Abstract: The present invention provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L. The invention further provides a capsule containing an inhalable powder composition wherein the composition comprises about 75% by weight or more levodopa, dipalmitoylphosphatidylcholine (DPPC) and a salt characterized by a working density of less than about 100 g/L wherein the capsule material comprises hydroxypropylmethylcellulose (HPMC) and titanium dioxide.

Abstract: The present invention provides novel, biocompatible matrices for cell encapsulation and transplantation. It further provides methods for delivering agents to encapsulated cells and to the local environment of a host system. The invention also provides methods for targeting and manipulating particular cells and/or proteins of the host system. In a composition aspect of the invention, a composition including a collection of capsules is provided. The capsules comprise an inner core, and the inner core is covered by an outer shell composed of a positive polyelectrolyte and a negative polyelectrolyte. The inner core of the capsules contains at least one cell.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: The present invention is directed to the administration of aminoglycosides. In particular, the present invention is directed to compositions and methods for the pulmonary administration of aminoglycosides. According to a preferred embodiment, compositions and methods are provided for the localized treatment of respiratory infections.

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: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: Disclosure of methods and compositions related to chemical conjugations to nanoparticles of polysaccharides cross-linked to poloxamers as well as nano-sized colloids comprised of polysaccharides and poloxamers. The nanoparticles may be produced by various methods including inverse miniemulsion polymerization processes which create nanogels of desired size, shape, and stability for controlled therapeutic drug delivery, imaging, and theragnostic applications.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

Abstract: The present invention relates to controlled release pharmaceutical compositions comprising fumaric acid ester(s) as active substance(s). The compositions are suitable for use in the treatment of e.g. psoriasis or other hyperproliferative, inflammatory or autoimmune disorders and are designated to release the fumaric acid ester in a controlled manner so that local high concentrations of the active substance within the gastrointestinal tract upon oral administration can be avoided and, thereby, enabling a reduction in gastro-intestinal related side-effects.

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 oral dosage form with active agents in controlled release cores and in immediate release gelatin capsule coats.

Abstract: A drug delivery system (DDS) for administration of a water soluble, cationic, and amphiphilic pharmaceutically active substance (API) which DDS comprises poorly water soluble nanoparticles formed by the API together with a Na-salt of N-all-trans-retinoyl cysteic acid methyl ester and/or a Na-salt of N-13-cis-retinoyl cysteic acid methyl ester. A pharmaceutical composition comprising such a DDS. Methods for preparation of such a DDS and such a pharmaceutical composition. Use of such a DDS and pharmaceutical composition for treatment of cancer.

Abstract: The present invention includes an oral pharmaceutical capsule comprising a shell, lanthanum carbonate or lanthanum carbonate hydrate, and a lubricant such as talc, wherein the shell encapsulates the lanthanum carbonate or its hydrate and the lubricant. Capsule shells comprise, for example, gelatin. The present invention also includes an oral pharmaceutical powder comprising lanthanum carbonate or lanthanum carbonate hydrate and a pharmaceutically acceptable excipient. The oral pharmaceutical capsules and powders of the present invention can be administered to treat a patient at risk of or suffering from hyperphosphatemia, at risk of or suffering from chronic kidney disease (CKD), at risk of or suffering from soft tissue calcification associated with CKD, or at risk of or suffering from secondary hyperparathyroidism.

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: Described embodiments include a final dosage form for administering a medicament to an animal, an article of manufacture, and method. A described final dosage form includes a dosage portion having a medicament and a release element in a first medicament-release state. The medicament has a first bioavailability to the animal. The release element is modifiable ex vivo to a second medicament-release state by an exposure to a stimulus, wherein the medicament has a second bioavailability to the animal. The final dosage form includes another dosage portion having another medicament and another release element in another first medicament-release state. In the another first medicament-release state, the another medicament has another first bioavailability to the animal. The another release element is modifiable ex vivo to another second medicament-release state by an exposure to another stimulus, wherein the another medicament has another second bioavailability to the animal.

Abstract: The present invention discloses an “Improved Oral Targetted Drug Delivery System (O-TDDS)” particularly suited for delivery of drugs having activity against the diseases located in the colon e.g. colon cancer, ulcerative colitis, protozoal infections etc. The system comprises two elements or parts viz. microspheres (drug+natural polymers such as guar gum or xanthan gum) and probiotics. Both the elements are packed together in a single, pharmaceutically acceptable oral dosage form such as a capsule. The system offers distinct advantages of drug delivery without undesirable side-effects of diarrhea, nausea or vomiting commonly encountered in case of anti-cancer drugs such as 5-Fluorouracil.

Abstract: A gel mass is provided that is useful in manufacturing enteric soft or hard capsules, or enteric tablets without coating.

Abstract: The present disclosure provides a once-daily water-soluble pharmaceutically active formulation for oral administration. In certain embodiments, the composition comprises a watersoluble pharmaceutically active organic compound incorporated into a small particulate, each particulate having a core of the water-soluble pharmaceutically active organic compound or an acceptable salt thereof in reversible association with a pharmaceutically acceptable drug-binding polymer. The core of the composition being surrounded by an insoluble water permeable membrane that is capable of delaying the dissolution of the pharmaceutically active compound therewithin and providing for extended release of the pharmaceutically active compound.

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: The present invention is directed to pediatric formulation of (R)-N-[-1-(1-naphthyl)-ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride (hereinafter referred to as Cinacalcet HCl) and method of administering the same.

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: The present invention relates to a novel drug delivery and release system, i.e. Self-emulsifying Drug Delivery System (SEDDS), of butylphthalide, to a preparation process thereof, and to a use thereof in a pharmaceutical formulation. The drug delivery system comprises as essential ingredients 1% to 65% of butylphthalide and 10% to 65% of a emulsifying agent, together with various excipients as required depending on the desired dosage forms. The present invention significantly increases the contact area between butylphthalide and the mucous membrane of the gastrointestinal tract, and therefore improves the absorptivity of the drug.

Abstract: The present application relates to encapsulated benefit agents, compositions comprising such encapsulated benefit agents and processes for making and using compositions comprising such encapsulated benefit agents that do not require or require a reduced amount of scavenger materials. Such encapsulated benefit agents, compositions comprising such encapsulated benefit agents are processed such that no or lower levels of scavenger materials are required.

Abstract: Pharmaceutical formulations are provided which are in the form of capsules or tablets for oral use and which include a medicament dapagliflozin or its propylene glycol hydrate and a pharmaceutical acceptable carrier therefor, which formulation is designed for immediate release.

Abstract: An abuse-resistant controlled release pharmaceutical composition comprising a pharmaceutically effective amount of discrete particles of an active capable of abuse, wherein surfaces of said particles are wetted with a water insoluble coating material, and preferably wherein said composition comprises a matrix, in which said particles are distributed, and which renders the abuse-capable compound within the matrix difficult to separate from the matrix; and a method for the preparation of a controlled release pharmaceutical composition having a reduced potential for abuse, comprising applying a pressure force to a mixture comprising a water insoluble material, and particles of a pharmaceutically active compound capable of inducing in a subject a reaction that is physiologically or psychologically detrimental if administered in an immediate release dosage form, thereby resulting in surface coated particles, and incorporating said surface coated particles into a pharmaceutical composition

Abstract: The invention relates to a pharmaceutical antidiabetic composition containing, among the active ingredients thereof, a plant extract of Englerina lecardii, preferably a hydroalcoholic extract of Englerina lecardii leaves. The composition is preferably formulated in the form of microspheres produced using an extrusion and spheronisation method, and then grouped together in capsules. In particular, the composition is intended for cases of type 2 diabetes.

Abstract: The present invention relates to metformin glycinate salt and pharmaceutical compositions thereof for the treatment of diabetes mellitus. The method includes administration of the metformin glycinate salt by various routes selected from oral, intravenous injectable, intramuscular injectable, nasal, intraperitoneal, or sublingual, in order to achieve a reduction in blood glucose levels. The invention further relates to the synthesis of a new 1,1-dimethylbiguanide glycinate salt, called Metformin Glycinate. The resulting salt exhibits advantages over other metformin salts. These advantages are due, in the first place, to the fact that the glycine counterion exhibits hypoglycemic effects by itself. Moreover, the salt exhibits more rapid absorption, reaching higher plasma concentrations than those produced with metformin hydrochloride.

Abstract: The present invention discloses a method of treating a disease condition susceptible to baclofen therapy, said method comprising orally administering once-a-day in the evening a controlled release drug delivery system comprising baclofen or its pharmaceutically acceptable salt or its derivatives and pharmaceutically acceptable excipients.

Abstract: Capsules that include a shell, a sensitizer, and an active material. Methods for using the capsules to spatiotemporally deliver active material. Representative shells include vesicles, polymers, and inorganic materials. Representative active materials include small molecules and proteins.

Abstract: A cosmetic peeling preparation which comprises a plurality of capsules. A capsule comprises a casing and a filling. The casing material is solid at 25° C. and selected from cosmetically conventional lipids, waxes, emulsifiers, natural polymers, synthetic polymers, and mixtures thereof. The filling comprises an oil or lipid mixture having a viscosity at 25° C. of from 3 to 50,000 mPas and one or more solid substances having an abrasive effect.

Abstract: Orally administrable polymer-carrying units for expanding in a stomach of a mammal to fill a space in the stomach, the polymer-carrying units including: a carrier; a plurality of polymer molecules expandable in aqueous solutions, releasably coupled to the carrier; and means for selectively decoupling the polymer molecules from the carrier so that the polymer molecules and carrier are released in the stomach, are provided.

Abstract: A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.

Abstract: The invention relates to microcapsules, and a continuous micro-encapsulation water-in-oil-in-water microencapsulation process through in situ and interfacial polymerization of the emulsion. The formulation comprises a continuous water phase having a dispersion of microcapsules which contain oil drops and wherein the inside of each oil phase drop—containing optionally oil-soluble materials—there is a dispersion of water, or aqueous extract or water dispersible material or water soluble material. The oil drops are encapsulated with a polymerisable material of natural origin. Such microcapsules are appropriated for spray-dry processes, to be used as dry powder, lyophilised, self-emulsifiable powder, gel, cream and any liquid form. The active compounds included in the microcapsules are beneficial to the health and other biological purposes.

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 invention describes soft gelatin capsules that encapsulate a water-insoluble active ingredient and an excipient composed of a crystallization inhibitor that stabilizes the water-insoluble inhibitor. The crystallization inhibitor being at least one mononacylglycerol compound whose acyl group is a fatty acid residue of 6-18 carbon atoms. The capsule contents are more resistant to turbidity, forming a coarse emulsion, and crystallization of the active ingredient compared with compositions absent the crystallization inhibitor.

Abstract: A controlled release dosage form of venlafaxine that comprises an immediate release pellet and an extended release pellet.

Abstract: The present invention relates to an oral pharmaceutical dosage form comprising micronized progesterone, an edible oil, a disintegrant, and a hydrophilic excipient. Particularly, the invention relates to a pharmaceutical dosage form wherein the dosage form is in a powder form and is contained in a pharmaceutically acceptable capsule. The present invention is also directed toward methods of making the dosage form, methods of using the dosage form, and kits comprising the dosage form.

Abstract: The present invention relates to oral dosage forms comprising Memantine or a pharmaceutically acceptable salt thereof, pharmaceutical formulations comprising the oral dosage forms, and methods for treating mild, moderate or severe Alzheimer's dementia, or neuropathic pain comprising the oral dosage forms and formulations.

Abstract: Disclosed in certain embodiments is an oral dosage form comprising: a therapeutically effective amount of an opioid analgesic; an opioid antagonist; and an irritant in an effective amount to impart an irritating sensation to an abuser upon administration of the dosage form after tampering.

Abstract: A hybrid encapsulate formulation obtained by mixing a starch/fragrance emulsion with a core-shell capsule suspension is provided as is a method of using the formulation in a personal care product, a beauty care product, a fabric care product, a home care product, a personal hygiene product, an oral care product and a method for releasing an encapsulated fragrance by moisture, shear, or a combination thereof.

Abstract: The present invention provides a composition, a dairy product, and a method for treating a disorder in a subject. The composition includes (i) polymeric nanoparticles and (ii) camel derived glycosaminoglycans (GAG)s ionic complex encapsulated into the nanoparticles, at least one active ingredient encapsulated into the nanoparticles, or combinations thereof. The nanoparticles are lactoferrin nanoparticles including camel derived lactoferrin, casein nanoparticles including camel derived casein, or combinations thereof. The dairy product includes ice cream or frozen yogurt, wherein the ice cream or frozen yogurt includes the composition and is derived from camel milk or other species of milk. The method for treating a disorder in a subject includes administering a therapeutic dose of the composition to the subject.

Abstract: The present invention relates to a composition comprising colostrum and at least one agent selected from the group of hydrocolloids, wherein said colostrum and at least one agent are bioconjugated. The bioconjugated composition has improved properties compared to colstrum compositions that are not bioconjugated with a hydrocolloid agent. The composition may be used in a variety of settings, for example for topical application for treating skin diseases and skin conditions. The present invention thus also relates to use of the composition and to a method for the preparation of the composition.

Abstract: The invention relates to a system for administering active ingredients, including nanocapsules comprising an oil, a cationic surfactant and a polymer selected from the group consisting of polyglutamic acid (PGA), polyglutamic-polyethyleneglycol acid (PGA-PEG), hyaluronic acid (HA) and polyasparagine (PAsn) or a combination of same and, optionally, an active ingredient, with the condition that when the polymer includes polyglutamic acid or polyglutamic-polyethyleneglycol acid (PGA-PEG) the active ingredient is not a didemnin or a tamandarin. The invention also relates to methods for obtaining said nanocapsule system, the pharmaceutical compositions thereof and the use of same in medicine.

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: Crystalline forms of imatinib mesylate (F, G, H, I and K) and their respective characterization are disclosed.

Abstract: The present invention relates to a pharmaceutical calcium acetate formulation and a process for making the same. In particular, the present invention relates to a calcium acetate capsule formulation comprising granules comprising calcium acetate along with other formulation adjuvants contained within a pharmaceutically acceptable capsule.

Abstract: Multi-layer solid oral dosage immediate release and extended release compositions and methods for delivering drug formulations using weak acid ion exchange resins in abnormally high pH environments.

Abstract: The present invention provides compositions, desirably pharmaceutical compositions, containing micronized tanaproget. The compositions can also contain microcrystalline cellulose, croscarmellose sodium, anhydrous lactose, and magnesium stearate; or can contain microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, povidone, and magnesium stearate. The compositions are useful in contraception and hormone replacement therapy and in the treatment and/or prevention of uterine myometrial fibroids, benign prostatic hypertrophy, benign and malignant neoplastic disease, dysfunctional bleeding, uterine leiomyomata, endometriosis, polycystic ovary syndrome, and carcinomas and adenocarcinomas of the pituitary, endometrium, kidney, ovary, breast, colon, and prostate and other hormone-dependent tumors, and in the preparation of medicaments useful therefor. Additional uses include stimulation of food intake.

Abstract: Provided herein are pharmaceutical formulations, comprising 4-((9-((3S)-tetrahydro-3-furanyl)-8-((2,4,6-trifluorophenyl)amino)-9H-purin-2-yl)amino)-trans-cyclohexanol, including pharmaceutically acceptable salts, solvates, isomers, isotopologues, tautomers and racemic mixtures thereof, and a pharmaceutically acceptable excipient; and their use for treating or preventing disease.

Abstract: An oral pharmaceutical composition comprises multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule, the composition comprising: a first population of a pharmaceutical active comprising a pharmaceutical active substance releasable at a first rate; a population of a basic substance; and a second population of a pharmaceutical active comprising a pharmaceutical active substance releasable at a second rate. In another embodiment, the oral pharmaceutical composition comprises multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule, the composition comprising: a population of a pharmaceutical active; a population of a basic substance; a population of enteric coated pharmaceutical active; and a population of enteric coated basic substance. The composition can provide multiple site specific delivery of a pharmaceutical active in a rapid, delayed and/or sustained release manner into the plasma.