Abstract: Methods of designing, generating, screening, and identifying one or more of these peptides possessing multiple functionalities, for example, including (i) high binding to a cellular target (e.g., melanin pigment in the eye), (ii) high cell-penetration (e.g., to enter cells and access melanin in the melanosomes), and (ii) low cytotoxicity have been developed. Peptides or drug conjugates thereof having these multiple functionalities are particularly effective for selective delivery, prolonged residence, and sustained release of active agents to the epithelial tissues via mucosal surfaces. Methods of using these peptides are also described.

Abstract: Improved hypotonic gelling vehicles are described as solubilizing agents for drugs and as a means to provide sustained drug delivery to the eye. It has been discovered that the addition of small amounts of low molecular weight PEG to hypotonic gel-forming compositions enhances the viscosity of the solution at the ocular surface, prologs tear break-up time and increases ocular comfort. Solubilizing drugs at higher concentrations enhances drug penetration into the tissues of the body, while the hypotonic gelling vehicle further improves distribution of the drug over a larger surface area for increased absorption and sustained release for reduced side effects and longer duration of action.

Abstract: Provided are methods to treat upper respiratory tract inflammatory diseases and conditions including (chronic) sinusitis, (chronic) rhinitis, and/or (chronic) rhinosinusitis (with or without polyps), as well as nasal polyposis. Further provided are substantially complete sinonasal microbial compositions, methods of producing same, and medical kits comprising same.

Abstract: The present disclosure provides methods, uses, and pharmaceutical compositions comprising and azole derivative (e.g., sulconazole) in the treatment or prevention of fibrotic disease or disorder or fibrosis, including Crohn's disease.

Abstract: Administration of therapeutic, prophylactic, or diagnostic agents that bind to a receptor or ligand in the eye or to the skin in microcrystalline form leads to increased delivery and long-lasting activity within the eye as compared with administration of the agent in non-crystalline form. Compositions and methods for delivery of active agents in microcrystalline form to the eye for the treatment, prevention and diagnosis of eye diseases and disorders are provided. In preferred embodiments, microcrystals include sunitinib malate in complex with pamoic acid. Administration of microcrystals of sunitinib malate/pamoic acid to the eye provides protection from glaucoma for up to 6 months or longer without retinal toxicity, following a single injection into the eye.

Abstract: Methods and materials for treating bacterial vaginosis (“BV”) are provided. Cervicovaginal secretions (“CVS”) from a woman with vaginal microbiota dominated (>50%) by one of the species of lactobacillus typically found in the human vagina, e.g. Lactobacillus crispatus, L. iners, L. gasseri, L jensenii, is transplanted to women with BV as a method for restoring beneficial vaginal microbial communities and/or increasing resistance to sexually transmitted disease. Efficacy can be enhanced, or the properties of the endogenous CVS improved, through administration of an acidifying agent such as lactic acid. The examples demonstrate the role of healthy CVS in disease resistance, and the effect of pH on CVS properties. The examples also describe the collection and transplantation of healthy beneficial CVS into women at risk for, or after treatment for, BV.

Abstract: The present disclosure provides methods, uses, and pharmaceutical compositions comprising and azole derivative (e.g., sulconazole) in the treatment or prevention of fibrotic disease or disorder or fibrosis, including Crohn's disease.

Abstract: Hypotonic microbicidal compositions including an antimicrobial, such as an antiviral compound, and a pharmaceutically acceptable carrier in a solution formulation having hypotonic osmolarity have been developed for administration rectally to the gastrointestinal mucosa. In a preferred embodiment for use in preventing or decreasing HIV infection, the microbicidal is tenofovir, or a prodrug or derivative thereof. The formulations may include additional agents such as surfactants to enhance cleansing, buffers, or preservatives. Polymers may be included for osmolarity as well as comfort.

Abstract: The present invention generally relates to reducing the mucoadhesive properties of a particle. In some embodiments, the particle is coated with and/or associated with a (poly(ethylene glycol))-(poly(propylene oxide))-(poly(ethylene glycol)) triblock copolymer. Methods for preparing inventive particles using a poly(ethylene glycol)-vitamin E conjugate as a surfactant are also provided. In some embodiments, methods are provided comprising administering to a subject a composition of particles of the present invention. Such particles with reduced mucoadhesive properties are useful in delivering agents to mucosal tissues such as oral, ophthalmic, gastrointestinal, nasal, respiratory, and genital mucosal tissues.

Abstract: Hypotonic microbicidal compositions including an antimicrobial, such as an antiviral compound, and a pharmaceutically acceptable carrier in a solution formulation having hypotonic osmolarity have been developed for administration rectally to the gastrointestinal mucosa. In a preferred embodiment for use in preventing or decreasing HIV infection, the microbicidal is tenofovir, or a prodrug or derivative thereof. The formulations may include additional agents such as surfactants to enhance cleansing, buffers, or preservatives. Polymers may be included for osmolarity as well as comfort.

Abstract: A population of polymeric particles for controlled release of therapeutic agents which have unacceptable toxicity when administered intravitreally can be safely administered suprachoroidally at the same intravitreal concentration or dose. In a preferred embodiment, the particles have a high loading of the agent and is released without a substantial initial burst release. Examples demonstrate safety and efficacy of delivery of acriflavine-containing particles when administered suprachoroidally. The examples demonstrate sustained release with low to no burst release of the highly water soluble agent for up to 60 days.

Abstract: Hypotonic formulations of hydrogel forming polymers, preferably poloxamers, have been developed for enhanced delivery through mucosa of therapeutic, diagnostic, prophylactic or other agents, to epithelial tissues, especially those having a mucosal coating. The polymers are administered at a concentration above, at or less than their critical gelling concentration (CGC) under isotonic conditions. The hypotonicity of the formulation is adjusted so that the polymer gels at the lower concentration. A Poloxamer gel administered into the vagina or colorectum at its CGC will form a “plug” of gel in the lumen.

Abstract: Hypotonic formulations of hydrogel forming polymers, preferably poloxamers, have been developed for enhanced delivery through mucosa of therapeutic, diagnostic, prophylactic or other agents, to epithelial tissues, especially those having a mucosal coating. The polymers are administered at a concentration above, at or less than their critical gelling concentration (CRC) under isotonic conditions. The hypo tonicity of the formulation is adjusted so that the polymer gels at the lower concentration. A Poloxamer gel administered into the vagina or colorectal at its CRC will form a “plug” of gel in the lumen.

Abstract: Hypotonic gelling vehicles are used as solubilizing agents for drugs and as a means to provide sustained drug delivery to a mucosal tissue. Solubilizing drugs at higher concentrations enhances drug penetration into the tissues of the body, while the hypotonic gelling vehicle further improves distribution of the drug over a larger surface area for increased absorption and sustained release for reduced side effects and longer duration of action.

Abstract: Hypotonic gelling vehicles are used as solubilizing agents for drugs and as a means to provide sustained drug delivery to a mucosal tissue. Solubilizing drugs at higher concentrations enhances drug penetration into the tissues of the body, while the hypotonic gelling vehicle further improves distribution of the drug over a larger surface area for increased absorption and sustained release for reduced side effects and longer duration of action.

Abstract: Mucus penetrating particles (MPPs) include one or more core polymers, one or more therapeutic, prophylactic and/or diagnostic agents; and one or more surface modifying agents. The surface modifying agents coat the surface of the particle in a sufficient density to enhance the diffusion of the modified nanoparticles throughout the mucosa, relative to equivalent nanoparticles that are not surface modified. Nanoparticles can be sufficiently densely coated with poly(ethylene glycol) (PEG) with a molecular weight of from 10 kD to 40 kD or greater coated with a surface density from about 0.1 to about 100 molecules/100 nm2, preferably from about 0.5 to about 50 molecules/100 nm2, more preferably from about 0.9 to about 45 molecules/100 nm2.

Abstract: Hypotonic microbicidal compositions including an antimicrobial, such as an antiviral compound, and a pharmaceutically acceptable carrier in a solution formulation having hypotonic osmolarity have been developed for administration rectally to the gastrointestinal mucosa. In a preferred embodiment for use in preventing or decreasing HIV infection, the microbicidal is tenofovir, or a prodrug or derivative thereof. The formulations may include additional agents such as surfactants to enhance cleansing, buffers, or preservatives. Polymers may be included for osmolarity as well as comfort.

Abstract: Hypotonic microbicidal compositions including an antimicrobial, such as an antiviral compound, and a pharmaceutically acceptable carrier in a solution formulation having hypotonic osmolarity have been developed for administration rectally to the gastrointestinal mucosa. In a preferred embodiment for use in preventing or decreasing HIV infection, the microbicidal is tenofovir, or a prodrug or derivative thereof. The formulations may include additional agents such as surfactants to enhance cleansing, buffers, or preservatives. Polymers may be included for osmolarity as well as comfort.

Abstract: Hypotonic formulations of hydrogel forming polymers, preferably poloxamers, have been developed for enhanced delivery through mucosa of therapeutic, diagnostic, prophylactic or other agents, to epithelial tissues, especially those having a mucosal coating. The polymers are administered at a concentration above, at or less than their critical gelling concentration (CGC) under isotonic conditions. The hypotonicity of the formulation is adjusted so that the polymer gels at the lower concentration. A Poloxamer gel administered into the vagina or colorectum at its CGC will form a “plug” of gel in the lumen.

Abstract: The present invention generally relates to reducing the mucoadhesive properties of a particle. In some embodiments, the particle is coated with and/or associated with a (poly(ethylene glycol))-(poly(propylene oxide))-(poly(ethylene glycol)) triblock copolymer. Methods for preparing inventive particles using a poly(ethylene glycol)-vitamin E conjugate as a surfactant are also provided. In some embodiments, methods are provided comprising administering to a subject a composition of particles of the present invention. Such particles with reduced mucoadhesive properties are useful in delivering agents to mucosal tissues such as oral, ophthalmic, gastrointestinal, nasal, respiratory, and genital mucosal tissues.