Abstract: The present invention provides a method of inhibiting tolerance to an opioid by a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject during opioid therapy. The pharmaceutical composition comprises a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.

Abstract: A method of modifying a surface of a medical device for implantation or disposition inside a patient is described. The medical device comprises a structure having at least one surface. The method includes the steps of: placing the medical device into a plasma chamber substantially free from contaminants and substantially sealing the plasma chamber from the atmosphere; removing at least an outermost layer of any oxide layer from the at least one surface of the structure by a plasma oxide-removal process, whilst maintaining the plasma chamber under seal from the atmosphere; and subsequently forming a new oxide layer at the least one surface of the structure by introducing at least one gas into the plasma chamber, whilst maintaining the plasma chamber under seal from the atmosphere. A medical device including a bulk material and an oxide layer disposed over at least one surface of the medical device. The oxide layer is substantially pure and free from contaminants.

Abstract: The present invention relates to an abuse-proofed, oral dosage form with controlled opioid-release for once daily administration, characterised in that it comprises at least one opioid with potential for abuse (A), at least one synthetic or natural polymer (C), optionally delayed-release matrix auxiliary substances, physiologically acceptable auxiliary substances (B), optionally a wax (D) and optionally at least one delayed-release coating, component (C) or (D) in each case exhibiting a breaking strength of at least 500 N, preferably of at least 1000 N.

Abstract: Fixed-dose combination drugs comprising an NSAID as a first drug component and a GABA-type calcium channel blocker as a second drug component are contemplated. Further contemplated aspects also include methods of administration of combination drugs and drugs contained herein.

Abstract: Disclosed herein are drug delivery punctal implants and methods of using the implants for the treatment of ocular disorders requiring targeted and controlled administration of a drug to an interior portion of the eye for reduction or prevention of symptoms of the disorder. The physical arrangement of drugs within the punctal plugs disclosed herein results, in several embodiments, in advantageous controlled delivery of one or more drugs to the eye of a patient.

Abstract: Granulations with granules having a high loading of an active pharmaceutical ingredient are disclosed. The active pharmaceutical ingredient has a high aqueous water solubility. The granules have a narrow particle size distribution and a smooth exterior surface.

Abstract: An alginate and stearic acid composition is described, including methods of molding it into tablets further comprising a drug, and methods of controlling the drug release from the tablets.

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: 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: 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: 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: 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: The invention relates to film-like forms of administration for the transmucosal delivery of antidiabetic peptides via the oral mucosa and to processes for the production thereof. Antidiabetic peptides refers to peptides which are an active compound for the treatment of diabetes mellitus, and includes insulins, insulin analogs, incretins and incretin mimetics.

Abstract: The present invention relates to a composition for preventing or treating hearing loss, containing an HMG-CoA reductase inhibitor and, more specifically, to a composition for preventing or treating diabetes-mediated hearing loss, containing, as an active ingredient(s), one or more types selected from the group consisting of atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin. A pharmaceutical composition containing an HMG-CoA reductase inhibitor, according to the present invention, inhibits auditory cell death caused by diabetes, and thus is very useful as an agent for preventing or treating diabetes-mediated sensorineural hearing loss.

Abstract: A formulation and method for treating or reducing ocular surface inflammation and associated diseases and disorders. The formulation includes targeted micelles that encapsulate tacrolimus within a pharmaceutically acceptable carrier, wherein the formulation is coated in arginine-glycine-aspartic acid peptide.

Abstract: The present invention relates to a nanocomposite ocular device that can release drugs within a close distance to the ocular surface and provide controlled and sustained release of the drug at a constant rate. The device can achieve both optical and medical functions. The device comprises a drug, one or more reservoir domains, and a barrier layer configured to block the drug diffusion paths from the reservoir domain to the ocular surface in the eye of the subject, wherein the drug partitions between the reservoir domain and the barrier layer, and the equilibrium drug solubility in the reservoir domain is at least five folds higher than that in the barrier layer.

Abstract: The invention relates to the oral cosmetic use of a combination of active agents comprising at least taurine, a derivative thereof and/or an acceptable salt thereof and at least one grape extract, as cosmetic active agents for improving the quality of the nails. More particularly, the present invention relates to the oral cosmetic use of such a combination for improving the solidity of the nails and for reducing and/or preventing their splitting.

Abstract: The disclosure is directed to medroxyprogesterone compositions suitable for subcutaneous injection comprising about 360 mg/ml to 440 mg/ml medroxyprogesterone acetate, 1.35 mg/ml to 1.65 mg/ml docusate sodium, polyethylene glycol, and water. Methods of using these compositions are also described.

Abstract: The present invention provides a method of inhibiting tolerance to an opioid by a human subject in need thereof. The method comprises administering an effective amount of a pharmaceutical composition to the subject during opioid therapy. The pharmaceutical composition comprises a) a non-steroidal anti-inflammatory drug (NSAID); and b) a co-agent selected from the group consisting of: fexofenadine, ketotifen, desloratadine, cetirizine, salts thereof and combinations thereof.

Abstract: A multi-layered pharmaceutical delivery system is contemplated in which the delivery of medicaments to patients is controlled via the sequential delivery of medicaments contained within ingestible solid pharmaceutical layers, preferably frozen in a media that liquefies following ingestion by a patient so as to release the medicament when ingested by melting. A frozen ice pop embodiment is contemplated to contain an outermost ingestible pharmaceutical layer enclosing further ingestible pharmaceutical layers sequentially enclosed within that inner pharmaceutical layer. Other embodiments are contemplated in which the layers are linearly sequenced within an external container that prevents ingestion of the subsequent layers until the prior layers have been ingested.

Abstract: A liquid composition includes: An alginic acid or a pharmaceutically acceptable salt thereof and a colloidal polysaccharide. The liquid composition of the present invention is suitable as a medical biomaterial for tissue repair to elevate mucosal tissues of the stomach and intestines during endoscopic resection. More specifically, the present invention relates to a submucosal injectable pharmaceutical liquid composition for use in endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) for medical applications, including alginic acid having a weight average molecular weight of 100,000 to less than 200,000 or a pharmaceutically acceptable salt thereof and a colloidal polysaccharide. The liquid composition of the present invention is suitable for use as a preparation for submucosal local injection that can maintain mucosal elevation for a long time when injected during endoscopic mucosal resection or endoscopic submucosal dissection.

Abstract: Disclosed a pregabalin-containing, high swellable, oral sustained-release triple layer tablet suitable for administration once daily.

Abstract: The present invention provides a system enabling the oral delivery of therapeutics derived from polyunsaturated fatty acids (PUFAs), their metabolites and derivatives, including, eicosanoids, prostaglandins, prostacyclins, leukotrienes, resolvins, endocannabinoids, thromboxanes, epoxyeicosa-trienoic acids (EETs), hydroxyeicostetraenoic acids (HETEs), and CMX-020. The delivery system includes a vehicle comprising a purified docosahexaenoic acid (DHA) in triglyceride or ester form; a purified eicosapentaenoic acid (EPA) in triglyceride or ester form; a combination of DHA, EPA in either triglyceride or ester forms; or a modified DHA, EPA, or omega-3 fatty acid analog; and optionally, an antioxidant, a surfactant, a solubilizer, a stabilizer, a lubricant, or a pH/tonicity adjustment agent.

Abstract: The present invention relates to the compound [2-[(5-nitro-1,3-thiazol-2-yl)carbamoyl]phenyl]ethanoate (Nitazoxanide) or 2-hydroxy-N-(5-nitro-2-thiazolyl)benzamide (Tizoxanide) for treating cholestatic and fibrotic diseases.

Abstract: The present invention provides a tablet showing high stability of the active ingredients (potassium-competitive acid blocker and acetylsalicylic acid) and stably and rapidly expressing the pharmacological effects of the active ingredients after administration. The present invention provides a tablet containing an inner core and an outer layer, wherein the inner core is an enteric-coated tablet containing acetylsalicylic acid, and the outer layer contains a potassium-competitive acid blocker free of enteric coating.

Abstract: The present invention relates to a rivastigmine-containing sustained-release pharmaceutical composition and, more specifically, to a rivastigmine-containing sustained-release pharmaceutical composition, which is a sustained-release preparation containing a pH-dependent delayed release phase, wherein, by controlling the release of the pharmaceutical composition to be minimized in the stomach at the initial stage of administration, the pharmaceutical composition can lower the maximum blood concentration (Cmax) compared with existing products while arriving at an effective blood concentration, thereby reducing side effects, and thereafter, maintaining the effective blood concentration through the sustained-release of main ingredients.

Abstract: Provided herein are therapies, and methods using that therapy, in the treatment of one or more of Type 2 diabetes (T2D), obesity, glucose intolerance and insulin resistance or to control weight gain in subjects. In particular, the subject may be candidates for treatment with one or more small molecule anti-diabetic drugs and the therapy may include implanting a population of pancreatic endocrine progenitor cells into the subject, where the cells are allowed to mature in vivo to produce a population.

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: 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: The invention provides dosage forms and methods utilizing nicotine to treat symptoms of a neurologic disorder. In some embodiments, the invention provides compositions for treatment of gait and balance problems associated with Parkinson's Disease.

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: The present invention relates to a nanocomposite ocular device that can release drugs within a close distance to the ocular surface and provide controlled and sustained release of the drug at a constant rate. The device can achieve both optical and medical functions. The device comprises a drug, one or more reservoir domains, and a barrier layer configured to block the drug diffusion paths from the reservoir domain to the ocular surface in the eye of the subject, wherein the drug partitions between the reservoir domain and the barrier layer, and the equilibrium drug solubility in the reservoir domain is at least five folds higher than that in the barrier layer.

Abstract: Methods and compositions are provided which comprise effective amounts of one or more analgesics, such as hydrocodone or acetaminophen, and an antiemetic, such as promethazine, to treat or prevent pain in a subject, and to reduce or prevent an adverse effect associated with the analgesics.

Abstract: Combinations of a first generation antihistamine for a quick onset with a maintenance dosage amount of a second or third generation antihistamine, along with an additional active agent such as a decongestant, a cough suppressant (an antitussive), a leukotriene receptor antagonist, a 5-lipoxygenase inhibitor, a bronchodilator, an expectorant, or a combination thereof, are disclosed. Methods of using such combinations by concomitant administration, either in the form of a single composition or multiple compositions, are further disclosed.

Abstract: Provided herein are pharmaceutically acceptable sodium nitrite and pharmaceutical compositions thereof. Also provided herein are methods for determining the total non-volatile organic carbon in a sodium nitrite-containing sample. Further provided herein are methods for producing pharmaceutically acceptable sodium nitrite. Still further provided herein are methods of treatment comprising the administration of pharmaceutically acceptable sodium nitrite.

Abstract: An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a swellable composition located in an immediate vicinity of one or more preselected surfaces. The coating comprises a defect wherein said defect is not a passageway through the preselected portion of the coating and operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.

Abstract: An oral drug delivery system comprising a coated tablet having one or more surfaces. The coated tablet further comprises a core and a coating surrounding the core. The core comprises an active ingredient composition comprising at least one active ingredient and a pharmaceutically acceptable excipient and a reactive composition located in an immediate vicinity of one or more preselected surfaces. The coating is operable to be reliably removed fully from the one or more of the preselected surfaces of the tablet upon contact with an aqueous environment, but not removed from at least one of the surfaces.

Abstract: Described herein are compositions, methods, and devices for relief of a cough, cold, sore throat, or allergy, or a related symptom. Also described herein are compositions, methods, and devices for the prevention, treatment and/or amelioration of a digestive illness or digestive discomfort, or a related symptom of either. Such compositions may be in the form of a liquid composition and include a plurality of pharmaceutical ingredients and a plurality of botanical ingredients.

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: 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 modified release levodopa dosage form.

Abstract: A once daily controlled release pharmaceutical compositions comprising tapentadol, wherein preferably the mean Tmax of tapentadol is reached after 10 hours of administration of the composition. The composition comprises tapentadol, such that it maintains serum concentration of tapentadol of at least about 20 ng/ml for at least about 17 hours after oral administration of the composition. According to one embodiment the controlled release pharmaceutical composition comprises tapentadol, which is gastroretentive.

Abstract: A method of alleviating or treating a condition which can be alleviated or treated by administering hyoscyamine comprises administering to a subject in need thereof a pharmaceutical dosage form which comprises at least one of hyoscyamine and a pharmaceutically acceptable salt thereof. The dosage form comprises two or more hyoscyamine formulations, at least one of the formulations being an immediate release formulation and at least one other one being a controlled release formulation.

Abstract: The present invention relates to a process for the preparation of dimethyl fumarate, a compound of formula I, in a purity of at least 99.0% as determined by HPLC, containing less than 400 ppm of an anion of a mineral acid and less than 5 ppm of dimethyl maleate.

Abstract: The present invention provides heteroaryl substituted pyrrolo[2,3-b]pyridines and heteroaryl substituted pyrrolo[2,3-b]pyrimidines that modulate the activity of Janus kinases and are useful in the treatment of diseases related to activity of Janus kinases including, for example, immune-related diseases, skin disorders, myeloid proliferative disorders, cancer, and other diseases.

Abstract: It has been desired to develop a coating composition, which is used for an orally-administered preparation having an improved administering property, and/or an easily administrable preparation that does not affect dissolution property. The present invention provides a coating composition comprising: a first thickener selected from the group consisting of a carboxyvinyl polymer and sodium alginate; a polyvalent metal compound; at least one type of a second thickener selected from the group consisting of xanthan gum, guar gum and sodium alginate, with the proviso that when the first thickener is sodium alginate the second thickener is not sodium alginate; and sucralose.

Abstract: The present invention relates to a composition, comprising (i) a matrix made of polymeric nanofibers, and (ii) an opioid agonist within the matrix.

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: 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: Methods and compositions are provided which comprise effective amounts of analgesic to treat a subject, including reducing or eliminating an adverse effect associated with the analgesic.