A method and device for treating a mammalian organism to obtain a desired local or systemic physiological or pharmacological effect is provided. The method includes administering a sustained release drug delivery system to a mammalian organism in need of such treatment at an area wherein release of an effective agent is desired and allowing the effective agent to pass through the device in a controlled manner. The device includes an inner core or reservoir including the effective agent, an impermeable tube which encloses portions of the reservoir, and a permeable member at an end of the tube.

An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

A delivery device including a substrate formed in a coil comprising a plurality of loops, an active agent deposited between an inner surface and an outer surface of the substrate formed in the coil, and a pair of end caps, each end cap disposed on a corresponding end of the coil.

Some embodiments of an infusion pump system can include a controller in which one or more features sets to be provided by the controller are enabled or disabled based upon the particular pump device that is connected to the controller. For example, in some embodiments, one or more advanced features of the controller are available to the user only when a first type of pump device (e.g., having predefined settings stored therein) is connected to the controller, and those advanced features of the controller are disabled when a second type of pump device is connected to the controller.

The present invention is directed to pharmaceutical compositions that allow for once-daily or alternate day dosage forms of topiramate. The proposed delayed/extended release single dosage form is equivalent to the immediate-release multiple dose daily regimen, and upon administration, provides steady state blood levels of topiramate. Formulations with increased bioavailability and improved pharmacokinetics are disclosed. A once-a-day administration of topiramate is advantageous over the multiple dose regimen both in terms of patient compliance and reduced adverse events, thus providing better treatment of the conditions for which the topiramate is indicated.

The invention relates to a pharmaceutical dosage form comprising (i) at least one formed segment (S.sub.1), which contains a first pharmacologically active ingredient (A.sub.1) and provides prolonged release thereof, and (ii) at least one further segment (S.sub.2), which contains a second pharmacologically active ingredient (A.sub.2) and provides immediate release thereof,
wherein the at least one formed segment (S.sub.1) exhibits a higher breaking strength than the at least one further segment (S.sub.2) and the at least one formed segment (S.sub.1) exhibits a breaking strength of more than 500 N.

The present invention relates to a device, system and a method for optimizing syringe based drug delivery profile with a treatment element and in particular, to such a device, system and method in which optimization is based on a plurality of data that directly and/or indirectly affect the optimization of the drug delivery profile. The device facilitating syringe based drug delivery, by optimizing drug delivery of the injected drug, records user's activity, and data relative to drug injections, comprising a disposable unit configured for a single use period and a rechargeable reusable unit having electronics comprising a sensor module.

The invention relates to a pharmaceutical composition in the form of a system in film form for transmucosal administration of steroid hormones. An administration system for steroid hormones which dissolves in the mouth and which releases with a high bioavailability is disclosed. The administration system in film form dissolves in the mouth preferably in a period of less than 30 min, and the steroid hormone entering the bloodstream transmucosally from the administration system leads to a rapid rise in the concentration in the blood. It is thus possible to achieve a maximum concentration of this steroid hormone in the blood in a period of less than 60 min after administration.

A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.

Methods of nighttime administration of amantadine to reduce sleep disturbances in patient undergoing treatment with amantadine are described, as well as compositions of extended release amantadine that are suitable for nighttime administration.