Abstract: The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquilizers, stimulants and narcotics.

Abstract: A problem of the present disclosure is, in one embodiment, to create a hard capsule formulation that includes a pharmaceutical agent or the like whose components deteriorate upon contact with an acid, in which the pharmaceutical agent or the like does not deteriorate due to gastric acid penetrating into the outer shell of the hard capsule. A hard capsule formulation comprising a hard capsule with acid resistance, in which the hard capsule is not treated with enteric coating, and the hard capsule formulation comprises an agent to inhibit invasion of gastric fluid and a pharmaceutical agent in the hard capsule.

Abstract: The present invention relates to the field of gastroenterology and, more particular, to the field of intestinal diseases. More specifically, it concerns uses and methods for the treatment of inflammatory bacterial diseases of the intestine. In particular, it relates to diseases that are associated with bacterial invasion of the intestinal mucus, including, inflammatory bowel diseases, and infectious bacterial diseases. Therefore, the present invention provides agents, a pharmaceutical composition and a kit for treating said diseases. It further relates to a use and a method for treating invasive bacterial diseases of the large intestine.

Abstract: Described herein is an association of at least one phosphate binder, at least one uremic toxin binder, at least one vasoactive antihypertensive agent and at least one antifibrotic agent for the management of progressive renal diseases including chronic kidney diseases (CKD) in domestic carnivores. Specifically, the application describes veterinarian compositions comprising such an association and the use thereof for the treatment of CKD conditions.

Abstract: Provided is an orally disintegrating tablet which shows high stability of the active ingredients (acetylsalicylic acid and PPI), and expresses the pharmacological effects of the active ingredients stably and rapidly after administration. A multiple-unit type orally disintegrating tablet containing enteric-coated micro granules containing acetylsalicylic acid, enteric-coated micro granules containing a proton pump inhibitor, and an additive, wherein an enteric coating layer of the enteric-coated micro granules containing acetylsalicylic acid contains an aqueous enteric polymer base and a sustained-release base.

Abstract: The present disclosure provides compositions and methods useful for treating or preventing diseases or disorders where beta amyloid accumulation or aggregation contributes to the pathology or symptomology of the disease, for example Alzheimer's disease.

Abstract: The present disclosure relates to aqueous compositions for use in the manufacture of capsule shells endowed with bulk enteric properties. The present disclosure also relates, in part, to aqueous dispersions suitable for the implementation of said manufacturing process, and to enteric capsule shells and hard capsules obtained therewith.

Abstract: Doxycycline formulations with a reduced food effect are disclosed. Particularly disclosed are modified release formulations which can be administered once a day and exhibit a reduced food effect. Methods of treating inflammatory conductions such as rosacea or inflammatory symptoms such as the papules and pustules of rosacea or acne vulgaris are also disclosed.

Abstract: Methods of treating renal cancer, including renal cell carcinoma, using mesalamine are disclosed herein. Mesalamine can be administered as a monotherapy or as part of a comprehensive treatment program, which can also include administration with other anti-cancer drugs, surgical treatments or exposure to ionizing radiation.

Abstract: Methods and compositions for treating, preventing or managing central nervous system cancers are disclosed. The methods encompass the administration of 4-amino-2-(2,6-dioxo-piperidine-3-yl)-isoindoline-1,3-dione, also known as Pomalidomide. Furthermore, provided herein are methods of treatment using this compound with chemotherapy, radiation therapy, hormonal therapy, biological therapy or immunotherapy. Pharmaceutical compositions and single unit dosage forms suitable for use in the methods provided herein are also disclosed.

Abstract: A shell-forming composition for a soft capsule comprising a non-gelatin component as the chief component, wherein the shell-forming composition is able to inhibit a decrease in physical strength (breaking strength) of the capsule when a phospholipid-containing oil with a phospholipid concentration of 20% or more by mass is used as the core of the capsule. The shell-forming composition for the soft capsule comprises (A) starch and/or dextrin, (B) a gelatinizer, (C) glycerin and (D) sorbitol, and the mass ratio of (C) glycerin:(D) sorbitol ranges from 100:30 to 100:120.

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin; and (b) a fill that includes at least one active ingredient, one or more polyethylene glycol, and a modified guar gum. The pharmaceutical soft gelatin capsule dosage form maintains its shell integrity (hardness) and fill viscosity after storage.

Abstract: The present invention relates to a stable solid oral pharmaceutical multi-component composition comprising combination of blood pressure lowering drugs with lipid lowering agent/s and optionally a platelet aggregation inhibitor in a single dosage form. The blood pressure lowering agents are selected from ?-adrenergic receptor blocking agent, ACE inhibitor and diuretic. The lipid lowering agent is selected from HMG Co-enzyme-A reductase inhibitor. The pharmaceutical composition made as per present invention a) overcomes any drug-drug interactions, b) exhibits pharmacokinetic and pharmacodynamic profile of individual therapeutic agent, c) has minimal side effects. The invention provides multi-component composition (MCC) to increase adherences to therapy. The MCC as per present invention provides compositions that maintain activity of all active ingredients without significant increase in adverse event profile. The present invention further relates to a method of preparing the said pharmaceutical composition.

Abstract: Provided are immediate or prolonged administration of certain potassium ATP (KATP) channel openers to a subject to achieve novel pharmacodynamic, pharmacokinetic, therapeutic, physiological, metabolic and compositional outcomes in the treatment of diseases or conditions involving KATP channels. Also provided are pharmaceutical formulations, methods of administration and dosing of KATP channel openers that achieve these outcomes and reduce the incidence of adverse effects in treated individuals. Further provided are method of co-administering KATP channel openers with other drugs to treat diseases of humans and animals.

Abstract: The present invention relates to the use of a novel class of cancer stem cell pathway (CSCP) inhibitors; to methods of using such compounds to treat refractory, recurrent, or metastatic cancers; to methods of selective killing cancer cells by using such compounds with specific administration regimen; to methods of targeting cancer stem cells by inhibiting Stat3 pathway; to methods of using novel compounds in the treatment of conditions or disorders in a mammal related to aberrant Stat3 pathway activity; and to processes for preparing such compounds and intermediates thereof, and to the pharmaceutical composition of relevant compounds, and to the specific methods of administration of these compounds.

Abstract: Gastric resistant film-forming compositions are described herein. The composition comprises a gastric resistant natural polymer, a film-forming natural polymer, and optionally a gelling agent. Suitable gastric resistant natural polymers include polysaccharides such as pectin and pectin-like polymers. The film-forming composition can be used to prepare soft or hard shell gelatin capsules which can encapsulate a liquid or semi-solid fill material or a solid tablet (Softlet®) comprising an active agent and one or more pharmaceutically acceptable excipients. Alternatively, the composition can be administered as a liquid with an active agent dissolved or dispersed in the composition. The compositions are not only gastric resistant but may also prevent gastric reflux associated with odor causing liquids, such as fish oil or garlic oil, encapsulated in a unit dosage form and esophageal irritation due to the reflux of irritant drugs delivered orally.

Abstract: Abuse deterrent solid dosage formulations containing 5-({[2-Amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid, and processes for the preparation and administration of these formulations.

Abstract: An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

Abstract: The disclosure relates to pharmaceutical compositions useful in the treatment of adrenal insufficiency in paediatric or elderly subjects.

Abstract: Disclosed herein are stable pharmaceutical dosage forms containing carbidopa, levodopa, and entacapone. The dosage forms are prepared by mixing carbidopa, levodopa, and entacapone and forming granules. In some embodiments the granules also include starch. Microcrystalline cellulose can be added as an extragranular excipient. The stable pharmaceutical dosage forms have a bioavailability that is substantially similar to a dosage form prepared by adding a substantial portion of carbidopa separately from levodopa and entacapone.

Abstract: The present invention relates to the design and development of nanocapsule systems for the administration of active substances, wherein the nanocapsules of the system have a mean diameter less than 1 ?m and are characterized by comprising (a) a protamine shell, (b) an oily core, and one or more surfactants characterized by having a hydrophilic-lipophilic ratio greater than 8, provided that said surfactant is not a phospholipid.

Abstract: In one embodiment, the present application discloses methods of treating diseases and disorders with sulfasalazine and pharmaceutical formulations of sulfasalazine where the bioavailability of the sulfasalazine is increased. In another embodiment, the present application also provides dosing regimens for treating neurodegenerative diseases and disorders with compositions comprising sulfasalazine.

Abstract: The present invention relates to an orally disintegrating tablet (ODT) containing asenapine maleate and to a process for preparing the ODT. In a first aspect, the present invention relates to an ODT containing asenapine maleate and low substituted hydroxypropylcellulose. In a second aspect, the present invention relates to an ODT containing crystalline asenapine maleate and the ODT is prepared using conventional tabletting techniques as direct compression and granulation. In a third aspect, the present invention relates to an ODT containing asenapine maleate and a carboxylic acid, and to the use of a carboxylic acid for enhancing storage stability of an asenapine maleate containing ODT.

Abstract: A poorly soluble drug containing microsphere with improved bioavailability, an oral formulation comprising the same, and a method of preparing the same are provided, wherein the poorly soluble drug containing microsphere is a solid dispersion wherein the poorly soluble drug is dispersed in the water-soluble polymer carrier in a noncrystalline form by spray drying, thus increasing bioavailability of the poorly soluble drug.

Abstract: The present invention relates to the field of methods for providing pharmaceutical compositions comprising poorly water-soluble drugs. In particular the present invention relates to compositions comprising stable, amorphous hybrid nanoparticles, comprising at least one protein kinase inhibitor and at least one polymeric stabilizing and matrix-forming component, useful in pharmaceutical compositions and in therapy.

Abstract: The present invention relates to pharmaceutical compositions of lurasidone or salts thereof. In particular, the invention relates to pharmaceutical compositions of lurasidone or salts thereof with one or more water-insoluble pharmaceutical excipients. The invention also relates to processes for the preparation of such compositions and use thereof for treatment of schizophrenia, bipolar disorders or senile dementia.

Abstract: The present invention relates to novel tablet dosage forms and methods of preparing these forms, which can be used for different classes of pharmaceutical active ingredients posing stability issues in a single unit system. The dosage form includes a first layer, which includes a tablet of one or more active pharmaceutical ingredients, which is inlayed in the first layer along with other pharmaceutically acceptable excipients, and a second layer that includes one or more active pharmaceutical ingredients optionally with other pharmaceutically acceptable excipients.

Abstract: Embodiments of the invention provide solid forms of magnesium glycinate dihydrate and compositions thereof, which are useful for treating hyperphosphatemia and which exhibit desirable characteristics for the same. The invention further provides processes for the production of solid forms of magnesium glycinate dihydrate.

Abstract: An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

Abstract: A process for providing a predetermined quantity of a particulate material in which the particulate material is deposited on a defined area of a sticky surface of a substrate. The process is suitable for deposition of particulate drug material on a substrate such as a strip form substrate which can then be compacted to provide a delivery device for delivering the predetermined quantity of the particulate material. Such a delivery device, and an apparatus to perform the process, comprise further aspects of the invention.

Abstract: The present invention provides a delayed and/or controlled release formulation of paroxetine or a pharmaceutically acceptable salt thereof that is formulated to release a substantial portion of the active ingredient (e.g., paroxetine) in the large intestine of an individual in need thereof. In one embodiment, the present invention provides a controlled release paroxetine composition comprising paroxetine or a pharmaceutically acceptable salt thereof, in a controlled release swallow pharmaceutical formulation, that upon administration, releases the paroxetine substantially in the large intestine. For example, the controlled release paroxetine formulation may be formulated to release greater than about 50% of the paroxetine in the large intestine.

Abstract: Disclosed are pharmaceutical compositions containing, as the active ingredients, a mixture of a hyaluronic acid polymer with a bradykinin B2 receptor antagonist. Said compositions have proved especially effective in the treatment of degenerative joint diseases such as osteoarthritis using intra-articular injections.

Abstract: An oral pharmaceutical composition of isotretinoin containing at least two lipidic excipients, one of them being hydrophilic (i.e. having an HLB value superior or equal to 10), the other being an oily vehicle.

Abstract: Disclosed in certain embodiments is a controlled release oral dosage form comprising a therapeutically effective amount of a drug susceptible to abuse together with one or more pharmaceutically acceptable excipients; the dosage form further including a gelling agent in an effective amount to impart a viscosity unsuitable for administration selected from the group consisting of parenteral and nasal administration to a solubilized mixture formed when the dosage form is crushed and mixed with from about 0.5 to about 10 ml of an aqueous liquid; the dosage form providing a therapeutic effect for at least about 12 hours when orally administered to a human patient.

Abstract: An oral methylphenidate powder which is reconstitutable into a final oral aqueous sustained release formulation containing at least about 50%, or at least about 80% by weight water based on the total weight of the suspension, is provided. The powder is a blend containing a combination of an uncoated methylphenidate-ion exchange resin complex, a barrier coated methylphenidate-ion exchange resin complex-matrix, and a water soluble buffering agent such that upon formed into an aqueous liquid formulation, the formulation has a pH in the range of about 3.5 to about 5, or about 4 to about 4.5. Following administration of a single dose of the oral aqueous methylphenidate suspension, a therapeutically effective amount of methylphenidate is reached in less than one hour and the composition provides a twelve-hour extended release profile.

Abstract: The present invention relates to co-extruded pharmaceutical compositions and dosage forms including an active agent, such as an opioid agonist, and an adverse agent, such as an opioid antagonist. Such compositions and dosage forms arc useful for preventing or discouraging tampering, abuse, misuse or diversion of a dosage form containing an active pharmaceutical agent, such as an opioid. The present invention also relates to methods of treating a patient with such a dosage form, as well as kits containing such a dosage form with instructions for using the dosage form to treat a patient.

Abstract: The present disclosure relates to acid resistant banding solutions for two piece hard capsules, and methods of making the same. The present disclosure also relates, in part, to a method for banding such capsules which provides an acid resistant seal between the capsule parts and achieves an increased acid resistance in vitro. The instant disclosure further relates to a capsule sealing solution formula that comprises shellac ink or shellac ink vehicle component.

Abstract: Oral pharmaceutical formulations of ibrutinib and/or a pharmaceutically acceptable salt thereof, methods for their administration, process of their production, and use of these formulations for the treatment of diseases treatable by ibrutinib such as cancer, inflammatory diseases, and autoimmune diseases.

Abstract: Pharmaceutical compositions of metabotropic glutamate 5 receptor (mGlu5) antagonists or a pharmacologically acceptable salt thereof are disclosed. The compositions contain the therapeutic active compound with non-ionic polymer and ionic polymer, binder and fillers in either matrix pellet, matrix tablet or coated pellets. The compositions provide a pH-independent in vitro release profile with NMT 70% in one hour, NMT 85% in 4 hour, and NLT 80% in 8 hours. The compositions are useful for the treatment of CNS disorders, such as Treatment-Resistant Depression (TRD) and Fragile X Syndrome.

Abstract: The present invention relates to a plurality of dosage forms comprising a first dosage form and second dosage form each comprising a therapeutic agent, such as an opioid; wherein the dosage strength of the second dosage form is greater than that of the first dosage form; and wherein the steady state Cave and the steady state AUC of the first and second dosage forms are dose proportional and the single dose Cmax of the second dosage form is less than the minimum level for dose proportionality with respect to the first dosage form. The present invention also relates to methods of administering such dosage forms to a patient, as well as to kits comprising such dosage forms and instructions for administration of the dosage forms to a patient. The inventors believe that the dosage forms and methods of the present invention will lead to improved safety and patient acceptance.

Abstract: Therapeutic compositions and methods for treatment of attention deficit disorder (ADD) or attention deficit hyperactivity disorder (ADHD) include dosage forms that deliver a therapeutic amount of active drug in a delayed and controlled release formulation. The dosage form can be administered at night and drug release is delayed for from 4 to 6 hours or longer, followed by an ascending release rate.

Abstract: A modified release composition comprising cyclosporin A for oral administration. The composition may comprise a core and a modified release coating, wherein the core comprises a hydrogel-forming polymer matrix and cyclosporin A. The composition may be in the form of a minibead. The compositions provide a pharmacokinetic profile and dissolution profile which provides release of cyclosporin A in the lower GI tract whilst minimising systemic exposure. Also disclosed are uses of the composition in the treatment of conditions affecting the lower GI tract, particularly the colon.

Abstract: The invention provides a multi-compartmented container suitable for the delivery of pharmaceuticals, medicines, vitamins, and the like.

Abstract: Solid, stable formulations of linaclotide suitable for oral administration are described herein as are methods for preparing such formulations. The formulations described herein contain a polypeptide consisting of the amino acid sequence Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (“linaclotide”; SEQ ID NO:1) or a pharmaceutically acceptable salt thereof. The linaclotide formulations described herein are stable and have a sufficient shelf life for manufacturing, storing and distributing the drug.

Abstract: The present invention provides microspheres comprising a plurality of nanocapsules accommodated in a gel forming polymer, the plurality of nanocapsules comprising an oil core carrying a non hydrophilic active agent and a shell of polymeric coating. The invention also provides a method for preparing the microspheres of the invention, pharmaceutical compositions comprising the same as well as methods of use of the microspheres, specifically, in therapeutic, cosmetic and diagnostic applications.

Abstract: A triggerable composition for two-stage, controlled release of a functional active chemical includes a trigonelline ester of a functional active with at least one hydroxyl group configured to release the functional active through a hydrolysis reaction upon contact with an aqueous medium, and an encapsulation material for encapsulating the trigonelline ester including a functional active, the encapsulation material triggerable to release the trigonelline ester upon the occurrence of an environmental stimulus. In other aspects, a viscous liquid or an absorbent article includes a triggerable composition for two-stage, controlled release of a functional active chemical, the composition including a trigonelline ester of a functional active with at least one hydroxyl group configured to release the functional active through a hydrolysis reaction upon contact with an aqueous medium, and an encapsulation material for encapsulating the trigonelline ester including a functional active.

Abstract: Described are oral dosage forms that contain abuse-deterrent features and that contain core-shell polymers that include an active pharmaceutical ingredient, with particular examples including immediate release dosage forms that contain a drug that is commonly susceptible to abuse.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising budesonide. The invention also relates to processes for the preparation of such compositions and using those compositions in the treatment of Inflammatory Bowel Disease and Irritable Bowel Syndrome including mild to moderate ulcerative colitis.

Abstract: The present invention is directed to seamless capsules and methods for making seamless capsules having a high oil content as described herein. More specifically, the present invention is directed to seamless capsules, and methods for making seamless capsules, made from a process involving the steps of: (a) preparing an emulsion comprising oil, water, an emulsifier, and at least one of a water-soluble monovalent metal salt, polyvalent metal salt, and an acid, wherein said oil is present in an amount of at least 50% by weight of said emulsion; with the proviso that said emulsion does not contain marmelo mucilage; and (b) adding portions of said emulsion to an aqueous gelling bath comprised of at least one ionic polysaccharide thereby encapsulating said portions of said emulsion in a polysaccharide gel membrane, and optionally (c) drying the resulting capsules by removing water.

Abstract: Described herein are pharmaceutical compositions for the delivery of poorly soluble active pharmaceutical ingredients. In particular, a substantially clear fexofenadine HCl solution in a soft gelatin capsule is described.