Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.

Abstract: A pharmaceutical composition for oral administration is disclosed herein, comprising a therapeutically active agent, SNAC and at least one antacid compound. Further disclosed herein is a pharmaceutical composition unit dosage form for oral administration of a therapeutically active agent is provided herein, the unit dosage form comprising: a core comprising the therapeutically active agent and SNAC (sodium 8-N-(2-hydroxybenzoyl)aminocaprylate); and an external layer comprising at least one protective agent selected from the group consisting of an antacid compound and a protease inhibitor. Methods and uses utilizing the aforementioned pharmaceutical compositions, as well as methods and uses utilizing co-administration, by oral administration, of at least one antacid composition, and a composition comprising the therapeutically active agent and SNAC, are further disclosed herein, for use in treating a condition treatable by oral administration of the therapeutically active agent.

Abstract: The disclosure is directed to pharmaceutical compositions for oral administration in form of coated tablets that exhibit modified release properties when administered as either whole or half tablets. In particular, the disclosure is directed to modified release tablets comprising deferiprone, said tablets being suitable for twice daily oral administration. The disclosure is also directed to methods of making and using the same.

Abstract: The present invention relates to a controlled release oral formulation comprising about 400 mg to about 800 mg of flavoxate salt as an active ingredient, suitable polymers, binders, and excipients, and lacking an acidifying agent. The present invention also provides a method of preparing the controlled release oral formulation of about 400 mg to 800 mg of flavoxate salt. The controlled release formulation of present invention may comprise micronized particles of drug. The controlled release formulation has a controlled release profile of up to 24 hours, that is pH independent, and that is alcohol dose dumping risk-free.

Abstract: Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Abstract: A method of cancer hyperthermia therapy includes placing a device including an exogenously-excitable polymeric material at a cancer hyperthermia therapy site of a patient. The method also includes supplying an exogenous energy to the device such that the exogenous energy excites the exogenously-excitable polymeric material at the cancer hyperthermia therapy site to heat the cancer hyperthermia therapy site to a hyperthermia temperature. A method of preparing a polymeric material includes combining an alcohol monomer, a seed of the polymeric material, and an aqueous liquid in a vessel. The method also includes adding an acid monomer to the vessel and supplying an exogenous energy to the vessel. The polymeric material is exogenously excited by the exogenous energy to heat the polymeric material. The method further includes removing water from the vessel and producing the polymeric material, which is a polyester, in the vessel.

Abstract: The invention provides a process for preparing sphingolipids, compositions comprising sphingolipids and further components, and for the use of the compositions.

Abstract: The invention relates to a solid oral extended release pharmaceutical dosage form comprising an extended release matrix formulation. The extended release matrix formulation comprises (1) at least one active agent, (2) at least one anionic surfactant, and (3) at least about 40% by weight (based on the weight of the extended release matrix formulation) of at least one polyethylene oxide. In certain embodiments, the molar ratio of the at least one anionic surfactant to the at least one active agent is from about 1:2 to about 10:1.

Abstract: There is described, inter alia, a coated bead comprising: (a) a granule; (b) a first layer coated over the granule, the first layer comprising a first amount of an active pharmaceutical ingredient comprising a central nervous system stimulant; and (c) a second layer coated over the first layer, the second layer being present in an amount sufficient to substantially delay release of the active pharmaceutical ingredient in the first layer until after the coated bead reaches a distal intestine portion of a subject to whom the coated bead is administered; and (d) the third layer coated over the second layer, the third layer comprising a second amount of the active pharmaceutical ingredient, the third layer being configured to permit substantially immediate release of the active pharmaceutical ingredient comprised therein. Embodiments related to a solid oral pharmaceutical composition are also described.

Abstract: The present invention relates to a pharmaceutical product comprising a combination of methotrexate and novobiocin, or any pharmaceutically acceptable salts of said compounds, and a pharmaceutical composition comprising (i) a therapeutic amount of methotrexate or any pharmaceutically acceptable salts thereof, and one or more pharmaceutically acceptable excipient, carrier or diluent, (ii) a non-therapeutic amount of novobiocin or any pharmaceutically acceptable salts thereof, and one or more pharmaceutically acceptable excipient, carrier or diluent. The invention further relates to a use of the pharmaceutical product and composition in therapy, such as prevention, progression prophylaxis and/or treatment of autoimmune diseases.

Abstract: The present invention relates to a binder free stable pharmaceutical composition comprising amorphous canagliflozin or a pharmaceutically acceptable salt or a prodrug thereof, and one or more pharmaceutically acceptable excipients, wherein the said composition is devoid of canagliflozin hemihydrate, and having acceptable chemical stability, polymorphic stability & comparative dissolution and bioavailability profile to that of INVOKANA® tablets.

Abstract: Baclofen formulations, including formulations that minimize variability between doses, that minimize variation in patient exposure baclofen metabolites, and are bioequivalent in regards to baclofen versus M1 metabolite ratios of baclofen tablets.

Abstract: The subject technology relates generally to pulmonary delivery of NSAIDs, such as aspirin.

Abstract: The invention relates to a pharmaceutical composition comprising the active ingredients rosuvastatin of formula I, with the systematic name (3R,5S,6E)-7-[4-(4-fluorophenyl)-2-(N-methylmethanesulfonamido)-6-(propan-2-yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid or its pharmaceutically acceptable salts, esters, hydrates or solvates, and ezetimibe of formula II, with the systematic name (3R,4S)-1-(4-fluorophenyl)-3-[(3S)-3-(4-fluorophenyl)-3-hydroxypropyl]-4-(4-hydroxyphenyl)azetidin-2-one or its pharmaceutically acceptable salts, esters, hydrates or solvates, as well as a preparation method of this pharmaceutical composition. The weight ratio of the layers is 1:2 to 2:1.

Abstract: The present invention relates to the field of prostate cancer treatment, and in particular the field of prostate cancer treatment by Androgen Deprivation Therapy (ADT). The present treatment involves oral administration of an estetrol component in conjunction with ADT.

Abstract: The present invention is directed to a composition that can be used to deliver an antipsychotic drug such as risperidone, paliperidone or a combination thereof, as an injectable in-situ forming biodegradable implant for extended release providing therapeutic plasma levels from the first day. The composition is in the form of drug suspension on a biodegradable and biocompatible copolymer or copolymers solution using water miscible solvents that is administered in liquid form. Once the composition contacts the body fluids, the polymer matrix hardens retaining the drug, forming a solid or semisolid implant that releases the drug in a continuous manner. Therapeutic plasma levels of the drug can be achieved from the first day up to at least 14 days or more even up to at least four weeks.

Abstract: The present invention is directed to a composition that can be used to deliver an antipsychotic drug such as risperidone, paliperidone or a combination thereof, as an injectable in-situ forming biodegradable implant for extended release providing therapeutic plasma levels from the first day. The composition is in the form of drug suspension on a biodegradable and biocompatible copolymer or copolymers solution using water miscible solvents that is administered in liquid form. Once the composition contacts the body fluids, the polymer matrix hardens retaining the drug, forming a solid or semisolid implant that releases the drug in a continuous manner. Therapeutic plasma levels of the drug can be achieved from the first day up to at least 14 days or more even up to at least four weeks.

Abstract: A biodegradable polyester is provided. The biodegradable polyester is a transesterification or esterification reaction product of a reactant (a) and a reactant (b). The reactant (a) is a modified linear saccharide oligomer. The reactant (b) is a polyester, or the reactant (b) includes a dicarboxylic acid and a diol. The modified saccharide oligomer is a reaction product of a saccharide oligomer and a modifier.

Abstract: An oral dosage formulation having one or more active pharmaceutical ingredients (APIs) or pharmaceutically acceptable salts thereof, 27 wt % to 34 wt % of hydroxypropyl methyl cellulose, 25 wt % to 53 wt % of high-density microcrystalline cellulose having a particle size of 50 micrometers to 100 micrometers, and 6.5 wt % to 8 wt % of lactose monohydrate. A non-exhaustive list of APIs that may be used in the oral dosage formulation includes: hydralazine or a pharmaceutically acceptable salt thereof; naltrexone or a pharmaceutically acceptable salt thereof; prazosin or a pharmaceutically acceptable salt thereof; torsemide or a pharmaceutically acceptable salt thereof; and aldosterone receptor antagonist(s) (e.g., spironolactone or eplerenone) or a pharmaceutically acceptable salt thereof. The formulations are used to treat disorders, including, but not limited to, heart failure-associated sleep apnea, uncontrolled or resistant hypertension, Crohn's disease, and systemic inflammation.

Abstract: Described are immediate release oral dosage forms that contain abuse-deterrent features. In particular, the disclosed dosage forms provide deterrence of abuse by ingestion of multiple individual doses. In addition, the disclosed dosage forms provide protection from overdose in the event of accidental or intentional ingestion of multiple individual doses.

Abstract: A chemoembolization therapy, which combines therapeutic effects of peripheral arterial occlusion with the local administration of an anti-cancer agent. A particle or microsphere occludes the arteries providing blood flow to the tumor, resulting in tumor oxygen deprivation. The anti-angiogenic agent is an anti-cancer drug.

Abstract: The invention is directed to pharmaceutical compositions comprising dextromethorphan and methods of use thereof. Formulations of the present invention include dextromethorphan or a pharmaceutically acceptable salt thereof in a sustained release formulation comprising a controlled release agent. Formulations of the present invention include a core tablet, optionally an active coating and, optionally a film coating. The pharmaceutical compositions may be used as an antitussive, and the invention further relates to the treatment of cough in a patient in need thereof.

Abstract: Described herein are an aspirin or active aspirin derivative and a COX-2 inhibitor, at least one of which has an enteric or partial enteric coating, administered in combination yet delivered sequentially, for the treatment and prophylactic treatment of diseases, symptoms and conditions. In some embodiments, the COX-2 inhibitor has the enteric coating; however, the aspirin or active aspirin derivative may additionally or alternately have the enteric coating. In all embodiments, the drug having the enteric coating or enteric formulation is targeted for absorption in the small intestine or colon, or both the small intestine and the colon.

Abstract: The disclosure provides, inter alia, compositions including cell-nanoparticle constructs and drug loaded nanoparticles, and methods for their use in the treatment of cancer. Also provided are unmodified cisplatin molecules encapsulated by silica nanoparticles, and their use in the treatment of cancer.

Abstract: An implantable device for delivery of a macromolecular drug compound is provided. The device comprises a core having an outer surface and a membrane layer positioned adjacent to the outer surface of the core. The core comprises a core polymer matrix within which is dispersed a drug compound having a molecular weight of about 0.5 kDa or more, the polymer matrix containing a hydrophobic polymer. Further, the membrane layer comprises a membrane polymer matrix within which the macromolecular drug compound is optionally dispersed. The membrane polymer matrix contains a hydrophobic polymer in combination with a hydrophilic compound, and the weight ratio of the hydrophobic polymer to the hydrophilic compound within the membrane polymer matrix ranges from about 0.25 to about 200.

Abstract: Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Abstract: Modified release formulations of gamma-hydroxybutyrate having improved dissolution and pharmacokinetic properties are provided, and therapeutic uses thereof.

Abstract: The present disclosure provides oral drug dosage forms comprising: (a) an erodible non-stimulant material admixed with an ADHD non-stimulant; and (b) an erodible stimulant material admixed with an ADHD stimulant, wherein the erodible non-stimulant material admixed with the ADHD non-stimulant is embedded in a substrate material, and wherein upon exposure to gastrointestinal fluid the ADHD non-stimulant is released according to a desired non-stimulant release profile and the ADHD stimulant is released according to a desired stimulant release profile. In some embodiment, the ADHD non-stimulant is released according to a sustained release profile. In some embodiments, the ADHD stimulant is released according to an immediate release profile. The oral drug dosage forms of the present disclosure are useful for the treatment of attention deficit hyperactivity disorder (ADHD). Also provided herein are methods of designing and manufacturing the oral drug dosage forms described herein.

Abstract: An abuse deterrent pharmaceutical composition including a drug susceptible to abuse, a first acid soluble ingredient, a first buffering ingredient, and a delayed release buffering component.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: Apparatuses and methods for electrokinetic transport of fluids to patients. Drug-containing solutions may be placed in vial-like reservoir, which is connected to an apparatus such as a traditional catheter or other device capable of holding a drug-containing solution. Instead of a vial-like reservoir, a doped infusion pad or a gel may be used as a source of the drug-containing solution. The reservoir and apparatus may thus be the same component. The methods and apparatuses disclosed herein may also be used to transport fluid alone to achieve a clinical effect. The apparatus is placed at the point of drug delivery. The counter-electrode may be placed in or on a patient. Current is passed from the reservoir to the counter-electrode. Through electrokinetic transport, drug-containing solution is delivered along a current path from the drug source to the counter-electrode. A hollow fiber catheter for use in electrokinetic transport is also disclosed.

Abstract: An oral solid non-pulsatile 24 hours prolonged-release composition including an amount of betahistine, or of a pharmaceutically acceptable salt thereof, equivalent to 48 mg of betahistine dihydrochloride, together with one or more pharmaceutically acceptable excipients or carriers, wherein the composition exhibits a dissolution profile according to which: up to 30% by weight of betahistine is dissolved in 1 hour; from 35% to 45% by weight of betahistine is dissolved in 2 hours; from 46% to 60% by weight of betahistine is dissolved in 4 hours; from 61% to 80% by weight of betahistine is dissolved in 8 hours; from 81% to 97% by weight of betahistine is dissolved in 16 hours; and from 98% to 100% by weight of betahistine is dissolved in 24 hours. It also relates to the treatment of a vestibular disease or condition, more particularly in the treatment of Ménière's disease.

Abstract: Solid dosage formulations of nitazoxanide or a nitazoxanide analogue are provided that comprise a controlled release portion and an immediate release portion. The pharmaceutical composition is typically in the form of a bilayer solid oral dosage form comprising (a) a first layer comprising a first quantity of nitazoxanide or analogue thereof in a controlled release formulation; and (b) a second layer comprising a second quantity of nitazoxanide or analogue thereof in an immediate release formulation. Method of using the formulations in the treatment of hepatitis C are also provided.

Abstract: There is herein provided valproic acid, or a pharmaceutically acceptable salt thereof, for use in treating or preventing a pathological condition associated with excess fibrin deposition and/or thrombus formation, wherein said treatment comprises treating a patient with valproic acid, or a pharmaceutically acceptable salt thereof, in a specific manner, and formulations for use or designed for use in such treatments.

Abstract: There is provided herein a pharmaceutical formulation having one or more component comprising valproic acid (VPA) and/or a pharmaceutically acceptable salt thereof; and one or more secondary acid, and optionally comprising one or more pharmaceutically acceptable excipient. There is also provided uses of such formulations.

Abstract: The present invention relates to a composition comprising or, alternatively, consisting of an effective amount of a mixture which comprises at least, or consists of: a) an extract of Pelargonium sidoides; b) an extract of Adhatoda vasica; and c) N-acetyl cysteine for use in a method for the preventive or therapeutic treatment of at least one respiratory tract disorder in a subject, wherein said treatment method comprises the administration of said composition to the subject.

Abstract: The present invention provides an impregnated porous carrier material comprising at least one active pharmaceutical ingredient (API) impregnated throughout the internal surface of a porous carrier. The present invention further provides immediate release and sustained release pharmaceutical dosage forms comprising the impregnated porous carrier material disclosed herein such that any single active pharmaceutical ingredient (API) content variability in the finished drug product has a relative standard deviation of less than 3%.

Abstract: Mixture of stabilised biologically available curcumin for orodispersible formulations, formulations of biologically available curcumin and orodispersible tablet with biologically available curcumin and its application. An orodispersible tablet with biologically available curcumin contains particles of extract of rhizome of plant Curcuma longa, which contains, at least, 95% by weight of curcumin, grounded to size 100 to 250 nm in mixture with mannitol in weight ratio 1 to 3:1 (mannitol:curcumin). Orodispersible tablet also contains an orodispersible carrier, and curcumin 100% biologically available through oral mucosa.

Abstract: Provided herein are osmotic dosage forms containing deutetrabenazine for use in the treatment of, e.g., hyperkinetic movement disorders. When orally administered to a subject on a once-daily basis, the dosage forms provide a favorable pharmacokinetic profile for the active agent indicating treatment efficacy over an extended period of time.

Abstract: Pharmaceutical granulations having a functional coating surrounding a core containing a water-soluble active pharmaceutical ingredient are disclosed. The functional coating provides for immediate release or controlled release of the active pharmaceutical ingredient. The pharmaceutical granulations can be used in oral pharmaceutical compositions.

Abstract: The present invention is directed to a composition that can be used to deliver an antipsychotic drug such as risperidone, paliperidone or a combination thereof, as an injectable in-situ forming biodegradable implant for extended release providing therapeutic plasma levels from the first day. The composition is in the form of drug suspension on a biodegradable and biocompatible copolymer or copolymers solution using water miscible solvents that is administered in liquid form. Once the composition contacts the body fluids, the polymer matrix hardens retaining the drug, forming a solid or semisolid implant that releases the drug in a continuous manner. Therapeutic plasma levels of the drug can be achieved from the first day up to at least 14 days or more even up to at least four weeks.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: Compositions containing iron, buffering agent and denatured protein have been prepared that are capable of increasing serum iron in a subject. For example, spray dried microbeads have been prepared containing iron entrapped within a protein matrix and unbound iron in a buffered composition that provides a gastroprotective effect, preserves iron in the more available Fe2+ form and improves iron bioavailability in humans relative to previously known vehicles for delivering iron to a subject.

Abstract: The present invention relates to a modified-release composition of mazindol and its use in the treatment of attention deficit disorders (ADD) or attention deficit/hyperactivity disorder (ADHD) or related deficit of alertness (i.e., incoercible sleepiness) or decline of vigilance (i.e., daytime somnolence) or excessive daytime sleepiness (e.g., narcolepsy, idiopathic hypersomnia) in particular in children, adolescents and adults.

Abstract: The present invention relates to a sustained-release pharmaceutical composition intended for animal use, which comprises a drug, a sugar, a wax, and a water-soluble polymer.

Abstract: The present invention encompasses a stabilized parasiticidal granule composition comprising a macrocyclic lactone compound and an insect growth regulator. The invention also encompasses methods of making and methods of using the granule for treating, controlling or preventing parasitic infestation or parasitic infection in an animal.

Abstract: A microcapsule includes an active component encapsulated within a polymerized hydrolyzed protein shell. The microcapsule has an average diameter that is less than one hundred micrometers as determined by a laser diffractometer.

Abstract: A liquid composition contains a salicylate compound (e.g. aspirin), glycerin triacetate, saccharin. The salicylate compound is soluble in the composition, which is particularly suitable for oral, parenteral or pulmonary administration.

Abstract: An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.