Abstract: This invention in general relates to novel pharmaceutical compositions for acid labile substances as well as for methods of making such. Specifically, the invention provides a pharmaceutical composition comprising about 1 to 75% by weight acid labile compound, up to about 5% by weight disintegrant, at least one protector coat layer used to separate and protect the acid labile substance from acid reacting groups and gastric juice, and at least one enteric coat layer which surrounds the protector coating layer and ensures delivery of over 80% the acid labile substance to the small intestine.

Abstract: This invention relates to a method for the manufacture of Bite-dispersion tablets which disperse easily and quickly in the oral cavity, after a gentle bite, without the aid of water, and if necessary includes masking the bitter taste of medicaments. The process comprises preparing a dry granulation of one or more of medicaments blended with suitable excipients, flavors and a combination of a waxy material and phospholipid (BMI-60) or an intense sweetener derived from fruit flavonoids (Neohesperidine) for taste-masking and compressing into tablets which can be packaged in bottles or blisters using conventional equipment.

Abstract: The present invention is directed to bioactive compositions that induce the repair of damaged or diseased connective tissues upon contact of the damaged or diseased tissues with the composition in vivo. More particularly the present invention is directed to the use of compositions comprising an effective amount of bone sialoprotein to enhance the repair of damaged or diseased bone.

Abstract: A formulation comprising lactoperoxidase, thiocyanate and/or iodide and a hydrogen peroxide donor system, in particular glucose oxidase and glucose, is useful for controlling plant-pathogenic microorganisms such as fungi and bacteria. Preferably the formulation also contains an oil.

Abstract: The present invention provides a composition for attracting scarabs. Liquid and solid formulations are provided, along with methods for their use, for controlling or eliminating scarabs, and/or protecting plants susceptible to scarab damage.

Abstract: Compositions and methods of preparing amino acid chelates and complexes are disclosed and described. Specifically, by (a) blending hydrated metal sulfate salts, amino acid ligands, and reaction modifiers; (b) confining the particulate blend in an enclosed environment; and (c) applying heat to the particulate blend in the enclosed environment causing the waters of hydration of the metal sulfate salt to be released into the enclosed environment causing a reaction resulting in the formation of a granular amino acid chelate or complex by effecting the reaction between functional electron rich groups of the amino acid ligand and a metal ion of the metal sulfate salt. The waters of hydration serve to provide the water necessary to enable a bonding reaction to take place between the electron rich functional groups of the amino acid ligand and the metal ion of the hydrated metal sulfate salt.

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 novel rapid-melt, semi-solid molded composition, including methods of making the same, and methods of using the same for the delivery of prophylactic and therapeutic active materials to a mammal wherein the prophylactic or therapeutic active is a psychotropic, a gastrointestinal therapeutic or a migraine therapeutic.

Abstract: A process for preparing a solid formulation of a lipid-regulating agent comprising dissolving said lipid-regulating agent particles in a surfactant solution, premixing an excipient, wet granulating the mixture, drying the mixture and forming a finished dosage form.

Abstract: A novel rapid-melt, semi-solid molded composition including at least one binder in an amount from about 0.01% to about 70% by weight; a salivating agent in an amount from about 0.05% to about 15% by weight, a diluent/bulking material in an amount from about 10% to about 90% by weight; and an active material in an amount from about 0.001% to about 70% by weight. Further, the inventive subject matter includes a method of preparing a rapid-melt, semi-solid molded composition comprising the steps of: melting at least one binder in an amount from about 0.01% to about 70% by weight with a salivating agent in an amount from about 0.05% to about 15% by weight, to form a mixture; mixing an active material with said mixture to form an active mixture; mixing a diluent/bulking material with said active mixture to form a final mixture; and molding said final mixture into said semi-solid molded composition.

Abstract: Film-forming compositions are disclosed that can comprise, on a dry solids basis, 25 to 75 percent by weight of certain starch derivatives having a DE less than about 1, 25 to 75% plasticizer, and 0.1 to 15% hydrocolloid gum. The starch derviatives can be chemically modified starches which range in molecular weight from 100,000 to 2,000,000. These starch-based systems can completely replace gelatin in edible film-forming applications such as soft and hard gel capsules.

Abstract: The present invention relates to a novel pharmaceutical composition and process for preparing swallowable methylcellulose tablets that disintegrate rapidly and meet USP disintegration standards in 0.1N hydrochloric acid as well as water.

Abstract: A multi-layer tablet for the instant and prolonged release of active substances comprises at least two layers where the first outer layer comprises a mixture of excipients and an active substance, allowing for the immediate release of the active substance within the first layer, and a second layer, arranged in contact with the first layer. The second layer comprises a nonbiodegradable inert porous polymeric matrix in which an active substance is dispersed, allowing for the prolonged release of the active substance within the second layer.

Abstract: A dosage form which rapidly disintegrates in the mouth and forms a viscous slurry of either microcapsules or a powder is described. The rapidly disintegrating dosage form is meant for direct oral administration by placing a tablet or capsule in the mouth of a patient. Upon disintegration, a viscosity of the resulting slurry increases so as to form an organoleptically pleasant viscous material which retards the spread of insoluble materials including the drug.

Abstract: A pharmaceutical composition has a blend of at least first and second components and a medicament in a sufficient amount to be therapeutic where the first component is hydroxypropylcellulose (HPC) and the second component is at least one other polymer selected from the group consisting of methylcellulose (MC), ethylhydroxyethylcellulose (EHEC), hydroxyethylmethylcellulose (HEMC), hydrophobically modified hydroxyethylcellulose (HMHEC), hydrophobically modified ethylhydroxyethylcellulose (HMEHEC), carboxymethylhydroxyethylcellulose (CMHEC), carboxymethyl hydrophobically modified hydroxyethylcellulose (CMHMHEC), guar, pectin, carrageenan, agar, algin, gellan gum, acacia, starch and modified starches, co-polymers of carboxyvinyl monomers, co-polymers of acrylate or methacrylate monomers, mono- and co-polymers of oxyethylene and oxypropylene and mixtures thereof and a medicament in a sufficient amount to be therapeutic, with the proviso that low-substituted hydroxypropylcellulose (L-HPC) is excluded from said firs

Abstract: The present invention discloses tablet formulations, produced by dry roller compaction comprising compacted granulates of a mixture of a medicament and an intra-granular disintegrant. The granulates are compacted together into a tablet with an extra-granular disintegrant, an optional extragranular lubricant and excipients.

Abstract: The present invention relates to a novel pharmaceutical composition and process for preparing swallowable methylcellulose tablets that disintegrate rapidly and meet USP standards in 0.1N hydrochloric acid as well as water.

Abstract: A method for producing a delivery system for transporting pharmaceuticals and other ingredients in a chewable and palatable form is provided. The delivery system comprises a lipid source in which drug actives are homogeneously suspended to form a high solids suspension which can be solidified and molded into an oral dosage form. The lipid source provides an external phase comprising the carrier for the suspension and also provides a hydrophobic film which continuously coats the hydrophilic drug actives and other ingredients. The suspension exhibits pseudoplastic and thixotropic properties which enable it to suspend a large volume of particles relative to the lipid source. The drug particles may be pre-encapsulated before mixing in with the suspension, which provides taste-masking and controlled release qualities to the products formed from the delivery system.

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.

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: The present invention provides devices and methods for stabilizing bicarbonate-based solutions for peritoneal dialysis or hemofiltration. The bicarbonate-based solutions of the present invention are formulated and stored in at least two parts—an alkaline bicarbonate concentrate and an acidic concentrate. The alkaline bicarbonate concentrate is adjusted to have a pH of about 8.6 to 10.0. The acidic concentrate is adjusted to have a stable, acidic pH ranging from about 1.0 to 3.0. Upon mixing, although some variation in the pH of the mixed bicarbonate solution exists, the inventors have discovered that with the appropriate selection of the parameters of the concentrates, the pH of the mixed solution is always within an acceptable physiological range.

Abstract: A solid preparation which comprises (i) a pharmaceutically active ingredient, (ii) one or more water-soluble sugar alcohols selected from the group consisting of sorbitol, maltitol, reduced starch saccharide, xylitol, reduced palatinose and erythritol, and (iii) low-substituted hydroxypropylcellulose having hydroxypropoxyl group contents of 7.0 to 9.9 percent by weight; which exhibits excellent buccal disintegration and dissolution and also appropriate strength.

Abstract: This invention in general relates to novel pharmaceutical compositions for acid labile substances as well as for methods of making such. Specifically, the invention provides a pharmaceutical composition comprising about 1 to 75% by weight acid labile compound, up to about 5% by weight disintegrant, at least one protector coat layer used to separate and protect the acid labile substance from acid reacting groups and gastric juice, and at least one enteric coat layer which surrounds the protector coating layer and ensures delivery of over 80% the acid labile substance to the small intestine.

Abstract: Quickly disintegratable compression-molded materials containing (a) fillers and (b) erythritol. These materials are highly disintegratable and soluble in the oral cavity or water and, therefore, can be easily taken. Also, they are highly hard and thus excellent in storage stability in the production and distribution stages. Owing to these characteristics, they can be appropriately blended with efficacious ingredients and used in the treatment or prevention of diseases in patients, in particular, the aged, infants or those having difficulty in swallowing.

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: Improved method of enhancing a population of one or more target microorganisms in the gastrointestinal tract of an animal, the improvement comprising providing to the animal a selected modified or unmodified resistant starch or mixtures thereof, such that the one or more microorganisms will selectively utilise the starch and/or increase in number and/or activity in the gastrointestinal tract, either uniformly throughout the gastrointestinal tract or at specific site or regions.

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: A liquid pesticidal composition, which is substantially free of water, comprising a hydrophobic pesticide or mixture of pesticides dissolved in an organic solvent and comprising as surfactants (a) a castor oil ethoxylate having 30-50 mol ethoxylate, (b) a branched C8-C18 alcohol ethoxylate having 5-10 mol ethoxylate, and (c) a tristyrenephenol-ethoxylate having 8-30 mol ethoxylate, or its phosphate or salt thereof. The compositions also include gels having a viscosity of 500 to 20,000 mPas and comprising additionally a gelling agent.

Abstract: The present invention relates to pharmaceutical compositions and methods for improved solubilization of triglycerides and improved delivery of therapeutic agents. Compositions of the present invention include a triglyceride and a carrier, where the carrier is formed from a combination of at least two surfactants, at least one of which is hydrophilic. Upon dilution with an aqueous solvent, the composition forms a clear, aqueous dispersion of the triglyceride and surfactants. An optional therapeutic agent can be incorporated into the composition, or can be co-administered with the composition. The invention also provides methods of enhancing triglyceride solubility and methods of treatment with therapeutic agents using these compositions.

Abstract: A directly compressible ultra fine acetaminophen granulation composition capable of being directly compressed into an acetaminophen tablet comprises from about 85 to about 95 wt % acetaminophen, from about 1 to about 4 wt % essentially water-insoluble tablet/capsule disintegrant, from about 0.5 to about 5.0 wt % polyvinylpyrrolidone, from about 0.5 to about 5.0 wt % totally pregelatinized starch, about 0.25 to about 3.0 wt % of a fluidizing agent, from about 0.25 to about 3.0 wt % of a lubricant, and optionally up to about 10 wt % of a co-active ingredient, the weight percents being based on the total weight of the dry components of the granulation composition, the granulation also comprising a moisture content of up to about 1.5 wt % based on the total weight of the dry components of granulation composition.

Abstract: A composition for cleaning or caring for the skin, teeth or hair or for cleaning smooth surfaces in described, which has an aqueous phase containing a pregelatinized, crosslinked starch selected from a C2-C5 hydroxyalkyl starch and a C2-C18 acyl starch. Preference is given to hydroxypropyl di-starch phosphate or di-starch C4-C18-alkanoate or alkenoate. The starch acts 1) as a stability improver, 2) as a viscosity regulator, 3) as a (co)emulsifier, 4) as a skin feel improving agent and 5) as an agent for improving hairdressing characteristics.

Abstract: A process for encapsulation of caplets in a capsule comprises the following steps: a. providing empty capsule parts; b. filling at least one of said capsule parts with one or more caplets; c. putting said capsule parts together; and d. treating the combined parts by cold shrinking. The solid dosage forms obtainable by such a process are tamper-proof in that they cannot be opened in a way to be reassembled without showing such opening process.

Abstract: The invention relates to an effervescent, rapidly disintegrating oral dosage form of (a) an alkali-sensitive active ingredient, (b) an effervescent base comprising at least one of (i) at least one alkaline earth metal carbonate, (ii) an organic edible acid, and (iii) an alkali metal salt of citric acid, and optionally (c) a pharmaceutically acceptable auxiliary ingredient, and to a process for preparing the dosage form.

Abstract: The present invention relates to a compressed formulation containing 1,1-GPS (1-O-&agr;-D-glucopyranosyl-D-sorbitol) or a mixture of sweetening agents composed of 1,1-GPS, 6-0-&agr;-D-glucopyranosyl-D-sorbitol (1,6-GPS) and 1-0-&agr;-D-glucopyranosyl-D-mannitol (1,1 GPM).

Abstract: A novel pharmaceutical combination is described, together with a method of making the same and a method of treating hypertensive patients using the same, wherein (1) the pharmaceutically active antihypertensive agent and citric acid and (2) the pharmaceutically active antikaliuretic agent and a nonionic surfactant are mixed, either together or separately, to form an essentially homogenous combination composition, and only thereafter blending with excipients to form the novel combination composition in solid dosage form.

Abstract: A pharmaceutical composition has a blend of at least first and second components and a medicament in a sufficient amount to be therapeutic where the first component is ethylcellulose (EC) and the second component is at least one other polymer selected from the group consisting of methylcellulose (MC), ethylhydroxyethylcellulose (EHEC), hydroxyethylmethylcellulose (HEMC), hydrophobically modified hydroxyethylcellulose (HMHEC), hydrophobically modified ethylhydroxyethylcellulose (HMEHEC), carboxymethylhydroxyethylcellulose (CMHEC), carboxymethyl hydrophobically modified hydroxyethylcellulose (CMHMHEC), guar, pectin, carrageenan, agar, algin, gellan gum, acacia, starch and modified starches, mono- and co-polymers of carboxyvinyl monomers, mono- and co-polymers of acrylate or methacrylate monomers, mono- and co-polymers of oxyethylene and oxypropylene and mixtures thereof. The medicament can be a variety of drugs or nutritional supplements.

Abstract: A pharmaceutical composition useful for treating ocular conditions, such as glaucoma. In particular, the pharmaceutical composition is a sustained release oral dosage composition for relieving intraocular pressure comprising methazolamide and a high molecular weight binder, wherein the composition provides sustained rate of methazolamide release in an in vitro drug release profile. A filler and a lubricant may also be included.

Abstract: A pharmaceutical composition has a blend of at least first and second components and a medicament in a sufficient amount to be therapeutic where the first component is selected from hydroxypropylcellulose (HPC), ethylcellulose (EC), or derivatives of HPC, EC, and hydroxyethylcellulose (HEC) and the second component is at least one other polymer. When HPC is the first component, hydroxypropylmethylcellulose (HPMC), HEC, or carboxymethylcellulose will not be the second component and when EC is the first component, HPMC will not be the second component. The medicament can be a variety of drugs or nutritional supplements. The pharmaceutical composition releases the medicament for a prolonged or sustained period of time and can be formulated into many dosage forms.

Abstract: Yeast-derived fiber has been demonstrated, as described herein, to effectively improve the serum lipid profile in humans, when provided as a dietary supplement, without some of the disadvantages known to accompany dietary supplementation with oat fiber or psyllium fiber. Described herein are dietary supplements comprising yeast fiber, e.g., &bgr;-glucan or glucomannan, and further comprising folic acid or a salt thereof, vitamin B6, vitamin B12, and vitamin E. The dietary supplements of the invention can further comprise fats, carbohydrates and proteins, for example, and other ingredients added to formulate a food product. Such food products can be in the form, for example, of solid or semi-solid foods, such as food bars, pudding, or spreads. By including folate and vitamin B6, the dietary supplement provides a second benefit of suppressing the level of homocysteine in the blood.

Abstract: A flexible capsule formed from a modified starch free of animal based gelatin. The invention provides a novel capsule defining a closed interior chamber, the capsule being formulated from a composition which is free of animal based gelatin comprising at least one plant based starch having been modified to have gelatin like properties; and a paint ball formulation, drug, vitamin, perfume or bath product contained within the capsule.

Abstract: A cyclodextrin derivative, wherein at least 60 percent of the free hydroxy groups of said cyclodextrin are acylated with acyl groups where at least one of said acyl groups comprise a free carboxylic group.

Abstract: Disclosed are conditioning shampoo compositions which provide improved hair or skin conditioning performance. These compositions comprise a detersive surfactant, select ethoxylated fatty alcohols having a fatty alcohol moiety containing from about 6 to about 30 carbon atoms and an ethoxylate chain containing from about 5 to about 150 moles of ethoxylation, a nonvolatile conditioning agent, preferably a nonvolatile silicone conditioning agent, having an average particle size of from about 5 um to about 2000 um, and water. The select ethoxylated fatty alcohols provide improved hair or skin conditioning by improving silicone deposition of large particle conditioning agents onto the hair or skin.

Abstract: Provided are tablet formulations in one embodiment comprising clavulanic acid or salt thereof, amoxycillin, and trehalose. The trehalose is, for example, amorphous anhydrous trehalose. The amorphous anhydrous trehalose is present in an amount, for example, of 5 to 50%. The formulation may further comprise, for example, desiccants, such as silica gel, or lubricants.

Abstract: A process for the preparation of solid formulations of a lipid-regulating agent having enhanced dissolution and absorption characteristics, in which a micronized mixture of the said lipid-regulating agent, and optionally one or more excipients, is suspended in a surfactant solution, dried and optionally granulated, and optionally converted to a finished dosage form.

Abstract: A process for preparing solid, amorphous paroxetine comprising: (A) mixing paroxetine free base or a pharmaceutically acceptable paroxetine salt with water and pharmaceutically acceptable polymer; and (B) drying to form a composition comprising amorphous paroxetine and polymer, eliminating the need for organic solvents common for the solvent process. The resultant amorphous solid paroxetine composition is free from crystalline form, and yet has good handling properties, making it suitable for pharmaceutical use in the traditional tablet dosage form.

Abstract: The present invention provides a pharmaceutical preparation in tablet form, where the active ingredient is an anti-epileptic medication, preferably a sustained release formulation, and most preferably a sustained release formulation where the active ingredient is carbamazepine. The product consists of carbamazepine particles coated with a single hydrophobic layer and is in a disintegrating tablet form.

Abstract: The present invention pertains to a stabilized pharmaceutical composition which comprises a mixture of (a) a pharmaceutical agent unstable at a pH above about 3.5; and (b) a stabilizing amount of an acidic pharmaceutically acceptable carrier to stabilize the pharmaceutical agent. The acidic pharmaceutically acceptable carrier is a dried premixture of a pharmaceutically acceptable carrier and an aqueous solution of an acid. The stabilized pharmaceutical composition has a pH value of less than about 3.5, and when stored at a temperature of about 50.degree. C. for about 4 weeks at about 27% relative humidity, retains at least about 80% of the pharmaceutical agent. This invention also pertains to sustained-release forms of the stabilized pharmaceutical compositions as well as to novel methods for preparing and using the stabilized pharmaceutical compositions and to stabilized pharmaceutical compositions made by the novel method.

Abstract: Pharmaceutical tablet which consists of:a) a first layer having the property of swelling considerably and quickly on contact with aqueous biological fluids, the first layer being produced by compression of a mixture or of a granulate comprising hydrophilic polymers, andb) a second layer adjacent to the first layer being formulated with hydrophilic polymers and with other auxiliary substances in order to give the preparation suitable properties of compressibility and in order to allow the release of alfuzosin hydrochloride within a predetermined time period.

Abstract: A directly compressible starch consisting in an intense white free-flowing powder showing both excellent compression profile and extremely good disintegration properties. This starch is especially designed to be used as a binder in direct compression processes where it yields very hard white tablets at relatively low compression forces. Tablets resulting from the compression of the above mentioned starch disintegrate in an aqueous medium at a very high speed and they additionally exhibit low friability pattern. This free-flowing starch also brings advantages when used as filler and binder in the filling of some hard gelatine capsules especially for these which are filled by pre-compression of the ingredients. This starch is characterized by regular and smooth partially swollen granules which can be either birefringent or non-birefringent. It can be prepared by spray-drying of a partially cooked starch.

Abstract: A sustained release pharmaceutical formulation includes a sustained release excipient including a gelling agent, an inert pharmaceutical diluent, an optional cationic cross-linking agent, and a medicament having moderate to poor solubility is disclosed. In certain embodiments, the sustained release excipient is granulated with a solution or suspension of a hydrophobic polymer in an amount effective to slow the hydration of the gelling agent when the formulation is exposed to an environmental fluid. In another embodiment, the tablet is coated with a hydrophobic polymer.