Abstract: Immediate and modified release oral dosage forms of tebipenem pivoxil including dosage form cores are provided. The dosage form core includes tebipenem pivoxil in free base or salt form, and excipients including a binder, a lubricant, optionally a diluent, and optional additional excipients. The weight to weight ratio of tebipenem pivoxil to the excipients in the dosage form core is from 30:60 to 60:30. The disclosure includes methods of treating bacterial infections including complicated urinary tract infections.

Abstract: A system for evaluating the effectiveness of an anti-counterfeiting measure employed for an item is provided. The system trains a classifier to indicate whether the anti-counterfeiting measure of an evaluation item is genuine or counterfeit. For evaluation items that have been classified as genuine or counterfeit, the system applies the classifier to determine whether the anti-counterfeiting measure of that evaluation item is genuine or counterfeit. The system then generates an effectiveness metric that indicates whether the anti-counterfeiting measure is effective based on evaluation items that are assessed as being genuine whose anti-counterfeiting measures are classified as being counterfeit.

Abstract: A system comprising one or more processors, and one or more non-transitory computer-readable media storing computing instructions that, when executed on the one or more processors, cause the one or more processors to perform operations comprising: displaying, one or more instructions on a user interface of a mobile device to instruct a user to capture each respective image of a prescription label; determining, using contrast, a location of each respective image in the set of images that is associated with the respective different portions of the prescription label on the medication package; reconstructing each of the respective different portions of the prescription label on the medication package as a flattened reconstruction of the respective different portions of the prescription label; and providing for display on the user interface a reconstructed prescription label. Other embodiments are disclosed herein.

Abstract: The present invention relates to a pharmaceutical formulation comprising the drug 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one in a solid dispersion with a matrix polymer that exhibits low hygroscopicity and high softening temperature, such as copovidone. The invention also relates to a daily pharmaceutical dose of the drug provided by such a formulation. In addition, the invention relates to the use of a matrix polymer that exhibits low hygroscopicity and high softening temperature in solid dispersion with 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one for increasing the bioavailability of the drug.

Abstract: The present invention relates to a pharmaceutical formulation comprising the drug 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one in a solid dispersion with a matrix polymer that exhibits low hygroscopicity and high softening temperature, such as copovidone. The invention also relates to a daily pharmaceutical dose of the drug provided by such a formulation. In addition, the invention relates to the use of a matrix polymer that exhibits low hygroscopicity and high softening temperature in solid dispersion with 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one for increasing the bioavailability of the drug.

Abstract: The invention relates to a metallic, nanoporous canister used to encapsulate cellular and/or biotherapeutic agents. The device is biocompatible and functions to wholly isolate a therapeutically active agent and/or cells therein. Their implantation, and survival in vivo, permits the local or systemic diffusion of their encapsulated cellular and/or biomolecular and therapeutics factors with the potential to promote repair of damaged or degenerated tissues in mammalian hosts, primarily humans.

Abstract: To make it possible to set a parameter, which is used for detection of a mark attached to a ground marker, according to the feature of the mark. Provided is an information processing apparatus including: an acquisition unit that acquires a captured image; a detection unit that detects a feature of a target object in the captured image; and a determination unit that determines, on the basis of the feature, a parameter used for an assessment of whether or not the target object is a predetermined object.

Abstract: The system captures portions of a label on a package in a set of images, reconstructs the label based on the set of images, identifies text in the label, determines associations of identified text and types of information, and stores the set of images, the reconstructed label, the identified text in the label, and the determined associations as, for example, a batch in a review queue. During a review process, the batch is reviewed and a structured prescription record is determined for the batch which is further used by the system and user of the system associated with the batch to provide various features to the user.

Abstract: The system captures portions of a label on a package in a set of images, reconstructs the label based on the set of images, identifies text in the label, determines associations of identified text and types of information, and stores the set of images, the reconstructed label, the identified text in the label, and the determined associations as, for example, a batch in a review queue. During a review process, the batch is reviewed and a structured prescription record is determined for the batch which is further used by the system and user of the system associated with the batch to provide various features to the user.

Abstract: The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

Abstract: There is provided a convenient new treatment of Parkinson disease by a frequent administration of optimal levodopa doses mimicking a continuous intravenous or infusion treatment, thus mitigating motor complications; and a new carbidopa/levodopa pharmaceutical unit form providing said new treatment.

Abstract: The present invention relates to a solid form, particularly to a 3D-printed immediate release solid dosage form (e.g. based on a pharmaceutical, nutraceutical, or food supplement composition). To overcome some of the solubility and disintegration problems inherited by 3D-printed solid dosage forms, the solid form comprises one or more channels, generally in the form of tubular passages or grooves, through the body of the solid form or the surface thereof.

Abstract: Disclosed herein is an oral dosage formulation suitable for treating a neurodegenerative disorder. The oral dosage formulation contains both sustained-release and immediate-release drugs. The sustained-release drug in the oral dosage formulation is memantine, and the immediate-release drug in the oral dosage formulation is donepezil and/or memantine, and the formulation is characterized in having a pH-independent dissolution profile of memantine at a pH range from about 1.0 to about 7.0.

Abstract: The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can be used in a variety of different applications, including as components of ingestible identifiers, such as may be found in ingestible event markers, e.g., pharma-informatics enabled pharmaceutical compositions.

Abstract: The present invention provides compositions and methods and for increasing the bioavailability of therapeutic agents in a subject. The compositions include at least one alkyl glycoside and at least one therapeutic agent, wherein the alkylglycoside has an alkyl chain length from about 10 to about 16 carbon atoms. In various aspects, the invention provides compositions and methods for oral delivery in the form of a tablet.

Abstract: The present invention relates to an oral dosage form for administration of ketamine and a method of preparing an oral dosage form for administration of ketamine, preferably once or twice a day.

Abstract: In a delayed release formulation comprising a core containing a drug and a delayed release coating for providing intestinal release, release of the drug in the colon is accelerated by including an isolation layer between the core and the delayed release coating. The delayed release coating comprises an inner layer and an outer layer. The outer layer comprises a pH dependently soluble polymeric material which has a pH threshold at about pH 5 or above. The inner layer comprises a soluble polymeric material which is soluble in intestinal fluid or gastrointestinal fluid, said soluble polymeric material being selected from the group consisting of a polycarboxylic acid polymer that is at least partially neutralized, and a non-ionic polymer, provided that, where said soluble polymeric material is a non-ionic polymer, said inner layer comprises at least one additive selected from a buffer agent and a base.

Abstract: Composition for the prolonged release of trimetazidine wherein the inner phase comprises trimetazidine and the outer layer comprises a retardant and an anti-agglomerant.

Abstract: A solid tablet formed through direct compression of powder, the powder comprising meloxicam as an active ingredient and one or more excipients which are homogenously dispersed within the tablet that can be broken into two, three or four units with each unit containing equal amounts of the meloxicam.

Abstract: According to the present invention, a multilayer tablet showing suppressed layer separation and a production method thereof are provided. A concave portion having a depth of not less than 0.1 mm Ka is formed on at least one surface Sa of the both front and back surfaces (Sa, Sb) of a multilayer tablet. Particularly, a multilayer structure obtained by, in tableting, forming a convex portion for forming the concave portion on at least the upper punch, and preliminarily compressing all layers in the multilayer tablet with the upper punch to form a concave portion having the same shape with a depth of not less than 0.1 mm on the upper surface of all layers, wherein the powder materials of the next layer are protruding into the concave portion, is a preferable embodiment.

Abstract: The present invention is directed to dosage forms that can be used in therapeutic methods involving the oral co-administration of a combination of at least two drugs, one of which impairs gastrointestinal absorption and one of which does not. The dosage forms are designed so that the drug impairing absorption is not released into the gastrointestinal tract of a patient until after the drugs that do not impair absorption have been released and substantially absorbed. The invention may be used in treatment of migraine using a combination of triptans and NSAIDs or in the treatment of pain using a combination of NSAIDs and opioid analgesics.

Abstract: A rapidly dispersing dosage form is described, which releases its active ingredients within a period of less than about ninety seconds. These dosage forms exhibit a three-dimensional shape that is retained for adequate storage but is readily dispersed in the presence of excess moisture. Also disclosed are methods of administration of a medicament and a process for the preparation of rapidly dispersing dosage forms.

Abstract: A dry-coated tablet 1 comprises an inner core 2 which contains an active component and an outer layer 3 which contains powdery solid components and coats the inner core 2. Openings 8c and 9c are formed in circular surfaces 2a and 2b respectively of the inner core 2, wherein each of the openings is larger than the average particle size of a component the average particle size of which is the smallest of the powdery solid components contained in the outer layer 3, and the inner surface 3a of the outer layer 3 penetrates in the openings 8c and 9c.

Abstract: Coated dosage forms comprising a tablet core, preferably in compressed form, that has a coating over its exterior surface and one or more patterns debossed in the tablet surface are disclosed. Methods for manufacturing such dosage forms are also disclosed.

Abstract: Disclosed herein is an oral dosage formulation that contains both immediate-release and sustained release drugs for treating neurodegenerative disorders. The immediate-release drug in the oral dosage formulation is an acetylcholinesterase inhibitor (AChEI) with a dissolution rate of releasing more than 80% of the AChEI within 60 min; and the sustained-release drug is memantine with a dissolution rate of releasing more than 80% of memantine within 12 hours.

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: Taste masked multi-layered particles include an inert core, one or more coating layer(s) comprising a pharmaceutically active ingredient and a binder, an intermediate coating layer (seal coating) free from a low molecular weight water-soluble ionic compound and including a water-soluble pharmaceutical film-forming compound selected from (i) HPMC and PEG or (ii) PVP, and an outer coating layer (final or taste masking coating) free from a low molecular weight water-soluble ionic compound and comprising (i) a poly(meth)acrylate or (ii) a mixture including 60-90% (w/w) EC and 10-40% (w/w) HPMC, where the pharmaceutically active ingredient is water-soluble and includes either at least one basic group and/or a bitter taste. Further disclosed are methods for the production of such particles and pharmaceutical compositions including such particles.

Abstract: Disclosed herein is a method for treating patient suffering from a disorder related to central nervous system with an oral dosage formulation that contains both sustained-release and immediate-release drugs. The sustained-release drug in the oral dosage formulation is memantine, and the formulation provides an average blood level Cmax of the memantine in a range of about 10-24 ng/mL during an average Tmax of about 10-45 hours. The immediate-release drug in the oral dosage formulation is an acetylcholinesterase inhibitor (AChEI), and the formulation provides an average blood level Cmax of the AChEI in a range of about 12-38 ng/mL during an average Tmax of less than about 4 hours.

Abstract: The present invention provides pharmaceutical compositions comprising azelastine, or a pharmaceutically acceptable salt or ester thereof including azelastine hydrochloride, and optionally one or more additional active agents. Preferred such compositions further comprise one or more pharmaceutically acceptable carriers or excipients that reduce the amount of post-nasal drip, and/or that minimize or mask the unpleasant bitter taste associated with post-nasal drip, of the compositions into the oral cavity, upon intranasal or ocular administration of the compositions. Especially effective excipients used in the compositions of the present invention are hypromellose as a viscosity modifier and sucralose as a taste-masking agent.

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: The present invention relates to pharmaceutical compositions comprising a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide, methods of manufacturing pharmaceutical compositions of the present invention, and methods of administering pharmaceutical compositions of the present invention.

Abstract: Pharmaceutical compositions with anti-obesity activity that act peripherally are provided, which comprise a premixture made up of pure orlistat as the active ingredient and other components that afford the premixture stability and suitable physical properties for simply preparing compositions for oral use with convenient dosage flexibility; and optionally necessary thickening, flavouring and colouring agents. A method for preparing said compositions is also provided. The orlistat content in the premixture is less than 20% of the total weight of the mass, preferably between 12 and 17%. The pharmaceutical composition can be formulated indistinctively from the premixture both as grooved tablets and powder for suspension.

Abstract: According to the present invention, a multilayer tablet showing suppressed layer separation and a production method thereof are provided. A concave portion having a depth of not less than 0.1 mm Ka is formed on at least one surface Sa of the both front and back surfaces (Sa, Sb) of a multilayer tablet. Particularly, a multilayer structure obtained by, in tableting, forming a convex portion for forming the concave portion on at least the upper punch, and preliminarily compressing all layers in the multilayer tablet with the upper punch to form a concave portion having the same shape with a depth of not less than 0.1 mm on the upper surface of all layers, wherein the powder materials of the next layer are protruding into the concave portion, is a preferable embodiment.

Abstract: Dividable galenical form for the modified release of active ingredient, wherein the non-subdivided galenical form and a portion of said form obtained by subdivision have identical dissolution profiles.

Abstract: Deeply scored pharmaceutical tablets are disclosed, along with pharmaceutical tablets with a score in a segment that adjoins a segment lacking a pharmacologically effective dose of any drug.

Abstract: Coated dosage forms comprising a tablet core, preferably in compressed form, that has a coating over its exterior surface and one or more patterns debossed in the tablet surface are disclosed. Methods for manufacturing such dosage forms are also disclosed.

Abstract: A composition including an optical substrate removably attached to an item. At least a portion of the substrate has a diffraction grating embedded therein or thereon. The grating has a resultant refractive index variation at a grating location. The grating provides an output optical signal indicative of a code when illuminated by an incident light signal.

Abstract: Pharmaceutical compositions with anti-obesity activity that act peripherally are provided, which comprise a premixture made up of pure orlistat as the active ingredient and other components that afford the premixture stability and suitable physical properties for simply preparing compositions for oral use with convenient dosage flexibility; and optionally necessary thickening, flavouring and colouring agents. A method for preparing said compositions is also provided. The orlistat content in the premixture is less than 20% of the total weight of the mass, preferably between 12 and 17%. The pharmaceutical composition can be formulated indistinctively from the premixture both as grooved tablets and powder for suspension.

Abstract: A pharmaceutical tablet adapted for accurate division of a dose of a drug into two or more smaller doses, which tablet has two or more segments.

Abstract: Disclosed herein is an oral dosage formulation that contains both immediate-release and sustained release drugs for treating neurodegenerative disorders. The immediate-release drug in the oral dosage formulation is an acetylcholinesterase inhibitor (AChEI) with a dissolution rate of releasing more than 80% of the AChEI within 60 min; and the sustained-release drug is memantine with a dissolution rate of releasing more than 80% of memantine within 12 hours.

Abstract: Accurate means of dosing with a compressed, segmented pharmaceutical tablet, and tablettes formed from said tablets, is disclosed.

Abstract: The invention provides a composition containing particulate composite of a polymer and a therapeutic agent. The composition also contains a complexing agent. The polymer interacts with the complexing agent in a host-guest or a guest-host interaction to form an inclusion complex. A therapeutic composition of the invention may be used to deliver the therapeutic agent and to treat various disorders. Both the polymer of the particulate composite and the complexing agent may be used to introduce functionality into the therapeutic composition. The invention also relates to a method of preparing a composition. The method combines a therapeutic agent, a polymer having host or guest functionality, and a complexing agent having guest or host functionality to form the therapeutic composition. The complexing agent forms an inclusion complex with the polymer. The invention also relates to a method of delivering a therapeutic agent.

Abstract: A pharmaceutical tablet adapted for accurate division of a dose of a drug into two or more smaller doses, which tablet has two or more segments.

Abstract: An immediate release compressed pharmaceutical tablet that has two or more segments and a top and a bottom and has a height that exceeds the width of the tablet. The height is measured vertically from the top to the bottom of the tablet while it is in the tablet die in which it is fully compressed, after compression has been completed. The width is measured as the greatest horizontal dimension of the tablet at a location halfway between the top and the bottom of the tablet, except that when the horizontal cross-section of the tablet is substantially rectangular, the width is defined by locating the two shorter sides of the perimeter of the horizontal cross-section, and measuring the length of a line that is at right angle to the shorter sides.

Abstract: The present invention provides solid preparations having two or more colors or a pattern of two or more different colors which can solve the problems of the prior art including the complexity of production processes and the low strength of solid preparations. Specifically, an object of the present invention is to provide solid preparations coated with a continuous film coating layer having two or more different colors or a pattern of two or more different colors which preparations are obtained by irradiating a part of the film coating layer containing one or more colorants with light, a process for the preparation of such solid preparations, and a film coating agent therefor.

Abstract: Described is a compressed multiple layer pharmaceutical tablet that has a height that exceeds the width of the tablet. The height is measured vertically from the top to the bottom of the tablet while it is in the tablet die in which it is fully compressed, after compression has been completed. The width is measured as the greatest horizontal dimension of the tablet at a location halfway between the top and the bottom of the tablet, except that when the horizontal cross-section of the tablet is substantially rectangular, the width is defined by locating the two shorter sides of the perimeter of the horizontal cross-section, and measuring the length of a line that is at right angle to the shorter sides. The layers can form a segment or, preferably, more than one segment.

Abstract: A divisible pharmaceutical tablet comprises an upper portion and a lower portion, the upper portion including at least one upper convex surface bordering at least one dividing notch. A ridgeline is formed between the at least one dividing notch and the at least one upper convex surface. The upper convex surface includes an apex defined at a location along the ridgeline.

Abstract: Disclosed herein is a method for treating patient suffering from a disorder related to central nervous system with an oral dosage formulation that contains both sustained-release and immediate-release drugs. The sustained-release drug in the oral dosage formulation is memantine, and the formulation provides an average blood level Cmax of the memantine in a range of about 10-24 ng/mL during an average Tmax of about 10-45 hours. The immediate-release drug in the oral dosage formulation is an acetylcholinesterase inhibitor (AChEI), and the formulation provides an average blood level Cmax of the AChEI in a range of about 12-38 ng/mL during an average Tmax of less than about 4 hours.

Abstract: The invention provides a composition containing particulate composite of a polymer and a therapeutic agent. The composition also contains a complexing agent. The polymer interacts with the complexing agent in a host-guest or a guest-host interaction to form an inclusion complex. A therapeutic composition of the invention may be used to deliver the therapeutic agent and to treat various disorders. Both the polymer of the particulate composite and the complexing agent may be used to introduce functionality into the therapeutic composition. The invention also relates to a method of preparing a composition. The method combines a therapeutic agent, a polymer having host or guest functionality, and a complexing agent having guest or host functionality to form the therapeutic composition. The complexing agent forms an inclusion complex with the polymer. The invention also relates to a method of delivering a therapeutic agent.

Abstract: The invention relates to a sustained release formulation for delivering one or more pharmaceutically active agents. The formulation comprises cross-linked high amylose starch and at least one pharmaceutically active agent, and optionally can be subdivided into smaller dosage forms where the smaller dosage forms have substantially the same sustained release properties as the formulation from which they were derived. The formulations can provide sustained release for up to at least 24 hours, and because of their divisability permits a recipient of the active agent or the person administering the active agent to titrate the dosage of the agent.