Abstract: Provided herein are oral dosage forms comprising a) a core tablet comprising (i) a drug layer comprising apremilast and hypromellose acetate succinate (HPMCAS) in an amorphous solid dispersion; and (ii) a swellable layer comprising one or more swellable polymers; and b) a coating layer disposed on the core tablet, wherein the oral dosage form surface comprises at least one drug release orifice. The disclosed oral dosage forms provide once-a-day dosing of apremilast and are suitable for treating diseases or disorders ameliorated by inhibiting phosphodiesterase subtype IV (PDE4).

Abstract: Described herein are methods for the administration of reboxetine, or a pharmaceutically acceptable salt thereof, to a human being in need thereof, resulting in a first maximum plasma concentration and a second maximum plasma concentration, wherein the two maxima are separated by a time period of about 2 hours to about 6 hours.

Abstract: The present disclosure relates to solid oral dosage forms comprising lumateperone, in free, or pharmaceutically acceptable salt form, optionally in combination with one or more additional therapeutic agents, processes for manufacture thereof and methods of use in the treatment or prophylaxis of disease.

Abstract: Disclosed are Self-Gelling materials and structures or materials or structures having one or more self-gelling components that overcome existing gel limitations due to hydrogel localization for medical applications by providing, for example, 1) microstructurally, or physically, anchored characteristics to help localize the gel, and the overall printed, or otherwise formed structure, giving structural form to the gel that allows the gel to be localized within the body, and even sutured in place, and mitigates gel migration and extends its residence time; 2) to provide an underlying 3D printed structure to help contain and support the gel after implantation; and more. Self-Gelling 3D printed structures may be further processed via milling to yield deconstructed scaffold micro-granules, with the composition and nano-/micro-structure of the original larger structure.

Abstract: Disclosed are compositions and methods of making basement membrane constructs having interior or luminal volumes. The interior or luminal volumes may be in the form of vascular networks for liquid (e.g., blood) or gas perfusion. The interior spaces may also contain cells, such as epithelial cells. Also disclosed are tissues and organs, and methods of making thereof, comprising basement membrane constructs.

Abstract: A 12-hour anti-tussive modified release solid tablet or tablet-in-capsule is described which comprises a benzonatate-silicon dioxide adsorbate powder in a hydrophilic matrix to provide a 12-hour modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 1% release of the benzonatate within half an hour as determined in an in vitro dissolution assay.

Abstract: The present disclosure relates to injectable compositions sterile injectable fluid compositions comprising a polysaccharide having a color in the visible spectrum, methods of forming the same, kits containing the same, and methods for performing agent-assisted procedures in a patient using the same.

Abstract: A method for treating or reducing a likelihood of hypoxia-ischemia induced brain damage and neurobehavioral dysfunction in neonates utilizes a relative high dose of nasally administered insulin. In one aspect, the method includes intranasally administering, to a neonate in need thereof, an effective dose of insulin comprising between 350 U to 2000 U insulin.

Abstract: The present disclosure relates to a two-component hair care agent including, separately from one another, an anhydrous carrier as a first component and, as a second component, an aqueous carrier. The anhydrous carrier includes a branched or unbranched alkane having a chain length of C10 to C30, a branched or unbranched fatty alcohol having a chain length of C8 to C22, an organic acid or an alkalizing agent and a pH sensitive color indicator. The aqueous carrier includes a cationic surfactant comprising an organic radical having a chain length of C12 to C30. In addition, the present disclosure relates to a method for the production of a cosmetic agent in which the first component and the second component are mixed together and the use of the two-component hair care agent for the care of keratinic fibers, in particular human hair.

Abstract: The present invention is directed to a co-processed lubricant excipient which can be used to manufacture tablets, and pharmaceutical compositions containing the same.

Abstract: This disclosure relates to dosage forms comprising bupropion hydrochloride, another salt form of bupropion, or the free base form of bupropion; dextromethorphan hydrobromide, another salt form of dextromethorphan, or the free base form of dextromethorphan, and a polymer. In some embodiments, the dosage form has no significant dose dumping of bupropion in the presence of ethanol in vitro. In some embodiments, the dosage form does not have a food effect for bupropion or dextromethorphan when taken with a high-fat meal in human subjects. Some embodiments include a method of treating a nervous system condition (such as depression, e.g.

Abstract: A transdermal delivery apparatus for delivering specific desired quantities of cream-base medicament or any flowable composition is disclosed. The apparatus comprises a revolving platform, a threaded screw-complex, a house, an applicator pad, and a safety cap. The revolving platform produces audible and tactile sensations upon interaction with projections from the house. The threaded screw-complex interacts with an elevator to transport the medicament upwards. The house confines an inner chamber to store the medicament. The applicator pad comprises a center outlet where the composition exits the chamber.

Abstract: A modified release benzonatate solid tablet or capsule is described which comprises a benzonatate adsorbate in a matrix with a sufficient amount of one or more pharmaceutically acceptable modified release pH-independent, substances to provide a modified release profile to the benzonatate, wherein there is substantially no benzonatate release from the tablet or capsule in the buccal cavity and no more than about 25% release of the benzonatate within 1 hour as determined in an in vitro dissolution assay.

Abstract: The present disclosure relates to a method for providing information for determining lung tumor through inhalation of a fluorescent contrast agent, more particularly to a method of inhaling a small amount of Indocyanine green. The present disclosure does not have the problem of the existing intravenous injection that the administered fluorescent contrast agent is distributed throughout the body. In addition, when comparing the cancer detection efficiency of inhalation administration and intravenous injection, the inhaled fluorescent contrast agent exhibits remarkably higher cancer detection effect than the intravenously injected fluorescent contrast agent.

Abstract: Methods and products for treating a subject diagnosed with an autism spectrum disorder, an intellectual disability, an anxiety disorder, a mood disorder, a disorder of social interaction, irritability, aggression, self-injurious behavior, hyperactivity, inattention, or Fragile X syndrome or brain neuroinflammation by administering a tablet or liquid or a solid ODT or ODF or SMEDDS containing a ticagrelor or ticagrelor salt or combination with a second agent which may include a magnesium ion containing-compound, a zinc ion containing-compound, a lysine or lysine salt, an arginine or arginine salt, lecithin, or a combination thereof, wherein the ODT or ODF or SMEDDS releases >50% of the ticagrelor or a pharmaceutically acceptable salt thereof and >50% of the second agent within 15 minutes.

Abstract: The invention relates to microbubble complexes for use in methods of sonodynamic therapy which comprise a microbubble attached to or otherwise associated with one or more linking groups, each linking group being bound to at least one sonosensitising agent and at least one chemotherapeutic agent. It further relates to the microbubble complexes themselves and to pharmaceutical compositions which contain them. The invention is particularly suitable for the treatment of deep-sited tumors, in particular pancreatic cancer.

Abstract: The invention provides materials presenting a biologically active matrix comprising a physiological fibrillar fibronectin network, such as implantable constructs, and their use for modulating cell behaviour and fate, including cell growth, proliferation and/or differentiation, such as for promoting tissue regeneration, for example, bone regeneration or vascularization. Also provided are constructs presenting a biologically active matrix comprising a physiological fibrillar fibronectin network for sustaining growth of stem cells or maintaining stem cells (maintaining stemness).

Abstract: A bone void filler preparation system that includes a processing vessel, a processing piston, a bone void filler preparation container and tubing. The processing vessel has a recess formed therein. The processing vessel is adapted to receive bone marrow aspirate. The processing piston includes an outer wall, a central wall member and a connection port. The outer wall has an upper edge and a lower edge. The central wall member extends inwardly from the outer wall intermediate the upper and lower edges of the processing piston. The central wall member has an aperture formed therein. The central wall member has a downwardly directed portion that defines an air-retaining region. The air-retaining region is closer to the outer wall upper edge than the aperture. The connection port is operably connected to the aperture. The processing piston is movable in the processing vessel recess. The bone void filler preparation container has an inlet portion and an outlet port.

Abstract: A novel orally administrable dosage form including a drug/active layer for loading a therapeutic agent and an extension layer for retaining the API or drug dosage form in the stomach of a subject in need thereof. Also disclosed is a method of treating diseases with the dosage form.

Abstract: A composition of a drug carrier, a pharmaceutical composition thereof, a preparation method and a use method thereof are provided. The composition of a drug carrier includes a first mixture and a second mixture. The first mixture includes a hydrophilic polymer, tricalcium phosphate and a water-soluble dispersant. The second mixture includes a water-absorbing material and a divalent cation salt. The pharmaceutical composition includes the composition of a drug carrier above and a drug for preparing an anti-inflammatory or antibiotic medicine. The preparation method of the composition of a drug carrier includes mixing the first mixture and the second mixture. The use method of the composition of a drug carrier includes mixing the first mixture with a drug and then adding the second mixture. Accordingly, topically applying the pharmaceutical composition on a surgical site may effectively release the drug thereon.