Abstract: The present invention relates to preparation of biodegradable microparticles formed from polylactide-polyglycolide copolymers (PLGA) polymer and how to achieve sigmoidal release of active pharmaceutical compound from the microparticles. In particular, the present invention relates to emulsification of an inner/oil phase to an outer/water phase followed by quenching and a single drying step for the preparation of microparticles having a preferred release profile of preferably basic/nucleophilic compounds such as risperidone. Alternatively the present invention is also suitable for hydrophobic compounds that have poor water-solubility and a high drug loading of >20% w/w is required. The release profile can be controlled by adjusting the degree of saturation of the outer/water phase with the organic solvent used in the inner/oil phase, the polymer concentration of the inner/oil phase and the temperature at the quenching step.

Abstract: The present invention relates to compressed tablets for peroral delivery of the cannabinoid cannabidiol (CBD). More particularly, the invention provides a compressed tablet having a tablet weight of 60-1200 mg, said tablet being composed of: •50-95 wt. % of a granulate; •5-50 wt. % of lactose; and •0-30 wt. % of other tablet excipients; wherein the granulate contains: a.2-15 wt. % of cannabidiol; b.2-30 wt. % of sucrose fatty acid mono-ester; c.30-96 wt. % of lactose; and d.0-25 wt. % of other granulate excipients. The compressed tablets according to the invention can conveniently be used in the treatment of psychosis disorders or anxiety disorders. The invention further provides a method for the manufacture of the compressed tablets.

Abstract: Compositions and methods to improve the pharmacokinetic profile of S-Adenosylmethionine (SAMe) are provided, as are methods of treating various disorders using SAMe formulations with improved pharmacokinetic profiles. More specifically, the invention is directed to methods of treating a disease or disorder in a subject and/or improving the nutritional status of a subject by administering formulations exhibiting improved pharmacokinetic profiles of exogenous SAMe. The method also includes the step of orally administering compositions of the invention to the subject once per day after overnight fast; that is prior to food intake in the morning.

Abstract: Method for the realization Hof a calcium phosphate-based biomaterial in form of granules and/or agglomerates of re-absorbable granules which can be used in the biomedical industry as, e.g., bone fillers, for increasing the bone mass, as a sealing for the internal orthopaedic prosthesis, for releasing drugs and/or medicaments and/or other substances beneficial for the organism. A calcium phosphate-based biomaterial in form of granules and/or aggregates thereof obtained according to such method.

Abstract: Provided is a sustained-release preparation containing pioglitazone or a salt thereof as an active ingredient and showing superior sustainability. A sustained-release preparation containing pioglitazone or a salt thereof, which shows a dissolution ratio of pioglitazone of average 25-58% at the 2-hour time point, and average 60-100% at the 4-hour time point, in a dissolution test according to the 50 rpm USP Paddle Method and using pH 2.0 KCl/HCl buffer at 37° C. as a test solution.

Abstract: Methods and compositions are provided for increasing the anaerobic working capacity of muscle and other tissues. Also provided are compositions formulated for the sustained release of free beta-alanine. Also provided is a dietary supplement formulated, for example, as a solid food product, an edible suspension, liquid or semi-liquid as described herein.

Abstract: Discrete micro and nanoscale particles are formed in predetermined shapes and sizes and predetermined size dispersions. The particles can also be attached to a film to form arrays of particles on a film. The particles are formed from molding techniques that can include high throughput and continuous particle molding.

Abstract: The present invention relates to mixed crystals comprising a) leavening agent and b) 0.1 to 5000 ppm by weight of crystallization aid, based on the total amount of the leavening agent, in the form of at least polymer, wherein when hydrophilic cellulose derivatives are used as crystallization aid, the amount thereof is reduced to less than 100 ppm by weight, based on the total amount of the leavening agent. The present invention further relates to the production of the mixed crystals and to the use thereof in the production of bakery products, as acid regulator in foods, in the production of cosmetics products, in the synthesis and formulation of pharmaceutical products, and also as blowing agent in industrial processes such as, for example, the production of foam rubber, or for fire-extinguishing formulations. The present invention relates, furthermore, to the production of bakery products.

Abstract: An oral product includes a body that is wholly receivable in an oral cavity. The body includes a mouth-stable polymer matrix, cellulosic fibers embedded in the mouth-stable polymer matrix, and an additive dispersed in the mouth-stable polymer matrix. The oral product is adapted to release the additive from the body when the body is received within the oral cavity and exposed to saliva.

Abstract: The present invention provides an orally disintegrating solid pharmaceutical dosage unit having a weight of 50-1,000 mg and containing at least 0.1 mg of an estetrol component selected from estetrol, estetrol esters and combinations thereof. This solid dosage unit consists of: 4-95 wt. % of granules consisting of: 3-80 wt. % of an estetrol component selected from estetrol, estetrol esters and combinations thereof; 20-97 wt. % C4-C12 sugar alcohol; 0-45 wt. % of one or more other pharmaceutically acceptable ingredients; and 5-96 wt. % of one or more pharmaceutically acceptable excipients. The solid dosage units of the present invention are particularly suited for sublingual, buccal or sublabial administration of the estetrol component.

Abstract: The presently disclosed subject matter describes the use of fluorinated elastomer-based materials, in particular perfluoropolyether (PFPE)-based materials, in high-resolution soft or imprint lithographic applications, such as micro- and nanoscale replica molding, and the first nano-contact molding of organic materials to generate high fidelity features using an elastomeric mold. Accordingly, the presently disclosed subject matter describes a method for producing free-standing, isolated nanostructures of any shape using soft or imprint lithography technique.

Abstract: A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.

Abstract: The invention relates to a new process for the production and/or purification of the salt of the compound (S)-2-[4-(2-fluorobenzyloxy) benzylamino]propanamide, i.e. ralfinamide, or the respective R-enantiomer, with methane sulfonic acid in high yields and very high enantiomeric and chemical purity in the form of the crystalline anhydrous polymorph identified as form A, wherein said salt is substantially free from impurities having genotoxic effect, such as (C1-C5)alkanylmethanesulfonates, and residual solvents known as potential precursors thereof, such as (C1-C5)alkanols or esters thereof with lower alkanoic acids.

Abstract: Provided herein are pharmaceutical formulations of dry-powder bendamustine suitable for pharmaceutical use. Also provided are methods of producing dry-powder bendamustine. The pharmaceutical formulations can be used for any disease that is sensitive to treatment with bendamustine, such as neoplastic diseases.

Abstract: The invention relates to developing a novel water and capsule formulation using fenofibrate which is difficult to dissolve and control its release rate in vitro. For example, the invention relates to the creation of capsules and wafers comprising: fenofibrate, a surfactant, a carrier wax, a film former, a plasticizer, and optionally a super disintegrant or other ingredients. The invention further relates to the process of forming such capsules and wafers.

Abstract: Use of a moulding composition comprising a polymer and a setting agent for wound debridement, wherein said use comprises adding water to said moulding composition to form a moulding fluid, applying said moulding fluid to a surface of a wound, allowing said moulding fluid to set in contact with said surface to form a solid covering on said surface, followed by removing said solid covering from the wound. The alginate composition adheres strongly to bacterial biofilms on the wound, whereby the biofilms are removed with the alginate composition. The moulding composition may be used in conjunction with a staining agent that undergoes a color change in the presence of bacteria or bacterial polysaccharides to show the presence and removal of the biofilm. Also provided are methods of treating wounds using the compositions.

Abstract: This invention relates to a method of improving CNS maturation in an infant by administering a mixture of natural tocopherols, wherein the composition contains an optimum tocopherol profile similar to that found in human breast milk, and can encompass a tocopherol profile from early stage to transitional to mature human breast milk. For ease of administration and maximized efficacy, the optimized mixture of natural tocopherols are typically delivered in an oral dosage form with a limited level of non-RRR alpha-tocopherols to maximize efficacy of the RRR alpha-tocopherol on stimulating post-natal CNS development.

Abstract: A metal nanoparticles-doped porous carbon bead having an average size of about 0.4 millimeter (mm) to about 0.6 mm is provided. The metal nanoparticles-doped porous carbon bead is doped with silver, copper, or combinations thereof.

Abstract: Systems and methods provide sugar alcohol to heat stressed ruminants to improve performance. During periods of high temperature or humidity, heat stressed ruminants may exhibit decreased dry matter intake, and in response, an effective amount of sugar alcohol such as sorbitol may be provided in the ruminant diet to cause performance to increase, which may include increased milk yield, improved feed efficiency or both compared to heat stressed dairy cattle without sugar alcohol in the diet.

Abstract: The disclosure provides polymers having antimicrobial activity and articles with the polymers coated thereon. The polymers include a first pendant group comprising a first cationic component, a second pendant group comprising a nonpolar component, and a third pendant group comprising an organosilane component. The disclosure also includes methods of coating medical device articles and body fluid-receiving substrates with the antimicrobial polymers. The methods further include the use of adhesion-promoting components.