Abstract: This invention relates to fat containing consumable food products comprising ?-cyclodextrin. The food products have reduced levels of bioavailable fat but have substantially the same fat, cholesterol and caloric content as a like food without ?-cyclodextrin. The invention also relates to methods for reducing the bioavailability of fats in fat containing food products without reducing caloric intake as determined by bomb calorimetry and to methods for increasing high density lipoproteins in a subject and reducing or controlling weight by administering the food products of this invention.

Abstract: A pharmaceutical composition comprising efavirenz wherein the efavirenz is in the form of nanoparticles is disclosed.

Abstract: The invention relates to an effervescent tablet for preparing a mouth rinsing solution, wherein the effervescent tablet exhibits a high release rate of budesonide. A high availability of the active ingredient during use as a mouth rinsing solution on the inflamed mucosa of the upper digestive tract is thereby achieved. The advantage of the formulation according to the invention lies in the bioavailability comparable to oral forms of administration, which allows the formulation to be used safely over an extended period of time.

Abstract: The invention is directed to oral modified/controlled release drug formulations which provide a rapid initial onset of effect and a prolonged duration of effect. Preferably, the peak concentration is lower than that provided by the reference standard for immediate release formulations of the drug, and the duration of effect falls rapidly at the end of the dosing interval.

Abstract: The object of the present invention is to provide, as a solid preparation for making it easy to take, thus improving patient's compliance etc., an intraorally rapidly disintegrating tablet which can be produced easily without any particular problem by a usual method of producing tablets with a usual tabletting machine, has practically unproblematic hardness, and disintegrate rapidly in the oral cavity. This tablet is produced by tabletting cores coated with a pharmaceutical disintegrating agent, wherein the core is a granule containing a water-soluble medicament or containing a medicament and a sugar.

Abstract: Opiates, amphetamines, barbiturates and other drugs such as benzodiazepines are extensively abused or misused and are frequently the cause of death by overdosing. These drugs are also prone to oxidation and the final degradation products depend on the reactants and the reaction conditions. This invention describes the use of inactivating agents such as permanganates, peroxides, persulfates, bismuthates, periodates or other oxidants in a dosage form as an approach to minimize abuse and overdose. The product is designed such that the inactivating agent is released if there is an attempt to extract the drug from the formulation or in cases of overdose. Once released, the inactivating agent quickly degrades the drug and converts it into inactive compounds. Since the reactants (drug and inactivating agent) are incompatible in situations of normal drug usage, they are kept separated within the vehicle of the invention, but released for interaction in case of misuse.

Abstract: In one aspect, the present invention features a tablet including a first region and a second region, wherein: (i) the first region and the second region each include at least 10%, by volume, of the tablet; (ii) the first region includes a pharmaceutically active agent and the composition of the first region is different from the composition of the second region; (iii) the first region has a density less than about 0.8 g/cc; and (iv) the first region disintegrates in the mouth when placed on the tongue in less than about 30 seconds; wherein the shape of the tablet includes two opposing major faces separated by a side wall, and the interface between the first region and the second region is along at least one major face of the tablet.

Abstract: The present invention relates to a solid molecular dispersion of fesoterodine hydrogen fumarate and a polymeric binder. The invention also relates to an inert core bead or particle which is coated with said solid molecular dispersion and to pharmaceutical formulations comprising such coated beads or particles.

Abstract: The present invention provides a chewable composition containing granules of water-soluble dietary fiber. The chewable composition has highly agreeable organolpetic properties and is consumable without the need of an ingestion aid.

Abstract: This invention relates to compressed solid oral dosage form able to contain a high load of active pharmaceutical ingredient, showing a controlled release profile, and consisting of individual particles wherein each individual particle comprises an active pharmaceutical ingredient and wherein each individual particle is coated with a layer comprising at least one plasticizer.

Abstract: A system for monitoring ingestion of medicine (21) comprises forming a digestible radio frequency identification (RFID) tag (10). The RFID tag is attached to the medicine. The RFID tag and medicine are ingested. A signal from the RFID tag is monitored.

Abstract: Multi-layer solid oral dosage immediate release and extended release compositions and methods for delivering drug formulations using weak acid ion exchange resins in abnormally high pH environments.

Abstract: The present invention relates to a solid phase pharmaceutical composition comprising one or more pharmaceutically acceptable excipients and an active pharmaceutical ingredient (“API”) which is a compound of formula A1 or A2 or a pharmacologically acceptable salt, solvate or hydrate thereof, wherein the API is not exposed to a basic compound.

Abstract: An abuse-deterrent pharmaceutical composition has been developed to reduce the likelihood of improper administration of drugs, especially drugs such as opioids. In a preferred embodiment, a drug is modified to increase its lipophilicity. In some embodiments the modified drug is homogeneously dispersed within spherical microparticles composed of a material that is either slowly soluble or not soluble in water. In some embodiments the drug containing microparticles or drug particles are coated with one or more coating layers, where at least one coating is water insoluble and/or organic solvent insoluble. The abuse-deterrent composition retards the release of drug, even if the physical integrity of the formulation is compromised (for example, by chopping with a blade or crushing) and the resulting material is placed in water, snorted, or swallowed. However, when administered as directed, the drug is slowly released from the composition as the composition is passes through the GI tract.

Abstract: The present invention relates to compounds derived from steroids of the general formula (I) wherein L represents a linker and R# represents a steroid residue, the use of compounds of the general formula (I) in medicine and for the prophylaxis and/or the treatment of infectious diseases. Furthermore described are pharmaceutical compositions containing at least one compound of the general formula (I). A further aspect of the invention relates to the synthesis of said compounds of the general formula (I).

Abstract: A solid oral controlled-release dosage form of hydrocodone is disclosed, the dosage form comprising an analgesically effective amount of hydrocodone or a pharmaceutically acceptable salt thereof, and controlled release material.

Abstract: The present invention is directed to formulations of genistein and methods for making and using the same. In particular embodiments, the formulations described herein include suspension formulations of nanoparticulate genistein.

Abstract: The present invention provides compositions, methods, and kits for improving health in a woman having elevated SHBG levels, or who is receiving oral estrogen supplementation, by non-orally administering an effective amount of an androgenic steroid. Further, the present invention provides compositions, methods, and kits for coadministering an effective amount of an orally administered estrogen and an effective amount of a non-orally administered androgenic steroid for women in need of estrogen supplementation.

Abstract: A method of treating the symptoms of spasticity comprises implanting a reservoir-based drug delivery composition into a subject to systemically deliver a therapeutically effective amount of tizanidine to the subject for a long period of time (e.g., one month or one year). The drug delivery composition may include a rate-controlling excipient (e.g., an elastomeric polymer) defining a reservoir containing at least one discrete solid dosage form (e.g., one or more pellets), which includes tizanidine free base and optionally, a sorption enhancer.

Abstract: Pharmaceutical compositions comprising 5-[2-pyrazinyl]-4-methyl-1,2-3-thione or an analogue, derivative, metabolite, prodrug, solvate or a pharmaceutically acceptable salt thereof; and a pharmaceutical carrier, which promotes association with the outer wall of a subject's digestive tract are described as well as their uses in treating and preventing mucositis and cachexia.

Abstract: A tablet that rapidly disintegrates in the oral cavity comprising a compressed blend of rapidly dispersing microgranules prepared by granulating a sugar alcohol or a saccharide or a mixture thereof having an average particle size less than about 30 microns and a disintegrant, and a taste-masked microcapsule containing at least one drug, the microcapsule being prepared by granulating a pharmaceutically acceptable formulation comprising at least one drug in a therapeutically effective amount and at least one polymeric binder that improves resilience of the microgranules, wet milling the granulated mass, and microencapsulating the milled granules to provide microcapsules.

Abstract: The present invention comprises a co-processed carbohydrate system, and formulations produced therefrom, which formulations are directly compressible into solid dosage forms, some of which rapidly and completely dissolve or disintegrate in the oral cavity within 60 seconds. The invention also comprises the solid dosage forms produced by directly compressing the co-processed carbohydrate system, some of which, when placed in the oral cavity, shall dissolve or disintegrate, preferably within about 60 seconds.

Abstract: The invention provides pharmaceutical compositions comprising a therapeutically effective amount of meloxicam, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical compositions are in the form of a fast disintegrating dosage form suitable for releasing meloxicam rapidly in the oral cavity. Also provided are processes for preparing a pharmaceutical composition of the invention. Further provided are methods of treating arthritis or pain in a subject in need thereof, the method comprising orally administering to the subject a therapeutically effective amount of a pharmaceutical composition according to the invention.

Abstract: Ingestible event markers having high reliability are provided. Aspects of the ingestible event markers include a support, a control circuit, a first electrochemical material, a second electrochemical material and a membrane. In addition, the ingestible event markers may include one or more components that impart high reliability to the ingestible event marker. Further, the ingestible event markers may include an active agent. In some aspects, the active agent, such as a pharmaceutically active agent or a diagnostic agent may be associated with the membrane.

Abstract: The present invention describes a directly compressible composite excipient prepared by coating calcium silicate with a carbohydrate. The present invention further describes the incorporation of the composite excipient into a tablet formulation. The orally disintegrating tablets are of optimal mechanical strength and disintegrate within 60 seconds in the oral cavity.

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: A dosage form comprises: (a) at least one active ingredient: (b) a core having a first surface portion upon which resides a first coating and a second surface portion which is substantially free of the first coating; and (c) a shell which resides upon at least a portion of the second surface portion, wherein the shell comprises a different material from the first coating. In another embodiment, the dosage form comprises: (a) at least one active ingredient; (b) a core comprising a center portion having an exterior surface and an annular portion having an exterior surface and an interior surface, wherein the annular portion interior surface is in contact with at least a portion of the center portion exterior surface, and a coating resides on at least a portion of the annular portion exterior surface; and (c) a shell which resides upon at least a portion of the exterior surface of the center portion, wherein the shell comprises a different material than the impermeable coating.

Abstract: A once a day bupropion hydrochloride formulation is disclosed.

Abstract: The present invention is directed to a sustained release pharmaceutical composition in oral dosage form consisting essentially of a pharmaceutically effective amount of a medicament and a hydrophobic material in the absence of a lactose or hydrophobic carbohydrate polymer, said medicament being present in an amount greater than about 25% of the pharmaceutical composition and having a water solubility greater than about 1 gram per 10 mL of water at 25° C., said hydrophobic material having a melting point ranging from at least about 40° C. to about 100° C. at 1 atm pressure, and being present in an amount ranging from about 3% to about 20% by weight of the pharmaceutical composition and in an amount less than the of the medicament, and said hydrophobic material not being present in coating of said pharmaceutical composition; said pharmaceutical composition being prepared by direct compression in the absence of or melting the hydrophobic material or the use of high shear mixer.

Abstract: A film-coated scored tablet in which the forms of respective parts associated with a score line are optimized so as to more preferably divide the film along the score line is provided.

Abstract: A controlled release delivery system composition and method applied to humans and animals, for oral, anal or vaginal administration of a biological component is disclosed. Preferably, a bacterium is delivered, and more preferably the bacterium is probiotic in nature, however, the biological component is not limited to the bacterium.

Abstract: The invention provides multilayer tablets that contain rilpivirine hydrochloride, emtricitabine, and tenofivir disoproxil fumarate. The tablets are useful for the treatment of HIV.

Abstract: The present invention relates to a multi-layer orally disintegrating tablet having (1) an enteric fine granule-containing layer containing a proton pump inhibitor and (2) an acetylsalicylic acid-containing layer, which shows high stability of the active ingredients (proton pump inhibitor, aspirin) and expresses the pharmacological effects of the active ingredients stably and rapidly after administration.

Abstract: A pharmaceutical composition is provided that includes an active ingredient in the form of a powder or granule, a water soluble high molecular weight excipient and a water insoluble hydrophilic amphiphilic excipient. These ingredients are solution mixed and dried to form a modified pharmaceutical ingredient in simultaneous contact with both the water soluble high molecular weight excipient and the water insoluble hydrophilic amphiphilic excipient. Adjuvants are compacted about the modified pharmaceutical ingredient as well as a release control agent. The release control agent being present at levels from 1 to 40 total weight percent of the pharmaceutical composition.

Abstract: A process for the preparation of a particulate material by a controlled agglomeration method, i.e. a method that enables a controlled growth in particle size. The method is especially suitable for use in the preparation of pharmaceutical compositions containing a therapeutically and/or prophylactically active substance which has a relatively low aqueous solubility and/or which is subject to chemical decomposition. The process comprising i) spraying a first composition comprising a carrier, which has a melting point of about 5° C. or more which is present in the first composition in liquid form, on a second composition comprising a material in solid form, the second composition having a temperature of at the most a temperature corresponding to the melting point of the carrier and/or the carrier composition and ii) mixing or others means of mechanical working the second composition onto which the first composition is sprayed to obtain the particulate material.

Abstract: Compositions, systems and methods for administration of small volume sufentanil drug dosage forms via the oral transmucosal route of a subject for treatment of pain.

Abstract: Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

Abstract: The present invention provides compositions that contain magnesium and threonate, or a threonate precursor molecule, formulated for extended or modified release to provide physiological concentrations over a desired time period. The extended release or modified release form is particularly useful in providing Mg to a subject while avoiding adverse side effects such as diarrhea.

Abstract: The present invention provides a method for producing spherical fine particles containing tamsulosin hydrochloride, the method includes the steps of: (1) mixing and stirring tamsulosin hydrochloride (a), microcrystalline cellulose (b), and water until a mixture of the component (a) and the component (b) is uniformly impregnated with the water; (2) granulating the mixture obtained in step (1) using an stirring granulator whose peripheral speed is set to be 5.5 to 9.0 m/s; and (3) drying the granules obtained in step (2). The present invention also provides spherical fine particles obtained according to the method, coated fine particles obtained by applying a coating to the spherical fine particles, and an orally disintegrating tablet containing the coated fine particles.

Abstract: Crystalline aripiprazole Type II can be formulated into pharmaceutical tablets having reduced dissolution profile variability upon storage.

Abstract: There is provided an alkaloid formulation comprising the reaction product of one or more alkaloids with one or more phosphate derivatives of one or more electron transfer agents.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: The use of levo-ornidazole in the preparation of medicine for preventing and treating the anti-anaerobic bacteria infection is provided. It is demonstrated that levo-ornidazole exhibits lower toxicity and less central inhibition effects than dextro-ornidazole or racemic ornidazole. L-ornidazole possesses pharmacokinetics characteristics, which are superior to that of the racemic ornidazole, and anti-anaerobic activities which are slightly better than or substantially the same as that of the racemic ornidazole. Also, this invention particularly relates to a preparation process, which comprises formulating L-ornidazole as anti-anaerobic infection pharmaceutical preparations, which are suitable for clinical uses.

Abstract: The invention relates to a rapidly disintegrating oral antihistamine dosage formulation and method of preparing the rapidly disintegrating formulation wherein the formulation is designed to dissolve in the buccal cavity of the patient.

Abstract: Provided are therapeutics, uses and methods in which neuro-regenerative therapy using neuroprotective agents, or anti-neuropathic agents, to prevent loss or restore hematopoietic capacity and progenitor mobilization.

Abstract: There is provided a formulation suitable for transmucosal administration comprising a short acting hypnotic drug, which formulation provides a measurable plasma concentration of drug within 10 minutes of administration. The formulation is capable of providing sleep on demand, and preferably comprises particles of drug, for example zolpidem or a pharmaceutically-acceptable salt thereof and a mucoadhesion promoting agent, such as sodium carboxymethylcellulose, which particles of drug and mucoadhesive are presented upon the surface of larger carrier particles.

Abstract: Medical devices containing time release drug substance are disclosed, including medical tubing, catheters, stents, cables (including fiber optic cables), pills, capsules, sheaths, threads, clamps, sutures, and endotracheal devices. A method for extruding multiple laminated flow streams using microlayer coextrusion to create various time release drug delivery products is also disclosed.

Abstract: Provided herein is a pharmaceutical composition that comprises a pharmaceutically acceptable carrier or diluent and, as an active ingredient, the compound 2-(1H-indazol-4-yl)-6-(4-methanesulfonyl-piperazin-1-ylmethyl)-4-morpholin-4-yl-thieno[3,2-d]pyrimidine bismesylate.

Abstract: The present invention provides compositions comprising methylnaltrexone or a salt thereof, and compositions and formulations thereof, for oral administration.

Abstract: Pharmaceutical compositions that have excellent storage stability even though they include a active component that is susceptible to degradation in an acidic environment are disclosed. The stabilized pharmaceutical composition of the invention includes a ring-opened 7-substituted-3,5-dihydroxyheptanoic or a ring-opened 7-substituted-3,5-dihydroxyheptenoic acid, or a pharmaceutically acceptable salt thereof, as an active component and a stabilizing effective amount of at least one amido-group containing polymeric compound or at least one amino-group containing polymeric compound, or combination thereof; wherein the stabilized pharmaceutical composition does not contain a stabilizing effective amount of another stabilizer or a combination of other stabilizers.