Abstract: Improved process for the isolation of laidlomycin from a fermentation broth includes increasing the pH of the fermentation broth and centrifuging the pH adjusted fermentation broth, resulting in an aqueous layer and a wet solid layer containing laidlomycin. After the aqueous layer is removed, the wet solid layer containing laidlomycin is dried. The process provides an efficient and high yielding method.

Abstract: Disclosed herein are compositions for the treatment of a disease in an animal including yeast extract of Saccharomyces cerevisiae, Bacillus licheniformis or Bacillus subtilis spores, and a carrier. Also included are animal feed compositions including the composition for the prevention, control and/or treatment of a disease in an animal and an animal's food/feed. The compositions are useful to prevent, control, and treat diseases such as necrotic enteritis in poultry when used in combination with an anticoccidal ionophore or coccidiosis vaccine.

Abstract: Disclosed herein are purified bacteriophage preparations that effectively lyse a plurality of C. perfringens strains. In one embodiment, a purified bacteriophage preparation includes four or more C. perfringens-specific bacteriophage, wherein each bacteriophage has lytic activity against at least five C. perfringens strains. In another embodiment, the purified bacteriophage preparation includes five or more C. perfringens-specific bacteriophage.

Abstract: An animal feed additive composition comprises an effective amount of a laidlomycin, a carrier, magnesium sulfate, and silicon dioxide. Other embodiments include methods of making the animal feed additive compositions, and the use of a laidlomycin in the manufacture of an animal feed additive for increasing the efficiency of feed utilization and rate of weight gain in domestic animals.

Abstract: The invention combines two different subunits with different release profiles in novel sustained-release oral dosage forms. In particular, the oral dosage forms include a subunit that comprises an opioid analgesic and a sustained-release material, wherein the dissolution rate in-vitro of the subunit, when measured by the standard USP Drug Release test of U.S. Pharmacopeia XXVI (2003) <724>, is less than about 10% within about 6 hours and at least about 60% within about 24 hours; less than about 10% within about 8 hours and at least about 60% within about 24 hours; or less than about 10% within about 12 hours and at least about 60% within about 24 hours; the dosage form providing a duration of therapeutic effect of about 24 hours.

Abstract: The present invention provides alcohol resistant oral dosage pharmaceutical forms and methods of using such oral dosage forms to avoid dose dumping if the dosage form is taken together with alcohol.

Abstract: Provided herein is a pharmaceutical composition comprising an antagonist, an agonist, a seal coat, and a sequestering polymer, wherein the antagonist, agonist, seal coat and at least one sequestering polymer are all components of a single unit, and wherein the seal coat forms a layer physically separating the antagonist from the agonist from one another. Methods for manufacturing such a pharmaceutical composition are also provided.

Abstract: The present invention provides cooling sheets for application to an extremity of a mammal, and methods for making and using such cooling sheets.

Abstract: A dosage form comprising a plurality of pellets, the pellets comprising a core element comprising morphine sulfate, a filler and a binder, wherein the morphine sulfate, calculated as the anhydrous form, comprises about 50 wt % to about 85 wt % of the total weight of the core element; and a controlled-release coating disposed on at least a portion of the core element, the coating comprising an insoluble matrix polymer which is insoluble at pH 1 to 7.5; an enteric polymer which is insoluble at pH 1 to 4 and soluble polymer which is soluble at a pH of 1 to 4, wherein the ratio of the acid soluble polymer to the enteric polymer is 1.45:1 to 2.5:1 on a weight basis, wherein the Cmax of the dosage form differs by less than 20% when administered to a mammalian subject in the fed state compared to the fasted state. Also included are methods of increasing patient compliance by administering the disclosed dosage form to a mammalian subject.

Abstract: The present invention provides oral pravastatin formulations comprising a physical mixture of pravastatin and at least one pharmaceutically-acceptable excipient, wherein the composition for at least 6 months after its preparation is stable and has a pH of greater than about 7 to less than 9, as well as methods for the preparation and use of these stable formulations.

Abstract: The invention combines two different subunits with different release profiles in novel sustained-release oral dosage forms. In particular, the oral dosage forms include a subunit that comprises an opioid analgesic and a sustained-release material, wherein the dissolution rate in-vitro of the subunit, when measured by the standard USP Drug Release test of U.S. Pharmacopeia XXVI (2003) <724>, is less than about 10% within about 6 hours and at least about 60% within about 24 hours; less than about 10% within about 8 hours and at least about 60% within about 24 hours; less than about 10% within about 10 hours and at least about 60% within about 24 hours; or less than about 10% within about 12 hours and at least about 60% within about 24 hours; the dosage form providing a duration of therapeutic effect of about 24 hours.

Abstract: A press-coat formulation comprising a core composition comprising a water-soluble active agent and a waxy material and a coating composition comprising the active agent and a polymer, wherein the coating composition is press-coated onto the core.

Abstract: A sequestering subunit comprising an aversive agent and a blocking agent, wherein the blocking agent substantially prevents release of the aversive agent from the sequestering subunit in the gastrointestinal tract for a time period that is greater than 24 hours; a composition comprising a sequestering subunit and a therapeutic agent in releasable form, wherein, optionally, the mechanical fragility of the sequestering subunit is the same as the mechanical fragility of the therapeutic agent in releasable form; a capsule or tablet comprising a sequestering subunit and a therapeutic agent; and a method of preventing abuse of a therapeutic agent.

Abstract: In a preferred embodiment of the invention, a solid dosage form is provided comprising a matrix, wherein the matrix comprises (a) a pharmaceutically effective amount of metformin or a pharmaceutically acceptable salt thereof and (b) a waxy matrix material. The invention also provides a method of making a solid dosage form, the method comprising: (a) hot melting a waxy material to form a melt, (b) granulating metformin or a pharmaceutically acceptable salt thereof with the melt to form a granulate; (c) milling the granulate; and (d) compressing granulate to form a matrix.

Abstract: This invention provides DNA sequences coding for Eimeria surface antigens, recombinant vectors containing such DNA sequences, transformed microorganisms containing such vectors and methods for producing the antigens using the transformed microorganisms. Methods are also provided for protecting poultry against coccidiosis using the Eimeria surface antigens. The surface antigens can be administered for such protection either as purified proteins or in the form of DNA encoding the proteins in a suitable viral vector such as vaccinia virus.