Abstract: The present invention relates to solid dispersions including, but not limited to, co-processed carbohydrates with different solubilities and concentrations, which have a microcrystalline plate structure. The solid dispersions, excipient systems and formulations of the present invention are highly compactable and durable and when compressed into solid dosage forms demonstrate uniform densification, low friability at low pressures, and and/or relatively constant low disintegration times at various hardnesses. The solid dosage forms of the present invention demonstrate superior organoleptics, disintegration, and/or robustness.

Abstract: Described herein are compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic. Also described are lyophilized compositions of antibodies and carrier proteins and methods of making and using the same, in particular, as a cancer therapeutic.

Abstract: A method of treating, reducing, or alleviating a medical condition in a patient is disclosed herein. The method includes administering to a patient in need thereof a biocompatible drug comprising one or more antiviral medications together with one or more cell pathway inhibitors, the patient having at least one of a respiratory tract inflammatory disease, a central nervous system inflammatory disease, and vasculitis. The one or more antiviral medications preventing an attachment of viruses to cell walls, blocking a penetration of the viruses into cells, and/or inhibiting virus replication by damaging nucleic acids of the viruses. The one or more cell pathway inhibitors blocking an inflammatory response of inflamed tissue without inhibiting an immune response of the patient.

Abstract: The present invention relates to anti-inflammatory drug formulation. Especially, this invention relates to corticosteroid prodrug nanoparticle. In a first aspect, this invention relates to a nanoparticle comprising a therapeutic agent and a surface coating material. The invention also relates to a process of manufacturing at least one nanoparticle of invention. The invention also relates to pharmaceutical composition and pharmaceutical kits.

Abstract: Formulations are described, containing silibinin or other active ingredients incorporated in lipid nanoparticle systems of the SLN and NLC type, and based on calixarenes, possibly mucoadhesive, or in micellar and nanoparticle systems based on amphiphilic inulin copolymers for use in the treatment of neurodegenerative ocular diseases. The versatility of the calixarene compound is also described, capable of charging and releasing active ingredients characterized by low water solubility, easy chemical and enzymatic degradation, low bioavailability, either of natural origin or not, to be used in the treatment of ocular diseases.

Abstract: The present invention provides a solid preparation comprising, based on 100 parts by weight of the solid preparation, a self-emulsifying composition comprising 0.1 to 0.5 parts by weight of dutasteride, 6 to 110 parts by weight of oil and 6 to 110 parts by weight of a surfactant, and 5 to 185 parts by weight of a coating excipient having pores accommodating the self-emulsifying composition formed in a surface thereof, and a method of manufacturing the solid preparation.

Abstract: Among other aspects, provided herein are multi-arm polymeric prodrug conjugates of pemetrexed-based compounds. Methods of preparing such conjugates as well as methods of administering the conjugates are also provided. Upon administration to a patient, release of the pemetrexed-based compound is achieved.

Abstract: Provided is a microsphere comprising a bead coated with a first calcium-containing mineral. Also provided is a method of producing a microsphere. Additionally, a method of administering a compound to a vertebrate is provided.

Abstract: A fibrous birth tissue composition fabricated from placental tissue is provided. Methods of processing a mammal's placental tissue to form a fibrous birth tissue composition are provided. Regenerative methods are also provided.

Abstract: Medical instrument includes a substrate, in which cells are in contact with or held on a surface of the substrate, and at least the surface of the substrate which holds the cells is formed of a fluorine-containing cyclic olefin polymer which contains a repeating structure unit represented by Formula (1), wherein in Formula (1), at least one of R1 to R4 is fluorine, an alkyl with 1 to 10 carbon atoms which contains fluorine, an alkoxy with 1 to 10 carbon atoms which contains fluorine, or an alkoxyalkyl with 2 to 10 carbon atoms which contains fluorine, R1 to R4 are selected from hydrogen and certain non-fluorinated groups when R1 to R4 do not contain fluorine, R1 to R4 may be the same as or different from each other, and R1 to R4 may be bonded to each other to form a cyclic structure.

Abstract: This patent includes a method for utilizing imaging biomarkers to improve pharmacologic dosing strategies. Specifically, biomarker specific CT and MM examination protocols are disclosed. Dose adjustments based on imaging biomarkers are discussed. Longitudinal analysis of imaging biomarkers is disclosed assess effectiveness of pharmacotherapy and dosing strategies thereof. Finally, manufacturing of a combination pill with day-to-day variations of drug quantities is disclosed.

Abstract: Provided are stem cell biomimetic microparticles comprised of at least one stem cell-derived paracrine polypeptide or growth factor embedded in a polymer core particle that further comprises an outer layer of at least one fragment of a cell membrane of a stem cell disposed on the core particle. The polymer core may be constituted of any biocompatible and biodegradable polymer or copolymer, or a combination thereof that allows the embedding of the paracrine factors and their prolonged release from the core. The core and hence the microparticles can be biodegradable, allowing eventual elimination from the recipient animal or human subject. The core particles are sized to allow both transport through blood vessels and extravasation from the blood vessels into the surrounding tissues. The core particle may further include at least one polypeptide or peptide growth factor to induce the generation and proliferation of a population of stem cells.

Abstract: This invention relates to high drug load compositions of medium chain triglycerides (MCT), and to methods for treatment with such compositions at amounts effective to elevate ketone body concentrations so as to treat conditions associated with reduced neuronal metabolism, for example Alzheimer's disease.

Abstract: Disclosed herein, inter alia, are compositions and methods of modulating macrophage activity. Provided is a method of treating a disease (e.g., a macrophage-associated disease, autoimmune disease, inflammatory disease, or a cancer of an organ in the intraperitoneal cavity), the method including intraperitoneally administering to a subject in need thereof a therapeutically effective amount of a nanoparticle composition or pharmaceutical composition. Provided is a silica nanoparticle non-covalently bound to a plurality of nucleic acids, wherein the silica nanoparticle has a net positive charge in the absence of the plurality of nucleic acids. Provided is a pharmaceutical composition including a nanoparticle composition as described herein, and a pharmaceutically acceptable excipient.

Abstract: The present disclosure provides a coacervate composition containing a protein drug, gelatin A, sodium alginate and an acid and a wound-healing agent including the same. The coacervate composition according to the present disclosure can be useful as a wound-healing material delivery system for effectively delivering a protein drug, particularly epidermal growth factor, to a wound site in the wound-healing field.

Abstract: A pharmaceutical composition containing a mixed polymeric micelle and a drug enclosed in the micelle, in which the mixed polymeric micelle, 1 to 1000 nm in size, includes an amphiphilic block copolymer and a lipopolymer. Also disclosed are preparation of the pharmaceutical composition and use thereof for treating cancer.

Abstract: It is provided a pharmaceutical composition comprising 3-beta-hydroxy-5-alpha-pregnan-20-one, at least one sterol or an ester thereof and a mixture of acylglycerols with a solid fat content of less than 25% at 25° C. and 0% at 37° C. In addition it is provided a method for preparing the pharmaceutical composition.

Abstract: Provided are methods and compositions to target delivery of cells to a tissue lesion, thereby treating the lesion. For example, biotinylated antibodies with affinity to a lesion epitope are administered at the lesion. Reparative cells including avidin and biotin are then administered at the lesion. The reparative cells are targeted to the lesion via avidin-biotin bridges to the antibodies, with additional cells recruited to the lesion via cell-to-cell avidin-biotin bridges. In certain examples, antibody-reparative cell complexes are formed by mixing the biotinylated antibodies with the reparative cells including avidin and biotin. The complexes are then administered at the lesion. In other examples, multivalent antibodies are used to target reparative cells to the lesion, such as by binding an epitope at the lesion and an epitope present on the reparative cell. In other examples, the antibodies are chemically linked to a reparative cell or to a nanosome containing a therapeutic agent.

Abstract: The present invention relates to the pharmaceutical composition comprising Zonisamide and one or more pharmaceutically acceptable excipients and also relates to the process for the preparation of the pharmaceutical composition comprising Zonisamide.

Abstract: Provided herein are nanoparticle-lipid composite carriers as theranostic agents, particularly for diagnosis and/or treatment of cancers and related diseases and conditions. In particular embodiments, the carrier composites comprise a lipid core and an outer shell of functionalized nanoparticles (fNPs).

Abstract: The present invention relates to a biodegradable nanocomplex. The biodegradable nanocomplex comprises a first electrically charged substance, a charge-redistribution substance, a second electrically charged substance and a carried substance, for holding the carried substance inside. The first electrically charged substance and the carried substance have the same electrical polarity, and the biodegradable nanocomplex has a nonuniformally and positively charge distribution along a radial direction thereof.

Abstract: The present invention provides compositions (such as pharmaceutical compositions), and commercial batches of such compositions, comprising nanoparticles comprising albumin and rapamycin. The compositions (such as pharmaceutical compositions) have specific physicochemical characteristics and are particularly suitable for use in treating diseases such as cancer. Also provided are methods of making and methods of using the compositions (such as pharmaceutical compositions).

Abstract: The present disclosure is directed to a method of preparing a pharmaceutical composition comprising tolerizing immune-modulating particles of polymer-encapsulated gliadin.

Abstract: Nitric oxide (NO) generating compositions can include a nitrite component, an acidifying component, and a support material configured to carry one of the nitrite component and the acidifying agent. In some examples, the support material can minimize NO generation prior to addition of an activating amount of a suitable solvent.

Abstract: The present invention provides methods for preventing, inhibiting or treating a surgical site infection associated with a surgical operation comprising the step of applying to the surgical site a biocompatible, biodegradable substrate being impregnated and/or having its surface coated fully or partially with a matrix composition which provides local controlled and prolonged release of at least one pharmaceutically active agent at the surgical site.

Abstract: The present invention relates to a technology for oral delivery of Poorly Bio-Available Therapeutic Agents and the formulations derived using this technology. Poorly Bio-Available Therapeutic Agents may belong to BCS class III/IV drugs or nutraceutical or any other agent which is required to be orally delivered having challenge of bio-availability in body. Therefore, invention further relates to a targeted delivery technology for enhanced bio-availability and controlled release without being degraded. The present invention further relates to the processes for the preparation of said compositions and formulations made thereof. The formulations of the present invention are useful to treat related conditions.

Abstract: The present disclosure provides compositions having different dissolution profiles. In particular, the compositions are formulated by adjusting the types and/or amounts of excipients and/or surfactants, and the compositions are prepared by spray drying processes.

Abstract: A composition comprising surfactant-enhanced phospholipid vesicles with one or more cannabinoid substance encapsulated therein is disclosed, wherein one or more surfactant is utilized for enhancing loading and increasing encapsulation efficiency of cannabinoid passenger molecules within phospholipid structures. A method is disclosed for making a surfactant-enhanced phospholipid vesicles with one or more cannabinoid substance encapsulated therein, wherein one or more surfactant is used for enhancing loading and increasing encapsulation efficiency of passenger molecules in phospholipid structures. A method of using surfactant-enhanced phospholipid vesicles with one or more cannabinoid substance encapsulated therein is disclosed wherein one or more surfactant enhances loading and increases encapsulation efficiency of cannabinoid substances in phospholipid structures.

Abstract: Provided are a core shell particle including a core which contains a Group III element and a Group V element, and a shell which covers at least a part of a surface of the core and contains a Group II element and a Group VI element, in which the core shell particle has a tetrahedral shape having one side with a length of 6 nm or greater; a method of producing the core shell particle; and a film formed of the core shell particle.

Abstract: The immunostimulatory effect of lipid nanoparticles (LNPs) continues to block their use for safe and effective delivery of pharmaceutical drugs. Consequently, there exists a need to develop effective LNP delivery systems with an increased therapeutic window that do not trigger an inflammatory response. Disclosed herein are lipid nanoparticles comprising a lipid phase and at least one lipophilic anti-inflammatory agent, and pharmaceutical compositions comprising lipid nanoparticles and methods for using lipid nanoparticles. The anti-inflammatory lipid nanoparticles disclosed herein may further serve as platforms for selective delivery of, for example, nucleic acid segments to target cells and tissues, such as antisense oligonucleotides, DNA, mRNAs, siRNAs, Cas9-guideRNA complex.

Abstract: Sensor devices including dissolvable tissue-piercing tips are provided. Methods of using and fabricating sensor devices are also provided.

Abstract: The present disclosure is directed to a topical composition, e.g., a physically and chemically stable topical composition of Fenoldopam comprising about 0.1% to about 5% by weight of Fenoldopam or a pharmaceutically acceptable salt thereof, at least one polyacrylamide-type gelling agent, at least one cellulose-type gelling agent, and at least one solvent, wherein the Fenoldopam is substantially solubilized in the composition, and wherein the composition is stable for at least twelve months at 25° C. and 60% relative humidity.

Abstract: Provided is a sheet including a base material comprising a biocompatible material and having at least two independent holes, and a bioactive substance, wherein at least one of the independent holes is an independent hole A containing the bioactive substance, wherein at least one of the independent holes is an independent hole B containing no bioactive substance, wherein a maximum diameter of the independent holes is less than 0.2 mm. Also provided is a sheet laminate including sheets laminated with each other, wherein each of the sheets includes a base material comprising a biocompatible material and having at least two independent holes, and a bioactive substance, wherein at least one of the independent holes is an independent hole A containing the bioactive substance, wherein at least one of the independent holes is an independent hole B containing no bioactive substance.

Abstract: This invention relates to kits including novel oral food challenge meal formulations. In particular, the invention also relates to kits including novel oral food challenge meal formulations, wherein the placebo dose formulation is indistinguishable from non-placebo dose formulations.

Abstract: Cancer treatment methods using thermotherapy and/or enhanced immunotherapy are disclosed herein. In one embodiment, the method comprising the steps of administering a plurality of nanoparticles to target a tumor in a patient, the nanoparticles being coated with an antitumor antibody, cell penetrating peptides (CPPs), and a polymer, and the nanoparticles containing medication and/or gene, and a dye or indicator in the polymer coating, at least some of the nanoparticles attaching to surface antigens of tumor cells so as to form a tumor cell/nanoparticle complex; exciting the nanoparticles using an ultrasound source generating an ultrasonic wave so as to peel off the polymer coating of the nanoparticles, thereby releasing the dye or indicator into the circulation of the patient and the medication and/or gene at the tumor site; and imaging a body region of the patient so as to detect the dye or indicator released into the circulation of the patient.

Abstract: Powdered composition comprising: (a) 100 parts by weight of at least one polyhydroxyalkanoate (PHA) in the form of particles having an average diameter (d50) from 1 ?m to 100 ?m, preferably from 5 ?m to 60 ?m; (b) from 0.1 to 10 parts by weight, preferably from 0.5 to 5 parts by weight, of at least one silicate or silica. The powdered composition, having a relatively low abrasivity index and high flowability, can be used in air-polishing without causing excessive abrasion of the enamel and of the root cementum and without causing sticking in the device. Furthermore, the presence of PHA, being a polymer characterized by high biodegradability, makes the powdered composition particularly suitable for use in the oral cavity.

Abstract: A nimodipine injection concentrate and diluted formulation comprises nimodipine (base or salt), an effective amount of a hydrophilic surfactant, and a pharmaceutically acceptable carrier for injection which is an aqueous solution, an organic solvent, an oil, or a cyclodextrin, such that the nimodipine is substantially contained in a concentrated injection solution, suspension, emulsion or complex as a micelle or a colloidal particle or an inclusion complex and the formulation is stable and clear. In certain embodiments, the hydrophilic surfactant is polysorbate 80.

Abstract: Methods of reducing oxidative damage to an eye of a subject are provided. Aspects of the method include intravitreal injection an antioxidant composition consisting essentially of a non-reducing sugar or a hydrate thereof. In some embodiments, the non-reducing sugar is trehalose. The methods can further include surgical removal of at least a portion of the subject's vitreous humor during a vitrectomy. Also provided are ophthalmic compositions, kits and pre-loaded injection devices for use in vitrectomy surgery which find use in the subject methods.

Abstract: The present invention relates to a method of producing furfural and extracting lignin from a hemi-cellulosic biomass solution comprising a total quantity of C5 sugars, comprising the steps of heating the hemi-cellulosic biomass solution to a temperature of at least about 200° C.; acidifying the hemi-cellulosic biomass solution with acid to produce the furfural in vapor phase; and condensing the furfural to recover furfural in solution, wherein the furfural is produced at a total molar yield of at least 70% of moles of furfural produced/the total moles C5 sugars present in the initial hemi-cellulosic biomass solution. Low molecular weight lignin can also be recovered from the hemi-cellulosic biomass solution prior to furfural production by membrane concentration, acidification, coagulation and filtration.

Abstract: The present invention relates to a docetaxel albumin nanoparticle pharmaceutical composition, a preparation method therefor, and a use thereof for manufacturing drugs for treating cancer. The pharmaceutical composition comprises docetaxel, albumin and amino acid(s), wherein the weight ratio between albumin and docetaxel is no more than 50, preferably is 20:1 to 1:1, and the weight ratio between amino acid(s) and docetaxel is not less than 0.5, preferably is 1:1 to 20:1.

Abstract: The invention pertains to a method of using oxymorphone in the treatment of pain by providing a patient with an oxymorphone dosage form and informing the patient or prescribing physician that the bioavailability of oxymorphone is increased in patients with renal impairment.

Abstract: An aerosol-generating article for producing an inhalable aerosol upon heating is provided, the article including a rod of an aerosol-generating substrate, the rod including from about 20 strands to about 200 strands of non-tobacco material including and configured to release at least one aerosol former, each strand of the strands having an equivalent diameter of at least about 0.1 mm, the strands being assembled such that the strands extend in a longitudinal direction of the rod; and a wrapper circumscribing the strands.

Abstract: The purpose of the present invention is to provide a novel medicinal agent that has an effect of decreasing a microvascular blood flow. Provided is a microvascular blood flow decreasing agent that contains an immune checkpoint inhibitor.

Abstract: The present disclosure is directed to pharmaceutical compositions comprising a PDE V inhibitor and one or more pharmaceutical excipients or additives wherein the pharmaceutical compositions are in the form of liquid pharmaceutical compositions. The pharmaceutical compositions of the present disclosure are useful for the treatment of diseases or conditions which are treatable by administration of PDE V inhibitor drug such as pulmonary arterial hypertension, erectile dysfunction, etc.

Abstract: The present disclosure relates to lipoprotein complexes and lipoprotein populations and their use in the treatment and/or prevention of dyslipidemic diseases, disorders, and/or conditions. The disclosure further relates to recombinant expression of apolipoproteins, purification of apolipoproteins, and production of lipoprotein complexes using thermal cycling-based methods.

Abstract: The present disclosure provides delivery systems for delivering FK506 locally to damaged nerve sites. Particulate FK506 incorporated into a fibrin gel, with the amount of FK506 sufficient to give an FK506 release rate over at least 14 days of at least 5 micrograms per milliliter of the treated tissue per day has been shown to remarkably improve axon regeneration. The delivery systems include particulate FK506 having sizes between about 500 microns to about 1 millimeter encapsulated in a fibrin matrix, powdered FK506 encapsulated within electrospun films, powdered FK506 encapsulated within a cellulose matrix, and a flexible film of small intestinal submucosa having a plurality of solid islands located on one side thereof, with each island containing a preselected amount of FK506 and a polyester.

Abstract: An ionic nanocomposite comprising a nanomaterial comprising charged groups disposed on at least a portion of a surface of the nanomaterial and a polymer material comprising charged pendant group and/or end functionalized charged groups, where the charged groups of the nanomaterial and the charged pendant groups of the polymer material have opposite charges and the nanomaterial and polymer material are connected by one or more ionic bonds. A nanomaterial can be nanoparticles comprising sulfate groups disposed on at least a portion of the surface of the nanoparticles. The polymer material can be a polymer with pendant imidazolium groups. An ionic nanocomposite can be present as a film (e.g., a thin film). An ionic nanocomposite can be used in devices. A nanocomposite can be used in various coating application.

Abstract: The present invention generally relates to improved methods for the manufacture of inhalation powders. More particularly, aspects of the disclosure relate to methods for in-line monitoring of powder blending by Raman spectroscopy.

Abstract: Methods of screening rinse-off personal care compositions can include the use of explant skin in combination with measurements for moisture and/or cell proliferation.

Abstract: Disclosed is a delivery device for delivering a payload, including a biological, chemical or biochemical substance, to a subject. The delivery device has a nanoparticle loaded with the payload, and porous coating structure over the loaded nanoparticle to prevent the payload from escaping the delivery device, while also preserving the activity of the payload and increasing effective utilization of the payload. Also disclosed is a delivery device for delivering a payload, including a natural virus, recombinant virus, or engineered virus. Also disclosed is a delivery device that has a liposome loaded with the payload and a biocompatible surface coating over the loaded liposome. Also disclosed are methods of fabricating the delivery devices and methods of using the delivery devices in treating health conditions, such as cancer, or in diagnostic applications.