Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

Abstract: One aspect of the present invention is directed to a composition. The composition includes a dispersion inducer comprising: H3C—(CH2)n—CHmCHmR, where is a single or double carbon-carbon bond, m is 1 or 2, n is 2 to 15, and R is a carboxylic acid, a salt, an ester, or an amide, where the ester or amide is an isostere or biostere of the carboxylic acid. The composition additionally contains an additive component selected from one or more of the group consisting of biocides, surfactants, antibiotics, antiseptics, detergents, chelating agents, virulence factor inhibitors, gels, polymers, pastes, edible products, and chewable products. The composition is formulated so that when it is contacted with a biofilm produced by a microorganism, where the biofilm comprises a matrix and microorganism on a surface, the dispersion inducer selectively acts on the microorganism and has a suitable biological response without a required direct effect on the matrix to disperse the biofilm.

Abstract: In one aspect, topical pharmaceutical compositions for treating a skin condition or disorder are provided. In some embodiments, the topical pharmaceutical composition is formulated as a lotion and comprises a therapeutically effective amount of an active agent; a viscosity increasing agent; a polymeric emulsifier; and an oil component. In some embodiments, the topical pharmaceutical composition comprises tretinoin.

Abstract: Compositions and methods are provided for enhancing the expression of human beta defensin 2 (HBD2) in human colon epithelium cells. The method comprises orally administering a composition comprising hyaluronan, where said hyaluronan has a molecular weight within the range of about 35 kDa.

Abstract: The present invention is directed to a liposome composition for use in the peritoneal dialysis of patients suffering from endogenous or exogenous toxicopathies, wherein the pH within the liposomes differs from the pH in the intraperitoneal cavity and wherein the pH within the liposome results in a liposome-encapsulated charged toxin. The invention also relates to a pharmaceutical composition comprising said liposomes. A further aspect of the present invention relates to a method of treating patients suffering from endogenous or exogenous toxicopathies, preferably selected from drug, metabolite, pesticide, insecticide, toxin, and chemical warfare toxicopathies, more preferably hyperammonemia, comprising the step of administering liposomes of the invention in a therapeutically effective amount into the peritoneal space of a patient in need thereof. Next to human, the present invention is particularly suitable to veterinary aspects.

Abstract: The present invention provides methods and compositions for treating chemotherapy-induced cognitive impairment. One embodiment of the present invention is directed to a method of treating chemotherapy-induced cognitive impairment by administering to a patient in need at least one thiosemicarbazone compound.

Abstract: Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

Abstract: A biological tissue adhesive composition is provided. The biological tissue adhesive composition comprises one or more macromolecules grafted with at least one catechol moiety and comprising at least one cross-linkable functional group, a first cross-linker for cross-linking the at least one catechol moiety, wherein the first cross-linker comprises or consists or a multivalent metal ion, and a second cross-linker for covalently cross-linking the at least one cross-linkable functional group, wherein the one or more macromolecules are cross-linked by (a) complex formation between the at least one catechol moiety and the multivalent metal ion, and (b) covalent bonding of the at least one cross-linkable functional group with the second cross-linker. Fabrication method and working principle of a biological tissue adhesive composition are also provided.

Abstract: The present invention relates to the use of compositions comprising trans-clomiphene for treating men with hypogonadism. The invention is also directed to methods for treating males with hypogonadism.

Abstract: A bone graft composition includes a biologically-resorbable cement and a plurality of processed bone particles, where each of the bone particles have a shape configured to interconnect with adjacent bone particles. A method for treating a bone defect using the bone graft compositions includes providing the bone graft composition and administering an effective amount of the bone graft composition to a site of a bone defect in a subject. Kits including a biologically-resorbable cement powder and a plurality of processed bone particles are also provided.

Abstract: According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

Abstract: A medical device material impregnated with a combination of antimicrobial agents, the combination of antimicrobial agents comprising a first antimicrobial agent, the first antimicrobial agent being triclosan and at least a second antimicrobial agent, wherein the combination of antimicrobial agents provides the device material with antimicrobial activity and inhibition of resistant microbial mutations for of the order of, or greater than, 80 days.

Abstract: A system and method includes delivery of a redox gas solution to treat onychomycosis, wherein the redox gas solution comprises a reactive species dissolved in a perfluorocarbon liquid, and wherein the perfluorocarbon liquid is dispensed onto a gas-permeable membrane and the perfluorocarbon liquid comprises of an anti-inflammatory in a perfluorocarbon liquid and wherein the reactive species may include, alone or in combination, one or more of reactive oxygen, reactive nitrogen, reactive chlorine, or reactive bromine species, and the perfluorocarbon liquid may include perfluorodecalin.

Abstract: In one aspect, pharmaceutical compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises digitally inserting into the lower third of the vagina of a subject having VVA a soft gelatin capsule containing a liquid pharmaceutical composition.

Abstract: In one aspect, compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises administering an estrogen to a subject having VVA by inserting a dosage form comprising a liquid pharmaceutical composition.

Abstract: The present invention is directed toward respirable dry powders and particles for systemic delivery of pharmaceutically active agents or delivery to the respiratory tract. The dry powders contain one or more monovalent metal cations (such as Na+), are small and dispersible.

Abstract: A process for producing a pharmaceutical lozenge formulation comprising the steps of: (a) providing a liquid composition comprising a salt of a non-steroidal anti-inflammatory drug (NSAID salt) and a solvent system, (b) providing a molten lozenge-forming composition, (c) mixing the liquid composition with the molten lozenge-forming composition, and, (d) forming the resulting mixture into lozenges each containing a therapeutically effective amount of said NSAID salt/NSAID mixture. The present application discloses the corresponding NSAID-containing lozenge compositions and their use for the manufacture of a medicament for treating sore throat.

Abstract: Iontophoresis, a minimally-invasive methodology that uses a weak electric current to enhance penetration of ionized molecules into tissues, was found to be an effective technique for the intraocular delivery of large bioactive molecules, specifically lutein.

Abstract: Compositions are provided comprising a balance between lysine and essential amino acids and metabolizable energy. The compositions are useful in methods to prevent or treat obesity in an animal without concomitant loss of lean muscle mass. The compositions may also be used in methods to preserve or to cause a gain in lean muscle mass in an animal in need thereof.