Abstract: Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.

Abstract: Disclosed herein are nutraceutical compositions comprising or consisting essentially of one or more types of polyphenols (e.g., a green tea polyphenol) and one or more types of reactive oxygen species, and methods for their use to treat gastrointestinal conditions, inflammatory conditions, and immune conditions.

Abstract: Controlled-release therapeutic compositions including melatonin combined with sedative and/or analgesic ingredients are described. The compositions have a solid core including melatonin in an acidified polymeric matrix. A sedative ingredient such as GABA receptor agonist may also be in the acidified polymeric matrix. The composition may include an expedited release portion providing a burst release of active ingredients and a sustained release portion providing a sustained release of active ingredients.

Abstract: Therapeutic compositions deliver a therapeutic amount of methylphenidate in a delayed and extended release formulation. The dosage form exhibits a lag time prior to release of from 6 to 8 hours or longer, followed by a sustained release period.

Abstract: The present invention primarily concerns the use of 2,3,6-trimethylcyclohexanol as a fragrance and/or flavoring. The invention also concerns new fragrance and/or flavoring compositions comprising 2,3,6-trimethylcyclohexanol and their use, perfumed and/or flavored articles comprising 2,3,6-trimethylcyclohexanol and various methods for imparting, modifying and/or enhancing certain scent and/or flavor notes.

Abstract: An object of the present invention is to provide an orally disintegrating tablet (super-rapid disintegrating tablet) that is heavy and relatively thin, and has an extremely high disintegrability (short disintegration time), and a high tablet hardness, and to provide a simple method for the production of said super-rapid disintegrating tablet without such a complicated process as freeze-drying. This invention relates to an orally disintegrating tablet having a specific surface area of from 1.50 to 4.00 mm2/mg and a weight of from 100 to 300 mg, particularly having a disintegration time in water of 7 seconds or less and an oral disintegration time of 6 seconds or less, a method for the production of said orally disintegrating tablet, and to a disintegrative particulate composition for use in said method.

Abstract: A chewing gum composition comprising cannabinoids or derivatives thereof and nicotine in the form of nicotine polacrilex is provided. The chewing gum composition is formulated to provide rapid and controlled release of cannabinoids and nicotine during chewing. Methods to provide tobacco and/or cannabis smoking cessation using the chewing gum composition according to this invention are also provided.

Abstract: The present application discloses modified release mucoadhesive formulations of mycophenolate mofetil and pharmaceutical compositions thereof useful in the treatment of, for example, post-transplant organ rejection. Method of preparing the formulations is also disclosed.

Abstract: The present invention relates to a composition comprising curcuminoid with green tea polyphenol or with a combination of glycine, proline and hydroxyproline for use in preventing or treating osteoarthritis. It also relates to a method of preventing or treating osteoarthritis in mammals, the method comprising administering to said mammal a composition which comprises curcuminoid with green tea polyphenol or with a combination of glycine, proline and hydroxyproline.

Abstract: Provided are HPMCAS powder having high solubility when dissolved in a solvent and being capable of suppressing generation of undissolved materials; and a method for producing the powder. More specifically, provided is hypromellose acetate succinate powder having an average ratio of L to D of from 2.0 to 3.0, wherein L and D mean maximum and minimum diameters of each particle, respectively. Also provided is a method for producing a hypromellose acetate succinate, comprising the steps of: dissolving hypromellose powder in a solvent, esterifying the dissolved hypromellose with succinic anhydride and acetic anhydride in the presence of a catalyst to obtain a reaction mixture, and mixing the reaction mixture with water to precipitate hypromellose acetate succinate, wherein the reaction mixture just before being mixed with the water has a viscosity of from 100 to 200 Pa·s.

Abstract: The disclosure provides dermal patch formulations that include a pharmaceutically active agent, such as one or more cannabinoids. The formulations can include dihydromyricetin for the purpose of increasing the flux of the pharmaceutical agent into human skin.

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: Methods of reducing gingivitis and plaque buildup by administering an oral care product (a dentifrice or a mouthwash) that consists essentially of a sea salt, preferably Dead Sea salt, and xylitol. In mouthwash and dentifrice embodiments, the oral care product contains aloe vera leaf juice.

Abstract: Oral care compositions consisting essentially of a Sea Salt, at least one essential oil, xylitol, and preferably, aloe vera juice and uses of such compositions to whiten teeth, reduce sensitivity of teeth/gums, and reduce xerostomia. In preferred embodiments directed to teeth whitening and xerostomia, the compositions also include coconut oil. Delivery systems for whitening teeth comprised of a strip formed be combining (i) one or a combination of teeth whitening ingredients selected from Dead Sea Salt, Cocos Nucifera (Coconut) Oil, Citrus Limon (Lemon) Peel Oil, and Salvia Officinalis (Sage) Oil and (ii) one or more gelling/thickening agents, wherein the strip is conformable to teeth surfaces and to interstitial spaces between teeth, without permanent deformation thereof, and is removably attached to a release liner. The strips may also contain one or more peroxides, metal chlorites, perborates, percarbonates, and peroxyacids.

Abstract: Formulations for oral transmucosal compositions that include aromatase inhibitors (AIs) in combination with transmucosal absorption enhancers are disclosed. Disclosed oral transmucosal compositions may be for immediate release or slow release, and may be administered to increase bloodstream testosterone levels and thereby reduce symptoms of testosterone deficiency. Disclosed oral transmucosal compositions may include liquid dosage forms, solid dosage forms, and chewing gums. Further dosage forms may include mucoadhesive thin strips, thin films, tablets, patches, and tapes, among others. Other dosage forms may be: mucoadhesive liquids such as gel-forming liquid; gel-forming; semisolids; and gel-forming powders, among other dosage forms that exhibit mucoadhesive properties, and provide oral transmucosal delivery of AIs. Disclosed oral transmucosal compositions may allow the delivery of AIs directly into the patient's bloodstream, thus providing high bioavailability of AIs; therefore, required dose may be lower.

Abstract: Disclosed herein are dentifrices comprising a zinc amino acid halide, which provide a precipitate of zinc oxide upon use with dilution with water and/or saliva. Methods of making and using the dentifrices are also provided.

Abstract: This disclosure describes a chewing gum composition comprising polyhexanide for the treatment and/or prevention of an infectious disease in the oral cavity. The present disclosure also describes a chewing gum composition formulated for the controlled release of polyhexanide and optionally, at least one additional water-soluble antiseptic agent.

Abstract: Compositions are disclosed herein that comprise a mixture of at least one Albizia extract and a Magnolia extract. In some embodiments, the composition comprises a mixture of at least one Albizia extract enriched for one or more macrocyclic alkaloids and at least one Magnolia extract enrich for one or more lignans.

Abstract: Provided herein are methods for treating a pulmonary infection in a patient in need thereof, for example, a nontuberculous mycobacterial pulmonary infection for at least one treatment cycle. The method comprises administering to the lungs of the patient a pharmaceutical composition comprising a liposomal complexed aminoglycoside comprising a lipid component comprising electrically neutral lipids and an aminoglycoside. Administration comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free aminoglycoside and liposomal complexed aminoglycoside, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient. The methods provided herein result in a change from baseline on the semi-quantitative scale for mycobacterial culture for a treated patient, and/or NTM culture conversion to negative during or after the administration period.

Abstract: An oral melatonin pharmaceutical dosage form that contains a sustained release dose of melatonin includes melatonin and an acid dispersed in a hydrogel-forming polymer matrix that combine after ingestion to form an acidic hydrogel containing the melatonin.