Abstract: This invention provides a method of treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the patient laquinimod as an add-on therapy to or in combination with interferon-?. This invention also provides a package and a pharmaceutical composition comprising laquinimod and interferon-? for treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention also provides laquinimod for use as an add-on therapy or in combination with interferon-? in treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention further provides use of laquinimod and interferon-? in the preparation of a combination for treating a patient afflicted with multiple sclerosis or presenting a clinically isolated syndrome.

Abstract: This invention relates to a solid pharmaceutical tablet comprising telithromycin or a salt thereof as an active ingredient in combination with a plasticizing effective amount of a microcrystalline cellulose diluent having a plastic behavior. Optional ingredients include a binder, a disintegrating agent and a lubricant, and the tablet may be optionally coated with a film-coating agent.

Abstract: A method to improve the safety of handling of drug substances that are dispensed as solid oral dosage forms is described that does not alter the drug-release profile and the therapeutic efficacy of the pharmaceutical product.

Abstract: This invention provides a method of treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome comprising administering to the subject laquinimod as an add-on therapy to or in combination with fingolimod. This invention also provides a package and a pharmaceutical composition comprising laquinimod and fingolimod for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention also provides laquinimod for use as an add-on therapy or in combination with fingolimod in treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome. This invention further provides use of laquinimod and fingolimod in the preparation of a combination for treating a subject afflicted with multiple sclerosis or presenting a clinically isolated syndrome.

Abstract: Drugs are formulated as oral dosage forms for controlled release in which the release rate limiting portion is a shell surrounding the drug-containing core. The shell releases drug from the core by permitting diffusion of the drug from the core. The shell also motes gastric retention of the dosage form by swelling upon imbibition of gastric fluid to size that is retained in the stomach during the postprandial or fed mode.

Abstract: The novel sustained release dosage form comprising an active agent and a combination of a non-swelling pH dependent release retardant and a non swelling pH independent release retardant polymer which provides pH-independent drug release for a considerable period of time after administration.

Abstract: The present invention relates to an enteric tablet with improved bioavailability, which is rapidly disintegrated after reaching the intestine to allow dissolution of the active ingredient, and which characteristically reduces the amount of talc to be used and is free of an alkali component.

Abstract: The purpose of the present invention is to provide a press-coated orally-disintegrating tablet characterized by containing an inner core which has an excellent disintegratability in oral cavity and a suitable hardness as a whole tablet. The present invention relates to a press-coated orally-disintegrating tablet with an outer layer surrounding an inner core wherein the inner core has a thickness in the range of 10 to 90% per that of the whole tablet, and the outer layer comprises (a) microcrystalline cellulose, (b) an inorganic excipient, and (c) one or more particular ingredients selected from the group consisting of crospovidone, starches, low substituted hydroxypropylcellulose and carmellose.

Abstract: The present invention relates to oral pharmaceutical compositions with controlled and/or programmed release containing at least one active ingredient having antimicrobial and/or anti-infectious activity for the treatment of infections of the large intestine, in particular the colon.

Abstract: Tablets and other objects are film coated by including in the tablet a film-forming polymer that is activated upon contact with an activating amount of liquid. The film-forming polymer, e.g., a cellulosic ether, is homogeneously mixed with the other ingredients of the tablet, shaped into any desirable form, loaded into a conventional coating apparatus, and sprayed or foamed with an activating amount of fluid, e.g., water, alcohol, etc., and dried. This coating process eliminates potential problems such as spray nozzle clogging, inappropriate coating fluid viscosity, and the inability to properly atomize the coating fluid. This coating process does not impart any appreciable weight or thickness gain to the tablet.

Abstract: Pharmaceutical compositions and single unit dosage forms of apremilast, i.e., (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoisoindoline-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 diseases or disorders ameliorated by the inhibition of TNF-? production in mammals.

Abstract: An enteric preparation having a film-forming property and acid resistance is provided by using a simple and efficient method without using a special cooling apparatus. More specifically, provided is a method for producing an aqueous enteric coating liquid including the steps of: partially neutralizing an aqueous suspension including a cellulosic enteric material with an aqueous alkali solution, and mixing the partially-neutralized aqueous suspension with a plasticizer. Also provided is a solid preparation including a core including a drug and a coating portion obtained by coating the core with the produced aqueous enteric coating liquid. Further, provided is a method for producing a solid preparation, including respective steps in the method for producing an aqueous enteric coating liquid and a step of coating a core including a drug with the produced aqueous enteric coating liquid.

Abstract: The present invention relates to a new coating composition and especially a new coating composition to be used with a specific coating device for providing an even, thin and enclosing coating on tablets, capsules or pills of different sizes and shapes in order to improve the taste and the swallowing characteristics of the tablets, capsules or pills.

Abstract: Coated dosage forms comprising a tablet core, preferably in compressed form, that has a coating over its exterior surface and one or more patterns debossed in the tablet surface are disclosed. Methods for manufacturing such dosage forms are also disclosed.

Abstract: The present invention aims to provide a solid pharmaceutical composition comprising: (a) an effective antibacterial quantity of antibiotic from the quinolone family, preferably, moxifloxacin or a pharmaceutically acceptable salt thereof; and (b) a pharmacologically acceptable carrier or excipient compatible with the active ingredient, said excipient being lactose-free. The invention also includes a process for obtaining a solid pharmaceutical composition comprising, as an active ingredient, an antibiotic from the quinolone family, with said process comprising the steps of: (a) mixing and homogenizing the active ingredient and dry excipients in the granulator, i.e.

Abstract: The present invention provides a dry-coated tablet comprising: an inner core containing, as active ingredients, (a) tegafur, (b) gimeracil, and (c) oteracil potassium; and an outer shell.

Abstract: The present invention provides a talc-free composition characterizable as non-tacky and having an average water vapor permeability of at most 5.0 times 10?7 grams per Pascal-hour-meter and having a capability of forming a non-tacky film having an average water vapor permeability of at most 5.0 times 10?7 grams per Pascal-hour-meter. Also provided are the non-tacky film, a method of coating a dosage form with the composition, and a manufactured article comprising the composition.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.

Abstract: The present invention provides a microcapsule pharmaceutical composition of at least a bisquinoline drug. said microcapsule comprises a drug core of a pharmaceutically effective amount of a bisquinoline drug and a polymeric coating over the core. This microcapsule pharmaceutical composition has desirable pharmaceutical properties, including taste masking effect and a high stability.

Abstract: A hydrophilic matrix is disclosed which comprises: a) at least one polyacrylic acid derivative in preferred amounts of 0.5-40%, b) at least one cellulose ether in preferred amounts of 30-90% and c) at least one disintegrant in preferred amounts of 2-50%, with respect to the weight of the matrix. This matrix is used in combination with at least one pharmaceutically acceptable active principle for manufacturing solid bioadhesive controlled release formulations for the treatment of vaginal disorders, such as vulvovaginal candidiasis, bacterial vaginosis or trichomoniasis. According to a preferred embodiment, the matrix is used in amounts of about 5-60% and the active principle in amounts of about 2-70%, with respect to the weight of the formulation.

Abstract: The invention relates to tablet comprising granules dispersed in at least one hydrophilic compound or matrix. The granules contain an active agent, at least one amphiphilic compound and at least one lipophilic compound. The tablet may include a gastro-resistant film coating.

Abstract: The invention relates to pharmaceutical compositions containing rosuvastatin calcium of formula (I) and processes for their manufacture.

Abstract: Coated tablets of (6-(5-chloro-2-pyridyl)-5-[(4-methyl-1-piperazinyl)carbonyloxy]-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazine) are provided. The tablets minimize the perceived bitterness of the medicament. A method for analyzing instantaneous dissolution of sub-microgram quantities of core material is also disclosed.

Abstract: Methods, compositions and devices utilizing stinging cells/capsules for conditioning a tissue prior to delivery of a pharmaceutical agent are described.

Abstract: The present invention relates to a granulate and a pharmaceutical composition comprising fesoterodine or a salt or a solvate thereof and stabilizer, in particular to a pharmaceutical composition comprising fesoterodine or a salt or a solvate thereof and sucrose, polyethylene glycol, cyclodextrin, and combinations thereof and to a process for its preparation. The granulate and the pharmaceutical composition are particularly useful as a medicament, especially for the treatment of urinary incontinence. The present invention relates to use of sucrose, polyethylene glycol, cyclodextrin, and combinations thereof for stabilizing fesoterodine or a salt or a solvate thereof in a pharmaceutical composition.

Abstract: The present invention relates to pharmaceutical compositions containing axitinib, which is known as N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide or 6-[2-(methylcarbamoyl)phenylsulfanyl]-3-E-[2-(pyridin-2-yl)ethenyl]indazole, or crystalline forms thereof, that protect axitinib from degradation, including photodegradation, as well as the therapeutic use of such compositions. The present invention also relates to novel photodegradants of axitinib.

Abstract: This invention provides a solid pharmaceutical formulation having high physical strength and further having excellent drug release properties and digestibility of excipients when administered, which comprises (a) an active medical ingredient and (b) a pre-gelatinized starch in an amount of 10 to 90% by weight, said pre-gelatinized starch being prepared by pre-gelatinizing a cheap and stable usual starch during the procedure for formulation. This invention also provides a method for preparing the solid pharmaceutical formulation.

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 provides various pharmaceutical compositions comprising an S1P receptor modulator, e.g. an S1P receptor agonist. In one aspect, there is provided a pharmaceutical composition having a coating. In other aspects, rapid disintegrating compositions are provided. In a further aspect, a pharmaceutical composition which is free of sugar alcohols is provided. In another aspect, the invention provides a pharmaceutical composition comprising a coating comprising an S1P receptor modulator.

Abstract: A process for producing anionic, nonionic, amphoteric or cationic derivatized polysaccharide products which demonstrate high clarity in surfactant-based compositions. The polysaccharide polymer is reacted for a sufficient time and at a sufficient temperature in the presence of water, caustic, and at least one surfactant. The polysaccharide polymer may optionally be reacted with an oxidizing agent, hydrolytic or proteolytic enzymes, molecular weight reducing agents and a cationizing agent and nonionic agent. The formed derivatized polysaccharide has a lower clarity in water than in an aqueous surfactant system. The derivatized polysaccharide product can be used in personal care and or household care products.

Abstract: The present disclosure describes compositions for intestinal delivery of enzyme formulations and methods of treating health problems with these formulations. More specifically, the enzyme formulations include at least one histaminase and various methods of treatment of physical conditions, such as inflammation, allergy, histamine intolerance, and intestinal cancer.

Abstract: A medicinal carrier is provided. The medicinal carrier comprises a first component, which is a biocompatible polymer with an amino group (—NH2); a saccharide; and a second component which is a biocompatible material. The saccharide grafts to the first component via the amino group (—NH2) of the first component, and the first component bonds to the second component via an ionic bond. The medicinal carrier can protect the medicine from gastric acid and swell or decompose to release the medicine under a specific pH condition, thus, showing a good applicability.

Abstract: Compositions and methods for improving the pharmacokinetics and reducing the risk of adverse events resulting from biguanide compound administration are provided, comprising administering delayed release formulations of such compounds having a lag phase release.

Abstract: The present invention relates to a process for the preparation of a medicament containing vardenafil hydrochloride trihydrate in solid form, in which vardenafil hydrochloride trihydrate is processed with suitable pharmaceutical auxiliaries at a temperature of from approx. 20° C. to approx. 45° C.

Abstract: A benzimidazole formulation which lacks an intermediate layer and yet which is stable both during storage and during the passage through the stomach, and which has low levels of residual volatile excipients, including but not limited to residual alkalinizing agents and/or residual solvents.

Abstract: Dual release oral tablet compositions of dexlansoprazole or pharmaceutically acceptable salts or hydrated forms thereof and processes for the manufacture of the tablet composition and its use in the treatment of gastrointestinal disorders.

Abstract: A once a day bupropion salt formulation is disclosed.

Abstract: Provided is an oral solid preparation of a compound anti-tubercular drug, wherein the active ingredients are rifampicin, isoniazid, pyrazinamide and ethambutol hydrochloride. The compound oral solid preparation is a coated tablet with coated core or a coated three-layer tablet, wherein the two active ingredients rifampicin and isoniazid do not contact directly. The compound oral solid preparation not only improves the stability of the compound preparation, but also improves the bioavailability of rifampicin.

Abstract: Disclosed herein are food-grade enteric coating compositions designed to release pharmaceutical and/or nutraceutical products at various regions of the intestines, wherein said compositions comprise a film former and a pore former. Also disclosed herein are methods of making and using same.

Abstract: A coated tablet formulation is provided which includes a medicament such as the DPP4-inhibitor, saxaglipitin or its HCl salt, which is subject to intra-molecular cyclization, which formulation includes a tablet core containing one or more fillers, and other conventional excipients, which tablet core includes a coating thereon which may include two or more layers, at least one layer of which is an inner seal coat layer which is formed of one or more coating polymers, a second layer of which is formed of medicament which is the DPP4-inhibitor and one or more coating polymers, and an optional, but preferable third outer protective layer which is formed of one or more coating polymers. A method for forming the coated tablet is also provided.

Abstract: Controlled release oral solid dosage form for the reduction of serum cholesterol levels in humans include a drug comprising an alkyl ester of hydroxy substituted naphthalenes (e.g., lovastatin) and a controlled release carrier, such that the dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug which occurs at about 10 to about 32 hours after oral administration on a once-a-day basis to human patients. The dosage form provides a therapeutically effective reduction in serum cholesterol levels. Methods of reducing serum cholesterol levels in humans are also disclosed.

Abstract: The present invention relates to pharmaceutical compositions comprising fixed dose combinations of a DPP-4 inhibitor drug and pioglitazone, processes for the preparation thereof, and their use to treat certain diseases.

Abstract: Oral dosage forms and granulations with a high loading of a methyl hydrogen fumarate prodrug are disclosed.

Abstract: A film-forming starchy composition for the film-coating of solid forms or the preparation of films. The inventive composition has an amylose content of between 25 and 45%, preferably between 30 and 44% and still more preferably between 35 and 40%, the percentages being expressed by dry weight in relation to the dry weight of starch contained in the composition, and includes at least one stabilized starch. A method for the film-coating of solid forms is disclosed and includes spraying the film-forming composition onto a moving nuclei bed. The film-forming composition is used for the production of films and capsules.

Abstract: A dosage form from which a burst release of a drug contained within a tampered dosage form is reduced or retarded by the presence in or on the dosage form of a TPTA (Tamper Prone Therapeutic Agent) trap. If the dosage form has not been tampered with, the TPTA trap does not significantly interfere with the rate of release of the drug from the dosage form. However, if the dosage form has been physically tampered with, the TPTA trap reduces or retards burst release of the drug from the dosage form.

Abstract: Disclosed herein is a lag time delayed-release combination pharmaceutical composition comprising of an angiotensin-II-receptor blocker and an HMG-CoA reductase inhibitor, as well as a preparation method thereof. The composition is designed based on chronotherapy in which active ingredients are administered to have different onset times, such that the release of each active ingredient of the composition in body can be lag time delayed to a specific rate. Also, the composition is very effective for the treatment of hypertension and the prevention of complications in patients having metabolic syndromes which show diabetes, obesity, hyperlipidemia, coronary artery diseases and the like. More specifically, the composition is a drug delivery system designed such that the release of each drug is controlled to a specific rate, and it can show the most ideal effect, when it is absorbed in body.

Abstract: The invention relates to pharmaceutical compositions containing rosuvastatin calcium of formula (I) and processes for their manufacture.

Abstract: This invention is related to direct compression of otilonium or its pharmaceutically acceptable salt having perfect powder flowability, good tablet weight distribution and no sticking to the punches.

Abstract: The invention relates to a novel solid pharmaceutical composition of telithromycin which facilitates swallowing by the patient.

Abstract: To provide pharmaceutical preparation exhibiting satisfactory dissolution property in a wide pH range. The pharmaceutical composition is characterized by containing (A) N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide, represented by the following formula (1), a pharmacologically acceptable salt thereof, or a hydrate of any of these, and (B) one or more species selected from the group consisting of a sugar alcohol and a water-swelling additive.