Abstract: A pharmaceutical composition comprising spheroids comprising a water-soluble active ingredient or a pharmaceutically acceptable salt thereof, microcrystalline cellulose and a sugar. Preferably the active ingredient is hydromorphone hydrochloride and the sugar is lactose. Surprisingly the incorporation of a sugar improves the dissolution rate of the spheroid formulation instead of reducing the dissolution rate by competing with the active ingredient for solubilization.

Abstract: A controlled release composition including spheroid cores of diltiazem. or a pharmaceutically acceptable salt thereof and optionally a spheronizing agent, the cores being coated with a controlled release layer, and a method of manufacturing the same, is disclosed. The spheronizing agent when present is preferably microcrystalline cellulose. Ethylcellulose is a preferred release coating. The controlled release coating preferably contains a plasticizer, a surfactant and a tack-modifier.

Abstract: A controlled release preparation for oral administration contains tramadol, or a pharmaceutically acceptable salt thereof, as active ingredient.

Abstract: A method for the manufacture of a laxative composition in dosage unit form which comprises the steps of melting a normally solid stool softener; dispersing and/or dissolving a stimulant laxative compound in the molten stool softener and mixing to obtain a uniform mixture; filling the molten dispersion into hard gelatin capsule shells; and allowing the capsules to cool and the melt or dispersion to solidify.

Abstract: A solid oral dosage form comprising diltiazem (or a pharmaceutically acceptable salt thereof) in controlled release form and hydrochlorothiazide in immediate release form. Preferably, the controlled release component comprises a plurality of spheroids comprising diltiazem and a spheronizing agent.

Abstract: The invention relates to a lousicidal shampoo composition of phenothrin as lousicidal agent distributed in a shampoo base of water and one or more surface active agents, the shampoo containing as antimicrobial preservative 2-bromo-2-nitropropane-1,3-diol alone or in combination with 2,4-dichlorobenzyl alcohol.

Abstract: A controlled release, solid, oral dosage form containing a 3-alkylxanthine, preferably theophylline, at least one hydrophilic or hydrophobic polymer, at least one wax having a melting point between 25.degree. and 90.degree. C. and between 3% and 10% (by weight) water.Preferably the dosage form is a tablet and the water content is between 4% and 9% (by weight). The amount of water present in the dosage form determines the rate of release of the 3-alkylxanthine.

Abstract: An ion exchange resin composition which is readily dispersible in water is provided. This resin composition comprises a granulated ion exchange resin, a pharmacologically active ingredient bound thereto with a sugar or sugar alcohol, and a sufficient amount of water, alcohol or aqueous alcohol to facilitate granulation. The invention further comprises a method for the preparation of such ion exchange resin composition.

Abstract: A solid controlled release, oral dosage form, the dosage form comprising a therapeutically effective amount of hydromorphone or a salt thereof in a matrix wherein the dissolution rate in vitro of the dosage form, when measured by the USP Paddle Method of 100 rpm in 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37.degree. C. is between 12.5% and 42.5% (by weight) hydromorphone released after 1 hour, between 25% and 55% (by weight) hydromorphone released after 2 hours, between 45% and 75% (by weight) hydromorphone released after 4 hours and between 55% and 85% (by weight) hydromorphone released after 6 hours, the in vitro release rate being independent of pH between pH 1.6 and 7.2 and chosen such that the peak plasma level of hydromorphone obtained in vivo occurs between 2 and 4 hours after administration of the dosage form.

Abstract: A controlled release pharmaceutical composition contains a number of spheroids, the spheroids containing a water-insoluble drug dispersed in a controlled release matrix. The matrix contains between 70% and 99.5% (by weight) of microcrystalline cellulose, between 0.5% and 4% (by weight) of a cellulose derivative and, optionally, up to 26% of a sugar or a sugar alcohol.The water insoluble drug must dissolve in water (pH 5) at 20.degree. C. to a concentration of less than 1.0 mg ml-1, preferably less than 0.5 mg ml-1. Preferred drugs are non-steroidal anti-inflammatory agents, especially fenprofen calcium, ibuprofen, ketoprofen, naproxen, diclofenac sodium, fenbufen, flurbiprofen, indomethancin, oxyphenbutazone, phenylbutazone or piroxicam.

Abstract: A controlled release pharmaceutical composition comprising a plurality of film coated spheroids, the film coated spheroids comprising a 3-alkylxanthine, a non-water soluble spheronising agent and between 4% and 9% (by weight) water, wherein the in-vitro dissolution rate of the 3-alkylxanthine from the film coated spheroids, when measured by the USP Paddle Method at 100 rpm in 900 ml aqueous buffer (pH 6.5 at 37.degree. C.) is between 7.5% and 25.0% (by wt) release after 1 hour, between 22.5% and 45.0% (by wt) release after 2 hours, between 40.0% and 60.0% (by wt) release after 3 hours, between 50.0% and 75.0% (by wt) release after 4 hours, between 70.0% and 92.5% (by wt) release after 6 hours, and between 80.0% and 100.0% (by wt) release after 8 hours. Preferably the water content is between 4% and 8%, especially between 4% and 7% (by wt) of the film coated spheroid formulation.

Abstract: A solid controlled release, oral dosage form, the dosage form comprising a therapeutically effective amount of hydromorphone or a salt thereof in a matrix wherein the dissolution rate in vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm in 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37.degree. C. is between 12.5% and 42.5% (by weight) hydromorphone released after 1 hour, between 25% and 55% (by weight) hydromorphone released after 2 hours, between 45% and 75% (by weight) hydromorphone released after 4 hours and between 55% ad 85% (by weight) hydromorphone released after 6 hours, the in vitro release rate being independent of pH between pH 1.6 and 7.2 and chosen such that the peak plasma level of hydromorphone obtained in vivo occurs between 2 and 4 hours after administration of the dosage form.

Abstract: A pharmaceutical composition in the form of a multiphase (especially a bilayered, optionally coated) tablet. The tablet has a narcotic analgesic phase containing a therapeutically effective quantity of a narcotic analgesic or an analgesically effective salt thereof (e.g. codeine phosphate) and a non-steroidal anti-inflammatory phase containing a therapeutically effective quantity of a non-steroidal anti-inflammatory carboxylic acid or an anti-inflammatory salt or ester thereof (e.g. ibuprofen). The narcotic analgesic phase is free from a non-steroidal anti-inflammatory carboxylic acid or salt or ester thereof, stearic acid and stearate salt, and the non-steroidal anti-inflammatory phase is free from a narcotic analgesic or salt thereof, stearic acid and a stearate salt. Further, both the narcotic analgesic phase and the non-steroidal anti-inflammatory phase contain a self-lubricating, compression aid, especially a self-lubricating, direct compression aid, such as microcrystalline cellulose.

Abstract: A solid controlled release, oral dosage form, the dosage form comprising an analgesically effective amount of dihydrocodeine or a salt thereof in a controlled release matrix wherein the dissolution rate in vitro of the dosage form, when measured by the USP Paddle Method at 100 rpm in 900 ml aqueous buffer (pH between 1.6 and 7.2) at 37.degree. C. is between 25% and 60% (by weight) dihydrocodeine released after 1 hour, between 45% and 80% (by weight) dihydrocodeine released after 2 hours, between 60% and 90% (by weight) dihydrocodeine released after 3 hours and between 70% and 100% (by weight) dihydrocodeine released after 4 hours, the in vitro release rate being independent of pH between pH 1.6 and 7.2 and chosen such that the peak plasma level of dihydrocodeine obtained in vivo occurs between 2 and 4 hours after administration of the dosage form.

Abstract: A solid, controlled release, pharmaceutical composition comprising an active ingredient incorporated in a matrix comprising a first substance selected from a water soluble polydextrose and a water soluble cyclodextrin and a second substance selected from a C.sub.12 -C.sub.36 fatty alcohol and a polyalkylene glycol.Preferably the first substance is a cyclodextrin, especially a beta-cyclodextrin, while the second substance is a C.sub.14 -C.sub.22 fatty alcohol, especially stearyl alcohol, cetyl alcohol, cetostearyl alcohol or myristyl alcohol. The matrix may also contain a cellulose ether, especially a hydroxyalkylcellulose or a carboxyalkylcellulose.

Abstract: A solid, controlled release, pharmaceutical composition comprising an active ingredient incorporated in a controlled release matrix comprising a water soluble polydextrose.The controlled release matrix may also contain at least one of a digestibele C.sub.8 --C.sub.50 substituted or unsubstituted hydrocarbon, especially a C.sub.12 --C.sub.36 fatty alcohol, and a polyalkylene glycol, especially polyethylene glycol. Optionally, the matrix may contain a cellulose ether, especially a hydroxyalkylcellulose or a carboxyalkylcellulose.

Abstract: Iodophor-containing suppositories are provided with improved rate of iodine release from the suppository. The suppository composition comprises an iodophor, a water soluble suppository base, at least one water soluble sugar having a molecular weight of between about 90 and 550, and water in an amount of at least about 30% by weight. The molecular weight of the sugar is preferably between about 150 and 370. The preferred iodophors are providone iodine and polydextrose iodine. The preferred suppository bases are gelling polysaccharides and the preferred sugars are monosaccharides, disaccharides and sugar alcohols. The rate of iodine release is improved because of the high concentration of water together with the presence of the low molecular weight sugar.