Abstract: An isomalt-containing mixture including a) 60-97% by weight of agglomerated isomalt, b) 1-25% by weight of crosslinked polyvinylpyrrolidone, c) 0.1-15% by weight of lubricant, d) 1-15% by weight of water-insoluble, film-forming polymers, e) 0-15% by weight of water-soluble polymers and f) 0-15% by weight of pharmaceutical auxiliaries, where the sum of components a) to f) is 100% by weight. Also processes for the preparation of the isomalt-containing mixture and tablets comprising the mixture.

Abstract: The pharmaceutical preparation for treating endometriosis contains at least 28, preferably 30, daily dose units, each of which contain dienogest, cyproterone acetate, or chlormadinone acetate at a daily dose that is at most twice that required to inhibit ovulation together with one or more pharmaceutical aids and/or carriers. The daily dose units are administered in a method of prophylaxis and/or therapy of endometriosis continuously during a time interval of at least 169 days or 25 weeks, preferably more than two years. The method effectively reduces endometriosis and associated pain, while undesirable side effects including bone density decrease are reduced or eliminated.

Abstract: The present disclosure is directed to a method for treating a disease or disorder in a patient at risk of developing an NSAID-associated ulcer by administering to said patient in need thereof a pharmaceutical composition in unit dose form comprising naproxen, or pharmaceutically acceptable salt thereof, and esomeprazole, or pharmaceutically acceptable salt thereof to said at risk patient and thereby decreasing the patient's risk of developing an ulcer.

Abstract: The present invention relates to an antibacterial agent and a hydrolysate made of at least one extract that has been produced by extraction using ethanol/water from dried plant material of: a) at least one of the plants selected from the group consisting of: Verbena officinalis L., Sambucus nigra L., Primula veris L., Primula elatior (L.) Hill, and Gentiana lutea L.; and a mixture thereof; or b) a mixture of: Verbena officinalis L., Sambucus nigra L., Primula veris L., Gentiana lutea L., and Rumicis herba; and subsequent removal of the ethanol/water extraction agent, wherein the hydrolysate can be obtained from the extract via hydrolytic treatment using a mineral acid. The hydrolyzates according to the invention show a pronounced antibacterial effect against germs relevant to the skin, ears, nose, and throat and respiratory systems.

Abstract: The disclosure provides compositions and methods and maintaining prostate health and relieving menstrual and menopausal related symptoms. The compositions comprise at least two of an icariin component, a quercetin component, a Maca component, a cocoa polyphenols component, and/or a rosmarinic acid component.

Abstract: The present invention is directed to a homogeneous, thermoreversible gel film comprising a film forming amount of kappa-2 carrageenan, and optionally at least one of a plasticizer, a second film former, a bulking agent, and a pH controlling agent; and processes for the preparation thereof. The present invention is also directed to soft capsules and solid forms containing the gel film, as well as processes for the preparation thereof.

Abstract: The present invention relates to compounds of general formula (I): wherein X is selected from the group consisting of O or S and R is a linear or branched, saturated or unsaturated aliphatic group with from 2 to 23 carbon atoms (C2 to C23), or a cyclic group, and which can contain substituents selected from the group consisting of hydroxy, alkoxy, amino, carboxyl, cyano, nitro, alkylsulfonyl or halogen atoms, a method of obtaining them, cosmetic or pharmaceutical compositions containing them and the use thereof for treating, caring for and/or cleaning skin, hair and/or nails, preferably those conditions, disorders or pathologies of the skin, hair and/or nails which require regulating melanogenesis.

Abstract: A pharmaceutical extended-release oral drug delivery system comprising as active ingredient Cefixime Trihydrate in combination with a hydrophilic matrix system, and optionally containing additional pharmaceutically acceptable constituents, wherein at least 20% up to but not more than 40% of Cefixime Trihydrate is released from said matrix within 1 hour from oral administration and the remainder of the pharmaceutical agent is released at a sustained rate.

Abstract: The present invention relates to Rifaximin polymorphic, salt, hydrate, and amorphous forms, to their use in medicinal preparations and to therapeutic methods using them.

Abstract: Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.

Abstract: The present invention relates to polypeptides having cellobiohydrolase I activity and polynucleotides having a nucleotide sequence which encodes for the polypeptides. The invention also relates to nucleic acid constructs, vectors, and host cells comprising the nucleic acid constructs as well as methods for producing and using the polypeptides.

Abstract: The invention provides stable controlled release monolithic coating compositions for use in coating pharmaceutical oral dosage forms comprising a polyglycol having a melting point greater than 55° C. and an aqueous dispersion of a neutral ester copolymer lacking functional groups.

Abstract: The invention relates to novel compositions including an aldosterone antagonist and administered according to a predetermined dosage for treating heart deficiency in non-human mammals.

Abstract: The present invention relates to acylated indanyl amines according to the general formula (I) wherein R1-R4 have the meanings given in the description, A is CH2, CHOH or CH—(C1-C3-alkyl), B is CH2 or CH—(C1-C3-alkyl), and R5 is an aryl or heteroaryl group, possibly substituted by the substituents listed in the description.

Abstract: A stable composition including botulinum neurotoxin and a cyclodextrin and a method of preserving botulinum neurotoxin and for producing a botulinum neurotoxin composition with improved stability properties in an efficient and economically advantageous manner. The invention seeks to alleviate the problems associated with rapid degradation or denaturation of botulinum neurotoxin by providing a novel composition that exhibits improved stability properties. The botulinum neurotoxin is preferably stabilized by forming a cyclodextrin inclusion complex.

Abstract: A method for treating a patient having ulcerative colitis, by administering a drug which containing an effective amount of tetracyclines is provided. The drug may also contain penicillins and/or metronidazoles.

Abstract: A composition of an oral medicine or an oral medicine which can prevent an unpleasant taste of the medicine is herein disclosed. It is granules, powders, syrups and the like which is prevented from an unpleasant taste, comprising a basic medicine having an unpleasant taste and an anionic polymer such as carrageenan.

Abstract: The present invention provides a pharmaceutical composition, presented as a solid unit dosage form adapted for oral administration of sodium oxybate. The preferred unit dosage form is a tablet comprising a relatively high weight-percentage of sodium oxybate, in combination with a relatively small weight-percentage of total excipients. This permits the tablets to contain/deliver a pharmaceutically effective amount, e.g., about 0.5-1.5 g of sodium oxybate in each tablet with a delivery profile similar to that of the liquid form. The tablets are bioequivalent to the liquid form.

Abstract: A stabilized solid preparation having stabilized drug content and stabilized appearance, comprising a main ingredient layer and a coating layer formed on the main ingredient layer, wherein the main ingredient layer comprises a granule or a fine particle comprising a substance capable of being unstabilized when losing water of crystallization and a water-soluble polymer and the coating layer comprises a water-soluble polymer and a sugar.

Abstract: Compositions of the present invention, comprising at least one digestive enzyme (e.g., pancrelipase) are useful for treating or preventing disorders associated with digestive enzyme deficiencies. The compositions of the present invention can comprise a plurality of coated particles, each of which is comprised of a core coated with an enteric coating comprising at least one enteric polymer and 4-10% of at least one alkalinizing agent, or have moisture contents of about 3% or less, water activities of about 0.6 or less, or exhibit a loss of activity of no more than about 15% after six months of accelerated stability testing.

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: A film-coated preparation having excellent storage stability, which contains a compound represented by the formula (I) below or a pharmacologically acceptable salt thereof, having a film layer containing one or more film coating base agents selected from polyvinyl alcohol, sodium carboxymethyl cellulose and pullulan.

Abstract: A cationic, oxidized polysaccharide or derivative thereof that has a mean average molecular weight (Mw) having a lower limit of 50,000 and an upper limit of 1,000,000 and an aldehyde functionality content of at least 0.001 meq/gram is used in personal care and household care compositions. This cationic, oxidized polysaccharide is prepared in continuous or batch processes using hydrolytic reagents, oxidizing reagents, or combination of hydrolytic reagents and oxidizing reagents. Personal care or household care compositions are prepared by adding the cationic, oxidized polysaccharide to a personal care or household composition containing at least one active ingredient other than the cationic, oxidized polysaccharide of this invention.

Abstract: The present invention describes a directly compressible composite prepared by co-processing a water-soluble excipient and calcium silicate. The present invention further describes the incorporation of the co-processed composite into a tablet formulation. The orally disintegrating tablets are of optimal mechanical strength and disintegrate within 60 seconds in the oral cavity.

Abstract: An all-natural tablet coating composition comprised entirely of Certified Organic ingredients and organic compliant ingredients which can be applied to a compressed tablet core using conventional film coating techniques is provided. The coating is useful for preparing organic dietary supplements in a coated tablet form that exhibits good physical and chemical stability, good aesthetics, and which is free of synthetic materials.

Abstract: A process for producing a solubilized ibuprofen, preferably in the form of a granulate, the process comprising the steps of: providing a mixture comprising solid ibuprofen and a first base selected from the group consisting of sodium hydroxide, potassium hydroxide, sodium carbonate, potassium carbonate, sodium glycinate, potassium glycinate and tribasic sodium and potassium phosphates and mixtures thereof, and reacting the ibuprofen and the first base in essentially dry state. The obtainable granulate and the pharmaceutical compositions and dosage forms that may be produced therefrom are distinguished by their high solubility and rapid disintegration and dissolution in aqueous media, by their good flow properties and compressibility, by rapidly achieving onset of analgesic effect.

Abstract: Pharmaceutical compositions having uniform drug distribution and potency utilizing laxofoxifene as an active ingredient and containing a silicon dioxide to reduce loss of the active ingredient during the manufacturing process and methods for manufacturing such compositions are disclosed.

Abstract: A modified-release tablet of bupropion hydrochloride comprising (i) a core comprising an effective amount of bupropion hydrochloride, a binder, a lubricant; and (ii) a control releasing coat surrounding said core; and (iii) a moisture barrier surrounding said control releasing coat, wherein the modified-release tablet is bioequivalent to Wellbutrin® or Zyban®/Wellbutrin®SR tablets.

Abstract: Crystalline polymorphous forms of the rifaximin (INN) antibiotic named rifaximin ? and rifaximin ? useful in the production of medicinal preparations containing rifaximin for oral and topical use and obtained by means of a crystallization process carried out by hot-dissolving the raw rifaximin in ethyl alcohol and by causing the crystallization of the product by addition of water at a determinate temperature and for a determinate period of time, followed by a drying carried out under controlled conditions until reaching a settled water content in the end product, are the object of the invention.

Abstract: A pharmaceutical composition of sirolimus comprising an inert core and a sugar overcoat, wherein said sugar overcoat comprises sirolimus, a poloxamer other than poloxamer 188, microcrystalline cellulose and binder has been developed.

Abstract: The invention relates to a primary composition in which at least one lipophilic bioactive compound is mixed with a whey protein, present in an amount effective to increase the bioavailability of the lipophilic bioactive compound. The invention also relates to an oral composition that contains the primary composition in a foodstuff, in a food supplement, or in a pharmaceutical preparation, and to a cosmetic preparation that contains the primary composition. Methods for increasing the bioavailability of the lipophilic bioactive compound and providing increased photostability and oxidation resistance are also provided.

Abstract: Gestagens, preferably dienogest, chlormadinone acetate or levonorgestrel, in combination with estrogens, for example ethinylestradiol, 17?-estradiol or estradiol valerate, and one or more pharmaceutically acceptable auxiliary agents/excipients provide lactose-free oral contraception. The possibility is provided of improving the prophylaxis for lactose intolerance concerning a possibly contributing factor and also in regard to the costly examinations for lactose intolerance. The invention is also suitable for long-term use.

Abstract: The present invention provides compositions and methods for increasing absorption of antibacterial agents, particularly third generation cephalosporin antibacterial agents, in oral dosage solid and/or suspension forms. Specifically, the composition is comprised of a biopolymer that is preferably swellable and/or mucoadhesive, a antimicrobial agent, and a cationic binding agent contained within the biopolymer such that the binding agent is tonically bound or complexed to at least one member selected from the group consisting of the biopolymer and the antimicrobial agent.

Abstract: The invention relates to the combination of polyvinyl acetate and water-insoluble, acid-insoluble, or alkali-insoluble polymers used for producing film coatings for forms of administration in which agents are released in a controlled manner, and methods for the production thereof. The controlled-release properties can be specifically adjusted by means of said combinations, resulting in films having excellent mechanical stability and storage stability. In particular, agents are released independent of the pH by means of the inventive forms of administration.

Abstract: In a solid pharmaceutical preparation containing 1) a basic medicinal component having an unpleasant taste; 2) a saccharide; 3) a polyanionic polymer; 4) a corrigent; and 5) carboxymethylcellulose, the unpleasant taste of the basic medicinal component having an unpleasant taste can be satisfactorily masked and excellent properties such as quick disintegration, appropriate preparation strength and high storage stability over a long period of time, etc., can be achieved. Further, a quickly disintegrating solid pharmaceutical preparation containing a medicinal component, a sugar alcohol and carboxymethylcellulose has excellent properties such as quick disintegration, appropriate preparation strength, high storage stability over a long period of time, etc.

Abstract: A novel method for the preparation of a tablet comprising a calcium-containing compound, the method involves a melt granulation process by which a sugar alcohol is melted and embeds the calcium-containing compound so that a sufficient taste masking of the chalkiness is substantially achieved and an unpleasant mouth feel of the calcium-containing compound is substantially avoided, while at the same time obtaining a low tablet volume. The method of the invention is especially suitable for the manufacturing of tablets having a high load of a calcium-containing compound.

Abstract: A combination of an anti-androgenic gestagen at a daily dose of from an ovulation-inhibiting dose up to at most twice the ovulation-inhibiting dose and from 0.1 to 10 mg of (6S)-5-methyltetrahydrofolate are used to produce a pharmaceutical preparation for therapeutically treating endometriosis while simultaneously reducing therapy side effects including the negative effect on bone density and/or bone metabolism, reducing the risk of osteoporosis and, in the event of pregnancy, reducing the risk of congenital malformations, such as medullary tube defects, cleft lip, cleft jaw, or cleft palate, and the risk of pregnancy complications, such as detachment of the placenta and premature birth. The preparation is suitable for long-term administration, which continues daily for at least 169 days to at least two years.

Abstract: It is intended to provide a milnacipran formulation which is more stable than a conventionally known milnacipran formulation, and a method of stabilizing a milnacipran formulation. The object could be achieved by using a milnacipran-containing composition in which milnacipran or a salt thereof is allowed to exist in a porous carrier, packing a powder containing milnacipran or a salt thereof in an HPMC capsule, or combining an additive which does not cause an interaction with milnacipran with time.

Abstract: The invention provides a rapidly disintegrating tablet comprising an active ingredient, a water soluble, directly compressible carbohydrate, and a water soluble, directly compressible filler. Also provided is a method of producing a rapidly disintegrating tablet, which method comprises wet granulating a mixture comprising a directly compressible, water soluble carbohydrate, a directly compressible, water insoluble filler, a beneficial ingredient, and a solvent, and compressing the granulate to produce the tablet.

Abstract: The present invention provides novel methods for treating cerebrovascular disorders, in which HGF is overexpressed by introducing an HGF gene. The methods of this invention using an HGF gene enable active treatment of cerebrovascular disorders, such as cerebral infarction, by gene transfer, and enable the maintenance of neuronal function and the suppression of infarcted areas in patients for whom appropriate treatment methods were unavailable until now.

Abstract: A sugar-coated agent that includes a core, a film layer that mainly includes a film component, the outer surface of the core being coated with the film layer, a sugar coating layer that mainly includes a sugar coating component, the outside of the film layer being coated with the sugar coating layer, and a middle layer that includes a film component and a sugar coating component and is provided between the film layer and the sugar coating layer, wherein within the middle layer, the concentration of the sugar coating component at the interface between the middle layer and the sugar coating layer is higher than the concentration of the sugar coating component at the interface between the middle layer and the film layer.

Abstract: The invention relates to the use of mixture of 2 to 60 wt. % of one or more polymers (I) with 40 to 98 wt. % of one or more polymers (II), whereby the polymer (I) is a (meth)acrylate copolymer, containing 90 to 100 wt. % radically polymerised of 40 to 95 wt. % of C1 to C4 alkyl esters of acrylic or methacrylic acid and 5 to 60 wt. % of units of (meth)acrylate monomers with an anionic group with 0 to 10 wt. % of further vinylic polymerisable monomers and polymer(ll) is a vinyl polymer different from polymer (I) or a polysaccharide or a derivative of a polysaccharide, containing 88 to 100 % neutral monomer units and up to 12 wt. % polymerisable monomer units with ionic groups, for production of a coated pharmaceutical formulation, containing an active agent core and a polymeric coating made from the mixture of polymers (I) and (II), characterised in that the glass temperature of polymer (I) is not more than 70° C.

Abstract: Restless legs syndrome (RLS) is characterized by an urge for leg movement, often with abnormal leg sensations. Symptoms are triggered by rest, often at night, and improve temporarily with movement, especially walking. This syndrome has a prevalence ranging from 7% to 15% and significantly contributes to sleep disorders. A method of prevention of restless legs syndrome is disclosed that comprises orally administering a composition containing a therapeutically effective amount of rifaximin to a patient exhibiting symptoms of restless legs syndrome.

Abstract: A nifedipine controlled release composition is provided comprising a drug-layer and a push-layer at a ratio of 1:0.5˜3 by weight. The drug-layer contains nifedipine and 40˜99 percent by weight of the drug-layer of hydrophilic polyvinylpyrrolidone homopolymer and/or copolymer carrier. The push-layer comprises about 10 to 80 percent by weight of the push-layer of osmopolymers, about 10 to 80 percent by weight of the push-layer of water-insoluble polymers, and about 5 to 50 percent by weight of the push-layer of osmagents. The composition is used in osmotic pump tablets for controlled release of nifedipine useful for administration once a day.

Abstract: Oral conjugated estrogen formulations are disclosed and described. In one aspect, the oral formulation may be a tablet having a core and one or more coatings thereon. In addition to conjugated estrogen ingredients, the core may include one or more organic excipients and one or more inorganic excipients. In one aspect, the organic excipients may include less than about 20% w/w of a cellulose ingredient, and less than about 50% w/w of a sugar ingredient. In another aspect, the inorganic excipients may include less than about 10% w/w of a calcium phosphate tribasic ingredient. In yet another aspect, the formulation does not crack when stored at about 40° C. and about 75% relative humidity for about 2 months.

Abstract: Compositions for pharmaceutical and other uses comprising clear aqueous solutions of bile acids which do not form any detectable precipitates over selected ranges of pH values of the aqueous solution and methods of making such solutions. The compositions of the invention comprise water; a bile acid in the form of a bile acid, bile acid salt, or a bile acid conjugated with an amine by an amide linkage; and either or both an aqueous soluble starch conversion product and an aqueous soluble non-starch polysaccharide. The composition remains in solution without forming a precipitate over a range of pH values and, according to one embodiment, remains in solution for all pH values obtainable in an aqueous system. The composition, according to some embodiments, may further contain a pharmaceutical compound in a pharmaceutically effective amount. Non-limiting examples of pharmaceutical compounds include insulin, heparin, bismuth compounds, amantadine and rimantadine.

Abstract: The invention provides a rapidly disintegrating tablet comprising an active ingredient, a water soluble, directly compressible carbohydrate, and a water soluble, directly compressible filler. Also provided is a method of producing a rapidly disintegrating tablet, which method comprises wet granulating a mixture comprising a directly compressible, water soluble carbohydrate, a directly compressible, water insoluble filler, a beneficial ingredient, and a solvent, and compressing the granulate to produce the tablet.

Abstract: Sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; methods for making the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof; and methods for using the sustained release formulations of oxymorphone or pharmaceutically acceptable salts thereof to treat patients suffering from pain are provided.

Abstract: Sustained release oral solid dosage forms of opioid analgesics are provided as multiparticulate systems which are bioavailable and which provide effective blood levels of the opioid analgesic for at least about 24 hours. A unit dose of the opioid analgesic contains a plurality of substrates including the opioid analgesic in sustained release form. The substrates have a diameter from about 0.1 mm to about 3 mm.

Abstract: The invention concerns compositions based on pullulan and a setting system for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard capsules. The composition preferably further contains a surfactant. By using aqueous solution of the inventive compositions, the hard pullulan capsules are produced by a conventional dipping moulding process under the same process condition range than conventional gelatine capsules.