Abstract: This invention relates to pharmaceutical dosage forms, particularly to pH dependent pharmaceutical dosage forms with enhanced and/or prolonged distribution of a pharmaceutical compound at a target site. More specifically, this invention relates to a controlled release intravaginal pharmaceutical dosage form and, more particularly, to a pharmaceutical dosage form which comprises microspheres encapsulated and/or embedded within a bioerodible polymeric matrix, together the microspheres and the matrix are formed into a caplet and/or tablet.

Abstract: The present invention relates to nanoparticles for encapsulating compounds, the preparation and uses thereof, said nanoparticles being based on a vegetable hydrophobic protein, particularly zein, and a water miscible non-volatile organic solvent, particularly propylene glycol. Said nanoparticles can encapsulate or incorporate a product of interest for use in the agricultural, cosmetic, food or pharmaceutical fields.

Abstract: The present invention relates to a pharmaceutical formulation, characterized by comprising flurbiprofen or a pharmaceutically acceptable salt of flurbiprofen, diacerein or a pharmaceutically acceptable salt of diacerein, as well as at least one or a properly-proportioned mixture of polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer or polyvinyl alcohol-polyethylene glycol copolymer.

Abstract: Provided herein are methods and compositions for oral administration of therapeutic proteins, improved protease inhibitor preparations, methods for producing same, and compositions comprising same.

Abstract: The invention is directed to isomeric mixtures of cyclosporine analogues that are structurally similar to cyclosporine A. The mixtures possess enhanced efficacy and reduced toxicity over the individual isomers and over naturally occurring and other presently known cyclosporines and cyclosporine derivatives. Embodiments of the present invention are directed toward cis and trans-isomers of cyclosporin A analogs referred to as ISATX247, and derivatives thereof. Mixtures of ISATX247 isomers exhibit a combination of enhanced potency and reduced toxicity over the naturally occurring and presently known cyclosporins. ISATX247 isomers and alkylated, arylated, and deuterated derivatives are synthesized by stereoselective pathways where the particular conditions of a reaction determine the degree of stereo selectivity. The ratio of isomers in a mixture comprises greater than about 80 percent by weight of the E-isomer and less than about 20 percent by weight of the Z-isomer, based on the total weight of the mixture.

Abstract: A dosage form comprising a capsule containing one or more tablets of 5-aminosalicylic acid or a salt thereof as an active ingredient where each of the one or more tablets is enterically coated is disclosed.

Abstract: A matrix formulation for a soft chewable capsule is provided which includes a gel-forming composition, a plasticizer, a polymer modifier, and water. The polymer modifier may be a carboxylic acid or other organic compound that alters the physical and/or chemical properties of the capsule formulation. A chewable soft capsule is also provided, having enhanced organo-leptic and processing properties. An active material may be delivered to a user using this dosage form. A method of forming the chewable soft capsule is also provided.

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: The present disclosure provides rapidly dissolving oral capsules and films comprising pullulan, a plasticizer, and a dissolution enhancing agent.

Abstract: This invention provides a hard capsule that has excellent stability even when filled with a solvent for dissolving poorly soluble drugs, and that also achieves reduction in disintegration time, thereby ensuring excellent solubility. Specifically, the hard capsule of the present invention has a film comprising: (A) a polymer or copolymer obtained by polymerizing or copolymerizing, in the presence of polyvinyl alcohol and/or a derivative thereof, at least one polymerizable vinyl monomer represented by Formula (1): H2C?C(R1)—COOR2??(1) wherein R1 represents hydrogen or methyl, and R2 represents hydrogen or alkyl having 1 to 4 carbon atoms; and (B) native gellan gum.

Abstract: The invention relates to compositions and methods for reducing cross-linking in the gelatin shell of gelatin capsules by incorporation of free amino acid into the capsule shell and by inclusion of an ester of carboxylic acid either into the capsule filling, and/or into the capsule shell and/or into the lubrication agent, or in combinations thereof. Described are soft gelatin capsules characterized by improved stability as compared with gelatin capsules that do not contain amino acid in the shell and carboxylic acid ester in the filling, shell or in the lubrication agent, or in combinations thereof.

Abstract: Provided herein are methods for treating certain conditions, including diabetes, obesity, and other metabolic diseases, disorders or conditions by administrating a composition comprising a biguanide or related heterocyclic compound, e.g., metformin. Also provided herein are biguanide or related heterocyclic compound compositions, and methods for the preparation thereof for use in the methods of the present invention. Also provided herein are compositions comprising metformin and salts thereof and methods of use.

Abstract: An article and method for reducing somnolence in a patient receiving tizanidine therapy. Tizanidine may be administered in the form of an immediate release multiparticulate composition at or around the time food is consumed. The composition may be packaged in a container for distribution.

Abstract: A remote treatment delivery system for an animal including a dosage projectile adapted to deliver a biologically active agent to an animal substantially without piercing the skin of the animal and containing a biologically active agent and a carrier in liquid or gel form, the carrier allows adhesion of the biologically active agent to skin, coat or fur of the animal; wherein the agent and the carrier are encapsulated in one or more encapsulating agents; and wherein the encapsulating agents forms a frangible shell.

Abstract: The present invention relates to metformin extended release (XR) formulations with improved compactability to provide reduced mass tablets, granulations, and capsules.

Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.

Abstract: The invention discloses stable formulations of acetylsalicylic acid or salts thereof, omega-3 fatty acids and amylose in soft gelatin capsules.

Abstract: The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.

Abstract: The present invention relates to oral controlled-release formulations of 5-(pyridinyl)-2(1H)-pyridinone compounds and their use in the treatment of a subject with heart failure, a stage, class or manifestation of heart failure, or at risk of developing or exhibiting symptoms of heart failure. The formulations of the invention release the compounds in the range of between 0.1 ?g/kg body weight/minute and 20 ?g/kg body weight/minute.

Abstract: Pharmaceutical compositions of a H2 receptor antagonist and ibuprofen are provided herein. The compositions comprise, e.g., a core and a shell separated by a barrier layer, bilayered or trilayered compositions, or liquid formulations. Also provided are methods of making the pharmaceutical compositions, and methods of treatment comprising administering the pharmaceutical compositions.

Abstract: The present invention deals with extended release pharmaceutical compositions comprising tolterodine, wherein the composition comprises: a) a drug layer comprising tolterodine tartrate, monosaccharide and/or disaccharide on an inert core; or a drug core comprising tolterodine tartrate, monosaccharide and/or disaccharide; and b) a polymer layer comprising extended release polymer(s). The invention also provides a process for the preparation of the above mentioned composition.

Abstract: The present invention relates to processes for the manufacture of suspensions comprising one or more water soluble or water insoluble pharmaceutical or nutraceutical active ingredients with a particle size in the range of from 0.01 to 10 micron. More specifically, suspensions prepared by this process can be used to formulate pharmaceutical compositions, especially in liquid fill capsules.

Abstract: The present invention discloses a tablet or a capsule for oral administration comprising 0.5-0% (w/w) hyaluronic acid or a salt thereof, an active pharmaceutical ingredient (API), and a coating.

Abstract: The invention relates in one aspect to a composition, specifically a jelly, the use of which composition as an auxiliary means is to ease the taking of oral medication in solid form, which composition comprises iota-carrageenan as a jellifying agent and citric acid as a salivating agent, characterized in that the composition further comprises maltodextrin. In another aspect, the composition comprises a calcium sequestrant for adjusting Ca-ion activity of the composition. In one embodiment, the composition comprises iota-carrageenan in 0.7-1.0% in mass, citric acid in 0.06-0.07% in mass, maltodextrin in 1.5% in mass, all relative to the total mass of the composition, and an amount of a calcium sequestrant such that the Ca-ion activity of the composition is between 20 ppm and 80 ppm.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

Abstract: Compositions of the present invention, comprising the combination of enterically coated and uncoated pancreatic enzyme-containing beads are useful for treating or preventing pancreatitis pain, and optionally disorders associated with digestive enzyme deficiencies.

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 is directed to a pharmaceutical composition in unit dose form for orally delivering doxycycline to a human, the pharmaceutical composition comprising: a capsule, wherein the capsule is coated with a delayed release layer; wherein the delayed release layer comprises about 4 to 6 mg of doxycycline monohydrate and a binding agent, and wherein the delayed release layer is coated with an enteric coating; wherein the enteric coating dissolves at pH of about 5 to 6, and wherein the enteric coating is coated with an immediate release layer; wherein the immediate release layer comprises about 32 mg of doxycycline monohydrate and a binding agent, wherein the relative mean Cmax of the pharmaceutical composition is within 80.00% to 125.00% of a Cmax value of 510±220.7 ng/mL, after administration of a single dose of the pharmaceutical composition to humans in a fasting state; and wherein the relative mean AUC(0-?) of the pharmaceutical composition is within 80.00% to 125.

Abstract: A pharmaceutical soft gelatin capsule dosage form that includes (a) a shell that includes gelatin and a plasticizer; and (b) a fill that includes at least one active ingredient, polyethylene glycol, polyacrylic acid, a neutralizing agent, and water. The neutralizing agent is a primary amine or a secondary amine, and is present in an amount necessary to provide a pharmaceutical soft gelatin capsule dosage form having stable dissolution after storage.

Abstract: The present application relates to a method for managing the development and manufacturing process of a therapeutically effective formulation. Peanut proteins are characterized from peanut flour and encapsulated formulations made using the peanut flour for oral immunotherapy of peanut allergies.

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, tranquillizers, stimulants and narcotics.

Abstract: An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).

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 pharmaceutical or nutraceutical composition with sustained release of an active ingredient according to the present invention comprises at least one coated granule; the coated granule being composed of a particle that comprises said active ingredient and is coated with at least two coatings that comprise a combination of excipients. The present invention relates also to a process for the preparation of the composition.

Abstract: The present invention provides pharmaceutical compositions suitable for oral and methods of treating subjects in need thereof. The pharmaceutical compositions of the present invention enhance bioavailability of at least one compound classified as BCS Class II, BCS Class III or BCS Class IV.

Abstract: The invention relates to a pharmaceutical formulation of nanonised fenofibrate, to a method for preparing same, and to the uses thereof.

Abstract: Pharmaceutical compositions and single unit dosage forms of 4-amino-2-(2,6-dioxopiperidine-3-yl)isoindoline-1,3-dione, or a pharmaceutically acceptable stereoisomer, prodrug, salt, solvate, hydrate, or clathrate, are provided herein. Also provided are methods of treating, managing, or preventing various disorders, such as cancer or an inflammatory disease.

Abstract: Pharmaceutical formulations that resist ethanol-induced dose dumping and methods of use thereof.

Abstract: A capsule formulation of pirfenidone is provided that includes pharmaceutically acceptable excipients. In one embodiment, this capsule formulation is capable of sustaining desirable pharmacokinetic responses in a patient. Further provided are methods of treating fibrotic conditions and other cytokine-mediated disorders by administering pirfenidone capsules of such formulation to a patient in need.

Abstract: An oral dosage form for administration to an animal comprising a biologically utilizable form of calcium and an extended release system that maintains the calcium level in the animal's bloodstream at a substantially beneficial level for a defined period of time.

Abstract: The present invention relates to pharmaceutical formulations comprising at least one acid-labile proton pump inhibiting agent and at least one antacid, which have improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, safety, as well as other improved pharmacokinetic, pharmacodynamic, chemical and/or physical properties. The present invention is directed to methods, kits, combinations, and compositions for treating, preventing or reducing the risk of developing a gastrointestinal disorder or disease, or the symptoms associated with, or related to, a gastrointestinal disorder or disease in a subject in need thereof.

Abstract: The present invention relates to compositions and methods for the prophylaxis or treatment of deficiencies in essential amino acid absorption and metabolism and/or of a pathology or symptom associated there with. In particular the invention concerns the treatment and/or prevention of ADHD, ADD and autism spectrum disorders. The present inventors have developed a method for prophylaxis or treatment of such symptoms and/or pathologies associated with a deficiency in essential amino acid absorption and/or metabolism, which method, stated generally, relies on the administration of nicotinamide, typically in a long-acting formulation so as to overcome the deficiencies of existing formulations, which have proven unsuitable for effective treatment.

Abstract: A pharmaceutical formulation comprises a plurality of seamless minicapsules having a diameter from 0.5 mm to 5 mm, at least some of the minicapsules containing a methyxanthine as one active ingredient, and at least some of the minicapsules containing a corticosteroid as another active ingredient.

Abstract: The present invention relates to stable pharmaceutical compositions comprising entacapone, levodopa and carbidopa, or pharmaceutically acceptable salts or hydrates thereof. The invention also relates to processes for the preparation of such compositions.

Abstract: A herbal composition comprising extracts or particulate material from the plants Epimedium Grandiflorum, Turnera diffusa var. aphrodisiaca, Ilex paraguariensis, and Sarsaparilla with an admixture of an emulsifying agent and a dispersing agent serves as a female aphrodisiac herbal composition, in particular for women suffering from lack of sexual desire and arousal disorders.

Abstract: Single oral solid dosage form comprising an immediate release first dosage composition having at least two antibiotic agents and a delayed release second dosage composition having a proton pump inhibitor are provided herein. The single oral solid dosage form according to some aspects of the invention can be used for the treatment of disorders associated with infection by H. pylori or the prevention of recurrence of disorders associated with infection by H. pylori.

Abstract: The invention relates to a pharmaceutical composition for oral administration comprising or consisting of (i) 10 to 30% weight, of at least one pharmaceutically active substance selected from the group consisting of water-soluble, oxidatively-degradable statins, preferably atorvastatin, cerivastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin or a combination thereof, (ii) 0.01 to 3% weight, of a first anti-oxidatively active substance (A1), (iii) 0.01 to 3% weight, of a second anti-oxidatively active substance (A2) that differs from the first anti-oxidatively active substance (A1), and (iv) 60 to 85% weight of at least one additive, selected from the group consisting of filler, binder, flow-regulating agent, disintegrant and anti-blocking agent or a combination thereof, and the use of the pharmaceutical composition in medicine.

Abstract: The present invention generally relates to orally administered pharmaceutical compositions of iron compounds with medium chain fatty acid salts. The invention further relates to methods of using the pharmaceutical compositions to treat iron deficiency and related disorders.

Abstract: The present invention relates to a pharmaceutical composition for treating hepatitis B virus infection comprising crystalline entecavir as the pharmaceutically active ingredient and one or more pharmaceutically acceptable excipients. The tablet and capsule of the pharmaceutical composition have improved stability compared to that of amorphous entecavir under the conditions of light, high temperature and high humidity.