Abstract: The invention relates to an orally administrable mucoadhesive film which comprises one or more bioactive ingredients and, as a major film-forming polymer, at least one alginate which is capable of forming a low viscosity aqueous solution. Also provided is a process for preparing such films.

Abstract: Embodiments of the invention relate to particles of active substances, methods for preparing the particles, formulations containing the particles, and metered dose inhalers containing such particles or formulations. In one embodiment, a composition of an aerosol formulation is provided and contains a particulate active substance of non-micronized, solid particles having a mass median aerodynamic diameter of less than 10 ?m suspended in a hydrofluorocarbon fluid vehicle at a concentration within a range from about 0.2% w/v to about 5% w/v. The aerosol formulation exhibits a flocculation volume of about 85% or greater about 1 minute after mixing the particulate active substance and the hydrofluorocarbon fluid vehicle. The particulate active substance contains an alkaloid ergotamine, pharmaceutically acceptable salts thereof, analogs thereof, or derivatives thereof.

Abstract: Provided are methods of improving the stability of antiseptic compositions that include elemental iodine and certain hydroxycarboxylic acids, as well as stable, ready to use antiseptic compositions suitable for use in the nose and anterior nares.

Abstract: Described here are devices, methods, and kits for treating sinusitis and related respiratory conditions by locally delivering active agents to the osteomeatal complex over a sustained period of time. The devices may be passively fixed within the osteomeatal complex and/or include one or more features that actively fix it within the osteomeatal complex. The devices may optionally include a portion that extends into a sinus ostium, sinus cavity, and/or the nasal passage to deliver an active agent.

Abstract: A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administrable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.

Abstract: A method and apparatus for reducing or eliminating pain after surgical procedures related to mucosal tissue, including tonsillectomy, adenoidectomy, or other pharyngeal operations. Certain embodiments provide a biodegradable film or covering that serves as a mechanical barrier to reduce pain caused, for example, by friction between solid food and healing tissue in the first few days after surgery. Some embodiments may include one or more therapeutic substances for locally reducing pain, facilitating healing and/or otherwise treating mucosal tissue at or near a tonsil bed.

Abstract: A hemorrhoid-treating composition comprising gentian violet and a lubricant or suppository base. A method of treating hemorrhoids by topically applying a composition comprising gentian violet and a lubricant or suppository base.

Abstract: This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.

Abstract: This invention relates to a gel formulation for nasal administration of a controlled release formulation of hormones to the systemic circulation and/or to the brain. The special lipophilic or partly lipophilic system of the invention leads to higher bioavailability of the active ingredient caused by sustained serum levels in plasma but also leads to a more favorable serum level profile. The special lipophilic or partly lipophilic system also allows for the modulation of brain functioning. The invention also relates to the nasal administration of steroid hormones for treatment of female sexual dysfunction (FSD) or female arousal disorder.

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: The present invention concerns methods, compositions and apparatus for administering active agents to the lungs of a subject.

Abstract: A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administerable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of additional pH adjusting substance in combination with the effervescent for promoting the absorption of drugs is also disclosed.

Abstract: The present invention relates to water-soluble films incorporating anti-tacking agents and methods of their preparation. Anti-tacking agents may improve the flow characteristics of the compositions and thereby reduce the problem of film adhering to a user's mouth or to other units of film. In particular, the present invention relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents and combinations thereof and at least one anti-tacking agent.

Abstract: Water-soluble, solid, film-shaped preparations comprising at least one film-forming polymer selected from the group consisting of the fully and partially hydrolyzed polyvinyl alcohols, and at least one water-insoluble, oily liquid which is incorporated into the film-forming polymer and amounts to at least 30 percent by weight, relative to the dry portion of the preparation. Methods for producing the preparations and the use thereof are also provided.

Abstract: A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administrable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.

Abstract: A composition is provided, wherein the composition comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer capable of hydrogen or electrostatic bonding to the hydrophilic polymer. The composition also includes a backing member. Active ingredients, such as a whitening agent, may be included. The composition finds utility as an oral dressing, for example, a tooth whitening composition that is applied to the teeth in need of whitening. The composition can be designed to be removed when the degree of whitening has been achieved or left in place and allowed to erode entirely. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

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: A rectally insertable device for localized drug delivery to the anal sphincter of a subject, a method of using the device and the use of the device is disclosed. The device comprises a shell for containing an active pharmaceutical ingredient, the shell being substantially impermeable to the active pharmaceutical ingredient wherein a lower portion of the shell is configured to release the active pharmaceutical ingredient from the shell and wherein when the device is inserted into the rectum of the subject, the lower portion of the shell is proximal to the anal sphincter, such that the active pharmaceutical ingredient is released proximal to the anal sphincter.

Abstract: A pharmaceutical dosage form adapted to supply a medicament to the oral cavity for buccal, sublingual or gingival absorption of the medicament which contains an orally administrable medicament in combination with an effervescent for use in promoting absorption of the medicament in the oral cavity. The use of an additional pH adjusting substance in combination with the effervescent for promoting the absorption drugs is also disclosed.

Abstract: A device for drug delivery to an orifice of a subject, comprising a shell which is elastically stressed by an active pharmaceutical ingredient, said shell containing and being substantially impermeable to said active pharmaceutical ingredient, wherein said shell has at least one hole sized for in-vivo release of said active pharmaceutical ingredient as a result of elastic stressing.

Abstract: The present invention relates to a method of easing childbirth using a composition having a lubricant effect for use in particular during human vaginal delivery. The methods comprise applying a bioadhesive composition comprising (a) a polyacrylic acid, (b) a water-soluble thickener and (c) a humectant and (d) optionally water.

Abstract: Methods for inhibiting the development of respiratory infections in humans are disclosed.

Abstract: Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Abstract: A method of orally administering jojoba for fat reduction, blood lipid reduction, and cancer prevention and treatment in humans is disclosed. The method incorporates a sufficient quantity of jojoba, defatted jojoba meal, jojoba extract, defatted jojoba meal extract, naturally derived or synthesized simmondsin, or any naturally derived or synthesized simmondsin derivative or analogue, including aglycon, or any mixture thereof into an individual's diet in the form of a food, dietary supplement, or drug to provide simmondsin component in an amount greater than 0.01% of one's total daily diet by weight, or 0.05 gram/day. The dosage amount and duration of the administration can vary to achieve and maintain one's desired body composition and blood lipid levels. The dosage and duration of administration are increased for cancer prevention and treatment.

Abstract: Provided are methods of delivering at least one pharmaceutical agent to the central nervous system (CNS) of a subject, methods of treating a neurological disorder or pain in a subject that include administering at least one pharmaceutical agent onto a SEM graft in the skull base of the subject. Also provided are methods of treating a neurological disorder or pain in a subject that include forming a SEM graft in the skull base of the subject and administering at least one pharmaceutical agent onto the SEM graft in the skull base of the subject. Also provided are methods of forming a SEM graft in the skull base of a subject, compositions for administration onto a SEM graft in the skull base or into an endonasal reservoir or endonasal reservoir device in a subject, and devices for administering such compositions onto a SEM graft in the skull base of a subject.

Abstract: Powdery compositions for intranasal administration, which comprise non-peptide/non-protein drugs and as a carrier, crystalline cellulose aggregates having a particular cribriform particle diameter, yield rapid action and high absorbability of the drugs.

Abstract: The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films contain at least one active agent, which may be administered to a user topically, transmucosally, vaginally, ocularly, aurally, nasally, transdermally or orally.

Abstract: Viral upper respiratory tract infections, upper respiratory infections, and common colds can be effectively treated by the administration of a combination of a nasal steroid and a nasal antihistamine. By the administration of the combination of a nasal steroid and a nasal antihistamine with the onset of cold symptoms, the histamine cascade and the inflammatory response are impeded or eliminated, reducing the severity, duration, or frequency of the onset of cold symptoms. The combination of a nasal steroid and a nasal antihistamine may be, for example, a physical mixture of the steroid and antihistamine, or it may effectively be a combination wherein the patient is administered one component (either the steroid or the antihistamine) followed by the other, without physical mixing beforehand.

Abstract: The present invention relates to the field of viral disorders, and in particular to the use of natural compounds to inhibit viruses and viral infection. Compositions comprising NGNA are provided for treating or preventing viral infections, such as those causing the common cold.

Abstract: The present invention relates to a pharmaceutical delivery device for application of a pharmaceutical to mucosal surfaces. The device comprises an adhesive layer and a non-adhesive backing layer, and the pharmaceutical may be provided in either or both layers. Upon application, the device adheres to the mucosal surface, providing localized drug delivery and protection to the treatment site. The kinetics of erodability are easily adjusted by varying the number of layers and/or the components.

Abstract: In one aspect, methods for separating biological tissue are described herein. In some embodiments, a method for separating tissue comprises providing a first composition comprising a polymerizable material, providing a second composition comprising a polymerization initiator, disposing the first composition at a first site beneath a first tissue layer, disposing the second composition at the first site, polymerizing the polymerizable material at the first site, and separating the first tissue layer from a second tissue layer.

Abstract: The present invention relates to the use of a container, made of an inorganic additive containing plastic material, for reducing physical/chemical interaction between the container and an oil, fat and/or wax containing formulation contained therein.

Abstract: This invention relates to a pernasally administrable preparation for the controlled release of sexual hormones to the systemic circulation, in particular to a formulation which enables its active ingredient to be absorbed in a sustained manner providing a better bioavailability at very low doses and longer duration of action.

Abstract: The present invention is directed to formulations of genistein and methods for making and using the same. In particular embodiments, the formulations described herein include suspension formulations of nanoparticulate genistein.

Abstract: The invention concerns a medicinal tablet to be sucked made with boiled sugar of solid consistency designed to dissolve in the buccal cavity, comprising at least an active principle. The invention is characterized in that it further comprises at least a matrix agent for slowing down the release of the active principle(s) which therefore remain in prolonged contact with the region of the mouth and the pharynx, the dissolving time in the buccal cavity being at least 15 minutes.

Abstract: Described here are devices, methods, and kits for treating sinusitis and related respiratory conditions by locally delivering active agents to the osteomeatal complex over a sustained period of time. The devices may be passively fixed within the osteomeatal complex and/or include one or more features that actively fix it within the osteomeatal complex. The devices may optionally include a portion that extends into a sinus ostium, sinus cavity, and/or the nasal passage to deliver an active agent.

Abstract: A method for blocking, neutralizing, or killing microorganisms that cause infectious disease in a mammal prior to or during the mammal encountering a contaminated environment or item includes: identifying a contaminated environment or item, wherein the contaminated environment or item is known or expected to be contaminated with harmful viral, fungal, or bacterial microorganisms; and administering a therapeutically effective amount of a barrier-forming composition to a mucosa of the mammal prior to or during the mammal encountering the contaminated environment or item. The barrier-forming composition provides a barrier on the mucosa that inhibits the microorganisms from contacting the mucosa. Other related methods are also included.

Abstract: The present invention relates to mucoadhesive drug delivery devices and their methods of preparation and use. More specifically the present invention relates to mucoadhesive drug delivery devices comprising one or more biocompatible purified proteins combined with one or more biocompatible solvents and one or more mucoadhesive agents. The mucoadhesive drug delivery devices may also include one or more pharmacologically active agents. The drug delivery devices of the present invention adhere to mucosal tissue, thereby providing a vehicle for delivery of the pharmacologically active agent(s) through such tissue.

Abstract: The present invention concerns a prolonged release bioadhesive mucosal therapeutic system containing at least one active principle, with an active principle dissolution test of more than 70% over 8 hours and to a method for its preparation. Said bioadhesive therapeutic system comprises quantities of natural proteins representing at least 50% by weight of active principle and at least 20% by weight of said tablet, between 10% and 20% of a hydrophilic polymer, and compression excipients, and comprising between 4% and 10% of an alkali metal alkylsulphate to reinforce the local availability of active principle and between 0.1% and 1% of a monohydrate sugar.

Abstract: Therapeutic delivery systems are provided which, in a first embodiment, contain a plurality of multiphase capsules in which first and second therapeutic agents are contained in separate phases within said multiphase capsules, and are disposed to deliver said first and therapeutic agents by at least two different delivery mechanisms.

Abstract: Described herein are respiratory drug condensation aerosols and methods of making and using them. Kits for delivering condensation aerosols are also described. The respiratory drug aerosols typically comprise respiratory drug condensation aerosol particles. In some variations the respiratory drug compound is selected from the group consisting of ?-adrenergics, methylxanthines, anticholinergics, corticosteroids, mediator-release inhibitors, anti-leukotriene drugs, asthma inhibitors, asthma antagonists, anti-endothelin drugs, prostacyclin drugs, ion channel or pump inhibitors, enhancers, or modulators and pharmaceutically acceptable analogs, derivatives, and mixtures thereof. Methods of treating a respiratory ailment using the described aerosols are also described. In general, the methods typically comprise the step of administering a therapeutically effective amount of respiratory drug condensation aerosol to a person with a respiratory ailment.

Abstract: Methods are provided for preparing and delivering an adjuvant for vaccines including lecithin and a polymer. The polymer is preferably polyacrylic acid-based and the delivery method involves administering a vaccine, including an antigen and the adjuvant, to a mucosal surface.

Abstract: A composition is provided, wherein the composition comprises a water-swellable, water-insoluble polymer, a blend of a hydrophilic polymer with a complementary oligomer capable of hydrogen or electrostatic bonding to the hydrophilic polymer. The composition also includes a backing member. Active ingredients, such as a whitening agent, may be included. The composition finds utility as an oral dressing, for example, a tooth whitening composition that is applied to the teeth in need of whitening. The composition can be designed to be removed when the degree of whitening has been achieved or left in place and allowed to erode entirely. In certain embodiments, the composition is translucent. Methods for preparing and using the compositions are also disclosed.

Abstract: There is provided a powder formulation for nasal delivery including a protein having a molecular weight of 10 kDa or greater and chitosan or a derivative thereof or a salt of chitosan or a salt of a derivative of chitosan. Preferably the protein is human growth hormone.

Abstract: The present invention relates to products and methods for treatment of narcotic dependence in a user. The invention more particularly relates to self-supporting dosage forms which provide an active agent for treating narcotic dependence while providing sufficient buccal adhesion of the dosage form.

Abstract: Embodiments of the invention relate to particles of active substances, methods for preparing the particles, formulations containing the particles, and metered dose inhalers containing such particles or formulations. In one embodiment, a composition of an aerosol formulation is provided and contains a particulate active substance of non-micronized, solid particles having a mass median aerodynamic diameter of less than 10 ?m suspended in a hydrofluorocarbon fluid vehicle at a concentration within a range from about 0.2% w/v to about 5% w/v. The aerosol formulation exhibits a flocculation volume of about 85% or greater about 1 minute after mixing the particulate active substance and the hydrofluorocarbon fluid vehicle. The particulate active substance contains an alkaloid ergotamine, pharmaceutically acceptable salts thereof, analogues thereof, or derivatives thereof.

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: Compositions for nasal administration, which comprise a pharmaceutical, a physiologically active peptide, or a peptide-related compound, and as the carrier thereof, crystalline cellulose with a specific particle diameter and/or partially pregelatinized starch are provided. Such compositions improve the in vivo absorption efficiency of pharmaceuticals.

Abstract: The present invention is directed to compositions comprising at least one nitric oxide donor and at least one second therapeutically active agent with antimicrobial or wound healing capability. In one embodiment, the nitric oxide donor is a nanoparticle which is designed to control for the amount and duration of release of nitric oxide. The nanoparticle may further comprise the additional therapeutically active agent. The composition is useful for enhancing wound healing and for treating and preventing microbial infection. In one embodiment, the composition is directed toward reducing oral bacteria or dental plaque. The combination of one or more nitric oxide donors and one or more additional therapeutically active agent results in unexpected synergistic effects, wherein both the antimicrobial efficacy of the nitric oxide and the antimicrobial or wound healing efficacy of the second therapeutically active agent are enhanced.

Abstract: Devices, systems and methods for stenting, spacing, draining, ventilating and/or delivering drugs and other therapeutic or diagnostic substances to desired locations within the bodies of human or non-human animal subjects, including methods and systems for treating paranasal sinusitis and ethmoid disease.