Abstract: A method for altering the PK profile of a pharmaceutical formulation containing a PDE-4 inhibitor, such as roflumilast, to reduce the spike in Cmax. The spike in Cmax is reduced by topically administering the PDE-4 inhibitor in combination with one or more phosphate ester surfactants. Reducing the spike in Cmax will reduce gastrointestinal side effects and result in better patient compliance.

Abstract: Film-forming compositions for soft capsule formation have from 2 to 20 percent by weight of a mixture of hydroxyalkylated plant starch and a plant sugar, from 15 to 25 percent by weight agar, no more than 5 percent by weight gelatin, no more than 1 percent by weight carrageenan, and water as the balance thereof. Soft capsules made from such a film-forming composition and methods of making the same are also disclosed.

Abstract: The present invention generally relates to sustained release 4-aminopyridine tablets, which include a core and a coating. The sustained release tablets of the invention are generally suitable for once daily oral administration for the treatment of neurological disorders.

Abstract: The present invention relates to sulfate-free aqueous personal care composition comprising a surfactant system comprising at least one methyl oleoyl taurate, one isethionate and one alkoxylated sulfosuccinate, and from about 0.2 pbw to about 15 pbw of a conditioning agent. It is also directed toward the use of such a composition for washing keratin substrates, in particular the hair or the scalp.

Abstract: The present disclosure provides novel methods for treating or preventing amyotrophic lateral sclerosis (ALS), methods for delaying the onset of neurological symptoms associated with ALS, increasing survival in subjects afflicted with ALS, and attenuating the decline of muscle strength associated with ALS in a subject in need thereof. The present disclosure also provides methods for treating or preventing ?-synucleinopathy or TDP-43 proteinopathy. The methods comprise administering to the subject an effective amount of a mitochondria-targeting peptidomimetic compound, such as (R)-2-amino-N—((S)-1-(((S)-5-amino-1-(3-benzyl-1,2,4-oxadiazol-5-yl)pentyl)amino)-3-(4-hydroxy-2,6-dimethylphenyl)-1-oxopropan-2-yl)-5-guanidinopentanamide, or a pharmaceutically acceptable salt, stereoisomer, tautomer, hydrate, and/or solvate thereof.

Abstract: Described herein are compositions and methods for the treatment of meibomian gland dysfunction. Said methods are performed by administering said composition comprising a selenium disulfide and an anhydrous semi-solid base. The stable anhydrous composition are substantially free of selenium disulfide agglomerates.

Abstract: An improved method is provided for treating a patient having a disorder responsive to PDE-4 inhibition by administering roflumilast. The improvement involves administering the roflumilast topically in a composition having a roflumilast release profile that produces in the patient a flattened plasma concentration time curve and a reduced Cmax relative to oral administration of a PDE4-inhibiting amount of roflumilast. Such disorders include inflammatory disorders such as inflammatory dermatoses, including psoriasis, atopic dermatitis and seborrheic dermatitis. Such disorders also include inflammatory diseases in a variety of organs, especially the lungs (asthma, COPD). Because of reduced side effects with topical administration due to the improved pharmacokinetics (PK) characteristics, it may be possible to provide higher systemic exposures (AUCs) with topical administration, resulting in greater therapeutic efficacy than with the oral route of administration.

Abstract: A method of preparing a pharmaceutical composition having a drug-containing core enclosed by one or more metal oxide materials is provided. The method includes the sequential steps of (a) loading the particles comprising the drug into a reactor, (b) applying a vaporous or gaseous metal precursor to the particles in the reactor, (c) performing one or more pump-purge cycles of the reactor using inert gas, (d) applying a vaporous or gaseous oxidant to the particles in the reactor, and (e) performing one or more pump-purge cycles of the reactor using inert gas. The temperature of the particles does not exceed 35° C. This produces a pharmaceutical composition comprising a drug containing core enclosed by one or more metal oxide materials.

Abstract: A biocompatible material for securing such implantable medical devices, for example by using an adhesive path.

Abstract: A method for altering the PK profile of a pharmaceutical formulation containing a PDE-4 inhibitor, such as roflumilast, to reduce the spike in Cmax. The spike in Cmax is reduced by topically administering the PDE-4 inhibitor in combination with one or more phosphate ester surfactants. Reducing the spike in Cmax will reduce gastrointestinal side effects and result in better patient compliance.

Abstract: The present disclosure provides medical products including an adhesive containing a carboxyalkyl cellulose and sorbitol. Such medical products can find use as a bolster material for use in conjunction with a surgical fastening device such as a stapler. Such adhesives may include advantageous properties such as the ability to retain tack while stored under a peelable cover. Related methods of manufacture and use are also described.

Abstract: Pharmaceutical compositions for and methods of treating an animal, including a human, and methods of preparing such compositions. The pharmaceutical compositions contain nonabsorbable compositions and may be used, for example, to treat diseases or other metabolic conditions in which removal of protons, the conjugate base of a strong acid and/or a strong acid from the gastrointestinal tract would provide physiological benefits such as normalizing serum bicarbonate concentrations and the blood pH in an animal, including a human.

Abstract: This invention relates to a pharmaceutical aerosol product suitable for administration by oral or nasal inhalation and its use in the treatment of respiratory diseases, in particular in the treatment of children. The aerosol composition comprises ciclesonide, ethanol and either 1, 1, 1, 2-tetrafluoroethane, or 1, 1, 1, 2, 3, 3, 3-heptafluoropropane.

Abstract: The present invention regards a method for filling containers with a single-dose composition comprising or, alternatively, consisting of mannitol in powder form. Such process comprises the following steps: a) breaking up a coherent mass of powder mannitol, so as to obtain a broken-up mass from said coherent mass; c) filling a plurality of containers with the broken-up mass of step a), wherein a bulk density of the coherent mass is smaller than a bulk density of the broken-up mass.

Abstract: A synthetic nutritional composition comprising a phospholipid and/or a metabolic precursor and/or metabolite thereof for use to promote, support or optimise de novo myelination, in particular the de novo myelination trajectory, and/or brain structure, and/or brain connectivity, and/or intellectual potential and/or cognitive potential, and/or learning potential and/or cognitive functioning in a subject, in particular a formula fed subject.

Abstract: One embodiment of the present invention is to improve the safety and efficacy of the administration of GHB or a salt thereof to a patient. It has been discovered that the concomitant administration of an MCT inhibitor, such as diclofenac, valproate, or ibuprofen, will affect GHB administration. For example, it has been discovered that diclofenac lowers the effect of GHB in the body, thereby potentially causing an unsafe condition. Furthermore, it has been discovered that valproate increases the effect of GHB on the body, thereby potentially causing an unsafe condition.

Abstract: A method of improving flavor of a combination of a composition for increasing circulating ketone levels is disclosed. A composition containing (D)-?-hydroxybutyric acid (D-BHB), (D)-?-hydroxyvaleric acid (D-BHV), and (D)-1,3 butanediol (D-1,3BD) is disclosed. Exemplary compositions may be incorporated into food, supplement, and beverage products.

Abstract: The present invention provides devices and methods for treating depression in a patient, comprising administering to the patient in need of the treatment a therapeutically effective amount of esketamine. In some embodiments, the depression is major depressive disorder or treatment resistant depression. In other embodiments, the therapeutically effective amount is clinically proven safe and/or effective. Also provided are methods to mitigate the risk or misuse or abuse of esketamine, instructions for use of the esketamine product, and methods for selling a drug product containing esketamine.

Abstract: Enteric softgel capsules comprise a fill material and an enteric shell composition, characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.

Abstract: Disclosed is the use of a water-soluble realgar solid dispersion in the preparation of an erythroid differentiation inducer for bone marrow hematopoietic stem cells and/or bone marrow hematopoietic progenitor cells. The water-soluble realgar solid dispersion is prepared from raw materials comprising 1 part by weight of realgar, 1-20 parts by weight of a polymer, and 0-5 parts by weight of a surfactant. The water-soluble realgar solid dispersion can induce bone marrow hematopoietic stem and/or progenitor cells to be differentiated into red blood cells, promote the accumulation of red blood cells in bone marrow cells, effectively alleviate the decrease in the number of red blood cells caused by the suppression of the erythroid differentiation of bone marrow hematopoietic stem and/or progenitor cells, improve anemia caused by hematopoietic failure, and protect bone marrow cells from the killing effect.