Abstract: The invention relates to coating of suppositories containing free unsaturated fatty acid, fatty acid ethyl ester and fatty acid monoglyceride that are susceptible to oxidative degradation. The coating retards oxidative degradation of unsaturated fatty acids and gives the suppository a non-oily and smooth surface. The coating will enhance the shelf-life of the suppository and allow their storage at room temperature for extended time period. The coating may or may not contain medicament such as local anesthetic or steroid. According to this invention chemically unstable fatty acids in coated suppositories can be used to stimulate the process of defecation or to treat disorders such as hemorrhoids, bacterial infections, viral infections and inflammations, as well as against fissura ani and pruritus ani. Furthermore, coating suppositories, that contain high concentrations of free fatty acids, can reduce acid induced rectal irritation.

Abstract: Abstract: A coating composition comprising a) a cellulose ether, and b) a water-dispersible starch which has, when measured as a 15 wt.-% dispersion in water at 25° C., a number average particle size of from 0.01 to 2 micrometers and a viscosity of not more than 2000 mPa·s, wherein the weight ratio between the cellulose ether and the water-dispersible starch is from 1:2 to 20:1, is useful for efficiently coating dosage forms with a low moisture permeability.

Abstract: This invention describes the use of sTNF-R as a targeting agent attached to liposomes incorporating anti-inflammatory drugs to treat arthritis and other inflammatory diseases. A variety of steroidal and non-steroidal drugs and disease modifying drugs and other anti-inflammatory compounds may be incorporated into the sTNF-R coated liposomes. The sTNF-R coated drug liposomes will accumulate within the inflamed site where the drug is released for maximum therapeutic effect. Other nanosized drug delivery vehicles such as dendrimers, micelles, nanocapsules and nanoparticles may be similarly coated with sTNF-R and used to deliver the drug to the site of inflammation.

Abstract: Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed.

Abstract: Stable pharmaceutical compositions of famotidine and ibuprofen in a single unit dosage form are disclosed herein. The compositions comprise a famotidine core having a reduced or minimal surface area surrounded by a layer of ibuprofen. In some embodiments, the ibuprofen is in direct physical contact with the famotidine.

Abstract: Disclosed are improved granular pharmaceutical preparations, together with improved methods and apparatus for preparation of granules for use in such preparations. Such methods are especially useful for making granules for solid oral dose pharmaceutical preparations, and are particularly suited to the production of granules comprising 5-aminosalicylic acid (5-ASA) for the treatment of inflammatory bowel disease. The granules exhibit a more sharply peaked length distribution, and hence aspect ratio distribution, and have a consequently much sharper dissolution profile after further processing.

Abstract: A multi-particulate pharmaceutical composition suitable for administration in a sprinkle dosage form said particles being less than 2 mm in diameter and comprising a) inert core particles b) an inner layer surrounding said inert core particles, said layer comprising atorvastatin calcium, methyl methacrylate butyl methacrylate-dimethylaminoethyl methacrylate copolymer and disintegrant and c) an outer taste masking layer surrounding the inner layer, said outer layer comprising methyl methacrylate butyl methacrylate-dimethylaminoethyl methacrylate copolymer.

Abstract: Adhesive patches for non-invasive pain relief comprising a molded backing layer including first and second well portions. An adhesive composition (e.g., chitosan derived) is disposed within the first well composition, and a skin penetrating anesthetic composition is disposed within the second well portion. The first well portion surrounds the perimeter of the second well portion, creating a barrier to prevent or minimize migration of the anesthetic composition outside the perimeter of the second well portion, targeting delivery to the desired site. The skin penetrating anesthetic composition includes a skin penetrating carrier (e.g., DMSO with small fractions of water and ethanol), a primary adhesive component (e.g., hydroxypropyl cellulose) to render the anesthetic composition sticky to the person's tissue, and at least one anesthetic component (e.g., -caine based components). Where two anesthetic components are included, one may act more rapidly to anesthetize pain than the first anesthetic component.

Abstract: A solventless method for forming a coating on a medical electrical lead is described. The method includes combining particles of a therapeutic agent with a polymeric material in a flowable form in the absence of a solvent to form a uniform suspension. A predetermined amount of the suspension is dispensed onto a portion of the lead and is then cured to form the therapeutic agent eluting layer. Additional layers such as a primer layer, fluoro-opaque layer and/or a topcoat layer can be formed using the solventless method. Employing a solventless method may avoid contraction of the layer being formed due to solvent evaporation during the curing process, and may facilitate greater control over the thickness of the therapeutic agent eluting coating.

Abstract: Taste-masked Ibuprofen granules and a process for preparation thereof, as well as an oral dosage form including such taste-masked Ibuprofen granules and the use of said granules in an oral dosage form.

Abstract: The present invention provides improved formulations of 6-mercaptopurine that exhibit better bioavailability and faster dissolution than previous formulations.

Abstract: The present invention provides non-peptide compounds of formula (I) wherein: X is —(C1-C8)allcyl-, aryl or -aryl(C1-C8)alkyl-; Y is —(C1-C8)alkyl- or absent; W is heteroaryl, (C3-C7)carbocycle or aryl, wherein any heteroaryl, (C3-C7)carbocycle or, aryl of W is optionally substituted with one or more (e.g. 1, 2, 3, 4 or 5) Z1 groups; R1 is (C1-C8)alkyl, (C2-C8)alkenyl, (C2-C8)alkynyl or aryl, wherein aryl is optionally substituted with one or more (e.g. 1, 2, 3, 4 or 5) groups selected from (C1-C8)alkyl, (C2-C8)alkenyl, (C2-C8)alkynyl, (C3-C7)carbocycle, halo(C1-C3)alkyl, —CN, NO2, halogen, —ORa, —SRa, —S(O)2NRbRc, —NRbRc, —NRaCORd, —C(O)Ra, —C(O)ORa, and —C(O)NRbRc; R2 is (C1-C8)alkyl, (C2-C8)alkenyl, (C2-C8)Jalkynyl or aryl, wherein aryl is optionally substituted with one or more (e.g.

Abstract: An exemplary method of printing medications on digestible substrates is described. Single component nonmagnetic toners with active pharmaceutical ingredients (API) embedded or “dissolved” in the toner are used. The binders for the toner are digestible. The “printing” process includes loading the single component non-magnetic toners from a sump to a donor roll and developing them either directly onto the substrate or through the use of an intermediate member. Traditional xerographic charge and exposure can be used to make the tablet “imprints”. Dosage is controlled through “solid area” or halftone development (when charge and exposure are used). The “printed” first layer may undergo cold or warm pressure fusing. This medicament layer is then subjected to another station to “print” a second layer of medical “tablet”. Multiple stations may be used to build up a complete personalized tablet. Optionally, a final station prints protective overcoat materials to finalize the “tablet”.

Abstract: A stable formulation of telmisartan and hydrochlorothiazide having both substances in separate units is prepared, exhibiting exceptional stability when subjecting to stress conditions.

Abstract: Provided are microparticles of active pharmaceutical ingredients, drug delivery vehicles comprising same, and methods for making them.

Abstract: The present invention herein provides an imidafenacin-containing orally rapidly disintegrating tablet which is excellent in the photostability. The present invention comprises the steps of: (A) granulating imidafenacin together with starch to thus give a granulated product having an imidafenacin concentration ranging from 0.001 to 3% by mass and a starch concentration ranging from 40 to 99.999% by mass; (B) covering the granulated product prepared in the step (A) with a non-cellulosic coating agent; and (C) blending the granulated product obtained in the preceding step (B) with an excipient and a disintegrating agent and then forming the resulting mixture into a tablet according to the compression molding technique.

Abstract: Disclosed is a computer-implemented method of pill analysis including the steps of acquiring a pill image having an image frame and detecting contrast shifts within the image frame to locate at least one object with an object outline. A first value for the object(s) is determined, where the value is an area, a position, a length, a width, an angle, a color, a brightness, a code, a shape, a crystal pile size, a crystal geometry, a substance identity, or a character identity. Based on the first and second values, the computer outputs a result to a user.

Abstract: This invention relates to a oral pharmaceutical formulation for methylphenidate or its analogs, derivatives, isomers or enantiomers, including d-threo-methylphenidate.

Abstract: The object of the invention consists of pharmaceutical formulations containing rifaximin in the shape of microgranules made gastroresistant by an insoluble polymer at pH values between 1.5 and 4.0 and soluble at pH values between 5.0 and 7.5, by their preparation and by their use in the manufacture of medicinal preparations useful in the treatment of inflammatory bowel diseases (IBD) and mainly Crohn's disease.

Abstract: A method of making catheters is disclosed in which the wall of the catheter has a porous structure for carrying additional agents, such as therapeutic agents, diagnostic agents and/or device enhancements. The method includes applying a base polymer material and an inert material over the outer surface of a core, and curing or consolidating the base polymer material to form a catheter having a porous polymer layer with the inert material contained within the pores thereof. The inert material can be applied with the base polymer material or in a separate step after the base polymer material has been partially cured or consolidated to form the porous polymer layer. Additional agents can be mixed with the inert material before it is applied to the catheter, or can be applied to the porous polymer layer of the catheter in a separate step after the inert material is removed therefrom.

Abstract: The present invention is a solventless method of producing polymer coated active pharmaceutical ingredient that is taste-masked and may be released in relatively short time. It employs high energy vibrations or acoustic mixing of API particles, water soluble coating material particles and hydrophobic polymer particles, with or without use of other pharmaceutically relevant powders as media. Additionally the method is capable of producing individually coated drug particles without agglomeration or the long drying times associated with solvent based coating methods.

Abstract: A taste masked particulate pharmaceutical formulation include a core that comprises an active pharmaceutical ingredient; at least a partial nanoparticle material layer on the core that comprises a nanoparticle material with a median particle size not greater than 100 nm; a first polymer layer that is at least partially water soluble and a second polymer layer that is water insoluble. The active pharmaceutical ingredient is completely released in 30 minutes in the USP Dissolution Test. A process of making the particulate pharmaceutical formulation using sequential fluidized bed coating steps under controlled conditions is also described.

Abstract: The present invention describes a process for the manufacture of a solid composition comprising a microorganism, which process comprises a first step of blending and/or compacting the microorganism with a salt of a medium or long-chain fatty acid to prepare a powderous mixture or compacted granulate, and a second step of providing said powderous mixture or compacted granulate with a coating. The microorganisms are preferably probiotics. The invention also relates to the solid composition obtained by said process and to its use in food.

Abstract: As detailed herein, a biocompatible apparatus comprises a porous material comprising ceramic nanotubes bound together with a filler material. The proportion of the filler material may be selected to provide porosity for the porous material that is biocompatible, and the porous material may be shaped to provide a compliant biomedical device. In one embodiment, the compliant biomedical device is a stent such as intravascular stent. A method for fabricating a biocompatible device is also described herein. The method may include growing ceramic nanotubes on a substrate, infiltrating the ceramic nanotubes with a filler material to provide a porous material having a porosity that is biocompatible, and removing the porous material from the substrate to provide a biocompatible ceramic device. The method may also include coating the biocompatible ceramic device with a drug-eluting material.

Abstract: Systems and methods for coating a particle core with a layer-by-layer film are disclosed.

Abstract: This invention relates to methods for the stabilization, storage and delivery of biologically active macromolecules, such as proteins, peptides and nucleic acids. In particular, this invention relates to protein crystals, formulations and compositions comprising them. Provided are methods and compositions for encapsulating proteins, glycoproteins, enzymes, antibodies, hormones and peptide crystals or crystal formulations into compositions for biological delivery.

Abstract: A process for producing a solid dispersion of an active ingredient which comprises feeding the active ingredient and a matrix-forming agent to an extruder and forming a uniform extrudate, wherein the extruder comprises at least two rotating shafts (2), each of the shafts (2) carrying a plurality of processing elements disposed axially one behind the other, the processing elements defining (i) a feeding and conveying section (R; A), (ii) at least one reverse-flight section (D), and (iii) a discharging section (E), wherein the processing elements defining the reverse-flight section (R; D) comprise at least one reverse-flight element (14) which is based on a screw-type element having a conveying direction being opposite to the general conveying direction of the extruder.

Abstract: A method is provided that produces nanocomposite materials containing well-dispersed, nanoparticles encapsulated in a polymer matrix. A feedstock comprising a colloidal dispersion of nanoparticles in a solvent and a polymer dissolved in the same solvent is passed through an ultrasonic nozzle using a flow control device, producing an aerosol of drops having diameters less than about 100 micrometers. The aerosol of drops is then mixed with a fluid that is miscible with the solvent, is a nonsolvent for the polymer, and destabilizes the colloidal dispersion. As a result, well-dispersed polymer-encapsulated nanoparticles precipitate. The method operates at atmospheric temperature and pressure and allows for independent control of the precipitation of the particle and of the polymer.

Abstract: The manufacture of compositions containing montelukast and to stable tablet compositions resulting thereof are disclosed, which include a first compaction step of a dry blend including, montelukast or a pharmaceutically acceptable salt thereof, and microcrystalline cellulose, and a further compression step into tablets.

Abstract: An apparatus includes a piezoelectric print head capable of ejecting a droplet of a coating substance towards a stent strut, a sensor capable of sensing a parameter of the droplet, and a controller, communicatively coupled to the print head and the sensor, capable of determining if the parameter of the droplet meets a requirement. A method includes ejecting a droplet of a coating substance towards a stent strut with a piezoelectric print head, sensing a parameter of the droplet, and determining whether the parameter of the droplet meets a requirement.

Abstract: An assembly and method for producing a condensation aerosol are disclosed. The assembly includes a heat-conductive metal substrate with an oxidation resistant exterior surface and a drug composition film on the exterior surface and is for use in an aerosol device. The thickness of the film and the surface of the substrate is such that the aerosol formed by vaporizing and condensing the drug composition the aerosol contain 10% by weight or less drug-degradation products and at least 50% of the total amount of the drug composition in the film. The methods for treating the exterior surface include heat and chemical treatment and formation of a protective overcoat.

Abstract: The present invention is directed to a Tobacco Free Hookah Smoking System that will have a head (bowl) at the upper end of a tubular stem that extends into the jar or Shisha containing water. One or more additional tubular members extend out of the Shisha making up the inhaling tube and the check valve. The spheres will be made from porous materials such as Hydroton® synthetic clay, or Growstones® glass (or a like substance) other stone materials, cobblestone, and other natural and synthetic porous materials. The spheres will be made by soaking in a solution of sweetener, glycerin and various flavorings along with the added option of herbal extracts/oils, vitamins, and other medical/health compounds. Ready Pack Smoke Cups containing the spheres will be available. An alternate embodiment will have the Cup Holder that can be filled with recycled porous spheres or porous spheres that have been purchased in bulk.

Abstract: A multiparticulate formulation includes a plurality of individual spheroidal enteric coated cores containing L-menthol from an at least 80% pure L-menthol source. A subcoat is beneath the enteric coat. The enteric coated cores have a diameter of not more than 3 mm. The multiparticulate formulation may be used to treat gastrointestinal disorders, such as irritable bowel syndrome.

Abstract: The present invention relates to a coated pharmaceutical composition containing regorafenib, a hydrate, solvate, metabolite or pharmaceutically acceptable salt thereof or a polymorph thereof and its process of preparation and its use for treating disorders.

Abstract: The present invention relates to a solid pharmaceutical composition including the active principle 6-oxo-6,7,8,9,10,11-hexahydrocyclohepta[c]chromen-3-yl sulfamate. The present invention also relates to polymorphs of the 6-oxo-6,7,8,9,10,11-hexahydrocyclohepta[c]chromen-3-yl sulfamate compound.

Abstract: A pharmaceutical composition comprises, as a first active agent, 6?,7?;15?,16?-dimethene-3-oxo-17?-pregn-4-ene-21,17-carbolactone (drospirenone) in an amount corresponding to a daily dosage, on administration of the composition, of from about 2 mg to about 4 mg, and, as a second active agent, 17?-ethinylestradiol (ethinylestradiol) in an amount corresponding to a daily dosage of from about 0.01 mg to about 0.05 mg, together with one or more pharmaceutically acceptable carriers or excipients. In a specific embodiment, the composition consists of a number of separately packaged and individually removable daily dosage units placed in a packaging unit and intended for oral administration for a period of at least 21 consecutive days, wherein said daily dosage units comprises the combination of drospirenone and ethinylestradiol. The composition may further comprise 7 or less daily dosage units containing no active agent or containing ethinylestradiol alone.

Abstract: A process for the coating of tablet cores, said tablet core comprising an effective amount of at least one pharmaceutically active compound, comprising spraying a coating solution or suspension comprising a sugar, or a starch, or a mixture of a sugar and a starch onto the tablets or tablet cores with the proviso that film-forming agents in the coating solution or suspension are excluded, to obtain coated tablets, such coated tablets and corresponding coating mixtures.

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: The present invention relates to rapid dissolve thin film drug delivery compositions for the oral administration of active components. The active components are provided as taste-masked or controlled-release coated particles uniformly distributed throughout the film composition. The compositions may be formed by wet casting methods, where the film is cast and controllably dried, or alternatively by an extrusion method.

Abstract: Disclosed is a microcapsule including a core having an oxidizable active (OA), the outer part of said core being in a solid form, and a water insoluble coating obtained from an encapsulating agent (EA), with the coating surrounding said core. In particular, there is disclosed a microcapsule wherein the EA is water soluble or organic solvent, in particular ethanol, soluble, or a microcapsule wherein said EA is an agent, the water solubility of which is pH-dependent. In particular, the core does not consist in or comprise a metal oxide, and the coating does not comprise a disintegrant, in particular sodium starch glycolate. Also disclosed is a process for preparing the microcapsules.

Abstract: A liquid composition which comprises an organic liquid diluent and at least one hydroxypropyl methylcellulose having 28 to 30 weight percent of methoxyl groups, 7 to 12 weight percent of hydroxypropoxyl groups and a sum of methoxyl groups and hydroxypropoxyl groups of from 38.5 to 42 weight percent is stable over an extended time period. The liquid composition is useful for preparing a solid dispersion comprising at least one active ingredient in at least one hydroxypropyl methylcellulose by spray-drying. Alternatively a solid dispersion can be produced by blending and extruding at least one active ingredient, at least one hydroxypropyl methylcellulose described above and optionally one or more adjuvants.

Abstract: The invention provides a nutritional supplement which includes micronutrients to facilitate reduction of cholesterol, and/or reduction of homocystein and/or reduction of low-density lipoprotein-cholesterol (LDL-C) oxidation in humans. In one embodiment the supplement is a multi-vitamin, a mineral supplement which includes at least one component known to reduce cholesterol. The invention further provides a method for tableting one fourth to one half of the daily effective dosage of a phytosterol containing nutritional supplement in a practical sized tablet and a method for reducing blood cholesterol in humans.

Abstract: A method for administration of ibuprofen to a subject in need of ibuprofen treatment is provided, in which an oral dosage form comprising a therapeutically effective amount of ibuprofen and a therapeutically effective amount of famotidine is administered three times per day.

Abstract: A multiparticulate composition is formed from a plurality of individual cores including a hydrophobic phase containing peppermint oil dispersed in a microcrystalline cellulose-based gel and a hydrophilic phase containing a hydrogel. An enteric coating is over the individual cores. The multiparticulate composition can be used to treat gastrointestinal disorders.

Abstract: An oral complex composition comprising omega-3 fatty acid esters and HMG-CoA reductase inhibitor, can effectively raise serum HDL level while reducing serum LDL and TG levels and can be used to treat hyperlipidemia owing to its good drug dissolution rate and storage stability with showing no delayed release behavior even after 6 months of accelerated storage.

Abstract: A polymeric hollow nanoshell or nanosphere for release of an agent is described, wherein the hollow nanosphere comprises at least one biodegradable polymer, characterised in that the polymer is cross-linked. The biodegradable mono-disperse nanospheres described are suitable for use as carriers of biomolecules, therapeutic agents and/or imaging agents.

Abstract: The invention essentially relates to oral dosage forms comprising a JAK3 inhibitor, preferably tasocitinib, suitable for modified release, and processes of preparing such oral dosage forms.

Abstract: This invention is related to direct compression of otilonium or its pharmaceutically acceptable salt having perfect powder flowability, good tablet weight distribution and no sticking to the punches.

Abstract: The invention relates to film products containing desired levels of active components and methods of their preparation. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.

Abstract: Pharmaceutical compositions and unit dosage forms comprising Compound I are disclosed.