Abstract: A premix parenteral solution for intravenous administration having amiodarone, as an active ingredient, solubilized in a solution of water for injection and about 0.4-12 mg/ml of a non-ionic surfactant to a concentration range of from 0.2 to 6 mg/ml is disclosed. The solution optionally may include an osmotic agent. No dilution of the solution is required before administering to a patient and the sterile packaged solution has an initial pH within the range of from about 2.9 to about 3.2, preferably about 3.1. Additionally, a method for producing an amiodarone solution suitable for intravenous administration is further disclosed.

Abstract: The invention relates to a solid composition in the form of a water-in-oil emulsion. The aqueous phase represents at least 70% by weight with respect to the total weight of the composition. The composition contains at least one silicone emulsifier and at least 3% by weight of at least one wax with respect to the total weight of the composition.

Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: The present invention provides oral dosage forms and compositions for administering antineoplastic agents, such as irinotecan, etoposide, paclitaxel, doxorubicin and vincristine, whose oral effectiveness is limited by pre-systemic and systemic deactivation in the GI tract. Gelling of the gastric retention vehicle composition, and in the case of solid forms concomitant expansion of the composition, retains the antineoplastic drug in the patient's stomach, minimizing pre-systemic and/or systemic deactivation of the drug.

Abstract: Bacterial infections may be treated using a high dosage regimen of amoxycillin and potassium clavulanate. Preferably, the dosage is provided by a bilayer tablet.

Abstract: Compositions which comprise, in a physiologically acceptable medium, at least one sapogenin or a derivative or natural extract containing the same, and at least one xanthine base are useful, in particular, for preventing or combating cellulite and/or for refining the figure or the contours of the face. Preferably, the composition comprises diosgenin or an extract of wild yam, combined with caffeine.

Abstract: The present invention includes a method for treating periodontal disease. The method comprises delivering to a pocket of a tooth with periodontal disease, a viscous, reddish-brown solution comprising sulfuric acid and sulphonated phenolic compounds. The method also comprises retaining the reddish-brown solution in the pocket for t time ranging from about 5 seconds to about 60 seconds.

Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.

Abstract: The invention is directed to methods and pharmaceutical compositions for the topical administration of opioid analgesic drugs such as morphine. In particular, the invention relates to topical administration of an opioid analgesic agent, e.g., morphine sulfate, to produce a localized analgesic effect in inflamed skin or mucosal tissue, and without a transdermal or transmucosal migration of opioid agent, e.g., into the systemic circulation.

Abstract: Bacterial infections may be treated using a high dosage regimen of amoxicillin and potassium clavulanate. Preferably, the dosage is provided by a bilayer tablet.

Abstract: The invention relates to a device for delaying the pylorus passage of orally administered medicament forms. Said device comprises a component which expands upon contact with the gastric juice and a polymer coat which is permeable to liquids but not to gases. The device can contain an active substance whose release into the gastric juice is mainly controlled by the medicament form into which it is incorporated. Unlike conventional medicament forms with delayed pylorus passage, the release of the active substance does not so much depend on the kind and structure of the polymer coat but is mainly determined by the incorporated medicament form. The inventive device can be easily rolled or folded and can be filled into capsules.

Abstract: The present invention is directed to a flowable composition that is suitable for use as a controlled release implant. The flowable composition includes a biodegradable thermoplastic polyester that is at least substantially insoluble in aqueous medium or body fluid. The flowable composition also includes a biocompatible polar aprotic solvent. The biocompatible polar aprotic solvent is miscible to dispersible in aqueous medium or body fluid. The flowable composition also includes leuprolide acetate.

Abstract: The inventive coating may be employed to deliver a pharmaceutical agent to a selected body area that is involved within the insertion or application of a medical device. Such medical devices may include silicone based urinary catheters and other medical implants as well as other silicone based devices having deformable portions which could benefit from the release of a pharmaceutical agent from its surface. The coating allows the introduction of the pharmacological additive having a release rate that is within acceptable pharmacokinetic criteria. The release rate is adjusted by utilizing different salt forms of the additive and adjusting the concentration of urethane and RTV silicone. The coating incorporates additive compounds such as anti-microbial, anti-fungals and other organic compounds. Methods are also provided for the manufacture of the subject coating and for the application of the same to surfaces of medical devices.

Abstract: A method for treating a microbial infection in a mammal, such as a human, comprising treating the mammal with a therapeutically effective amount of a polymer comprising an amino group or an ammonium group attached to the polymer backbone via an aliphatic spacer group. The polymer can be a homopolymer or a copolymer. In one embodiment, the polymer is a copolymer comprising a monomer having a pendant ammonium group and a hydrophobic monomer.

Abstract: The present invention relates to a controlled drug release system in which a certain ratio or retinoic acid is incorporated into a microsphere comprising biodegradable polymer and amphoteric block copolymer having both hydrophilic and hydrophobic groups.

Abstract: The invention provides a novel pharmaceutical kit comprising a controlled release pharmaceutical compositions for oral use containing midodrine and/or its active metabolite desglymidodrine. The controlled release composition is designed to release midodrine and/or desglymidodrine after oral intake in a manner which enables absorption to take place in the gastrointestinal tract so that a relatively fast peak plasma concentration of the active metabolite desglymidodrine is obtained, followed by a prolonged and relatively constant plasma concentration of desglymidodrine. The invention also provides a method for treating orthostatic hypotension and/or urinary incontinence, the method comprising administration to a patient in need thereof of an effective amount of midodrine and/or desglymidodrine in a kit.

Abstract: The present invention relates to a sustained release preparation of a lipophilic drug, comprising a drug dispersion wherein the lipophilic drug and a water-soluble substance are dispersed, in a solid state at the body temperature of an animal or a human being to which the preparation is to be administered, in a water-impermeable and biocompatible material.

Abstract: The present invention is directed to a method and system for delivering a drug into the systemic circulation. The method comprises establishing a drug depot in a patient's skin and/or sub-skin tissues by applying a transdermal drug delivery system on the patients skin, for a predetermined time so that a drug depot is formed in said user's skin and/or sub-skin tissues. A heating source is placed proximate to the skin area to rapidly release a bolus of the drug from the depot into the systemic circulation when there is a need to rapidly increase the drug's concentrations in the systemic circulation.

Abstract: Bacterial infections may be treated using a high dosage regimen of amoxycillin and potassium clavulanate. Preferably, the dosage is provided by a bilayer tablet.

Abstract: A microcapsule having a mean diameter of from about 0.1 to about 5 mm, a membrane and a matrix containing at least one active principle wherein the microcapsule is the product of the process comprising the steps of (a) forming an aqueous matrix by heating an aqueous solution comprised of a gel former, an anionic polymer selected from the group consisting of a salt of alginic acid and an anionic chitosan derivative and active principle; (b) adding the aqueous matrix to an aqueous solution of chitosan.