Abstract: The present invention pertains to a dual control sustained release drug delivery system which comprises a core and a porous coating layer over the core, wherein the coated core comprises (A) a core comprising in percentages by weight of the core composition (a) a medicament present in an amount from about 60% to about 90%; (b) an edible material having a melting point from about 25.degree. C. to about 100.degree. C. selected from the group consisting of (i) fatty acids having an iodine value from about 1 to about 10, (ii) natural waxes, (iii) synthetic waxes, and (iv) mixtures thereof, present in an amount from about 5% to about 40%; and (B) a porous coating layer over the core comprising in percentages by weight of the coating layer composition (a) a pH-independent water-insoluble polymer present in an amount from about 40% to about 80%; and (b) a water-soluble film forming polymer present in an amount from about 20% to about 60%.

Abstract: Solid compositions of certain cholinergic compounds are stabilized in starch. Especially compositions of corn starch combined or mixed with the 0-substituted-1,2,5,6-tetrahydro-3-pyridine oxime ether, CI-979 HCl, a cognition activator, have been found stable in a heated environment of up to 60.degree. C. over 17 days such that no losses were detected by HPLC analysis. A solid peroral pharmaceutical formulation for the treatment of cognitive disorders is based on the bicomponent composition of active ingredient and stabilizer using appropriate amounts of other excipients or components known in the formulation art.

Abstract: Novel pharmaceutical compositions are comprised of the salt or ion pair formation of a non-steroidal anti-inflammatory drug and an antihistamine or other decongestant. The physico-chemical characteristics of these compositions show them to be substantially different from their parent acid or base and will enable the preparation of dual action sustained or enhanced relief therapy regimens. The compositions also possessed enhanced stability and therefore the multi-symptom relief can be incorporated into a number of dosage forms such as capsules, tablets, elixirs, ointments and the like.

Abstract: Novel pharmaceutical compositions are comprised of the salt or ion pair formation of a non-steroidal anti-inflammatory drug and an antihistamine or other decongestant. The physico-chemical characteristics of these compositions show them to be substantially different from their parent acid or base and will enable the preparation of dual action sustained or enhanced relief therapy regimens. The compositions also possessed enhanced stability and therefore the multi-symptom relief can be incorporated into a number of dosage forms such as capsules, tablets, elixirs, ointments and the like.

Abstract: A solid composition for stabilizing the dosage of cognition activator CI-979 HCl by formation of a complex with cyclic polydextrose. In particular, compositions with HP.beta.CD have been found to stabilize CI-979 HCl even in the presence of other excipients such as sodium carbonate. Pharmaceutical formulations for the treatment of cognitive disorders in humans are based on the stabilizing composition of CI-979 HCl and cyclic polydextrose, including appropriate amounts of other excipients or components as known in the formulation art.

Abstract: Calcium lactate antibacterial complexes in parenteral dosage forms are provided that are relatively free from tissue irritation following injection, comprising a quinolone or naphthyridine.

Abstract: Improved oral formulations are prepared by admixing gemfibrozil with from 1 to 4%, by weight, of a pharmaceutically acceptable surfactant having an HLB value of from about 10 to about 50.

Abstract: The present invention is a stabilized enteric-coated pharmaceutical dosage form and processes for the preparation thereof. Dissolution stability after storage of the dosage form under high stress conditions is improved by an enteric-coated dosage form having an enteric coating wherein the coating is of the acrylic resin kind of from 14 mg/cm.sup.2 to 24 mg/cm.sup.2 or an enteric coating wherein the coating is of the acetate kind of from 14 mg/cm.sup.2 to 24 mg/cm.sup.2 and having a second coating of hydrophilic coating for example, hydroxypropyl cellulose, hydroxymethyl cellulose or hydroxypropylmethyl cellulose.

Abstract: A new series of copolymers which are useful as coatings for solid dosage forms, for transdermal devices, for wound dressing materials, and for contact lenses. Also disclosed are methods for preparing monomers and polymers as well as pharmaceutical compositions containing such polymers.

Abstract: An orally administrable formulation of a biologically active, acid sensitive, proteinaceous agent comprises a composition of a lyophilized mixture of the proteinaceous agent and maltose, optionally with a particulate diluent. This composition is then uniformly coated with an alkaline-soluble polymeric film containing at least one partially esterified polymethacrylic acid as a major component.

Abstract: A water-dispersible formulation of gemfibrozil comprising finely divided particles of pure gemfibrozil uniformly coated with a mixture of a wax and at least one hydrophilic material, the coated particles in turn being overcoated with a minor amount of a surfactant.

Abstract: Improved thrombin formulations, stable at room temperature using stabilizing quantities of a polyol and a buffer at specific pHs are described wherein crude thrombin is first purified by two-stage ion exchange chromatography.

Abstract: A new series of copolymers which are useful as coatings for solid dosage forms, for transdermal devices, for wound dressing materials, and for contact lenses. Also disclosed are methods for preparing monomers and polymers as well as pharmaceutical compositions containing such polymers.

Abstract: A disintegratable gemfibrozil tablet providing both immediate and enteric release is compressed from a mixture of a first granulation of gemfibrozil with at least one acid-disintegratable binder and a second granulation formed from the first granulation but regranulated or coated with an alkali-disintegratable formulation of at least one substantially alkali-soluble and substantially acid-insoluble polymer.

Abstract: The penetration of various drugs through living membranes, eg., skin, is improved by their use in topical compositions containing certain penetration-enhancer systems.

Abstract: Saturated or unsaturated fatty acids of 8-18 carbon atoms or a C.sub.1 -C.sub.4 alkyl ester thereof in an aqueous system are described as skin absorption enhancers resulting in effective and non-irritating transdermal compositions comprising the above in combination with a therapeutically active ingredient.

Abstract: The invention concerns a novel copolymer of N-morpholinoethyl methacrylate and 2-hydroxyethyl methacrylate which can be used in transdermal delivery systems or in oral controlled release products. The invention also concerns a process for preparing the copolymer and a method of using it to administer pharmaceutically active substances.

Abstract: A new series of copolymers such as N-isopropyl-3-methylene-2-pyrrolidone and 2-hydroxyethylmethacrylate which are useful as coatings for solid dosage forms, for transdermal devices, for wound dressing materials, and for contact lenses. Also disclosed are methods for preparing monomers and polymers as well as pharmaceutical compositions containing such polymers.

Abstract: The oxidation--and color-stability of certain ace inhibitors is optimized when they are formulated with a stabilizer and at least one lubricant and/or excipient.