Abstract: The present invention relates to pharmaceutical dosage forms, for example to a tamper resistant dosage form including an opioid analgesic, and processes of manufacture, uses, and methods of treatment thereof.

Abstract: A method to determine medication adherence may include detecting whether a wearable electronic device is in use. The method may include detecting one or more markers in sweat vapor of the user using a chemical marker sensor of the wearable electronic device. The method may include, in response to detecting that the system is in use, determining whether the user has taken a therapeutic agent that includes the one or more markers based on detecting the one or more markers in the sweat vapor.

Abstract: The disclosure is directed to, in part, compounds, or pharmaceutically acceptable salts or solvates thereof, for modulating the activity of aldehyde dehydrogenase such as ALDH2 and/or methods for treating and/or preventing an alcohol related disorder such as alcohol use disorder, alcohol induced disorder, alcohol abuse, alcohol dependence, alcohol intoxication, alcohol withdrawal, and the like and/or methods for reducing the amount of alcohol consumed, reducing alcoholic cravings, or increasing the percentage of no heavy drinking days for a subject with alcohol use disorder.

Abstract: Methods for attaching a radio frequency (RF) transmitter to an animal are provided. The methods can include providing an RF transmitter and providing an injection device having a needle of gauge of 9 or smaller; providing the RF transmitter into the injection device; and providing the RF transmitter through the 9 gauge or smaller needle and into the animal.

Abstract: An abuse resistant oral pharmaceutical composition, comprising: a barrier layer, comprising a first polymer; a diffusion layer, comprising a second polymer, substantially covering the barrier layer, wherein the diffusion layer is bonded to the barrier layer and comprises a drug that is substantially homogeneously distributed within the second polymer and diffuses from the diffusion layer within the gastrointestinal (GI) tract; and optionally an expansion layer comprising an expandable polymer, wherein the expansion layer is substantially covered by the barrier layer. Methods of making the same and methods of using the same are also provided.

Abstract: A programmable medication dispenser is provided to securely dispense medication to a patient and mitigate the risk of diversion of the medication to an unauthorized user. The programmable medication dispenser may include a processor, a memory, a housing, a biometric verification module, an inner receptacle having a plurality of compartments for storing the medication, and a gate for dispensing the medication from one of the compartments. A patient may access the medication stored within the medication dispenser according to a prescribed dosing schedule based on instructions executed by the processor after verifying his or her identify via the biometric verification module. A system is also provided for securely dispensing, monitoring, controlling medication for a patient using the programmable medication dispenser and for mitigating the risk of diversion of the medication to an unauthorized user.

Abstract: The invention relates to a dosage form comprising a physiologically effective amount of a physiologically active substance (A), a synthetic, semi-synthetic or natural polymer (C), optionally one or more physiologically acceptable auxiliary substances (B) and optionally a synthetic, semi-synthetic or natural wax (D), wherein the dosage form exhibits a resistance to crushing of at least 400 N and wherein under physiological conditions the release of the physiologically active substance (A) from the dosage form is at least partially delayed.

Abstract: The present invention provides immediate release abuse resistant or deterrent formulations such as ingestible dosage form articles suitable for the delivery of one or more medicaments or other active materials.

Abstract: Disclosed are solid oral pharmaceutical compositions that that are intended to provide protection against overdose and tampering, as well as abuse deterrence. The compositions contain a plurality of granules or multi-particulates. A first population of multi particulates contains an API or drug susceptible to abuse, a polymer matrix, and an outer coating that contains a cationic pH dependent polymer. These multi particulates also contain a plasticizer and a surfactant. A second population of multi particulates contains a viscosity building polymer and an alkaline buffering agent. Compositions may further include a disintegrant, and/or additional viscosity building polymers and/or alkaline buffering agents and/or ion exchange polymers. Also disclosed are the methods of making and using the compositions.

Abstract: This invention relates to abuse-deterrent pharmaceutical compositions and dosage forms and manufacturing processes thereof, the compositions comprising an agonist and antagonist that are difficult to separate visually, physically, or chemically. The compositions comprise a tacky amorphous polymer and a crystalline polymer curing agent for the amorphous polymer such that the agonist is releasable and the antagonist is non-releasable unless the dosage forms are tampered with. The non-extractable dosage forms reduce the potential for prescription drug abuse.

Abstract: A system to determine medication adherence may include a chemical marker sensor, a verification sensor, and a processor. The chemical marker sensor may be configured to detect one or more markers in sweat vapor of a user. The verification sensor may be configured to detect whether the system is in use. The processor may be communicatively coupled to the chemical marker sensor and the verification sensor and may be configured to determine whether the user has taken a therapeutic agent that includes the one or more markers based on signals generated by the chemical marker sensor and the verification sensor.

Abstract: We disclose a method of tagging nutritional or drug compositions using chemical entities which are known to be safely consumed and which are detectable using known techniques, including near IR spectroscopy. The chemical entities used as tags may be detected in easily obtainable biological samples, including urine and feces. The biological sample may be deposited into a medical toilet which may analyze the biological sample using an analytical device associated with the medical toilet. The tag may be identified and quantified to then identify and quantify the nutritional or drug composition the subject consumed along with the tag. This system may be used to track the source of a food or drug, confirm compliance to a prescribed diet or drug treatment, confirm drug consumption in clinical trials, identify the source of contaminated food, and identify the food substances used to produce food products.

Abstract: Described herein are controlled release oral pharmaceutical compositions and methods for making the same. These pharmaceutical compositions provide a non-burst release of one or more active pharmaceutical ingredients. In particular, a non-burst controlled release oral pharmaceutical composition comprising a capsule and an abuse deterrent controlled release matrix comprising one or more active pharmaceutical ingredients are described.

Abstract: Disclosed is an analgesic composition including an opioid analgesic and a therapeutically effective amount of P7C3, and the present analgesic composition may treat acute and facilitated pain very effectively, and has a significantly high synergistic effect compared to the effect by administration of individual drugs.

Abstract: The present invention relates to a solid pharmaceutical cation-exchange resin composition allowing the preparation of a stable resin suspension in an aqueous vehicle and the resin being easily resuspended in the case of sediment formation. Said composition comprises hydroxypropyl methylcellulose and pregelatinized starch as functional excipients. The invention also relates to a solid form for oral administration comprising the composition, to the use thereof for the preparation of oral solid forms, and to said composition for use in the treatment of hyperkalaemia.

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

Abstract: Disclosed herein is a method of upregulating regulatory T-cells, and treating diseases that would benefit from such upregulation, by administering an alpha-2 receptor agonist.

Abstract: Ready-to-use foamable pesticide compositions that contain a particulate pesticide suspended therein and applicators for dispensing such compositions. Methods for treating pests such as arthropods by contacting pests with such compositions are also provided.

Abstract: Ready-to-use foamable pesticide compositions that contain a particulate pesticide suspended therein and applicators for dispensing such compositions. Methods for treating pests such as arthropods by contacting pests with such compositions are also provided.

Abstract: The invention is directed to a method of detecting a biological substance in the nasal secretion and diagnosing a disease following the detection of the biological substance wherein the biological substance is not related to a respiratory disease. The invention also provides treatment of the diseases following the detection of the biological substance and/or diagnosis of the disease. In some embodiments, the diseases are cancer, hepatitis, smell loss, taste loss, diabetes, and leprosy. The invention also provides a kit for diagnosing a disease. The present invention includes methods of analyzing samples from the nose for the detection of biological substances. In particular, nasal secretion or nasal mucus is collected and analyzed for biological substances. The results of this analysis are then suitable for use in diagnosis, prognosis, and determination of suitability of therapeutic interventions.

Abstract: A solid administration form, protected from parenteral abuse and containing at least one viscosity-increasing agent in addition to one or more active substances that have parenteral abuse potential. The agent forms, when a necessary minimum amount of an aqueous liquid is added, on the basis of an extract obtained from the administration form, a preferably injectable gel that remains visually distinct when introduced into another quantity of an aqueous liquid.

Abstract: The present invention relates to a method for protecting and. recovering nucleic acids. This method may be applied in a verification method of products using molecular code systems or it may be applied in a storage method for nucleic acids. The invention further provides specific particles, their use in secure marking; products suitable for such verification method, to processes for manufacturing such products and methods for reading the information.

Abstract: Ready-to-use foamable pesticide compositions that contain a particulate pesticide suspended therein and applicators for dispensing such compositions. Methods for treating pests such as arthropods by contacting pests with such compositions are also provided.

Abstract: Disposable absorbent articles comprising an absorbent material and an antimicrobial composition are disclosed. The antimicrobial composition includes a carrier comprising fatty alcohol and a poly(alkyleneoxy) polymer, and an antimicrobial agent. The antimicrobial composition may be coated on to component substrates such as nonwovens and films, that are incorporated into disposable absorbent articles, such as disposable infant diapers, adult incontinence articles, feminine hygiene articles such as sanitary napkins, wound dressings, bandages, panty liners and tampons, personal care wipes and household wipes to provide odor control, and control of microbial growth.

Abstract: The present invention provides an oral care composition, containing at least 0.5% by weight of silica agglomerates, wherein each of the silica agglomerates has: (i) an overall particle size from 200 ?m to 2000 ?m, and (ii) a crush strength from 0.1N to 5N. The silica particles that make up the silica agglomerate can have an average particle size from 1 ?m to 50 ?m. The composition can have a viscosity from 10 to 90 BKU. The present invention also provides a method of encouraging proper tooth cleaning by administering the oral care composition of the present invention to a subject's tooth surface.

Abstract: A dual release oral dosage system/dosage form comprising an immediate release component/composition and a delayed release component/composition is described. Each of the immediate release component/composition and delayed release component/composition comprises one or more of doxylamine, an analog thereof, a derivative thereof, a prodrug thereof, a metabolite thereof and/or a salt thereof, and one or more of pyridoxine, a salt thereof, a metabolite thereof and/or a salt of the metabolite. The dual release oral dosage system/dosage form exhibits an improved pharmacokinetic profile relative to the current Diclectin® formulation and is useful for example for the alleviation of the symptoms of nausea and vomiting, for example in the case of nausea and vomiting in pregnancy (NVP).

Abstract: The present invention relates to bath compositions that may release nitric oxide when combined with an aqueous solution, thereby producing a nitric oxide releasing soak and/or bath. The present invention also relates to methods of using nitric oxide releasing bath compositions.

Abstract: The invention relates to a dosage form that is thermoformed without discoloration and is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse. The invention also relates to a corresponding method for producing said dosage form.

Abstract: Water soluble marking compounds comprising a transition metal oxyanion and at least one ammonium cation, comprising a nitrogen atom at least one further group selected from the group consisting of OH, COOH, NH2, NHC1-5 alkyl, and N(C1-5 alkyl)2, wherein the two C1-5 alkyl may be the same type of alkyl or different alkyls, may be used to obtain clear imageable coatings.

Abstract: The invention relates to a dosage form that is thermoshaped without being extruded and that is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse and optionally physiologically acceptable adjuvants. The invention also relates to a corresponding method for producing said dosage form.

Abstract: Milk-based products and drinks are provided including specified forms of identified proteins or fragments thereof, as are methods for the use of such milk-based products and drinks in the promotion of sleep.

Abstract: The invention discloses an article for swaddling in the mouth to deliver pharmacologically active substances, particularly nicotine, in combination with dyes or flavorings, across the buccal membranes when said article is swaddled in the mouth. Advantageously, the article comprises an indicator element at one end protruding from the mouth such that when the article is swaddled in the mouth the indicator element conveys information about the commercial origin of the article or the substances and flavorings delivered thereby. The article comprises a non-edible substantially cylindrical core element, such as a toothpick, and the indicator element may be a bulb, trinket, insignia or other marking. In a preferred embodiment, the invention makes a social statement about the beneficial uses of nicotine. Methods for using the invention to mitigate sensations of nervousness and boredom are also disclosed.

Abstract: A method of treating mucosal inflammation associated with a pathological condition in a mammal is provided. The method comprises the step of inhibiting 5-HT signaling at a target site in order to block 5-HT7 receptor function.

Abstract: A therapeutic composition for treatment of a body tissue which includes an aqueous solution of a cross-linked polymer being capable of: (i) maintaining a liquid state in storage at room temperature for at least 24 hours; and (ii) assuming a gel state following deposition within the body tissue. The therapeutic composition can be effectively administered into a damaged body tissue via injection or catheterization, thereby treating the damaged body tissue.

Abstract: The present invention is directed to the neutralizing prolactin receptor antibody 006-H08, as well as maturated forms thereof, and antigen-binding fragments, pharmaceutical compositions containing them and their use in the treatment or prevention of benign disorders and indications mediated by the prolactin receptor such as endometriosis, adenomyosis, non-hormonal female contraception, benign breast disease and mastalgia, lactation inhibition, benign prostate hyperplasia, fibroids, hyper- and normoprolactinemic hair loss, and cotreatment in combined hormone therapy to inhibit mammary epithelial cell proliferation. The antibodies of the invention block prolactin receptor-mediated signaling.

Abstract: The present invention relates to rapidly dissolving edible film dosage form incorporating a physical-chemical identifier and/or indicia. The physical-chemical identifier and/or indicia may correspond to an active ingredient that may be evenly distributed throughout the film. The physical-chemical identifier and/or indicia may be associated with at least one section of the film composition and/or associated with a sealed pouch or package containing the film composition and provide information to the consumer, practitioner, producer or regulator that is relevant to the edible film dosage form.

Abstract: Embodiments disclosed herein relate to thermostable storage of one or more therapeutic agents, including at least one detectable indicator. In an embodiment, the one or more therapeutic agents including at least one detectable indicator are included in at least one glassy substance. Also disclosed are embodiments relating to delivery devices for administration of the thermostable therapeutic agents.

Abstract: The invention is directed to a method of detecting a biological substance in the nasal secretion and diagnosing a disease following the detection of the biological substance wherein the biological substance is not related to a respiratory disease. The invention also provides treatment of the diseases following the detection of the biological substance and/or diagnosis of the disease. In some embodiments, the diseases are cancer, hepatitis, smell loss, taste loss, diabetes, and leprosy. The invention also provides a kit for diagnosing a disease. The present invention includes methods of analyzing samples from the nose for the detection of biological substances. In particular, nasal secretion or nasal mucus is collected and analyzed for biological substances. The results of this analysis are then suitable for use in diagnosis, prognosis, and determination of suitability of therapeutic interventions.

Abstract: The invention relates to a dosage form that is thermoformed without discoloration and is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse. The invention also relates to a corresponding method for producing said dosage form.

Abstract: The present application relates to novel narcotic formulations having a decreased injection abuse potential In a representative embodiment, the formulation comprises methadone hydrochloride (6-dimethylamino-4,4-diphenylheptan-3-one, a synthetic opiod), meglumine, cellulose, lactose, and magnesium stearate The application further illustrates methods for making the contemplated formulations.

Abstract: The invention relates to cleaning and food processing aide applications whereby unique compositions of GRAS or food additives were developed to assess the effectiveness of cleaning procedures at various stages of the processes and to assess the delivery and adherence of food processing aides. Employing such solutions to clean and/or sanitize processing equipment provides a method to evaluate and enhance the effectiveness of procedures used to remove the respective fluorescent detergents, sanitizers or organic residues from equipment or niches and reduce contamination. Similar compositions were developed for assessing processing aide food surface coverage, contact time and adherence. In addition, unique compositions were invented that increase processing aide coverage and adherence. Quantification of the presence or absence of the fluorescent GRAS or food additive compositions produces results for validation, monitoring and/or verification of food safety intervention procedures/processes.

Abstract: The invention relates to a pharmaceutical form for combating chemical submission, comprising an active ingredient and at least one compound which enables immediate modification of the organoleptic characteristics of a beverage into which the pharmaceutical form is introduced, said compound being selected from the group comprising an opacifier, a fluorescent agent, floating particles, particles that are perceptible in the mouth, effervescent microgranules, and mixtures thereof; it also relates to the use of these compounds for combating chemical submission and to a method for combating chemical submission using said pharmaceutical forms.

Abstract: The invention relates to the use of semuloparin or a pharmaceutically acceptable salt thereof for the extended prevention of a mortality and/or morbidity event, more specifically venous thromboembolism and death, in a patient having undergone hip fracture surgery.

Abstract: The invention relates to a dosage form that is thermoshaped without being extruded and that is safeguarded from abuse, comprising at least one synthetic or natural polymer having a breaking strength of at least 500 N in addition to one or more active substances that could be subject to abuse and optionally physiologically acceptable adjuvants. The invention also relates to a corresponding method for producing said dosage form.

Abstract: A therapeutic composition for treatment of a body tissue which includes an aqueous solution of a cross-linked polymer being capable of: (i) maintaining a liquid state in storage at room temperature for at least 24 hours; and (ii) assuming a gel state following deposition within the body tissue. The therapeutic composition can be effectively administered into a damaged body tissue via injection or catheterization, thereby treating the damaged body tissue.

Abstract: A method of verifying the identity of a dispensed pharmaceutical includes the steps of: reading identifying indicia on a pharmaceutical vial containing a dispensed pharmaceutical; determining the identity of a prescribed pharmaceutical called for by the identifying indicia; acquiring an image of the dispensed pharmaceutical through the vial; comparing the image of the dispensed pharmaceutical to data storage comprising image data associated with pharmaceuticals; acquiring spectral data for the dispensed pharmaceutical through the vial; comparing the spectral data of the dispensed pharmaceutical to data storage comprising spectral data associated with pharmaceuticals; and automatically determining whether the image and the spectral data of the dispensed pharmaceutical confirm that the dispensed pharmaceutical matches the prescribed pharmaceutical.

Abstract: Films that comprise an active agent for delivery to a tissue. The films may include carboxyls that form a chemical association with the active agent and/or hydrophilic domains or particles that comprise the active agent.

Abstract: The composition is a blood clotting composition including at least one hemostatic agent and an indicator agent that adheres to the skin on or around the wound, the indicator agent being specifically identifiable to the hemostatic composition. The composition can be adapted to be applied to a wound as an emergency trauma treatment in homes, public places, trauma treatment centers, at accident locations, in the field of military combat, or any other potential site of severe trauma as a first response to reduce or stop bleeding. The composition can include at least one clotting agent, an analgesic, a bactericide (such as silver), and at least one antibiotic. An applicator device for the composition is included.

Abstract: Ready-to-use foamable pesticide compositions that contain a particulate pesticide suspended therein and applicators for dispensing such compositions. Methods for treating pests such as arthropods by contacting pests with such compositions are also provided.

Abstract: The present invention relates to a process for the production of an abuse-proofed solid dosage form containing at least one active ingredient with potential for abuse and a synthetic or natural polymer with a breaking strength of =500 N, characterized in that a corresponding mixture is processed by melt extrusion with the assistance of a planetary-gear extruder.