Abstract: The present invention relates to a process for producing a solid, coated pharmaceutical composition by a melt coating process. The process is adapted to provide a solid, coated pharmaceutical composition by melt coating, which has a fast release.

Abstract: This invention relates to an abuse deterrent dosage form of opioid analgesics, wherein an analgesically effective amount of opioid analgesic is combined with a polymer to form a matrix.

Abstract: Solid pharmaceutical dosage forms comprising (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate (telotristat) are disclosed, as well as methods of making them and compositions useful in their manufacture.

Abstract: The present invention relates to extended release pharmaceutical compositions of paliperidone and process of preparation thereof.

Abstract: The invention relates, in one aspect, to a tablet having an internal core and external coating, both comprising melatonin and separated by an internal coating which does not comprise melatonin. The tablet is useful as a medicinal product, dietetic or food supplements for the treatment or as adjunctive therapy in sleep disorders.

Abstract: Oral administration forms are described for the controlled release of an antibiotic selected from the group consisting of rifampicin, rifabutin, rifapentine, rifalazil and mixtures thereof, for treating bacterial infections of the gastrointestinal tract, in particular travellers' diarrhoea, hepatic encephalopathy, ulcerative colitis, irritable bowel syndrome (IBS), Crohn's disease, and IBD (inflammatory bowel disease) in general. Moreover, said oral administration forms allow reduction of the amounts of antibiotic to be taken, with respect to the known administration forms and without reaching blood concentrations such as to select resistant strains of tuberculosis mycobacteria.

Abstract: The present invention relates to an extended release composition comprising as active compound Venlafaxine Hydrochloride, in which Venlafaxine Hydrochloride is coated on a non pareil inert core, which coated core is then coated with polymeric layer which enables the controlled release of the Venlafaxine Hydrochloride.

Abstract: The disclosure relates to substantially uniform, high density microspheres and methods of making the microspheres. The microspheres can be made to be small in size with a narrow range of particle size distribution and a high sphericity. In one aspect, the microspheres provided herein are provided in the form of spherical cores comprising maltodextrin or maltodextrin and starch and are prepared using a centrifugal tumbling-granulating-coating apparatus. In another aspect, the spherical cores can be powder-coated with one or more layers of small particles, such as starch particles. The microspheres provided herein can be used as cores for multi-particulate solid dosage delivery systems as well as other pharmaceutical, nutraceutical, food, personal care, and other applications.

Abstract: A method of preparing enteric hard capsules, and an enteric hard capsule prepared by the method. The method may include: dissolving an enteric base material, a capsule forming aid, and a neutralizing agent in water at room temperature to prepare an aqueous composition; heating the aqueous composition to a first temperature that is higher than a gelation start temperature of the aqueous composition; cooling the heated aqueous composition to a second temperature that is lower than the gelation start temperature; immersing a mold pin heated to a third temperature that is higher than the gelation start temperature into the aqueous composition; removing the mold pin from the aqueous composition to obtain a film coated on the mold pin; maintaining the film on the mold pin at a fourth temperature that is higher than the gelation start temperature for a first time period to fix the film onto the mold pin; and drying the fixed film at a fifth temperature for a second time period to obtain a capsule shell.

Abstract: A method for coating medication for a medical product is disclosed. A technique for coating gel in a viscous semisolid state is provided to facilitate coating of medication. Coating of medication on an article can be facilitated using gel, and coating of medication on an article such as an article made of silk and an article made of polypropylene can be further facilitated.

Abstract: Tablet-in tablet paliperidone formulations and processes for preparation and use thereof are provided.

Abstract: The invention relates to an enteric-coated capsule containing cationic nanoparticles for oral insulin delivery, in particular to a type of cationic nanoparticle including a polycationic and mucoadhesive polymer and a biodegradable polymer, wherein each of the nanoparticles has positive surface charge and enhanced permeability for paracellular insulin delivery; the enteric-coated capsule further includes a pH-sensitive polymer as the coating. The enteric-coated capsule containing cationic nanoparticles, when being orally administered to a subject, are configured to prevent the acidic degradation of the active substance such as insulin before being released from said cationic nanoparticles to a specific absorption site along the gastrointestinal tract.

Abstract: The invention provides decomposing apparatus which comprises a first sub-component and a first micro device comprising a decomposable material, wherein the sub-component comprises a drug, a medical kit, a micro-disease detection system, or an auto-navigation system. Also within the invention are methods for fabricating such apparatus.

Abstract: An extended release pharmaceutical composition comprising micronized desvenlafaxine base, at least one pH modifier and at least one release controlling agent and its process for preparation. An extended release monolithic tablet is also provided. Further extended release tablets comprising micronized desvenlafaxine base; at least one pH modifier; at least one release controlling agent; and at least one binder; wherein, the proportion of binder in the tablet is greater than about 3.0% of the total weight of the tablet and wherein, the pH modifier is present in a proportion of more than about 15 parts for each of the 100 parts of the desvenlafaxine base is also provided. Also provided is process for preparation of extended release tablet.

Abstract: An oral pharmaceutical composition of the present invention comprising fenofibric acid or a pharmaceutically acceptable salt thereof, and 0.22 to 1 part by weight of an alkalifying agent based on 1 part by weight of fenofibric acid has improved bioavailability and a minimized absorption deviation in the gastrointestinal tract, which is useful in treating hyperlipidemia and hypertriglyceridemia.

Abstract: The present invention provides stabilized prolonged release pharmaceutical compositions comprising atypical antipsychotic drug like paliperidone or pharmaceutically acceptable salts thereof without incorporating surfactant and/or water penetration enhancer. Such compositions are preferably in the form of a matrix wherein one or more release controlling agents are present in and/or on the matrix. Further, such compositions comprise one or more release controlling agent and exhibits desired in vitro release of drug with or without lag period. The invention also provides a process for the preparation of such compositions.

Abstract: A method for preparing a solid oral dosage form comprising up to about 160 mg of oxycodone or a salt thereof to control pain in substantially all patients is disclosed. The method comprises forming spheroids comprising a spheronising agent and oxycodone or a salt thereof, and coating the spheroids with a controlled-release film coat. Repeated “q12h” (i.e., every 12 hour) administration of the dosage form through steady-state conditions results in a mean maximum plasma concentration of oxycodone up to about 240 ng/ml from a mean of about 2 to about 4.5 hours after administration, and a mean minimum plasma concentration up to about 120 ng/ml from about 10 to about 14 hours after administration.

Abstract: A method for stabilizing a polymeric structure against thermo-oxidative degradation is described. A polymeric core structure is provided with a skin layer that contains a skin resin in which the skin resin at least partially envelops a portion of the core structure. The skin structure then provides a barrier that thereby stabilizes the portion of the structure that is enveloped. The skin resin is made from a treated polyarylene sulfide.

Abstract: The present invention relates to a nanoporous membrane for flux control in response to electrical stimulation. The nanoporous membrane includes a supporting layer with a plurality of pores; and an electrically responsive layer that is connected to around the entrances of the pores and undergoes a volume change by oxidation or reduction caused by electrical stimulation to thereby lead to a change in pore size.

Abstract: Multiparticulate compositions having S-adenosylmethionine an active ingredient are disclosed. The multiparticulates have spheroidal core comprising S-adenosylmethionine, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methyl cellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: The present invention concerns a method for coating granules comprising mesalazine, with a coating mixture comprising two polymers, polymer I and polymer II; said polymer I being selected to allow formation of a closing membrane around said granules in the absence of said polymer II, and said polymer II being selected to act as a water-soluble pore former in said coating mixture; wherein a) the amount of polymer I is adjusted to provide a closing membrane in the absence of polymer II, and b) the amount of polymer II in said coating mixture is adjusted to obtain coated granules which exhibit controlled release of mesalazine. The invention further concerns a product obtainable by the coating method.

Abstract: Enteric coated multiparticulate compositions that use 5-HTP as an active ingredient are disclosed. The multiparticulates have a spheroidal core comprising 5-HTP, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methylcellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: Enteric coated multiparticulate compositions that use a L-carnitine compound an active ingredient are disclosed. The multiparticulates have spheroidal core comprising a L-carnitine, microcrystalline cellulose, and hydroxypropyl methylcellulose; a sub-coat comprising hydroxypropyl methyl cellulose on the spheroidal core; and an enteric coat on the sub-coated spheroidal core. The average diameter of the particulates is about 0.1-3 mm. Other aspects of the invention include methods of making and methods of using the multiparticulate compositions.

Abstract: A compressed core for a pharmaceutical dosage form comprising a mixture of (a) at least one pharmaceutically acceptable organic acid, and (b) at least one pharmaceutically acceptable excipient is described. Such compressed core is useful for the preparation of pharmaceutical compositions containing a drug in which dissolution of the drug is favored in acidic environments. Also described are pharmaceutical compositions comprising such compressed core.

Abstract: A paliperidone double-layered osmotic pump controlled release tablet and the preparation method thereof are disclosed. The double-layered osmotic pump controlled release tablet comprises a rigid membrane, a push layer, a drug layer, an isolation layer and an aesthetic coating, wherein the rigid membrane contains a semi-permeable polymer, a porogen and/or a plasticizer and has one or more drug release orifices on one end, the push layer comprises an expanding material, an osmotic agent, a binder, a colorant and a lubricant, the drug layer contains a pharmaceutically active ingredient, a hydrophilic polymer, an osmotic agent, a colorant, a lubricant and an antistatic agent, the isolation layer is located between the inner surface of the rigid membrane and the push layer, and contains a hydrophilic polymer. The paliperidone double-layered osmotic pump controlled release tablet shows an increasing drug release rate at early stage and keeps a constant drug release rate at later stage.

Abstract: The present invention provides various pharmaceutical compositions, in particular for oral administration, formulated for extended release of active compounds useful in the treatment of neurodegenerative diseases, in particular Parkinson's disease, and injuries to the nervous system. The active compound comprised within these compositions is preferably selected from N-propargyl-1-aminoindan, an enantiomer thereof, or a pharmaceutically acceptable salt thereof, more preferably rasagiline or a pharmaceutically acceptable salt thereof.

Abstract: Porous materials and methods for forming them are disclosed. One method for immobilizing micro-particles and/or nano-particles onto internal pore surfaces and/or external pore surfaces of porous materials includes suspending the micro-particles and/or nano-particles in a liquid adapted to swell, soften, and/or deform either the porous materials and/or the particles, thereby forming a liquid-particle suspension. The method further includes adding the suspension to the porous materials; and removing the liquid, thereby forming the porous materials having the micro-particles and/or nano-particles immobilized on the internal pore surfaces and/or the external pore surfaces.

Abstract: The present invention provides an implantable device having a biosoluble coating comprising a polyelectrolyte and a counterion and the methods of making and using the same.

Abstract: A method for electrostatic coating of medical devices such as stents and balloons is described. The method includes applying a composition to a polymeric component of a medical device which has little or no conductivity. The polymeric component could be a material from which the body or a strut of the stent is made or could be a polymeric coating pre-applied on the stent. The polymeric component could be the balloon wall. A charge can then be applied to the polymeric component or the polymeric component can be grounded. Charged particles of drugs, polymers, biobeneficial agents, or any combination of these can then be electrostatically deposited on the medical device or the coating on the medical device. One example of the composition is iodine, iodine, iodide, iodate, a complex or salt thereof which can also impart imaging capabilities to the medical device.

Abstract: Disclosed are formulations which are designed to delay release of rasagiline while maintaining specific pharmacokinetic properties.

Abstract: The present invention describes a pharmaceutical dosage form with site- and time-controlled gastrointestinal release of active ingredient.

Abstract: Enteric coated multiparticulate formulations that use L-menthol as an active ingredient are disclosed. In one embodiment, the multiparticulate formulation comprises a plurality of particulates having a reduced release under gastric conditions and an elevated release at neutral pH. The particulates comprise a core comprising L-menthol as an active ingredient. The L-menthol is supplied to the core as an at least 80% pure L-menthol material. An enteric coating is over the core. The enteric coating is effective to release at least about 80% of the L-menthol within about two hours of being placed in a substantially neutral pH environment. Other aspects of the invention include methods of making and methods of using the multiparticulate formulations.

Abstract: The present invention relates to pharmaceutical compositions for the controlled and sustained release of active substance comprising a biodegradable polymer or copolymer. Furthermore, the invention relates to pharmaceutical compositions for the controlled and sustained release of at least one active substance such as peptides or hormones and analogues thereof and the manufacturing process of such pharmaceutical compositions.

Abstract: A wet shaving system is disclosed including a blade member and a skin-engaging portion in proximity to said blade member, the skin-engaging portion comprising a solid polymeric shaving aid composite including an exposed portion containing a water-soluble shaving aid dispersed in a water-insoluble polymeric matrix, the water soluble shaving aid being coated with mineral oil.

Abstract: The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.

Abstract: The present invention provides a method of applying a drug-polymer coating on a stent. A stent framework is dipped into a first polymeric solution including a first polymer, a first therapeutic agent, and a first solvent. The polymeric solution is dried and the first polymer is cured to form a thin drug-polymer layer on the stent framework. The steps of dipping the stent framework into the first polymeric solution, drying the first polymeric solution, and curing the first polymer are repeated until a target drug-polymer coating thickness is disposed on the stent framework. A drug-polymer coated stent including a stent framework and a laminated drug-polymer coated stent, a system for treating a vascular condition, and a method of treating a vascular condition are also disclosed.

Abstract: The invention includes a core-and-shell dosage form or unit in which the core contains API and in which the shell substantially governs the release such as by controlling diffusion of API through the shell. The shell may comprise a release-blocking polymer, and particles of a release-regulating polymer. The shell may be substantially impervious but the release-regulating polymer may become suitable to allow diffusion through it when activated. The core may include a buffer region between the shell and the API-containing portion of the core. The dosage form may include multiple units. The dosage form of the invention is capable of providing a release profile whose time scale can be adjusted by adjusting powder composition, and which may be approximately zero-order release. The invention further includes methods of manufacturing such a dosage form, such as three-dimensional printing.

Abstract: A tablet comprising a core containing an active agent, and a coating, the core being disposed within the coating such that the coating has a thickness about a longitudinal axis (X-Y) of about 4.85 to 4.95 mm. The position of the core within the coating dictating that the active agent is released rapidly after a lag time during which time no active agent is released.

Abstract: Disclosed herein is a process for the preparation of a stable sustained-release biocidal composition containing microencapsulated biocide and wherein the process comprises the steps of: (i) adsorbing the biocide onto an inert carrier by grinding to attain the required particle size and wherein the ratio of biocide; inert carrier is in the range of about 1:99 to about 99:1 (ii) optionally coating with an appropriate amine or imine compound or a water resistant film forming polymer and dispersing the resultant biocide encapsulated inert carrier in an aqueous medium in the presence of suitable dispersing agent (iii) adding at least one thickening agent to re-disperse the encapsulated biocide containing partial amount of non-encapsulated biocide if any and (iv) preparing an aqueous or solvent based sustained release biocide dispersion. Also disclosed is a stable, sustained-release biocidal composition prepared by such process and uses thereof.

Abstract: The present invention relates to a pulsatile-release pharmaceutical formulation of dexlansoprazole composed of a single type of enteric coated pellets and the process for the preparation thereof.

Abstract: The present invention includes compositions and methods for the use of an encapsulation additive having between about 0.1 to about 30 percent isolated and purified vitelline protein B to provide for mixed and extended release formulations.

Abstract: The present invention relates to a stent having a longitudinally-extending passage defined by a plurality of seamless strut elements with spacing between them. Each of these strut elements are in the form of lines defining the passage. The strut elements have a thickness in the range of 30 microns to 150 microns and are formed as at least one written layer. Also disclosed are methods of making the stent.

Abstract: An implantable device is described based on an implant having a textured outer surface of polymer material with limited transparency. A smooth outer polymer coating covers and cross-links with the textured outer surface to form a coated implant of greater transparency than the polymer material of the implant.

Abstract: The present invention relates to an extended release composition comprising as active compound Venlafaxine Hydrochloride, in which Venlafaxine Hydrochloride is coated on a non pareil inert core, which coated core is then coated with polymeric layer which enables the controlled release of the Venlafaxine Hydrochloride.

Abstract: A unit multiparticulate dosage form for delivering one or more basic, active pharmaceutical ingredients into the body in need of such medications to achieve target PK (pharmacokinetics) profiles is described. The dosage form comprises one or more multicoated drug particles (beads, pellets, mini-/micro-tablets) having a barrier coating and a lag-time coating. Each Timed Pulsatile Release (TPR) bead population exhibits pre-determined lag-time followed by differing release characteristics. The composition and thickness of the barrier coating, composition and thickness of the lag-time coating, ratio of IR beads to one or more TPR bead populations and total dose may be varied depending on the alkalinity, pH-dependent solubility and elimination half-life of the active ingredients to achieve target PK profiles (suitable for a once or twice daily dosing regimen) in patients in need of such medications.

Abstract: A composition comprising nanoparticles of a hydrolysable silicon-contain material for use as a delivery system for a bioactive ingredient, wherein surface of the silicon-containing material is associated with a stabilizing agent which modifies the rate of hydrolysis of the silicon-contain material and/or inhibits the rate of orthosilicic acid polymerisation and a method of promoting the controlled release of orthosilicic acid on degradation of a composition comprising nanoparticles of a hydrolysable silicon-contain material, the method involving the treatment of the surface of the silicon-containing material with a stabilizing agent to modify the rate of hydrolysis of the silicon-containing material and/or inhibit the rate of orthosilicic acid polymerisation.

Abstract: The present invention relates to pharmaceutical compositions, and methods of preparing such compositions, comprising one or more populations of controlled-release particles comprising one or more proton pump inhibitors. The present invention also relates to pharmaceutical dosage forms, including orally disintegrating tablets, tablets, capsules, and methods for their preparation.

Abstract: An oral pharmaceutical dosage form comprises pharmacologically effective amounts of an acid-susceptible proton pump inhibitor and an H2 receptor antagonist in combination with at least on pharmacologically acceptable excipient which causes a delayed release and/or an extended release of the proton pump inhibitor. The H2 receptor antagonist is included in the dosage for in such a way that it is rapidly released after administration. This dosage form is suitable for the treatment of conditions associated with an excessive secretion of gastric acid and provides a suitable combination of a rapid onset and a long-lasting duration of the effect. The invention also relates to a method for manufacturing such a dosage form and to a method for the treatment of conditions associated with the secretion of gastric acid.

Abstract: A method of coating an implantable medical device may include providing an implantable medical device, applying a polymer base to the medical device, and directing a first solution including therapeutic agent and solvent through the nozzle onto a target zone of the polymer base coating to penetrate the polymer base coating. The solution may be directed at the target zone until a predetermined concentration of the therapeutic agent can be integrated within the polymer base coating.

Abstract: A pH dependent drug delivery system comprising a pH sensitive graft copolymer, a therapeutically active agent and other pharmaceutically acceptable ingredients. More specifically, a composition which is capable of suppressing the drug release in the acidic pH prevalent in the stomach and releasing the drug over an extended period of time at pH prevalent in the intestinal region.