Abstract: An extended-release drug delivery composition and method of administering the same is provided. The composition comprises microspheres loaded with a biologically-active agent and suspended in a soluble polymer capable of forming a film upon injection onto a biological surface.

Abstract: The invention relates to Histamine H4 receptor antagonists or inhibitors of Histamine H4 receptor gene expression for the treatment and/or the prevention of vestibular disorders.

Abstract: An infusion assembly is provided. Such an infusion assembly includes a first infusion body and a first nozzle operably engaged with the first infusion body. A first plunger is configured to translate longitudinally within the first infusion body for dispensing a first substance out of the first infusion body through the first nozzle. The plunger has a translating member and a stopper piston separable and removable from the translating member. Once separated, the stopper piston is capable of receiving a second nozzle of a second infusion body such that the first substance, along with a second substance in the second infusion body, are capable of being sequentially administered to a target site. An associated method and kit are also provided.

Abstract: A composition for the treatment of otitis in a mammal includes therapeutically anti-otitis effective amounts of propolis compounds in a pharmaceutically acceptable carrier, along with an antimicrobial metal-containing nanoparticles selected from the group consisting of silver, gold, aluminum, copper and zinc; and curcumin in a pharmaceutically acceptable carrier. In addition, the invention is directed to a method of treating an animal suspected of suffering from otitis comprising administering to an ear of the animal a composition as described above.

Abstract: The invention relates to Histamine H4 receptor antagonists or inhibitors of Histamine H4 receptor gene expression for the treatment and/or the prevention of vestibular disorders.

Abstract: The present invention provides for pharmaceutical preparations, devices, systems and methods for the treatment of otic diseases and conditions. In various embodiments, the preparations, devices, systems and methods enable sustained drug release for the treatment or prevention of hearing loss, infections, and other pathological conditions of cochlea and inner ear.

Abstract: The present invention relates to compositions and methods useful for the treatment of ear disorders, administered to a treated ear in the form of a foam or a mousse. Administering a medicament in such forms will increase the residence time of the medicament in the ear canal, provide relatively uniform distribution of the composition, and can increase the penetration of the active pharmaceutical ingredient in the affected area, may release active substances slowly, enhance treatment effectiveness, increase compliance and is more convenient to use than currently available ear medications. The administration in the form of a foam or a mousse may preferably be provided as a metered dose, of a volume suitable to fill the ear canal.

Abstract: Disclosed herein are compositions and methods for the treatment of otic disorders with CNS modulating agent compositions and compositions administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and compositions onto or via perfusion into the targeted auris structure(s).

Abstract: Methods and products are provided for treating a wound or infection in a mammal or disinfecting a surface with a hypochlorous acid solution that has been activated by a catalyst. Additionally provided is a process for preparing an antimicrobial product that produces an activated hypochlorous acid solution for use as an antimicrobial.

Abstract: Disclosed herein are compositions and methods for the treatment of otic diseases or conditions with free-radical modulating agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: An implant for insertion through a punctum and into a canalicular lumen of a patient. The implant includes a matrix of material, a therapeutic agent dispersed in the matrix of material, a sheath disposed over a portion of the matrix of material and configured to inhibit the therapeutic agent from being released from the matrix of material into the canalicular lumen and to allow the therapeutic agent to be released from a surface of the matrix of material to a tear film, and a retention structure configured to retain the implant within the canalicular lumen.

Abstract: Methods and materials useful for applying pharmacologic agents to the ear are described. The methods involve delivering a composition that contains at least one viscogenic agent and at least one pharmacologic agent to the epidermal surface of the tympanic membrane via the ear canal. The composition is delivered to the tympanic membrane in a flowable form and, after delivery to the tympanic membrane, becomes sufficiently viscous such that the pharmacologic agent is localized against the tympanic membrane. Such compositions can be used to prophylactically and/or therapeutically treat middle and inner ear conditions, including otitis media.

Abstract: Disclosed herein are methods for the treatment of otic diseases or conditions with intratympanic compositions and formulations of multiparticulate auris sensory cell modulating agent administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: A process for the preparation of a bioadhesive laminate comprising a hot-melt extruded reservoir layer and a hot-melt extruded backing layer is provided. The reservoir layer comprises a thermoplastic bioadhesive composition containing an active agent. An active agent-containing thermoplastic bioadhesive hydrophilic composition is hot-melt coextruded with a hydrophobic composition to form at least a bi-layered laminate. The hydrophilic composition and the hydrophobic composition have at least one polymer in common. In addition, the melt flow index of the hydrophobic composition is within 50% of the melt flow index of the hydrophilic composition. As a result, the laminate has a uniform transverse cross-section and/or a uniform longitudinal cross-section throughout a major of the length of the laminate. Moreover, when the laminate is divided into unit doses of approximately the same size, they have a high degree of content uniformity with respect to the active agent(s) present therein.

Abstract: A method utilizing a dissolvable device for the internal delivery of medication and more particularly to the use of fibers or non-woven fabrics made of a safe polymer material incorporating a medication that is released by dissolution of the fibers or non-woven fabrics over time, and more particularly a treatment method for controlling or regulating the pH in the vagina by stabilizing and adjusting the pH in the vagina by minimizing the impact of the vaginal flora.

Abstract: Anti-infective articles capable of preventing infection associated with implantation of medical devices include low levels of anti-infective agents, may cover only a fraction of the portion of the medical device and be effective, or may rapidly elute anti-infective agent, without sustained elution, and still be effective.

Abstract: Disclosed herein are compositions and methods for the treatment of otic diseases or conditions with cytotoxic agent compositions and formulations administered locally to an individual afflicted with an otic disease or condition, through direct application of these compositions and formulations onto or via perfusion into the targeted auris structure(s).

Abstract: Disclosed is a composition comprising betamethasone, griseofulvin and tea tree oil, for use in the treatment of ear fungal infections, particularly otomycosis, particularly infections caused by Aspergillus niger or Candida albicans. The composition may be in the form of ointment, cream, gel or liquid, e.g. ear drops.

Abstract: The present invention relates to compositions and methods useful for the treatment of ear disorders, administered to a treated ear in the form of a foam or a mousse. Administering a medicament in such forms will increase the residence time of the medicament in the ear canal, provide relatively uniform distribution of the composition, and can increase the penetration of the active pharmaceutical ingredient in the affected area, may release active substances slowly, enhance treatment effectiveness, increase compliance and is more convenient to use than currently available ear medications. The administration in the form of a foam or a mousse may preferably be provided as a metered dose, of a volume suitable to fill the ear canal.

Abstract: A composition for treating ear infections in animals includes an antifungal agent, an antibiotic agent, a steroidal anti-inflammatory agent, and an acid dissolved to form a liquid. The acid aids in keeping the steroidal anti-inflammatory agent in solution, and enhances the bactericidal effect of the composition. The method of preparing such composition includes dissolving the antifungal agent, steroidal anti-inflammatory agent, and acid in dehydrated alcohol, dissolving the antibiotic agent in propylene glycol, combining the two solutions together, heating the combination and then cooling the composition. Several drops of the composition are applied at least twice per day to the affected area of the animal's ear.

Abstract: A medical implant device having a substrate with an oxidized surface and a silane derivative coating covalently bonded to the oxidized surface. A bioactive agent is covalently bonded to the silane derivative coating. An implantable stent device including a stent core having an oxidized surface with a layer of silane derivative covalently bonded thereto. A spacer layer comprising polyethylene glycol (PEG) is covalently bonded to the layer of silane derivative and a protein is covalently bonded to the PEG. A method of making a medical implant device including providing a substrate having a surface, oxidizing the surface and reacting with derivitized silane to form a silane coating covalently bonded to the surface. A bioactive agent is then covalently bonded to the silane coating. In particular instances, an additional coating of bio-absorbable polymer and/or pharmaceutical agent is deposited over the bioactive agent.

Abstract: Chronic Otitis Media with Effusion (COME), Recurrent Acute Otitis Media (RAOM), cholesteatoma, and other bacterial ear conditions may be treated by applying a solvating system containing greater than 0.2 wt. % surfactant to a bacterial biofilm in the middle or inner ear, disrupting the biofilm, and applying a protective layer of a polymeric film-forming medical sealant.

Abstract: The present invention relates to the supply of coenzyme Q which is highly useful in maintaining human health, and provides a method and preparations whereby coenzyme Q can be efficiently supplied to patients having difficulties in oral administration, aged having swallowing difficulties and patients with diseases caused by topical disorders. It is found that the coenzyme Q concentration in the blood or topical mucosae can be elevated by using a composition for transmucosal administration containing oxidized coenzyme Q and/or reduced coenzyme Q as the active ingredient, wherein the total content of the oxidized coenzyme Q and the reduced coenzyme Q amounts to 0.0001 to 99% by weight of the whole composition.

Abstract: The invention features methods of making living tissue constructs that can be used to repair perforations in tympanic membranes, the repair constructs themselves, and methods of repair.

Abstract: The present invention provides compositions containing (i) a pharmaceutically active agent selected from a group consisting of an arylcycloalkyamine or a derivative, analogue or pharmaceutically active salt thereof, and (ii) a biocompatible polymer or a combination of biocompatible polymers. These compositions or medicaments containing these compositions may be used for the prevention and/or treatment of inner ear diseases, e.g. tinnitus.

Abstract: The present invention relates to a biological implantation material and method of preparing the same, which comprises the steps of: (i) treating a tissue derived from animal or human with alcohol; (ii) contacting the said tissue with an enzyme selected from the group consisting of dispase, DNAse, RNAse and pepsin in a solvent; (iii) treating the tissue obtained in step (ii) with alkaline solution; and (iv) treating the tissue obtained in step (iii) with acid solution.

Abstract: A composition and methods for the treatment of symptoms due to disorders, disease or trauma that impairs normal function of die Eustachian tube and alters vital structures or tissues of the middle ear. This includes diseases and disorders of the Eustachian tube altered by tubal incompetence, inflammatory phenomenon as rhinitis, nasal allergies, infections by microorganisms, tympanic membrane rupture or trauma and variants. The composition is comprised of solution including L-Ascorbic acid and a pharmaceutically acceptable liquid carrier and delivery system. The administration of which is applied topically in appropriate composition and dosage for intranasal or trans tympanic route in the form of drops, spray, aerosol, rinse, douche, gel, or devices.

Abstract: A composition and methods for the treatment of symptoms due to disorders, disease or trauma that impairs normal function of die Eustachian tube and alters vital structures or tissues of the middle ear. This includes diseases and disorders of the Eustachian tube altered by tubal incompetence, inflammatory phenomenon as rhinitis, nasal allergies, infections by microorganisms, tympanic membrane rupture or trauma and variants. The composition is comprised of solution including L-Ascorbic acid and a pharmaceutically acceptable liquid carrier and delivery system. The administration of which is applied topically in appropriate composition and dosage for intranasal or trans tympanic route in the form of drops, spray, aerosol, rinse, douche, gel, or devices.

Abstract: Chronic Otitis Media with Effusion (COME), Recurrent Acute Otitis Media (RAOM), cholesteatoma, and other bacterial ear conditions may be treated by applying a solvating system containing greater than 0.2 wt. % surfactant to a bacterial biofilm in the middle or inner ear, disrupting the biofilm, and applying a protective layer of a polymeric film-forming medical sealant.

Abstract: The invention relates to an otorhinological delivery device comprising at least one pharmaceutically active agent. According to the invention the device comprises a core comprising said at least one pharmaceutically active agent wherein said core is made of an elastomer composition selected from the group consisting of poly(dimethylsiloxane), a siloxane-based elastomer comprising 3,3,3-trifluoropropyl groups attached to the Siatoms of the siloxane units, a siloxane-based elastomer comprising poly(alkylene oxide) groups and mixtures thereof, and a membrane encasing said core, said membrane being made of a same or a different elastomer composition than said core, said elastomer composition being selected from the group consisting of poly(dimethylsiloxane), a siloxane-based elastomer comprising 3,3,3-trifluoropropyl groups attached to the Siatoms of the siloxane units, a siloxane-based elastomer comprising poly(alkylene oxide) groups and mixtures thereof.

Abstract: A formulation containing one or more biologically active substances dissolved, dispersed, emulsified, or suspended within a vehicle of one or more citric acid esters and/or citric acid ethers. Methods for making and using are disclosed, as are kits for administration of the pharmaceutical formulation.

Abstract: A veterinary composition comprising at least one keratolytic and cerumenilytic cleaning agent, a at least one bactericide agent, at least one yeast control agent and at least one anti-irritant and anti-pruriginous agent, which is useful for preventing otitis in dogs and cats.

Abstract: Aqueous pharmaceutical solution compositions preserved with a cationic preservative and comprising a cationic drug and a sulfonated styrene/maleic anhydride copolymer are disclosed. The compositions are particularly well suited for topical ophthalmic use, but may also be used as topically administrable otic or nasal compositions.

Abstract: The invention relates to the use of a gel mass based on reaction products of polyols and polyisocyanates, wherein the polyol component consists of one or more polyols with hydroxyl numbers below 112 and where appropriate other polyols and additives known from polyol chemistry, the isocyanate number of the reaction mixture lies in the range of 15 to 59.81 and the product of the isocyanate functionality and the functionality of the polyol components is at least 6.15, as a coupling medium for transmitting acoustic waves from a sound source onto the body of the patient.

Abstract: A composition for relieving a sensation of respiratory discomfort and/or for promoting natural regeneration of mucous membranes of the nasal cavity. The composition contains levomenthol at a concentration between 10 and 250 mg/l, dissolved in an aqueous ionic solution having an osmolarity at least equal to that of an aqueous solution of sodium chloride at 9 g/l. The aqueous ionic solution is pure sea water, diluted sea water, an aqueous sodium chloride solution, an aqueous sodium chloride solution further containing at least one salt found in sea water, or a mixture thereof.

Abstract: The invention relates to nanoscale particles suited especially for use in tumor therapy by hyperthermia. Said particles comprise a (preferably superparamagnetic) iron oxide-containing core and at least two shells surrounding said core. The (innermost) shell adjoining the core is an envelope which comprises groups capable of forming cationic groups and is broken down by human or animal tissue at such a slow rate as to allow for association of the core surrounded by said envelope with the surface of cells and/or for absorption of said core into the inside of cells.

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 inplanted 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: Liquid pharmaceutical compositions for administration to a mucosal surface, comprising a therapeutic agent and a pectin with a low degree of esterification are described. Such compositions gel, or can be adapted to gel, at the site of application in the absence of an extraneous source of divalent metal ions.

Abstract: An ophthalmic composition for use in reducing ocular irritation comprising histamine, at a concentration of between about 0.01 and 1.0% by weight, in a pharmaceutically acceptable carrier, adapted for ophthalmic administration.

Abstract: A method of promoting drainage of congested middle ear fluid in a subject in need of such treatment is disclosed. The method comprises administering to the middle ear of the subject a uridine triphosphate such as uridine 5′-triphosphate (UTP), an analog of UTP, or any other analog, in an amount effective to promote drainage of congested middle ear fluid by hydrating mucous secretions in the middle ear or by stimulating ciliary beat frequency in the middle ear or eustachian tube. The method is useful for treating patients afflicted with otitis media and other middle ear diseases, otitis externa, and inner ear diseases including Ménière's Disease. Pharmaceutical formulations and methods of making the same are also disclosed. Methods of administering the same would include any liquid suspension (including nasal drops or spray), oral, inhaled by nebulization, topical, injected or suppository form.

Abstract: The invention relates to the treatment of serous otitis media (glue ear). A medicament is disclosed which comprises a surface active phospholipid (SAPL) which is instilled as a powder into the middle ear. The SAPL has an affinity for the surface of the Eustachian tube and forms a film over its surface which prevents or deters reblockage of the tube.

Abstract: An antimicrobial tympanostomy tube used to alleviate bacteriostatic infections following myringotomy which is compatible with otologic tissue associated with the middle ear. The tube is formed from a microporous thermoplastic or thermoset resin having incorporated therein 0.5 to about 15% by weight of a silver compound capable of migrating to the surface of tube sidewalls to impart a therapeutically effective level of antibacterial activity throughout the sidewall surface so as to provide long-term prevention of infections which may otherwise result during or after surgery or implantation of the tube.

Abstract: Delivery devices capable of delivering one or more active substances by diffusion through plural micropores in the membrane or by osmotic pumping through one or more preformed passageways in the membrane are provided. The device has an about centrally located expandable core completely surrounded by an active substance-containing layer, which is completely surrounded by the membrane. The device is capable of delivering insoluble, slightly soluble, sparingly soluble and very soluble active substances to an environment of use. The preferred delivery rate is zero order. The device can deliver an active substance for a period of about 12-24 hours.

Abstract: A food composition containing viable algae. The food composition includes primarily entrapped living algae cells capable of photosynthetic multiplication which increases the nutritional content of the food composition. Further disclosed is a food composition including primarily fibrous structures containing living algae cells capable of photosynthetic multiplication within the fibrous structures. Further disclosed are methods for producing the compositions, the methods including the steps of: (a) suspending live algae cells in a suitable medium; (b) placing the suspended live algae cells into a setting bath; and (c) incubating to form entrapped living algae cells. In some cases the method further includes the step of bubbling a gas through the setting bath.

Abstract: There is provided an aqueous liquid pharmaceutical composition which comprises Gatifloxacin (chemical nomenclature: (±)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline carboxylic acid) or its salt and disodium edetate. Further, there are provided a method for raising corneal permeability of Gatifloxacin, a method for preventing precipitation of Gatifloxacin crystals, and a method for preventing coloration of Gatifloxacin by incorporating disodium edetate into an aqueous liquid preparation containing Gatifloxacin or its salt.

Abstract: An immunoisolatory vehicle for the implantation into an individual of cells which produce a needed product or provide a needed metabolic function. The vehicle is comprised of a core region containing isolated cells and materials sufficient to maintain the cells, and a permselective, biocompatible, peripheral region free of the isolated cells, which immunoisolates the core yet provides for the delivery of the secreted product or metabolic function to the individual.

Abstract: The present invention provides a method for treating a demyelinating disease in a subject which includes administering to the subject a therapeutically effective amount of a high affinity neuromodulatory Na,K-ATPase so as to treat the demyelinating disease.

Abstract: A chitosan-based polymeric nitric oxide donor composition comprising a modified chitosan polymer and a nitric oxide [N2O2] dimer, wherein the nitric oxide [N2O2] dimer is bonded directly to the backbone of the modified chitosan polymer without further binding through a nucleophile residue or moiety. The chitosan-based polymeric nitric oxide donor composition is capable of site specific delivery and controlled release of nitric oxide under physiological conditions. The chitosan-based polymeric nitric oxide donor composition further provides a carrier having medically beneficial properties. A method is further included for preparing a chitosan-based polymeric nitric oxide donor composition comprising reacting a nitric oxide dimer (80-100 p.s.i.) with a modified chitosan polymer in the presence of sodium methoxide at room temperature.

Abstract: The invention relates to stable, pulverulent lycopene formulations, comprising lycopene having a degree of crystallinity of greater than 20%, processes for their preparation and their use as an additive to foodstuffs, cosmetics, pharmaceuticals and animal feedstuffs.

Abstract: The present invention relates to preparations alleviating the symptoms caused by drying of the mucous membranes of the body. The preparations contain trimethylglycine as an active agent. The invention also relates to the use of trimethylglycine as an agent alleviating the symptoms of dry mucous membranes in different preparations intended for the body care and hygiene, and to a method of alleviating the symptoms, caused by drying, appearing on the mucous membranes of the body.