Abstract: The present application provides a method for treating or preventing Celiac disease. In one embodiment the method comprises administering to a patient in need thereof a composition comprising minicapsules, wherein the minicapsules comprise a steroid in a liquid, semi-solid or solid core, the minicapsules having release profiles to release the steroid in an active form at one or more sites along the gastrointestinal tract, the one or more sites comprising the proximal small intestine beginning at the duodenum and ending at the ileum. In a related embodiment the method comprises administering budesonide to a patient in need thereof in a pre-solubilised drug delivery format.

Abstract: Pharmaceutical compositions in unit dose form comprising a hard or soft capsule containing a fill consisting of one or more inert ingredients, and one or more coatings on the capsule, wherein at least one coating comprises at least one active pharmaceutical ingredient.

Abstract: An embodiment of the present invention relates to a therapeutic combination including (a) lacosamide and/or a pharmaceutically acceptable salt thereof; and (b) levetiracetam and/or a pharmaceutically acceptable salt thereof. The combination can be provided in a single dosage form or separate dosage forms.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: A medicament comprising a dispersion of Red Yeast Rice extract in Omega-3 Oils. The medicament is supplied in capsules such that a daily dose is dispensed in an integral number of capsules. A dispersant is used, preferably Lysine and bamboo. The ratio of Red Yeast Rice Extract to EPA+DHA is in the range between about 1.4 and 2.8. The medicament reduces cholesterol, triglycerides, and reduces serious heart incidents.

Abstract: A matrix formulation for a soft chewable capsule is provided which includes a gel-forming composition, a plasticizer, a polymer modifier, and water. The polymer modifier may be a carboxylic acid or other organic compound that alters the physical and/or chemical properties of the capsule formulation. A chewable soft capsule is also provided, having enhanced organo-leptic and processing properties. An active material may be delivered to a user using this dosage form. A method of forming the chewable soft capsule is also provided.

Abstract: A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.

Abstract: The present invention provides methods for reducing A? deposition, A? neurotoxicity and microgliosis in an animal or human afflicted with a cerebral amyloidogenic disease, such as Alzheimer's disease (AD), by administering therapeutically effective amounts of the (R)-enantiomer of the dihydropyridine compound nilvadipine, also known as (?)-nilvadipine, to the animal or human. Further provided are methods for reducing the risk of A? deposition, A? neurotoxicity and microgliosis in animals or humans suffering from traumatic brain injury by administering (?)-nilvadipine after the traumatic brain injury and continuing treatment for a prescribed period of time thereafter.

Abstract: The present invention provides methods for reducing A? deposition, A? neurotoxicity and microgliosis in an animal or human afflicted with a cerebral amyloidogenic disease, such as Alzheimer's disease (AD), by administering therapeutically effective amounts of the (R)-enantiomer of the dihydropyridine compound nilvadipine, also known as (?)-nilvadipine, to the animal or human. Further provided are methods for reducing the risk of A? deposition, A? neurotoxicity and microgliosis in animals or humans suffering from traumatic brain injury by administering (?)-nilvadipine after the traumatic brain injury and continuing treatment for a prescribed period of time thereafter.

Abstract: A pharmaceutical preparation comprising EPA in an appropriately assimilable form where of all the fatty acids present in the preparation at least 90%, and preferably at least 95%, is in the form of EPA and where less than 5%, and preferably less than 3%, is in the form of DHA is provided.

Abstract: Described are new uses of recombinant adenoviral vectors in vaccination regimens, such as prime/boost set-ups and subsequent vaccinations and applications for gene therapy. Moreover, also described are new assays to determine the best regimen for applying the most suitable recombinant viral vector in a vaccination or gene therapy setting.

Abstract: An innovative pharmaceutical form for controlled drug release relates to systems obtained by the assembly of individual release modules, of which the capacity to release the drug in time and in space depends on the way in which the modules have been assembled. The modular structure offers high reproducibility of manufacture and flexibility of release.

Abstract: Liquid softgel fill formulations include (i) 26-32% by weight acetaminophen, (ii) 47-51% by weight polyethylene glycol having an average molecular weight of 200-800, (iii) 3-7% by weight propylene glycol, (iv) 9-13% by weight Povidone K17, and (v) 6-10% by weight purified water. The fill formulations are free of alkali metal ions. Also disclosed are a method of preparing the above-described fill formulations and softgel capsules containing the same fill formulations.

Abstract: The invention provides a composition comprising microparticles of a water-insoluble or poorly soluble compound, at least one phospholipid, and at least one surfactant, produced by applying an energy to a mixture comprising particles of the compound, the at least one phospholipid, and the at least one surfactant so as to obtain the microparticles. The invention also provides a process for preparing microparticles of a water-insoluble or poorly soluble compound. The process includes mixing particles of a water-insoluble or poorly soluble compound with at least one phospholipid and at least surfactant to form a mixture and applying energy to the mixture sufficient to produce microparticles of the compound. The methods of the invention allow for the production of microparticles smaller than particles produced through previously known methods and the microparticles exhibit advantageous properties including remarkable resistance to particle size growth during storage.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: The present invention is directed to compositions and methods of delivery of CoQ-10 solubilized in monoterpenes. Use of monoterpenes as dissolving agents, greatly effects the ability to incorporate greater amounts of bioactive CoQ-10 in formulations, such as soft gel capsules.

Abstract: The present invention relates to 1 or 2 C16-C18 acyl glycerol based compounds which are capable of activating G-protein coupled receptor 119 and thereby stimulate GLP-1 release. Compounds of the present invention are useful in the prophylaxis and/or treatment of metabolic disorders and complications thereof, such as, type 2 diabetes mellitus (T2DM), obesity, insulin resistance, and cardiovascular disease.

Abstract: A pharmaceutical composition comprising a phenylamidine derivative or a salt thereof, represented by a general formula, wherein R1 and R2 may be same or different, and represent an optionally substituted C3-4alkyl group; and one or more agents selected from azole antifungal agents, polyene antifungal agents, candin antifungal agents and fluoropyrimidine antifungal agents, and a method for combination use of the phenylamidine derivative or a salt thereof and the agents are useful for treating fungal infections caused by a fungal pathogen.

Abstract: The invention provides compositions for an administration to a mammal orally or in a suppository that include one or more edible oils (preferably including one or more omega-3 fatty acids), one or more plant stanols, phytosterols, or esters thereof, and admixed in the one or more edible oils one or more water-soluble vitamins and/or minerals, for example, vitamins B6, B9 and/or B12. The invention also provides a method of making the compositions comprising mixing the foregoing components to form a suspension or emulsion of the vitamins and/or minerals in the edible oils. The mixture can be inserted into hollow soft or hard capsules, gelcaps or caplets. The edible oils can coat particles of the water-soluble vitamins and/or minerals, which may provide them with an improved absorption in the body due to an increased resistance to degradation in the acidic environment of the stomach.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: The invention relates to a controlled release composition comprising a combination of isosorbide dinitrate and hydralazine, such as hydralazine hydrochloride, that in operation delivers the drug in a pulsed or multi-modal manner for the treatment of angina, ischaemic heart disease, arterial hypertension and related disease conditions. Preferably, the isosorbide dinitrate and hydralazine hydrochloride can be released from the dosage form in an erodable, diffusion and/or osmotic-controlled release profile.

Abstract: The present invention relates to, inter alia, pharmaceutical compositions comprising a polyunsaturated fatty acid and to methods of using the same to treat or prevent cardiovascular-related diseases.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: Dosage forms and drug delivery devices suitable for administration of pharmaceutical compounds and compositions, including the oral drug administration of compounds.

Abstract: A composition for vaginal insertion is in the form of a softgel, a two-part gelatin capsule, a tablet, or a suppository. The composition is designed to promote the growth of native vaginal flora, but does not promote the growth of Gardenerella vaginalis and Candida albicans. The composition includes a prebiotic in a pharmaceutically acceptable excipient and is essentially free of probiotics, lactoferrin, and plant extracts containing isoflavones.

Abstract: Stable solutions of lipophilic drugs, such as cyclosporin, forming a polar lipid self-emulsifying drug delivery system. The solutions can include lipophilic drugs, such as cyclosporin, dissolved in a polar lipid, such as having a C6-C12 fatty acid monoglyceride content of at least about 50%, surfactants and triglycerides. The composition forms a fine emulsion on exposure to water. The encapsulated dosage form of this composition needs neither a hydrophilic component nor air-tight blister packaging, and is particularly suitable for oral administration.

Abstract: The present invention provides a composition comprising a cefditoren, or a salt, derivative, prodrug, or other form thereof, for example, cefditoren pivoxil, useful in the treatment and prevention of infections and related conditions. The invention provides a composition which comprises nanoparticulate particles comprising the cefditoren, or a salt, derivative, prodrug, or other form thereof and at least one surface stabilizer. The nanoparticulate particles have an effective average particle size of less than about 2000 nm. The invention provides also a composition that delivers a cefditoren, or a salt, derivative, prodrug, or other form thereof, or nanoparticles comprising the same, in a pulsatile or continuous manner.

Abstract: Pharmaceutical compositions of metabotropic glutamate 5 receptor (mGlu5) antagonists or a pharmacologically acceptable salt thereof are disclosed. The compositions contain the therapeutic active compound with non-ionic polymer and ionic polymer, binder and fillers in either matrix pellet, matrix tablet or coated pellets. The compositions provide a pH-independent in vitro release profile with NMT 70% in one hour, NMT 85% in 4 hour, and NLT 80% in 8 hours. The compositions are useful for the treatment of CNS disorders, such as Treatment-Resistant Depression (TRD) and Fragile X Syndrome.

Abstract: A matrix formulation for a soft chewable capsule is provided which includes a gel-forming composition, a plasticizer, a polymer modifier, and water. The polymer modifier may be a carboxylic acid or other organic compound that alters the physical and/or chemical properties of the capsule formulation. A chewable soft capsule is also provided, having enhanced organo-leptic and processing properties. An active material may be delivered to a user using this dosage form. A method of forming the chewable soft capsule is also provided.

Abstract: A matrix formulation for a soft chewable capsule is provided which includes a gel-forming composition, a plasticizer, a polymer modifier and water. The polymer modifier may be a carboxylic acid or other organic compound that alters the physical and/or chemical properties of the capsule formulation. A chewable soft capsule is also provided, having enhanced organo-leptic and processing properties. An active material may be delivered to a user using this dosage form. A method of forming the chewable soft capsule is also provided.

Abstract: The present invention provides methods of treating a human or other mammal infected with a parasitic microorganism by administering an effective amount in unit dosage form of a C8-C16-alpha, beta-unsaturated aliphatic aldehyde, such as trans-2-dodecenal, to the human or other mammal. The parasitic microorganisms may include trypanosomes, bacteria, fungi and nematodes.

Abstract: The present invention relates to a method for preparing microcapsules by coacervation, and to the use of transglutaminase for cross-linking in complex coacervation. The present invention relates further to coacervation processes in general in which a material to be encapsulated is added to a solution comprising at least one colloid below the gelling temperature of the colloid. According to a method of the present invention, an emulsion or suspension of hydrophobic material is prepared after cooling a solution that includes hydrocolloids below the critical gelling temperature of a coacervate phase.

Abstract: The invention relates to a pharmaceutical formulation of nanonised fenofibrate, to a method for preparing same, and to the uses thereof.

Abstract: Described are controlled release nanoparticulate formulations comprising a nanoparticulate agent to be administered and a rate-controlling polymer which functions to prolong the release of the agent following administration. The novel compositions release the agent following administration for a time period ranging from about 2 to about 24 hours or longer.

Abstract: The present invention provides a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which includes: a soft gelatin capsule shell including gelatin and sugar alcohol as a plasticizer, and a mixture including a 15-keto-prostaglandin compound and a pharmaceutically acceptable vehicle which is filled in the shell. By encapsulating the 15-keto-prostaglandin compound in the specified soft gelatin capsule shell, stability of the compound is significantly improved.

Abstract: The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.

Abstract: The present invention relates to oral dosage form with active agents in controlled release cores and in immediate release gelatin capsule coats.

Abstract: The invention provides a delivery device for the delayed release of an active agent in the gastrointestinal tract comprising a core, comprising an active agent; a first outer coating, comprising a relatively hydrophobic substantially water insoluble polymer having substantially water insoluble hydrophilic particles embedded therein; and a first inner coating layer, comprising an agent that can cause the dissolution of at least one of the water insoluble components of the outer coating, and optionally a water soluble polymer, such that the insoluble particles in the outer coating, upon absorption of liquid, form channels leading to the inner coating layer, thus enabling the dissolution thereof, whereby the agents contained therein are released to cause the dissolution and/or degradation (destruction) of the outer coating, and the release of the pharmaceutically acceptable active agent from the core of the device.

Abstract: The present invention relates to methods of co-administration of various vitamin and mineral compositions, and in a specific embodiment, said methods comprise co-administering one composition comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D3, vitamin E, iron, magnesium and zinc, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states; and kits provided for co-administration of various vitamin and mineral compositions, and in a specific embodiment, said kits comprise one composition comprising vitamin A, beta carotene, B-complex vitamins, vitamin C, vitamin D3, vitamin E, iron, magnesium and zinc, and a second composition comprising omega-3 fatty acids such as DHA, to supplement the nutritional needs of individuals within physiologically stressful states.

Abstract: This document relates to methods and materials for administering bile acid compounds to treat conditions associated with constipation. For example, formulations designed for the delayed-release of a bile acid compound (e.g., sodium chenodeoxycholate) to treat constipation are provided.

Abstract: Disclosed is a method for stabilizing a pharmaceutically active bi-cyclic compound of formula (I): comprising the step of: admixing the same with a polyol and/or a fatty acid ester other than glyceride and a composition obtained by the method. In addition a soft gelatin capsule formulation of the compound of formula (I) obtained by incorporating the compound in a soft gelatin capsule shell comprising gelatin and a polyol plasticizer.

Abstract: Disclosed is a method for stabilizing a pharmaceutically active bi-cyclic compound of formula (I): comprising the step of: admixing the same with a polyol and/or a fatty acid ester other than glyceride and a composition obtained by the method. In addition a soft gelatin capsule formulation of the compound of formula (I) obtained by incorporating the compound in a soft gelatin capsule shell comprising gelatin and a polyol plasticizer.

Abstract: Dosage forms comprising therapeutically active compounds are disclosed herein.

Abstract: This invention discloses drug-delivery compositions, methods of making prodrugs, and methods of drug delivery using a self-assembled gelator. The backbone of the gelator can contain a drug or prodrug, such as acetaminophen or salicin. Additional drugs or agents can be encapsulated in the gelator. Enzymatic or hydrolytic cleavage can be used to release the drugs.

Abstract: A material comprising from 30 to 80% by weight of ursolic acid, from 2 to 25% by weight of oleanolic acid and from 1 to 68% by weight of triterpenoic acids other than ursolic acid or oleanolic acid, or derivatives of any of these acids, said percentages being based on total weight of said acids or derivatives and the percentages of said acids or derivatives adding up to 100%, can be used in the prevention or treatment of hypersensitivity and/or hyper-reactivity.

Abstract: The present invention relates provides pharmaceutical compositions comprising an amorphous carvedilol salt and one or more pharmaceutically acceptable excipients, wherein the amorphous carvedilol salt is formed in situ during the preparation of the pharmaceutical composition. The amorphous carvedilol salt is preferably an amorphous carvedilol phosphate salt. The pharmaceutical compositions can be prepared by providing one or more inert cores; contacting the core or cores with a solution or a dispersion comprising carvedilol, an acid component and optionally a binder, in a solvent; removing the solvent; and optionally coating the core or cores with an extended release composition. Preferred pharmaceutical compositions contain both immediate-release pellets and at least one population of extended-release pellet.

Abstract: Medicaments and therapeutic compositions contain (1) phospholipids having 4,7,10,13,16,19-docosahexaenoic acid covalently bound thereto and (2) at least one omega-3 polyunsaturated fatty acid, or at least one pharmaceutically acceptable omega-3 polyunsaturated fatty acid derivative or mixtures thereof, wherein about 25% of the total 4,7,10,13,16,19-docosahexaenoic acid moieties in the composition are covalently bound to phospholipids, and wherein components (1) and (2) are present in amounts effective to support overall neurological health in a subject.

Abstract: Medicaments and therapeutic compositions contain (1) at least one omega-3 polyunsaturated fatty acid, or at least one pharmaceutically acceptable omega-3 polyunsaturated fatty acid derivative or mixtures thereof, (2) glucosamine sulfate, and (3) undenatured Type II collagen. One source of the fatty acids or derivatives thereof is fish oil. The compositions are useful for promoting joint health in a subject.