Abstract: Provided are methods and compositions useful for treating/aches and/or pains. The compositions comprise an aqueous medium having dispersed or dissolved therein an herbal therapeutic agent and/or an analgesic agent, wherein the composition is effective when delivered to the mucosal membrane.

Abstract: Lung surfactant compositions are provided which can form a swelling phase when dispersed in a medium containing electrolytes. Hereby, a more active spreading of the lung surfactant into the alveoli can be obtained after administration to the lungs. Further provided are a pharmaceutical composition and a pharmaceutical kit comprising a lung surfactant composition as well as to a method for the treatment, prevention and/or diagnosis of respiratory distress syndrome or other pulmonary diseases that are associated with a deficiency of a lung surfactant.

Abstract: A composition and method for the treatment of chronic sinusitis in which a composition containing desirable colonial bacteria is applied externally in the form of either a spray or a flush. The bacteria are selected from the genus Lactobacillus and the genus Bifidobacterium. The selected bacteria are provided in a therapeutically effective amount in a water solution.

Abstract: A free radical quenching composition is disclosed comprising a liposome containing at least two antioxidants selected from the following group: beta-carotene, vitamin E, vitamin C, glutathione, niacin, and optionally at least one trace metal (Zn, Se, Cr, Cu, Mn). Also disclosed is a method for reducing the undesirable side effects of free radicals in a mammal by administering to a mammal in need of such antioxidants an effective amount of liposomes containing at least two antioxidants.

Abstract: A method to treat an animal in need thereof with one or more parasiticides by administering those one or more parasiticides to the nasal pharynx of the animal. A method to increase an animal's blood levels of one or more avermectin compounds/milbemycin compounds such that the blood levels of those one or more avermectin compounds/milbemycin compounds reach a maximum concentration in about 24 hours, and such that those blood levels exceed about 2 ng/ml for at least 96 hours post administration.

Abstract: The present invention provides novel compositions and methods for using the S(+) enantiomer of desmethylselegiline (N-methyl-N-(prop-2-ynyl)-2-aminophenylpropane), for the treatment of selegiline-responsive diseases and conditions. Diseases and conditions responsive to selegiline include those produced by neuronal degeneration or neuronal trauma and those due to immune system dysfunction. Effective dosages are a daily dose of at least about 0.015 mg/kg of body weight.

Abstract: Bioadhesive, closed-cell foam film, sustained release, delivery devices for administering an active agent or combination of active agents to a subject are provided. Methods for making such delivery devices and to methods for using such delivery devices offering the controlled and sustained release of an active agent or combination of active agents to a subject, preferably a near zero-order release, are also provided.

Abstract: The invention provides methods for induction of an antigen-specific, mucosal cytotoxic T lymphocyte response useful in preventing and treating infections with pathogens that gain entry via a mucosal surface.

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 present invention provides compositions and methods for administering oxybutynin while minimizing the incidence and or severity of adverse drug experiences associated with oxybutynin therapy. In one aspect, these compositions and methods provide a lower plasma concentration of oxybutynin metabolites, such as N-desethyloxybutynin, which is presumed to be contributing at least in part to some of the adverse drug experiences, while maintaining sufficient oxybutynin plasma concentration to benefit a subject with oxybutynin therapy. The invention also provides isomers of oxybutynin and its metabolites that meet these characteristics of minimized incidence and/or severity of adverse drug experiences, and maintenance of beneficial and effective therapy for overactive bladder.

Abstract: A patient's upper airway condition such as snoring and sleep apnea is treated by selecting a particulate material selected for limited migration within tissue and for encouraging a fibrotic response of tissue to the material. A bolus of the particulate material is injected into the tissue area to structurally stiffen the tissue.

Abstract: The present invention is directed to glassy matrix solid oral dosage forms useful for transmucosal oral administration of a nicotine active.

Abstract: Improved edible films for mucoadhesion are provided. The films include at least three types film forming agents other than pullulan, such as maltodextrins, hydrocolloids and fillers. Preferably, the maltodextrin has a dextrose equivalent of less than 20. Medicaments and other additive agents can also be incorporated into the edible films. In this regard, the edible films can be utilized to deliver or release the medicaments into an oral cavity, thereby providing effective oral treatment with respect to, for example, oral cleansing and breath freshening.

Abstract: The invention disclosed herein relates to biochemical methods for the elimination of corneal collagen fiber disorganization to improve vision. Disorganization of corneal collagen fibers is seen in corneal scars, corneal opacification and corneal haze. In addition, the invention relates to biochemical methods for the elimination of corneal collagen fiber disorganization resulting from accidental traumatic injury to the cornea and from refractive surgery for such as radial keratotomy (RK), photorefractive keratectomy (PRK), and laser in situ keratomileusis (LASIK) so as to improve visual acuity and quality of vision.

Abstract: A lipid or other hydrophobic or amphiphilic compound (collectively referred to herein as “hydrophobic compounds”) is integrated into a polymeric matrix for drug delivery to alter drug release kinetics. In embodiments where the drug is water soluble, the drug is released over longer periods of time as compared to release from the polymeric matrix not incorporating the hydrophobic compound into the polymeric material. In contrast to methods in which a surfactant or lipid is added as an excipient, the hydrophobic compound is actually integrated into the polymeric matrix, thereby modifying the diffusion of water into the microparticle and diffusion of solubilized drug out of the matrix. The integrated hydrophobic compound also prolongs degradation of hydrolytically unstable polymers forming the matrix, further delaying release of encapsulated drug.

Abstract: The present invention discloses compositions derived from an isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain, suitable for topical application to the skin or mucosal membranes of a mammal, which are utilized to inhibit the growth of bacterium, yeast, fungi, virus, and combinations thereof. The present invention also discloses methods of treatment and therapeutic systems for inhibiting the growth of bacterium, yeast, fungi, virus, and combinations thereof, by topical application of therapeutic compositions which are comprised, in part, of isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain.

Abstract: Inhalatory pharmaceutical compositions containing Formoterol as active ingredient, comprising: a vial containing a sterile liquid vehicle suitable for inhalation; a reservoir chamber cap containing a powder mixture consisting of Formoterol or a related salt in micronized form and one or more excipients, soluble in the vehicle and suitable for respiratory use.

Abstract: The invention disclosed herein relates to a pharmaceutical composition comprising a carrier and an active ingredient, wherein the carrier is fish gelatin and the composition is a fast-dispersing dosage form designed to release the active ingredient rapidly on contact with a fluid. In one embodiment, the composition is designed for oral administration and releases the active ingredient rapidly in the oral cavity on contact with saliva. The fish gelatin can be obtained from cold water fish sources and is preferably the non-gelling, non-hydrolyzed form. A process for preparing such a composition and a method of using fish gelatin in a fast dispersing dosage form are also provided.

Abstract: The present invention is related to a process for obtaining a composition comprising peptides bound to one or more heat shock protein(s) and for possibly recovering from said composition the bound peptides, wherein the peptides resulting from a previously in-vitro hydrolysis of at least one immunogenic and antigenic macromolecular structure, are mixed in-vitro with one or more heat shock protein(s). The present invention is also related to the compositions obtained by said process.

Abstract: Preparations to be applied to the oral or nasal cavity which contain aminoethanesulfonic acid and a mucosal stimulant. When these preparations are applied to the oral or nasal cavity, aminoethanesulfonic acid can be quickly and efficiently absorbed via the activated oral or nasal mucosa. The administration of these preparations quickens recovery from fatigue.

Abstract: Disclosed herein are methods for treating or preventing a disease in mammals having the characteristics of Type 1 diabetes comprising administering insulin or disease suppressive fragments of insulin or analogs thereof in oral or aerosol dosage forms to said mammals. Also disclosed herein are pharmaceutical formulation or dosage forms for use in the methods.

Abstract: Methods and pharmaceutical compositions for using desmethylselegiline. In particular, the present invention provides novel compositions and methods for using desmethylselegiline for selegiline-responsive diseases and conditions. Diseases and conditions responsive to selegiline include those produced by neuronal degeneration or neuronal trauma and those due to immune system dysfunction. Desmethylselegiline is the R-(−) enantiomer of N-methyl-N-(prop-2-ynyl)-2-aminophenylpropane. Claimed compositions include both the R-(−) isomer and mixtures of the R-(−) and S(+) isomers. Pharmaceutically acceptable acid addition salts may also be used. Effective dosages are a daily dose of at least about 0.015 mg/kg of body weight.

Abstract: The present invention teaches a composition comprising a &bgr;-adrenergic agonist in a bioadhesive carrier. Preferably, the composition comprises terbutaline in polycarbophil. The present invention additionally teaches the local administration of a &bgr;-adrenergic agonist for the purpose of treating or preventing dysmenorrhea or premature labor. Using this composition and the method of treatment provides sufficient local levels of the drug to provide therapeutic efficacy, but avoids many untoward adverse events.

Abstract: The invention provides the use of Hepatitis A virus capsid, or a mucosally immunogenic fragment or epitope thereof, for the manufacture of a mucosal vaccine composition for administration to a mucosal surface of a patient to induce production of serum Immunoglobulin G antibody against Hepatitis A. Preferably the vaccine composition is administered by the intranasal route.

Abstract: The invention relates generally to a method which utilizes iodine as a broad spectrum microbicide wherein the active agent may be applied in nasal passages in the manner of a decongestant type nose spray. The spray is intended particularly for human use. It is to be applied in the event of known or suspected exposure of the individual to common cold virus, flu, or other infective microbial agents including for example, bacteria, viruses, rickettsia, and even mold and fungus. The active agent is based on an iodine solution and may also contain one or more of the following: sodium hypochlorite solution, or a solution of chlorine or hypochlorites plus a salt of chloride, bromide or iodide. Alternatively, the solution may further contain iodine and a bromine solution, or a solution of iodine, bromine plus a salt of chloride, bromide or iodide such as sodium chloride, zinc chloride, sodium bromide, zinc bromide, sodium iodide or zinc iodide.

Abstract: Immune response modifier compounds—imidazoquinoline amines, imidazopyridine amines, 6,7-fused cycloalkylimidazopyridine amines, and 1,2-bridged imidazoquinoline amines—are useful for the treatment of TH2 mediated diseases by administering a therapeutically effective amount of such compounds in order to inhibit TH2 immune response, suppress IL-4/IL-5 cytokine induction and eosinophilia, as well as enhance TH1 immune response.

Abstract: The present invention is an improvement in the treatment of migraine headaches. By administering dihydroergotamine as a sublingual spray or aerosol, major limitations of past treatments are circumvented thereby allowing for higher efficacy and fewer side effects of treatment at lower doses.

Abstract: The present invention relates to a titratable dosage transdermal delivery system for systemic delivery of a therapeutic agent or drug. The system comprises a plurality of patch units that are connected along one or more borders. The plurality of patch units are divisible into units along the one or more borders having one or more lines of separation. Each patch unit is surrounded by a border. The therapeutic patch has at least a backing layer and a therapeutic agent comprising layer. The dosage of therapeutic agent delivered to a patient is proportional to the number of patch unit applied per treatment. The system enables systemic administration of a titratable dosage of therapeutic agent, adjustable by the patient under the direction of a physician, through the skin or mucosa. Moreover, the invention relates to a method of making the titratable dosage transdermal delivery system.

Abstract: An adjuvant for vaccines comprising lecithin and a polymer, whereby the polymer is preferably polyacrylic acid.

Abstract: Formulations of nicotine for use in nicotine replacement therapy. The formulations are intended for application in the oral cavity where upon the uptake of nicotine mainly takes place through the buccal mucosa. The formulations essentially comprise apolar, polar and surface-active components. The formulations may be administered in combination with other nicotine formulations.

Abstract: Buccal aerosol sprays or capsule using polar and non-polar solvent have now been developed which provide biologically active compounds for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprises formulation I: polar solvent 37-98.58%, active compound 0.005-55%, optionally containing flavoring agent 0.1-10%.

Abstract: The present invention relates to a pharmaceutical formulation for intranasal administration comprising morphine or pharmaceutically acceptable salt thereof at a pH from about 3.0 to about 7.0. Such formulations provide enhanced absorption of morphine or pharmaceutically acceptable salts thereof. In one embodiment, the present invention provides a method for eliciting an analgesic or anesthetic response in a mammal which includes nasally administering a therapeutically effective amount of morphine or pharmaceutically acceptable salt thereof at a pH from about 3.0 to about 7.0.

Abstract: This invention provides a matrix adhering to the nasal mucosa which allows improved transfer into the brain of a drug exerting its effect in the brain and is capable of continuously supplying the drug into the brain. This matrix contains a polyglycerol fatty acid ester, the drug exerting its effect in the brain, and a viscogenic substance.

Abstract: An antigenic preparation for use in the treatment or prevention of Helicobacter infection in a mammalian host, comprises the lipopolysaccharide (LPS) of Helicobacter bacteria, particularly the LPS of H. pylori or H. felis, or an immunogenic fragment thereof.

Abstract: The aromatic composition is for nasal administration and has a pharmaceutically-acceptable aqueous saline solution carrier combined with sesame oil and an essential oil such as peppermint oil and eucalyptus oil. The composition is withdrawn into a syringe and an output portion is sealingly applied to the nostril before the composition is injected therein to rinse the nostril.

Abstract: The present invention pertains to a quick disintegrating tablet in buccal cavity, characterized in that drug-containing particles with a mean particle diameter of approximately 50˜approximately 250 &mgr;m and an apparent specific gravity of approximately 0.5˜approximately 1.2 consisting of a bitter tasting drug and/or drug of inferior fluidity and a pharmaceutical preparation carrier and obtained by spray drying are added to a quick disintegrating tablet in buccal cavity comprising a drug and saccharide.

Abstract: Compositions and methods for improving cellular internalization of one or more compounds are disclosed. The compositions include a compound to be delivered and a biocompatible viscous material, such as a hydrogel, lipogel, or highly viscous sol. The composition also include, or are administered in conjunction with, an enhancer in an amount effective to maximize expression of or binding to receptors and enhance RME of the compound into the cells. This leads to high transport rates of compounds to be delivered across cell membranes, facilitating more efficient delivery of drugs and diagnostic agents. Compositions are applied topically orally, nasally, vaginally, rectally, and ocularly. The enhancer is administered with the composition or separately, either systemically or preferably locally. The compound to be delivered can also be the enhancer.

Abstract: Methods are provided for purifying peptides and proteins by incorporating the peptide or protein into a diketopiperazine or competitive complexing agent to facilitate removal one or more impurities, i.e. undesirable components, from the peptide or protein. In a preferred embodiment, a peptide, such as insulin, containing one or more impurities, e.g., zinc ions, is entrapped in diketopiperazine to form a precipitate of peptide/diketopiperazine/impurity, which is then washed with a solvent for the impurity to be removed, which is a nonsolvent for the diketopiperazine and a nonsolvent for the peptide. Formulations and methods also are provided for the improved transport of active agents across biological membranes, resulting for example in a rapid increase in blood agent concentration.

Abstract: Disclosed are methods and compositions for increasing tissue oxygen levels by administration of superoxygenated compositions of tissue surfaces. The methods are applicable to treatment of a wide variety of conditions including burns, bedsores, ulcers, necrosis and anaerobic infections.

Abstract: Methods for the treatment, management, or prevention of apnea and apnea disorders, or symptoms thereof, using a therapeutically effective amount of substantially optically pure R(+) ondansetron, or a pharmaceutically acceptable salt thereof, substantially free of its S(−) stereoisomer.

Abstract: The common cold is caused by a virus. Antiviral compounds that kill viruses would then be most likely to serve as a remedy for the common cold. This invention seeks to offer a unique use of an antiviral agent, ethanol (with or without additional homeopathic and/or herb ingredients) through the unique topical application of a mouthwash to a sore throat that is often the first symptom of a common cold. The sore throat is caused by the virus setting up to enter the body after which a cascade of immune response symptoms will occur. Current cold remedies do nothing but treat these immune response symptoms. This invention is unique in that it destroys the virus directly, blocking the cold virus at its point of entry, and the remaining cold symptoms never appear. It does not matter how many cold viruses exist, because the antiviral nature of ethanol kills viruses upon contact.

Abstract: A dosage form for intranasal and/or inhalation administration of an analgesic having low opioid receptor binding activity to a warm blooded animal, that includes a pharmaceutically effective amount of the analgesic. A preferred analgesic is tramadol, a tramadol and/or a pharmaceutically acceptable salt, metabolite or derivative thereof. Methods of making and using the formulation according to the invention are also provided.

Abstract: A therapeutic composition for use as a nasal spray the aids in decongesting of the nasal passages by osmotic effect, thinning of mucus and stimulation of ciliary function. Preferred embodiments of the composition contain a sugar solution, a sodium bicarbonate solution, saline, glycerin, water, and a preservative.

Abstract: The present invention relates to a per oral, oral, or intranasal pharmaceutical mucoretentive, aqueous liquid composition comprising from about 2% to about 50%, by weight of the composition, of colloidal particles of silica, titanium dioxide, clay, and mixtures thereof and a safe and effective amount of a pharmaceutical active selected from the group consisting of analgesics, decongestants, expectorants, antitussives, antihistamines, sensory agents, gastrointestinal agents, and mixtures thereof; wherein the composition has a sedimentation volume ratio of greater than about 0.90 and wherein the triggered viscosity ratio of the composition is at least about 1.2. The present invention further relates to a method of coating the alimentary canal and nasal mucosa, in particular to a method of preventing or treating symptoms of upper respiratory tract infections or upper respiratory tract tissue irritation or damage, by administering a safe and effective amount of the above composition.

Abstract: The present invention relates to a beauty method in which a sound skin condition can be maintained or created and/or deep relaxation can be appreciated, wherein a comfort-stimulating means capable of acting on the mind is introduced in addition to a care cosmetic means.

Abstract: A dressing and method of treating wounds is provided. The dressing can comprise water-soluble or swellable polymers capable of forming viscous aqueous or non-aqueous solution and form a gel, and which may be dehydrated and milled to form a powder. The dressing can be constructed in the form of a sponge or sheet impregnated with the gel, or may contain a tooth-whitener, and may be coated onto a non-porous, porous or micro-porous backing. Wounds treated with dressings in accordance with embodiment of the invention will tend to heal without the formation of a typical hard scab. The dressing may also be covered with a protective coating such as a cyanoacrylic liquid or spray, or may be attached to a backing such as an adhesive bandage to protect the wound from an excessively fluids environment and from mechanical stresses.

Abstract: The libido of adult human female patients is increased by the bolus delivery of a testosterone which is preferably dihydrotestosterone. The formulation is preferably aerosolized and inhaled into a patient's lungs where particles of testosterone deposits on lung tissue and then enter the patient's circulatory system. The patient's testosterone level is quickly enhanced well above baseline levels for a short period and subsides to baseline levels with normal metabolism thereby providing desired short term effects on enhanced libido without undesirable effects of long term enhanced testosterone levels. Additional formulations are provided including formulations for aerosolized delivery of sildenafil citrate which are delivered to male or female patients.

Abstract: A method of treating mucus hypersecretion, the causative factor in chronic obstructive pulmonary disease (COPD), asthma and other clinical conditions involving COPD, comprises administering a compound that inhibits exocytosis in mucus secreting cells or neurones that control or direct mucus secretion. Also described is a compound, for use in the treatment of hypersecretion of mucus, which inhibits mucus secretion by inhibiting mucus secreting cells, and/or inhibiting neurotransmitter release from neuronal cells controlling or directing mucus secretion.

Abstract: This invention relates to the chemoprevention of prostate cancer and, more particularly, to a method of suppressing or inhibiting latent prostate cancer comprising administering to a mammalian subject a chemopreventive agent and analogs and metabolites thereof. The chemopreventive agent prevents, prevents recurrence of, suppresses or inhibit prostate carcinogenesis; and treats prostate cancer.

Abstract: Compositions and methods are provided for the administration of particulates comprising at least one bioactive agent which, in selected embodiments, may comprise and immunoactive agent. In this respect, the invention provides for both topical and systemic delivery of the bioactive agent using, for example, the respiratory, gastrointestinal or urogenital tracts. The particulates may be in the form of dry powders or combined with a non-aqueous suspension medium to provide stabilized dispersions. In preferred embodiments, the disclosed compositions will be used in conjunction with inhalation devices such as metered dose inhalers, dry powder inhalers, atomizers or nebulizers for targeted delivery of the agent to mucosal surfaces.