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.

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: Some embodiments are directed to a multimaterial powder used in the field of metallurgy and plasturgy. The multimaterial powder includes support particles having a median particle size distribution between 1 ?m and 100 ?m and functionalising particles having a median particle size distribution that is a factor of 10 to 1000 lower relative to the support particles. The powder is characterised in that the support particles and the functionalising particles form composite grains having a core-shell structure that each have a core formed by a support particle, and a shell, that covers between 10 and 100% of the surface of the support particle and which is formed by at least one surface layer of the functionalising particles.

Abstract: The instant invention relates to a process for the preparation of a pharmaceutical composition in sustained-release tablet form comprising from 600 milligrams to 2400 milligrams of Pirfenidone (PFD), in such a way that the drug is bioavailable during an extended period of time of 12 hours from its administration. In this way, the anti-fibrotic and anti-inflammatory action of the drug Pirfenidone is optimized. Moreover, the instant invention offers advantages and a higher therapeutic efficacy compared to other pharmaceutical forms of Pirfenidone for oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; it shows a better activity with regard to the reduction and/or regression of deleterious effects in breast capsular contracture observed after the surgical implantation of breast implants in humans and has an important anti-TNF-? and anti-TGF-?1 action for the treatment of hepatic fibrosis.

Abstract: The instant invention relates to a process for the preparation of a pharmaceutical composition in sustained-release tablet form comprising from 600 milligrams to 2400 milligrams of Pirfenidone (PFD), in such a way that the drug is bioavailable during an extended period of time of 12 hours from its administration. In this way, the anti-fibrotic and anti-inflammatory action of the drug Pirfenidone is optimized. Moreover, the instant invention offers advantages and a higher therapeutic efficacy compared to other pharmaceutical forms of Pirfenidone for oral administration and its therapeutic application in the regression of chronic renal failure secondary to primary glomerulosclerosis; it shows a better activity with regard to the reduction and/or regression of deleterious effects in breast capsular contracture observed after the surgical implantation of breast implants in humans and has an important anti-TNF-? and anti-TGF-?1 action for the treatment of hepatic fibrosis.

Abstract: Provided are compositions and methods for treating multiple sclerosis (MS). One embodiment of the disclosed method entails orally administering to a MS patient a first amount of aspirin and a second amount of fumaric acid or an ester or a salt thereof. In some embodiments, the aspirin is administered at from about 80 mg to about 500 mg per day and the fumaric acid or ester or salt thereof is administered at about 360 mg per day.

Abstract: The present invention relates to a composite preparation with various dosage forms comprising mosapride and rabeprazole. The composite preparation prepared according to the present invention allows rapid release of a drug without deteriorating its release by an interaction between mosapride and rabeprazole, thus exhibiting an improved drug release rate and bioavailability, while having excellent product stability and being capable of significantly lowering the amount of the excipient. Accordingly, the composite preparation of the present invention can improve patients' drug compliance due to the size of its dosage form.

Abstract: The invention relates to an oral pharmaceutical composition in the form of a sustained-release tablet comprising an active ingredient capable of being misused, which composition makes it possible to combat misuse by injection.

Abstract: A composition which is used for the production of a solid preparation exhibiting a small variation of dissolution even at a low content of hydroxypropyl methyl cellulose (HPMC), and others. More specifically, provided are a composition for a solid preparation, the composition including HPMC having a polydispersity of 4.0 or more, as determined by absolute molecular weight measurement, and having a viscosity at 20° C. of 1,500 to 15,0000 mPa·s, as determined in a 2% by mass aqueous solution thereof, and an active ingredient; the solid preparation including the composition; and a method for producing a tablet including a step of dry-mixing said HPMC with an active ingredient to obtain a mixture, or granulating a mixture including said HPMC and an active ingredient to obtain a granulated product, and a step of tableting the mixture or the granulated product to obtain a tablet.

Abstract: A pharmaceutical composition containing the therapeutically active ingredients of azelastine or a pharmaceutically acceptable salt of azelastine and memantine or a pharmaceutically acceptable salt of memantine is disclosed. A method of using the pharmaceutical composition for treating patients suffering from mental, behavioral, cognitive disorders is also disclosed.

Abstract: The present invention relates to a solid oral pharmaceutical dosage form suitable for making a suspension comprising acid labile benzimidazole compounds and process for preparing the same. The prior art discloses various technical challenges associated with the granules for reconstitution into suspension like agglomeration of particles, viscosity and gelling time. The solid oral pharmaceutical dosage form of the present invention forms a homogeneous suspension upon admixing with an aqueous medium and exhibits desired technical attributes like viscosity, drug release, gelling time, dissolution and reduced adherence to nasogastric and gastric tubes.

Abstract: A pharmaceutical composition containing the therapeutically active ingredients of azelastine or a pharmaceutically acceptable salt of azelastine and memantine or a pharmaceutically acceptable salt of memantine is disclosed. A method of using the pharmaceutical composition for treating patients suffering from mental, behavioral, cognitive disorders is also disclosed.

Abstract: The invention is directed to pharmaceutical compositions such as tablets that exhibit delayed release properties when administered as either whole or half tablets. The invention is also directed to delayed release tablets comprising deferiprone for oral administration, for which twice daily administration is bioequivalent to the same daily dose of an immediate release tablet administered thrice daily. The invention is also directed to methods of making and using the same.

Abstract: A pharmaceutical composition for colon targeting, a method for treating a colon-related disease using the same and a preparation method thereof are disclosed. The pharmaceutical composition of the present disclosure comprises: a core matrix comprising a cross-linked hydrogel and an active ingredient, wherein the active ingredient is dispersed in the cross-linked hydrogel, and a content of the active ingredient is 65 wt % to 95 wt % based on a total weight of the core matrix.

Abstract: The present invention relates to non-hormonal compositions and methods for inducing a condition of aspermia, azoospermia, or severe oligozoospermia in the male subject such that these compositions and methods for administering the same may be used as male contraception. Embodiments of the present invention may comprise a composition comprising an alpha-1-adrenoreceptor antagonist, such as (R)-silodosin, for daily administration to a male subject. The compositions and related methods may further include pharmaceutically acceptable carriers. The present invention further includes formulations which allow for a delay such that delayed or missed dose(s) do not nullify the contraceptive effect of the treatment regimen. Such compositions and methods may also avoid the side effects associated with typical formulations of alpha-1-adrenoreceptor antagonists.

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: Controlled-release therapeutic compositions including melatonin combined with sedative and/or analgesic ingredients are described. The compositions have a solid core including melatonin in an acidified polymeric matrix. A sedative ingredient such as GABA receptor agonist may also be in the acidified polymeric matrix. The composition may include an expedited release portion providing a burst release of active ingredients and a sustained release portion providing a sustained release of active ingredients.

Abstract: Disclosed herein are compositions and methods for modulating cereblon neosubstrates. A small molecule modulator of Formula (I*), or a pharmaceutically acceptable salt or solvate thereof can be used to modulate cereblon neosubstrates.

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 method for analyzing related substances in a pharmaceutical composition containing an amphiphilic block copolymer comprising a hydrophilic block and a hydrophobic block as a polymeric drug carrier, related substances identified thereby, and a method for evaluating a pharmaceutical composition by using the same are provided. Preferably, the method comprises evaluating a polymeric micelle pharmaceutical composition, which comprises an amphiphilic block copolymer comprising a hydrophilic block (A) and a hydrophobic block (B), and paclitaxel or docetaxel as a poorly water-soluble drug, by using a compound represented by Chemical Formula 1, wherein the hydrophilic block (A) comprises one or more selected from the group consisting of polyethylene glycol or derivatives thereof, polyvinylpyrrolidone, polyvinyl alcohol, polyacrylamide and combinations thereof; and the hydrophobic block (B) is polylactide.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

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: A porous silica material for use as a pharmaceutical or dietary active ingredient having pores in the mesoscale range (2-50 nm), wherein the average pore size of the pores in the mesoscale range is in the range of 2 to 25 nm, and the pore size distribution (PSD) in the mesoscale range is such that at least 80% of the pores fall within the range of 2 to 25 nm.

Abstract: Provided are a solid preparation comprising an alkyl cellulose which provides excellent moldability and disintegrability even in a small amount of the alkyl cellulose, and a production method therefor. Specifically, provided are a solid preparation having an alkyl cellulose having a specific surface area by BET method of 0.5 to 10.0 m2/g and a dissolution start temperature of 5 to 27° C.; and a method for producing a solid preparation having the steps of: mixing a cellulose pulp and a first alkali metal hydroxide solution with stirring to obtain alkali cellulose, reacting the alkali cellulose with an alkylating agent to obtain a first reaction mixture, mixing the first reaction mixture and a second alkali metal hydroxide solution with stirring and without further addition of any alkylating agent to obtain a second reaction mixture, and pulverizing an alkyl cellulose isolated from the second reaction mixture to obtain an alkyl cellulose.

Abstract: Disclosed is a single unit oral dosage form having, in combination, inositol and an extended release clonidine or extended release guanfacine. In one aspect, a method for treating ADHD and/or associated symptoms thereof includes administering to an ADHD patient the single unit oral dosage form. In another aspect, a method for treating ADHD and/or associated symptoms thereof includes administering to an ADHD patient inositol in combination with extended release clonidine or extended release guanfacine, whether administered separately or as a single dosage form.

Abstract: A press coated tablet for delayed release of an active ingredient comprising: (a) a core comprising one or more active ingredients, and; (b) an erodible delayed release barrier surrounding the core and comprising a wax and two or more grades of L-HPC, wherein the wax and L-HPC are provided in a weight ratio of wax to L-HPC of from 30%:70% to 70%:30%. The invention also relates to a method of making the press coated tablet.