Abstract: The invention provides an oral solid formulation comprising (a) a controlled release component comprising a core comprising levodopa, wherein the core is coated with a muco-adhesive coating and the muco-adhesive coating is externally coated with an enteric coating; and (b) an immediate release component comprising levodopa. The invention further provides a method for making and using the oral solid formulation.

Abstract: Disclosed are pharmaceutical compositions and oral dosage forms including capsules containing (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate, and related methods. The capsule fill can include an additive and about 14 wt % to about 42 wt % for androst-4-en-17?-ol-3-one esters that comprise (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate or a combination of (17-ß)-3-oxoandrost-4-en-17-yl undecanoate, (17-ß)-3-oxoandrost-4-en-17-yl dodecanoate, and (17-ß)-3-oxoandrost-4-en-17-yl tridecanoate. A single oral administration to a male subject of one or more dosage forms with a total androst-4-en-17?-ol-3-one equivalent dose of about 150 mg to about 895 mg is provided. In another embodiment, a method for providing a serum concentration of androst-4-en-17?-ol-3-one within a target PK performance for a male subject is provided.

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: The invention provides an oral solid formulation comprising (a) a controlled release component comprising a core comprising levodopa, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric polymer; and (b) an immediate release component comprising levodopa.

Abstract: The disclosure generally relates generally to lipid nanodiscs, in particular to lipid nanodiscs formed from acryloyl-based copolymers. A lipid nanodisc according to the disclosure includes a lipid bilayer having a first hydrophilic face and a second hydrophilic face opposing the first hydrophilic face, and a hydrophobic edge between the opposing hydrophilic faces, and an acryloyl-based copolymer encircling the hydrophobic edge of the lipid bilayer. The acryloyl-based copolymer includes a first monomer unit having a pendant hydrophobic group and a second monomer unit having a pendant hydrophilic group. Methods of making and characterizing the lipid nanodiscs are also disclosed.

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: Methods are provided for treating or preventing human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) in a virologically suppressed patient in need thereof comprising switching the patient from an antiretroviral treatment regimen comprising at least three antiretroviral agents to a treatment regimen comprising only two antiretroviral agents. In one aspect the two treatment regimen consists of dolutegravir, rilpivirine and at least one pharmaceutically acceptable excipient, diluent or carrier. In another aspect of the invention, there is provided a multilayer tablet comprising dolutegravir or a pharmaceutically acceptable salt thereof and rilpivirine or a pharmaceutically acceptable salt thereof.

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: The present invention relates to a modified-release composition comprising orlistat and acarbose, comprising individually distinct parts with different release patterns: a) a first part, G1, comprising from about 5 to about 70% w/w of the total dose of acarbose, b) a second part, G2A, comprising from about 30 to about 95% w/w of the total dose of acarbose, c) a third part, G2B, comprising from about 10 to about 90% w/w of the total dose of orlistat, and d) a fourth part, G3, comprising from about 10 to about 80% w/w of the total dose of orlistat, and the total concentration of acarbose and orlistat, respectively, in the composition is 100% w/w.

Abstract: There is provided a controlled-release antibiotic socket for securely holding an implantable medical device that is made from: at least one film having at least one polymer layer, where the at least one film is formed into the socket; at least one antibiotic agent; and at least one opening in the socket, where the at least one polymer layer comprises a biodegradable elastomeric polymeric material; and the at least one antibiotic agent is dispersed within at least one of the at least one polymer layers and/or, when the film comprises at least two polymer layers, the at least one antibiotic agent is disposed as a separate layer between two polymer layers. Also disclosed is the film used to make the socket and uses of both the socket and film.

Abstract: The instant disclosure is directed to a vaginal care composition that restores pH balance, and thereby reduces vaginal dryness, irritation, dyspareunia, post-coital bleeding, infections, vaginal and pelvic pain and increases vaginal lubrication. In some embodiments, the vaginal care composition comprises stem cell-derived exosomes (e.g., mesenchymal stem cell (MSC)-derived exosomes), an antioxidant and a pH buffer. Another aspect of the disclosure is directed to methods for improving vaginal health by administering the vaginal care composition of the instant disclosure.

Abstract: This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.

Abstract: Provided are methods for treating, ameliorating, reversing and/or preventing a Helicobacter pylori (H. pylori) infection in an individual in need thereof, comprising: administering to the individual in need thereof a therapeutic combination comprising: (a) a composition comprising or consisting of: vonoprazan or a vonoprazan fumarate, or a 5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine monofumarate, or a 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methyl-methanamine fumarate), optionally TAKECAB™; and (b) an antimicrobial or antibiotic drug or composition.

Abstract: Provided is an oral soft gel capsule that includes a psychedelic compound. Also provided is a method of treating in a subject a disease or disorder ameliorated by a psychedelic compound, that includes orally administering to a subject an oral soft gel capsule that includes a therapeutically effective amount of the psychedelic compound. Also provided is a method of orally administering to a subject an oral soft gel capsule that includes a therapeutically effective amount of the psychedelic compound. Also provided is a method of orally administering to a subject an oral soft gel capsule that includes a low dose (e.g., microdose or sub-therapeutic dose) of the psychedelic compound.

Abstract: The disclosure relates to a mucoadhesive sustained-release vaginal tablet including at least one probiotic strain of the genus Lactobacillus compressed with an excipient suitable for conferring upon the tablet the properties of vaginal wall mucoadhesion and sustained release.

Abstract: An oral dosage form of ticagrelor includes a core and a semi-permeable membrane coating the core. The core comprises a first drug layer and a push layer. The first drug layer contains ticagrelor that is sufficient to deliver an effective amount of the drug over an intended delivery time. The push layer comprises a swelling agent and an osmogen agent. The semi-permeable membrane has at least one passageway formed therethrough, positionally configured to face the first drug layer, but not to face the push layer, of the core, and functionally configured to allow the ticagrelor to realize an extended release out of the core upon contacting an aqueous environment. The dosage form optionally further includes a second ticagrelor-containing drug layer coating the semi-permeable membrane, thereby providing a starting effective dose upon administration. The dosage form can realize once-a-day administration of ticagrelor of patients in need thereof.

Abstract: New soft capsules are described having within them a fill which contains thyroid hormones such as thyroxine T4 or triiodothyronine T3) and a high amylose-starch, optionally associated with vegetable hydrocolloids and/or glycerol. Compared to traditional capsules, these capsules have a strong and unexpected increase in the stability of T4 or T3 during storage.

Abstract: The present invention relates to compositions and methods for imaging and treating various diseases and disorders, including cancers. The composition of the invention can include a plurality of biodegradable micro-beads, each embedding a plurality of nano-beads, further including a polymer, a radionuclide, a radionuclide chelator, a radioligand, a chemotherapeutic agent, and a cell-penetrating peptide. Upon injection into a blood vessel supplying a cancer tumor, the micro-beads lodge into the tumor and degrade, releasing the nano-beads with a therapeutic or diagnostic agent. The compositions and methods of the invention provide a more homogeneous and deeper distribution of radiation or chemotherapeutic agents throughout the target tumor. The micro-beads provide a local, sustained, and controlled delivery nano-beads including therapeutic or diagnostic agents.

Abstract: The invention provides a pharmaceutical composition comprising sodium lauryl sulfate, hydroxypropyl methylcellulose (HPMC), a copolymer of vinylpyrrolidone and vinyl acetate, and a therapeutically effective amount of metaxalone or a pharmaceutically acceptable salt thereof. Related processes and methods are also disclosed.

Abstract: An oral gastro-retentive delivery device is provided which unfolds rapidly upon contact with gastric juice. The device is configured in a collapsed configuration for oral intake and unfolding for gastric retention for a predetermined period of time and eventually reducing in size for passage through the rest of the GI track.

Abstract: The invention relates to stable pharmaceutical compositions comprising the compound of the below formula, or pharmaceutically acceptable salts, solvates, hydrates or morphological forms thereof

Abstract: A water-soluble prolamin composition, such as a zein composition, and methods for producing the same. A method for tagging items comprising applying a plurality of non-coding DNA tags in a prolamin composition, such as a zein composition, wherein the selection of the particular taggants corresponds with a binary or nonbinary code sequence containing information about the tagged items.

Abstract: A method of treating patients by using a pharmaceutical composition for intra-intestinal administration comprises (i) a dopamine replacement agents, (ii) a dopamine decarboxylase inhibitor (DDI), and (iii) a COMT inhibitor where the composition is continuously administrated.

Abstract: The present invention relates to a pharmaceutical composition comprising pomalidomide, maltodextrin and a filler, wherein the weight ratio of maltodextrin to filler ranges from 1:1 to 1:2. The invention further relates to the use of said pharmaceutical composition as medicament in the treatment of multiple myeloma.

Abstract: Nutraceutical composition for the activation of sirtuins in humans, the composition including from 10% by weight to 15% by weight of honokiol; from 12% by weight to 40% by weight of pterostilbene; from 22% by weight to 32% by weight of polydatin; from 25% by weight to 40% by weight of ellagic acid and from 1.5% by weight to 3% by weight of a mixture of zinc, seleniun, chromium and nicotinamide, the composition promoting the inhibition of cell degradation and aging phenomena.

Abstract: Novel methods for isolating fish roe/egg extracts, notably a coagulum and a sediment extract, enriched in phospholipids and omega-3 fatty acids are described. Novel compositions comprising omega-3 polyunsaturated fatty acids and micronutrients, which may be used for the management of neurological conditions such as ADD-ADHD, autism, cognitive impairment, and mood disorders are also described. These compositions are homogenous compositions comprising effective amounts of omega-3 fatty acids in microencapsulated or emulsified form, and/or from the sediment extract from fish roe/egg, vitamin B6, magnesium, zinc and copper, and may further comprise additional ingredients such as folic acid (e.g., L-methyl folate) and gamma-linolenic acid (GLA).

Abstract: The invention relates a process for preparing a cross-linked starch-based polymer comprising the following steps: 1) dissolving a starchy material in a suitable solvent to form a starchy material solution; and 2) adding a episulfide of formula (I), wherein R1, R2, R3 and R4 are independently selected from hydrogen and (C1-C3)alkyl in the starchy material solution in order to obtain the disulfide crosslinked starch-based polymer. In another aspect the invention concerns a disulfide-cross-linked starch-based polymer obtainable by the process of the invention, that is characterized by only disulfide bridges.

Abstract: A liquid oral pharmaceutical dosage form, comprising pharmacologically effective amounts of at least one histamine H2-receptor antagonist in a hydrophobic/lipophilic liquid substantially free from water comprising at least one viscosity enhancing agent, and pharmacologically effective amounts of one or more antacid(s) in a liquid comprising at least one viscosity enhancing agent and at least one flavor, wherein the two liquids are physically separated from each other and wherein the two liquids have matching rheological profiles and a package comprising multiple liquid oral dosage forms as well as a method of treating a gastric disease or disorder by use of the liquid oral pharmaceutical dosage form.

Abstract: A conveyer mechanism (110) may include one or more composition inspection units provided along the intended product transport path. The product's composition, e.g., it's ink composition, is compared with a predetermined standard, to determine whether the product is acceptable. A bar code (48, 45.1, 47.1, 85) may be provided to an external surface of the article for identification/traceability purposes.

Abstract: The present disclosure generally relates to film-forming compositions and capsules formed from such compositions, including processes for using such compositions to make capsules. In some embodiments, the film-forming compositions are free of animal products and carrageenan.

Abstract: Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.

Abstract: The present invention provides a particle comprising pirfenidone and a lipid, particularly magnesium stearate, and having a mean particle diameter of 5 ?m or less, and a powder formulation comprising the particle and a carrier.

Abstract: The present invention relates to a process for manufacturing porous silica particles comprising at least one bioactive compound, whereby the particles are adapted for lung, nasal, sublingual and/or pharyngeal delivery of said at least one bioactive compound and have an MMAD between 0.5 and 15 ?m with a GSD less than 2.5. The invention also relates to a pharmaceutical composition comprising said silica particles and a use of the silica particles in the diagnoses, prevention and/or treatment of local and/or systemic disorders, such as disorders of the lung, nose, sublingual and/or pharynx.

Abstract: The present invention provides a food that is effective for improving the intestinal environment by promoting proliferation of intestinal lactic acid bacteria and the like. The present invention provides a food that is effective for improving the intestinal environment, wherein the food includes (1) ?-polyglutamic acid or a composition containing ?-polyglutamic acid, and (2) oligosaccharide or a composition containing oligosaccharide.

Abstract: The present invention relates to a modified release coated capsule and a process to obtain that capsule.

Abstract: The present invention relates to a composition for stimulating muscle growth, repair and maintenance and the method of using the same. The present invention generally relates to compositions and methods for supporting muscle anabolism. The compositions described herein are pharmaceutical or nutritional compositions suitable for preserving muscle mass, strength, and/or function in a subject in need thereof. The compositions are based on a specially formulated mixture of essential amino acids (EAAs) and protein with additional components. Use of the compositions herein may prevent muscle atrophy associated with periods of rest, such as those following surgery, injury, inactivity and during recovery from disease.

Abstract: The present invention relates to parenteral cannabinoid formulations, and more particularly to cannabinoid containing intravenous (IV) formulations. Preferably the parenteral containing formulation comprises a cannabinoid; an isotonic agent; a surfactant; and one or more stability enhancers. Furthermore the cannabinoid may be selected from one or more of cannabichromene (CBC), cannabichromenic acid (CBCV), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabidivarin (CBDV), cannabigerol (CBG), cannabigerolpropyl variant (CBGV), cannabicyclol (CBL), cannabinol (CBN), cannabinol propyl variant (CBNV), cannabitriol (CBO), tetrahydrocannabinol (THC), tetrahydrocannabinolic acid (THCA), tetrahydrocannabivarin (THCV) and tetrahydrocannabivarinic acid (THCVA).

Abstract: Provided is a liquid system comprising a first component and a second component the components selected from the group consisting of carbohydrates, sugar alcohols, food grade acids, food grade non-aqueous solvents and food grade salts wherein: a. the second component is different than the first component; b. the system has a melting point lower than each of the components; and c. the liquid system comprises 7% or less water. The systems are useful for protecting an active ingredient in a food system wherein the ingredient is stable at room temperature and retains its sensory properties after being diluted into an aqueous beverage for example to form a flavored aqueous beverage.

Abstract: Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.

Abstract: The present invention relates to an oral enteric high-dose tablet comprising mesalazine as the active substance as well as its use.

Abstract: Disclosed are microcapsules that include an inhibitor of the mammalian target of rapamycin (mTOR) within the microcapsules, and pharmaceutical compositions and kits that include the microcapsules. Also disclosed are methods for treating or preventing an age-related disease, condition, or disorder in a subject that involve administering to a subject a pharmaceutically effective amount of microcapsules that includes an inhibitor of mTOR within the microcapsules.

Abstract: Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.

Abstract: The present disclosure provides for a capsule dosage form of triamterene, the dosage form comprising: a) triamterene having a weight percentage in a range of 25-45% with respect to the total ingredients in the capsule dosage form; b) magnesium stearate having a weight percentage in a range of 1.5-13% with respect to the total ingredients in the capsule dosage form; and c) at least one diluent having a weight percentage in a range of 42-73.5% with respect to the total mixture/ingredients encapsulated in the capsule dosage form. The present disclosure also provides for a convenient process for preparation of the capsule dosage form.

Abstract: The present invention relates to an oral complex preparation comprising: a capsule containing a fat-soluble first drug; and a solid preparation containing a second drug, the solid preparation being embedded into the capsule and including an oil-proof material coating layer on the surface thereof The oral complex preparation of the present invention prepared by embedding the solid preparation including the oil-proof material coating layer on the surface thereof and containing the second drug into the capsule containing the fat-soluble first drug enables two types of drug ingredients to be simultaneously administered.

Abstract: This invention relates to treatment of cancer using antibody drug conjugates that comprise PBD molecules in combination with Bcl-2 inhibitors.

Abstract: Phase-inverted capsules of a prodrug of budesonide are provided for treatment of bowel diseases.

Abstract: Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-4,5-dihydro-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.

Abstract: The present invention relates to crystalline forms of ibrutinib, designated as Form S1, Form S2, Form S3, Form S4, and an amorphous form, designated as Form A1, and processes for their preparation, pharmaceutical compositions comprising these forms, and their use for the treatment of Bruton's tyrosine kinase (BTK) mediated diseases.

Abstract: In the present invention there is provided a pharmaceutical composition for oral administration which comprises bendamustine or a pharmaceutically acceptable, ester, salt or solvate thereof as an active ingredient, and a pharmaceutically acceptable excipient and which shows a dissolution of the bendamustine of at least 60% in 20 minutes, 70% in 40 minutes and 80% in 60 minutes, as measured with a paddle apparatus at 50 rpm according to the European Pharmacopoeia in 500 ml of a dissolution medium at a pH of 1.5. The invention further relates to the above pharmaceutical composition for use for the oral treatment of a medical condition which is selected from chronic lymphocytic leukemia, acute lymphocytic leukaemia, chronic myelocytic leukaemia, acute myelocytic leukaemia, Hodgkin's disease, non-Hodgkin's lymphoma, multiple myeloma, breast cancer, ovarian cancer, small cell lung cancer and non-small cell lung cancer.

Abstract: The invention provides a controlled release oral solid formulation comprising (a) a controlled release component comprising core comprising levodopa and/or an ester of levodopa or salts thereof, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric coated polymer; and a method of using the controlled release oral solid formulation to treat Parkinson's disease or primary parkinsonism.