cells being dispersed in a biocompatible hydrogel or extracellular matrix, and then forming around the core a surrounding external biocompatible thermoplastic or hydrogel jacket free of said cells projecting externally thereof, said jacket having molecular weight cutoff permitting passage of molecules to and from the core through said jacket to provide said biologically active product or function.

Abstract: A method for treatment of a neurodegenerative condition in a patient comprising implanting in the patient at least one immunoisolatory vehicle comprising a corc comprising a volume of at least 1 .mu.l and at least 10.sup.4 living cells which secrete at least one biologically active product, said cells being dispersed in a biocompatible matrix comprising a hydrogel or extracellular matrix components, and an external jacket surrounding the core, the jacket comprising a biocompatible hydrogel or thermoplastic, the jacket being free of cells projecting externally thereof, said jacket having a molecular weight cutoff permitting the passage of the biologically active product from the core through the jacket.

Abstract: The invention is directed to a method of treating otitis which comprises introducing an antibacterially-effective amount of a composition comprising a non-ototoxic, topical, otic pharmaceutic composition comprising (a) ciprofloxacin in aqueous solution in an amount effective for antibacterial action; (b) a non-ionic viscosity augmenter unaffected by pH and ionic level, said viscosity augmenter being present in an amount effective for augmenting viscosity of the composition to a viscosity greater than that of water, said viscosity augmenter being at least 85% hydrolyzed polyvinyl alcohol; (c) a non-ototoxic preservative present in an amount effective for antibacterial action, the preservative being benzyl alcohol; (d) water sufficient to produce an aqueous composition; (e) hydrocortisone in aqueous suspension in an amount effective for anti-inflammatory action; (f) lecithin in an amount effective for enhancing suspension of other constituents in the composition; and (g) polysorbate ranging from polysorbate 20

Abstract: A method of forming an implantable and retrievable immunoisolatory vehicle is disclosed, the method comprising the steps of first forming a jacket of biocompatible thermoplastic or hydrogel, and then loading the jacket with a core comprising a volume of at least 1 .mu.l and at least 10.sup.4 cells capable of secreting a biocompatible matrix comprising a hydrogel or extracellular matrix, said jacket having a molecular weight cutoff permitting passage of molecules thereacross to provide said biologically active product or said function.

Abstract: A method for oxidatively consuming volatile sulfur compounds selected from the group consisting of dimethylsulfide, hydrogen sulfide, and methylmercaptan at the epithelial barrier of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices to maintain the epithelial barrier and reduce penetration of any of Candida, Actinobacillus actinomycetumcomitans, Pseudomonades, and Porphyromonas gingivalis, said method comprising the step of applying to the orifices a composition comprising a topical preparation selected from the group consisting of liquid solutions, suspensions, semi-solids, salves, creams, and suppositories, wherein the topical preparation contains chlorine dioxide in a concentration in the range of about 0.005% to about 2.0% and a phosphate compound selected from the group consisting of disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodiuit phosphate, or sodium monofluorophosphate in a concentration in the range of about 0.02% to about 3.

Abstract: A stable solution, cream, salve, or spray composition containing chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the prevention and treatment of abnormal conditions of the epithelium of bodily orifices. Examples of such abnormal conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices include bacterial infections, such as Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis, and fungal infections, such as Candida, and leukoplakia. The preferred concentration ranges are in the range of about 0.005% to about 2.0% chlorine dioxide, and in the range of about 0.02% to about 3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of about 6.0 to about 7.

Abstract: A method of making an immunoisolatory vehicle comprised of a core comprising living cells dispersed in a biocompatible matrix is disclosed, the cells being capable of secreting a biologically active product or of providing a metabolic or immunologic function to an individual, and an external jacket surrounding said core which is a biocompatible, permselective thermoplastic or hydrogel, said jacket being free of said cells, comprising coextruding a suspension comprising said cells dispersed in a precursor matrix material comprising extracellular matrix components or a biocompatible hydrogel precursor, and a solution of a biocompatible jacket precursor from a nested dual-bore extrusion nozzle, wherein the suspension of (a) is coextruded from the inner bore and the solution of (b) is coextruded from the outer bore of the nozzle, to form said jacket as the solution of (b) and the suspension of (a) arc coextruded; and exposing the vehicle to a treatment that forms a core comprising a volume of at least 1 .mu.

Abstract: Immunoisolatory vehicles having a core and a surrounding jacket are disclosed, the core having a volume in excess of 1 .mu.l and at least about 10.sup.4 living cells capable of secreting a biologically active product or of providing a biological function to a patient, the cells dispersed in a biocompatible matrix formed of a hydrogel or an extracellular matrix component, and the external jacket being permselective, biocompatible and having a molecular weight cutoff permitting passage of molecules between the patient and the core through said jacket to provide said biological product or function.

Abstract: A method of providing a biologically active molecule or metabolic or immunologic function to a patient, comprising implanting into the body of the patient at least one immunoisolatory vehicle comprising a core comprising a volume in excess of 1 .mu.l and at least about 10.sup.4 living cells dispersed in a biocompatible matrix formed of a hydrogel or extracellular matrix components, said cells being capable of secreting a biologically active product or of providing a metabolic or immunologic function to the patient; and an external jacket surrounding said core, said jacket being formed from a thermoplastic or hydrogel, said jacket being free of said cells projecting externally therefrom, said jacket being biocompatible and having a molecular weight cutoff permitting passage of molecules between the patient and the core through said jacket to provide said biologically active product of function.

Abstract: The invention provides novel compositions of matter for delivering water-insoluble steroid drugs suitable for therapeutic use. The invention also provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of .ltoreq.30 .mu.m which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.

Abstract: Compositions for delivery of pharmacologically active agents and methods for their administration are provided. In one embodiment, the compositions include a complex of a polycationic polymer and a pharmacologically active agent in a pharmaceutically acceptable carrier. The compositions in one embodiment permit transport of pharmacologically active compounds across mucosal membranes for systemic delivery. The polycationic polymer may be, for example, a polycationic carbohydrate such as a chitosan or a chitosan salt or derivative. The therapeutic agent a preferred embodiment is a vaccine or a nucleic acid, such as a gene or antisense oligonucleotide. The composition may be provided in different forms such as a solution, dispersion, powder or in the form of microspheres.

Abstract: Cells for implantation into a patient are packaged within a barrier of immunoprotective tissue prior to implantation to obviate or minimize rejection of the cells. The preferred immunoprotective tissue for forming the barrier is cartilage. The tissue is formed into a layer that is thin enough to allow diffusion of nutrients and gases into the center of a cell mass packaged within the immunoprotective tissue. Typically the layer is less than 300 microns, preferably between 5 and 20 microns. Cells to be implanted, typically dissociated parenchymal cells including hepatocytes, Islets of Langerhans, or other cells having metabolic functions, are then placed on the tissue layer, and the layer is folded to seal the cells to be implanted within the tissue layer. In the preferred embodiment, the dissociated cells are first seeded onto a polymeric fiber matrix.

Abstract: The invention is directed to an improved system for controlled release of biologically active materials and to a liquid composition for its formation. The liquid composition is composed of a thermoplastic polymer, rate modifying agent, bioactive material and organic solvent. The liquid composition is capable of forming a biodegradable and/or bioerodible microporous, solid polymer matrix. The matrix is useful as an implant in patients (humans and animals) for delivery of biologically active substances to tissues or organs.

Abstract: Water-soluble pressure-sensitive adhesives include a water-soluble polymer that is made tacky at room temperature by addition of a water-soluble plasticizer that is miscible with the polymer. Suitable polymers are solid at room temperature; and have a hydrophilicity as measured by water uptake greater than about 25%; they are liquid at room temperature and have a boiling point higher than about 80.degree. C. The adhesives according to the invention may conveniently be provided in dry film form. Preferred water-soluble pressure-sensitive adhesives of the invention adhere both to mucosal surfaces and to a variety of materials that may constitute a part of a device or prosthesis to be held in a body cavity that has a mucosal lining. Also, a laminated device for the controlled release of a substance within a mucosa-lined body cavity includes the substance dissolved or dispersed in either or both of a water-soluble pressure-sensitive adhesive layer and optionally one or more water-soluble polymer layers.

Abstract: A method for treating atopic dermatitis, hayfever, asthma and pruritis that includes topical or systemic application of an effective amount of buspirone or a buspirone derivative or its pharmaceutically acceptable salt, other than a quaternary salt, optionally in a pharmaceutically-acceptable diluent or carrier.

Abstract: A stable solution, cream, salve, or spray composition containing activated stabilized chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the prevention and treatment of abnormal conditions of the epithelium of bodily orifices. Examples of such abnormal conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices include bacterial infections, such as Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis, and fungal infections, such as Candida, and leukoplakia. The preferred concentration ranges are between about 0.005%-2.0% chlorine dioxide, and between about 0.02%-3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.

Abstract: A composition for administration to the mucosa comprises a pharmacologically active compound and a polycationic substance. The polycationic substance is preferably DEAE-dextran or chitosan and the pharmacologically active compound is preferably insulin or calcitonin. The composition may be a solution, dispersion, powder or microspheres. Other enhancers, such as lysophosphatidylcholine, can be included if desired.

Abstract: The invention provides novel compositions of matter containing water-insoluble steroid drugs suitable for therapeutic use. The invention provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of .ltoreq.15 .mu.m which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.

Abstract: The present invention relates to a new spongy material consisting essentially of hyaluronic acid or its derivatives. The characteristics of the new pharmaceutical preparations consist in assuring high concentrations of active principle for a long period of time, by exploiting the characteristics of slow release of the active principle.The new pharmaceutical preparations can be utilized advantageously in all the numerous situations of microsurgical practice (in particular the ones relating to ear or in odontostomatology), in which it is necessary to use a substance that can be metabolized by the organism and is capable of making easier flap take, reepithelialization of mucous membranes, stabilization of grafts and filling of cavities.The specific use of the new pharmaceutical preparations is particularly important and useful in the various ear pathologies and in the practice of otologic, otoneurosurgical and odontostomatological microsurgery, such as for instance repair of tympanic perforations.

Abstract: A carrier composition that is a liquid at or below room temperature forms a high viscosity layer or gel at body temperature, which comprises a water-soluble, nonionic cellulose ether having a cloud point not higher than 40.degree. C., a charged surfactant and optional additives in water. The carrier composition can be used for oral or local administration of a pharmacologically active substance to the skin, mucous membrane, the eye or a body cavity.

Abstract: A stable solution, cream, salve, or spray composition containing activated stabilized chlorine dioxide and phosphates, such as disodium hydrogen phosphate, sodium dihydrogen phosphate, trisodium phosphate, and sodium monofluorophosphate, is disclosed for the prevention and treatment of abnormal conditions of the epithelium of bodily orifices. Examples of such abnormal conditions of the epithelium of the rectal, vaginal, urethral, oral, nasal, ocular, and auditory canal orifices include bacterial infections, such as Actinobacillus actinomycetemcomitans and Porphyromonas gingivalis, and fungal infections, such as Candida, and leukoplakia. The preferred concentration ranges are between about 0.005%-2.0% chlorine dioxide, and between about 0.02%-3.0% phosphate. The phosphate compound retards escape of chlorine dioxide in the pH range of 6.0 to 7.

Abstract: Hydrophilic composite polymer articles are provided which comprise at least one hydrophilic polymer in a powder form and one or more liquid components of which at least one is hydrophilic and which can be polymerized with said hydrophilic polymer. This composition is produced from a homogeneously mixed paste which can be molded or cast into a desired shape which will subsequently set. The resulting article has a shape-retaining, non-tacky flexible consistency which allows the shape to be further modified, if necessary.Such object can be then cured by any of the conventional curing methods to retain its shape permanently. The final properties of the composite can be tailored to suit the final application by using fillers or modifiers. In the medical field, such articles can be utilized as a sustained release devices as they can be loaded with the desired therapeutic drugs. These articles can be made non-toxic and biocompatible and used as prosthetic devices.

Abstract: A biocompatible moldable curable polymer/monomer system capable of curing at ambient temperatures to provide an elastomer product while producing a lower exotherm than previously used systems. The system includes an alkyl acrylate or methacrylate homopolymer or copolymer; a monomer mixture of higher alkylacrylate or methacrylate combined with one or more of acrylic acid, methacrylic acid and their lower alkyl esters; and a plasticizer and optionally cross-linking agents, anti-tack agents, and activators or photoinitiators. The moldable systems is a dough used for making earmoulds and earpieces or in fabrication of prostheses.

Abstract: A device useful for the treatment of infections of the middle ear in a prophylactic manner. A preferred device involves the use of a biodegradable support incorporating a therapeutically active agent, such as a drug. The device can be surgically inserted into the middle ear and there expand in order to substantially contact the walls of the middle ear. As it biodegrades, the expanded device provides prolonged, responsive release of active agent to the middle ear.

Abstract: Balanced pH, thermo-irreversible gels are ideal vehicles for drug delivery to a body cavity of a mammal. The gels contain a mixture of a polyoxyalkylene block copolymer or polyether together with an ionic polysaccharide which is thermo-irreversibly gelled in the presence of a counter-ion.

Abstract: A method of inhibiting phospholipase A2 in the control of inflammation, wherein delta-6,9,12,15-octadecatetraenoic acid (stearidonic acid) and/or delta-8,11,14,17-eicosatetraenoic acid is administered alone or in a pharmaceutically acceptable diluent or carrier.

Abstract: A non-aqueous pharmaceutical liquid suspension having improved bioavailability for oral administration comprises an active ingredient suspended in an edible, non-aqueous carrier vehicle such as an oil, wherein the active ingredient is in the form of controlled release particles containing the active ingredient and optionally an excipient in intimate admixture with at least one non-toxic polymer, the particles being coated with, distributed through or adsorbed onto said polymer, and the particles further having an average size in the range 0.1 to 150 microns and a predetermined release of active ingredient.

Abstract: Balanced pH, thermo-irreversible gels are ideal vehicles for drug delivery to a body cavity of a mammal. The gels contain a mixture of a polyoxyalkylene block copolymer or polyether together with an ionic polysaccharide which is thermo-irreversibly gelled in the presence of a counter-ion.

Abstract: This invention is directed to a delivery system and a method useful for the treatment of benign ovarian secretory disorders in female mammals by administering an LHRH composition. The method comprises administering during the entire follicular phase of the menstrual cycle, beginning at the time of menses, an LHRH composition and sufficient levels of an estrogenic steriod to counteract the possibility of side effects which may develop during prolonged therapy with LHRH. Following the follicular phase, at the beginning of the luteal phase, and for the entire course of the luteal phase, the LHRH/estrogenic steroid combination administered during the follicular phase, in combination with a physiological amount of progestational steroid, is administered.

Abstract: Povidone-Iodine (PVP-I) solutions stable according to U.S.P. standards and a method for preparing the same are disclosed. The PVP-I solution includes a microbicidal effective amount of available iodine and an alkalinizing agent in an effective amount to maintain the stability of the solution for a desired shelf-life of the solution when said solution is stored in a substantially nonpermeable container, the solution being non-buffered. In preferred embodiments, the iodophor solution is a microbicidal PVP-I solution for ophthalmic use.

Abstract: A cyclic peptide designated FR115224, administered parenterally in a cyclodextrin carrier, which exhibits antiallergic activity.

Abstract: The present invention provides a pharmaceutical granule composition comprising cimetidine and, as a granulating agent and taste-masking agent, an ester of a polyhydroxy compound, and where desired a palatable pharmaceutically acceptable emulsifier. Particular esters are glycerol esters. The granules of the present invention can be used in the preparation of chewable tablets which have good palatability and bioavailability.

Abstract: A solubility modulated drug delivery device for controlled release of a therapeutically active ingredient into an environment of use is disclosed. The device comprises a core composition of a solubility modulating agent consisting of a complexing agent or a surfactant and a diffusible, water soluble, therapeutically active agent. The core composition is surrounded by a water insoluble semipermeable wall which is substantially impermeable to the core composition and permeable to the fluids in the environment of use and contains apertures through which active agent is released.

Abstract: An allergological test for detecting an allergic condition, said test consisting in contacting the mucous membrane direct with the allergen or the anti-IgE antibody linked to a solid phase, so that a rapid in situ incubation is obtained of the allergen or of the anti-IgE antibody with the mucous membrane antibodies, and in the successive in vitro determination of the specific or total IgE through radioimmunological or immunoenzymatic procedures. Said testing procedure is carried out by employing a plastic material application device comprising one or more receptacles or housing in which some supports are inserted, such supports bearing allergens or anti-IgE antibodies linked to the supports themselves. Said testing procedure can also be employed for performing a particular test of specific challenging.

Abstract: A controlled release powder containing discrete micro-particles for use in edible, pharmaceutical and other controlled release compositions is disclosed. The micro-particles have an average size in the range of from 0.1 to 125 .mu.m. Each of the micro-particles is in the form of a micromatrix of an active ingredient uniformly distributed in at least one non-toxic polymer. The micro-particles have a predetermined release of active ingedient when the dissolution rate thereof is measured according to the Paddle Method of U.S. Pharmacopoeia XX at 37.degree. C. and 75 r.p.m.

Abstract: An artificial tear suspension system is provided which includes bioerodible mucin-type particles, lipid-type material and aqueous-type material. The bioerodible mucin-type particles are suspended in either the lipid-type material or the aqueous-type material or both. The system provides all of the components of the natural tear film layers, and thus when administered to the eye provides an effective tear film which mimics the natural tear film.

Abstract: An ophthalmic treatment system is provided which includes three-dimensional particles of bioerodible material suspended in a liquid carrier or ointment carrier having a pH acceptable to the eye. The particles are at least 0.5 mm in greatest dimension and are not greater than 0.4 mm to 0.7 mm in smallest dimension when disposed in the ocular environment. The treatment system provides reliable, prolonged continuous treatment without irritating the eye.