Abstract: The present invention relates generally to a method of blunting the postprandial glycemic response in a human by feeding an induced viscosity fiber system. The invention also relates to an induced viscosity fiber system and the liquid products that incorporate the induced viscosity fiber system. Further, the invention relates to a method of incorporating soluble fiber into a liquid product without the typical negative organoleptic or physical stability issues. The invention also relates to a method of inducing the feeling of fullness and satiety by feeding the induced viscosity fiber system.

Abstract: The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures.

Abstract: Methods for preparing products containing moisture-sensitive materials, including biological materials such as proteins, peptides or live cells, comprising at least the steps: (i) providing a coating liquid comprising at least one active, a sugar polymer and a water soluble/miscible solvent; (ii) providing a quantity of microparticles comprising at least water soluble gel forming solid particles; (iii) fluidizing said quantity of microparticles within a processing chamber of a of a suitable apparatus to form a fluidized bed of said microparticles; (iv) spraying said coating liquid onto said fluidized bed from beneath the fluidized bed to coat said microparticles therewith under saturated moisture conditions; and (vi) allowing coated microparticles to dry, are described. Also described are compositions and uses.

Abstract: Disclosed are several preferred embodiments of hydrogen peroxide which are packaged with ease of use and extended shelf-life in mind. The embodiments include foam, mist, gel, and disposable towelette forms of H2O2. Optional ingredients of topical pain relievers and skin protectants are also disclosed, as are their methods of use.

Abstract: A method produces starch or starch-containing products from starch-containing plant raw materials. The method is distinguished by the inclusion of an electric pulse method.

Abstract: Disclosed herein is a oral extended release dosage form comprising a plurality of granules of an effective amount of a pharmaceutically active compound, at least one amino acid, and an intragranular polymer in which the granule is dispersed within a hydrophilic extragranular polymer matrix which is more rapidly hydrating than the intragranular polymer. The amino acid is selected for hydropathy characteristics depending on solubility characteristics of the active compound.

Abstract: A penetrating antibiotic gel for treating pain, inflammation and other pathological conditions affecting musculoskeletal tissues and other soft tissues of the body. The composition includes an antibiotic compound and a mobilizing agent in an amount sufficient to enable the antimicrobial compound to penetrate into the sub-dermal soft tissues. The antimicrobial compound may be a macrolide antibiotic compound such as azithromycin, erythromycin or roxithromycin, for example, and the mobilizing agent may be an organogel compound, such as pluronic lecithin liposomal organogel (PLO). The composition may further include a penetration enhancing adjuvant, such as d-limonene, for example. The composition may be applied topically so as to penetrate into the sub-dermal soft tissues, or may injected so as to be absorbed into the soft tissues locally.

Abstract: The invention relates to a gel based on poly-?-1,4-D-glucan and, optionally, on starch as well as on a swelling agent, to a method for the production thereof, and to the use of a gel of this type.

Abstract: A controlled release dosage form for sertraline has a core comprising a sertraline-containing composition and a water-swellable composition wherein the water-swellable composition is in a separate region within the core. A coating around the core is water-permeable, water-insoluble, and has at least one delivery port therethrough. In one embodiment, the dosage form releases sertraline to the use environment at an average rate of 6 to 10 wt % per hour from the second to the twenth hour after introduction to a use environment and less than about 25 wt % for the first two hours and at least 70 wt % by the twelfth hour, where the percentages correspond to the mass of drug released from the tablet divided by the total mass of drug originally present in the tablet.

Abstract: The present invention is directed to medical devices or pharmaceutical composition, each containing a synthetic, biodegradable, biocompatible polymer that is the reaction product of a polybasic acid or derivative thereof, a monoglyceride, and a cationic polyol.

Abstract: This invention discloses compositions and methods for preparing biocleavable or biodegradable micelle compositions for carrying and releasing drugs and other active agents for therapeutic or other medical uses. Methods are also disclosed for preparing biocleavable cyclodextrin micelle carriers that release drugs under controlled conditions. The invention also discloses biocleavable or biodegradable micelle compositions that are coupled to biorecognition molecules for targeting the delivery of drugs to their site of action.

Abstract: This invention relates to a method of producing a bioadhesive composition comprising the steps of preparing a solution of a solvent and a polymer mixture wherein the polymer mixture comprises at least one natural or synthetic polycarboxylated polymer and at least one polysaccharide; drying the solution to form a solid; and heat treating the solid to effect cross-linking and to form the bioadhesive composition.

Abstract: The invention relates to a process for preparing a soft tablet capable of being chewed or disintegrated in the oral cavity. The tablet is prepared by forming a tablet having a friability of less than about 2% from a mixture comprising a pharmaceutically active ingredient, an excipient in the form of a hydrate, and a water-swellable excipient, and then applying sufficient energy, preferably in the form of heat, to the tablet for a sufficient time to decrease the hardness of the tablet by at least about 20%.

Abstract: Encapsulation compositions in which an encapsulate (A) is encapsulated in a matrix (B) may be prepared by: (i) mixing matrix (B) with a liquid plasticizer and encapsulate (A) in an extruder, to obtain a melted mixture of encapsulate (A) and matrix (B); and (ii) extruding the melted mixture, to obtain an extruded mixture.

Abstract: A thermal adhesion granulation process for preparing direct tabletting formulations or aids is disclosed. The process comprises the step of subjecting all or part of a mixture comprising: A) from about 5 to about 99% by weight of one or more diluent excipients and/or from 0 to about 99% by weight of a pharmaceutically active ingredient; B) from about 1 to about 95% by weight of a binder excipient; optionally with, C) from 0 to about 10% by weight of a disintegrant excipient; to heating at a temperature in the range of from about 30 to about 130° C. under the condition of low moisture or low content of a pharmaceutically-acceptable organic solvent in a closed system under mixing by tumble rotation until the formation of granules.

Abstract: A composition and a method for administering an improved supplement to prevent bone density loss. The composition combines a calcium compound with inulin, and optionally magnesium, Vitamin D3, Vitamin K, Vitamin C, and may combine a soy isoflavone, all in a dietary acceptable form in a beverage, a beverage preparation, a paste, a bar, or a cookie.

Abstract: Production of purified, parenterally administrable starch by washing starch containing more than 85% amylopectin in order to remove surface-localized proteins, lipids and endotoxins, dissolving the starch in aqueous medium, molecular weight reduction by shearing, and optionally removal of residual water-soluble proteins, preferably by anion exchange chromatography. Purified starch and microparticles based on such starch.

Abstract: A viscous gel for delivering minor effective amounts of active substances through the nasal membrane into the body.

Abstract: A coating for masking or reducing the detectable presence of certain characteristic odor or odors, taste or tastes of pharmaceutical preparations, particularly Valerian extracts, is described. The coating comprises from one to three coating compartments, in any combination or as a single-layer amalgam. The first coating compartment comprises a hydroxyalkyl cellulose and an anti-tackiness agent. The second coating compartment may comprise a sugar and at least one anti-tackiness agent. The third coating compartment may comprise a methacrylate copolymer, a hydroxyalkyl cellulose and an anti-tackiness agent.

Abstract: A stable, solid product of selected starches, active agricultural agents and optionally surfactants and or adjuvants which is readily dispersible in aqueous medium and compatible when dispersed.

Abstract: Orally administrable compositions comprising cation cross-linked polysaccharides are provided. The compositions have the ability to mask the taste and delay the release of an active material included therein. A novel method for the preparation of the compositions is also provided. The cation cross-linked polysaccharide is preferably selected from alginic acid and demethylated pectin and the composition further comprises a digestible polymer, preferably chosen from starch, starch derivatives, &agr;-glucans, peptides and polypeptides.

Abstract: Disclosed is an oral controlled release macrolide pharmaceutical formulation. In a preferred embodiment, the formulation comprises a citrate salt of a preferred macrolide, clarithromycin. Also disclosed are methods for preparing, isolating and characterizing soluble and stable citrate salt of macrolides and use thereof in all solid dosage forms of macrolides.

Abstract: Compositions containing a low dose of entecavir are administered on a daily basis to treat hepatitis B virus infection and/or co-infections. Formulations for the oral administration of a low dose of entecavir are provided. Other pharmaceutically active substances can be included in the entecavir composition or can be separately administered for the treatment of hepatitis B virus infection or for the treatment of co-infected patients.

Abstract: The invention relates to a pharmaceutical implant for controllably releasing a drug in a subject and methods for manufacturing and administering the implant. The implant is made of associated microparticles of a drug dispersed in a biodegradable polymer. The microparticles are sufficiently associated so that the implant maintains a predetermined shape but are not fused together so as to form a single monolithic structure. The drug can be controllably released in a subject by administration of the pharmaceutical implant without the need of a suspending fluid.

Abstract: A pharmaceutical composition is provided containing an admixture of phenytoin sodium and an erodible matrix which extends the release of the phenytoin sodium over about a two hour period. The erodible matrix comprises binder(s) and diluent(s) which control the release of drug from the pharmaceutical composition. The erodible matrix can further comprise an alkaline pH modifier.

Abstract: The present invention relates to the utilisation of water-insoluble linear poly-&agr;-glucan as UV filter, e.g., in sun protection products or in cosmetic as well as medical preparations. The invention also relates to a sun protection product which contains a biotechnically produced, water-insoluble linear poly-&agr;-glucan as UV filter.

Abstract: Suspensions, emulsions or dispersions of therapeutically active agents which are water insoluble or water intolerant such as nutritional supplements, herbal products, drugs, bacteria, yeast, vitamins and minerals are prepared as suspensions in edible vegetable oils such as orange, lemon, soybean, cotton seed, peanut, canola corn oil, sunflower, safflower, palm kernel, palm and coconut. The active therapeutic agent may be in crystalline or amorphous form, it may be a liquid as for example an oil such as vitamin B or beta carotene, or a preparation of a comminuted plant structure such as flower, parts, leaf; stern, root or tree bark, or an extract of a dried plant structure or a freeze dried preparation of a vital bacteria or yeast. The suspension is formed by active mixing of the active agent and oil.

Abstract: The invention concerns cosmetic compositions containing, in a cosmetically acceptable medium, as thickening system: (A) at least a non-ionic associative polyurethane and (B) at least a non-ionic polymer comprising at least a fatty chain.

Abstract: An enteric coated pharmaceutical dosage form comprising an H+,K+-ATPase inhibitor is disclosed. The dosage form comprises at least two portions of the H+,K+- ATPase inhibitor to be released in at least two consecutive pulses. The dosage form has at least one fraction with a pulsed delayed release and another fraction with instant release of the H+,K+-ATPase inhibitor. The portions are released in time by from 0.5 and up to 12 hours interval, preferably by from 0.5 and up to 8 hours, and more preferably by from 0.5 and up to 4 hours interval. The dosage form is intended for once daily administration.

Abstract: A swallowable, solid dose form composition for treating upper gastrointestinal tract distress containing bismuth subsalicylate, carbonate or bicarbonate salt, disintegrating agent, anionic or nonionic surfactant, and microcrystalline cellulose is described.

Abstract: The present invention provides a moisture-retentive cooling gel, a laminate thereof, and a moisture-retentive cooling plaster, which offer moisture-retaining and cooling effects for a controlled duration and have superior functionality, e.g., capability of delivering and transporting an effective ingredient such as a pharmacological active ingredient, a perfume or a deodorant. The moisture-retentive cooling gel comprises: a water-retentive matrix (a1) of a water-soluble polymer having a water content of not lower than 40 wt %; and fibers (f) dispersed in the water-retentive matrix, the fibers (f) having a hydrophilic property at least at surfaces thereof, some of the fibers (f) being exposed on a surface of the water-retentive matrix (a1). The gel has a higher water content and a higher water vaporization rate. An endothermally water-dissolvable compound may be retained in the water-retentive matrix and/or the fibers for enhancement of the cooling capacity of the gel.

Abstract: Disclosed herein are composition comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.

Abstract: A forming oil-in-water emulsion in the form of a cream comprising, in an aqueous medium, at least: a) from 5 to 20% of an exclusively nonionic surfactant system comprising at least one foaming nonionic surfactant; b) from 10 to 50% of an oily phase containing at least one water-insoluble oil whose solubility parameters dD, dP and dH according to Hansen's solubility space satisfy the conditions: 15.5 (J/cm3)½≦dD≦18.0 (J/cm3)½ and 0 (J/cm3)½≦dA≦6.5 (J/cm3)½ with dA=(dP2+dH2)½ c) and, as a gelling agent, at least one crosslinked homopolymer or copolymer formed from at least one cationic or anionic monomer containing ethylenic unsaturation and from a crosslinking agent containing polyethylenic unsaturation. This composition is useful in cosmetics, dermatology and hygiene as a base for cleansing products for the skin, the hair, the mucous membranes and the scalp.

Abstract: A stable, solid product of selected starches, active agricultural agents and optionally surfactants and or adjuvants which is readily dispersible in aqueous medium and compatible when dispersed.

Abstract: This invention relates to a method of using compressible polysaccharides having a tap density of less than 0.4 g/ml as a filler/binder for tablets prepared by direct compression, excipient blends including said polysaccharides, a method of tableting an active ingredient therein from the excipient blends and the tablets produced therefrom. More particularly, this invention relates to the use of low-density starches as binders for tablets prepared by direct compression, excipient blends, and methods of tableting an active ingredient therein from such starches. Further, this invention describes a starch-based excipient composition having a tap density of less than 0.4 g/ml, which has excellent moisture resistance.

Abstract: An oral pharmaceutical formulation, which comprises, in a hydroxypropylmethylcellulose capsule, a camptothecin analogue dispersed or solubilized in a semi-solid matrix of a polyethyleneglycol with a molecular weight ranging from 400 to 20000.

Abstract: A taste masked composition which comprises a bitter tasting drug, a combination of two enteric polymers comprising, a methacrylic acid copolymer and a phthalate polymer is described. The composition of the present invention is prepared by dissolving the active ingredient, the methacrylic acid copolymer and the phthalate polymer in a solvent and recovering the composition from the solution thereof.

Abstract: The present invention provides improved oral dosage form formulations of efavirenz that are useful in the inhibition of human immunodeficiency virus (HIV), the prevention or treatment of infection by HIV, and in the treatment of the resulting acquired immune deficiency syndrome (AIDS). In particular, the present invention relates to compressed tablets or capsules comprising efavirenz that contain one or more disintegrants that enhance the dissolution rate of the efavirenz in the gastrointestinal tract thereby improving the rate and extent of absorption of efavirenz in the body. The present invention also relates to the process of making such tablets or capsules.

Abstract: Syrup formulations comprising water and compacted granulates which are mixture of amoxycillin and clavulanic acid, together with an intra-granular disintegrant.

Abstract: The present invention is an oral drug delivery system for delivering unpalatable pharmaceuticals, wherein the pharmaceutical delivery system comprises a lipid, dry particles including at least one pharmaceutical and at least one filler, and a surfactant, wherein the dry particles are continuously coated by the lipid and form a suspension with the lipid, making the pharmaceutical more palatable.

Abstract: The subject of the invention is a process for modifying amylaceous (starchy) materials comprising a stage of chemical fluidification and a stage of stabilization, simultaneous or not simultaneous, these two stages being performed in the dry phase and by the use of a plycarboxylic organic acid. The acid can be chosen particularly from among citric acid, adipic acid, azelaic acid and their mixtures. The process is advantageously performed at a temperature between 90° C. and 170° C., at a pH below 4 and during a total period between 3 minutes and 8 hours. The starchy material subjected to fluidification and stabilization can be cationic.

Abstract: Film-forming compositions are disclosed that can comprise, on a dry solids basis, 25 to 75 percent by weight of certain starch derivatives and 25 to 75% primary external plasticizer. The starch derivatives can be chemically modified starches that range in molecular weight from 100,000 to 2,000,000. The high levels of plasticizer in the films give excellent film flexibility and integrity.

Abstract: Disclosed herein is a tableted oral extended release dosage form comprising a plurality of granules of an effective amount of a pharmaceutically active compound, at least one amino acid, and an intragranular polymer in which the granule is dispersed within a hydrophilic extragranular polymer matrix which is more rapidly hydrating than the intragranular polymer. The amino acid is selected for hydropathy characteristics depending on solubility characteristics of the active compound.

Abstract: An absorbent article having a bodyside liner includes a hydrophilic lotion formulation on the outer bodyfacing surface thereof. The hydrophilic lotion formulation comprises from about 10 to about 90 weight percent of a hydrophilic solvent, from about 5 to about 90 weight percent of a high molecular weight polyethylene glycol, and from about 0 to about 60 weight percent of a fatty alcohol. The hydrophilic lotion formulation has a reduced adverse effect on the absorbent and liquid uptake properties of the liner and the absorbent body when compared to conventional lipophilic or hydrophobic lotion formulations. The hydrophilic lotion formulation acts as a lubricant to reduce the abrasion of the skin caused by the liner and also transfers to the skin to provide improved skin health.

Abstract: A pharmaceutical composition for controlled onset and sustained release of an active ingredient, said composition comprising: (i) a core comprising: (a) an active ingredient; (b) a hydrophilic carrier; (c) a hydrodynamic diffusion enhancer; and optionally (d) conventional pharmaceutically acceptable excipients selected from the group consisting of binders, fillers and lubricants and combinations thereof; and (ii) a functional coating membrane surrounding said core.

Abstract: A dry moisture barrier film coating composition for forming a moisture barrier film coating for pharmaceutical tablets and the like comprises polyvinyl alcohol, soya lecithin, and optionally a flow aid, a colorant, and/or a suspending agent. A liquid coating solution or dispersion for forming a moisture barrier film coating for pharmaceutical tablets and the like comprises polyvinyl alcohol, soya lecithin, water, and optionally a flow aid, a colorant, and/or a suspending agent. A method of coating pharmaceutical tablets and the like with a moisture barrier film coating comprises forming a liquid coating solution or dispersion for forming a moisture barrier film coating for pharmaceutical tablets and the like comprising polyvinyl alcohol, soya lecithin, water, and optionally a flow aid, a colorant, and/or a suspending agent, applying the coating solution or dispersion onto the tablets to form a film coating on the tablets, and drying the film coating on the tablets.

Abstract: The present invention provides a suppository comprising a hydrophobic hydroxypropyl methylcellulose. The present invention is useful as a suppository base which has little interaction with a drug and has an excellent retainability.

Abstract: Controlled-release formulations providing a “pulsed” plasma profile of a sedative-hypnotic compound having a particularly short half-life are provided. The formulation contains a sedative-hypnotic compound or precursor thereof that is metabolized to generate a sedative-hypnotic compound in vivo, wherein the compound has a mean plasma half life ranging from 0.1 to 2 hours; and at least one release retardant such that, following administration of the formulation to a patient, the patient has specified pulsed plasma profile for the sedative-hypnotic compound as disclosed herein. In a preferred embodiment, the sedative-hypnotic compound is NBI-34060.

Abstract: A process for preparing free-flowing and, during handling, dust-free microparticles. The particles are at least 90% by weight, have a diameter of 100-400 &mgr;m, and contain one or more active ingredients in a glassy matrix. Generally, the process of the invention comprises the steps of (1) preparing an aqueous solution of the matrix materials, (2) mixing the flavor into the aqueous solution with stirring to form an emulsion or suspension, (3) spraying the emulsion in a spray drying tower under a supply of hot air to quickly create a semi-solid skin allowing outtake of moisture (water), and (4) subsequently subjecting the resulting particles to continued drying at lower temperatures in a fluid bed.

Abstract: Disclosed herein are compositions comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.