Abstract: Dispersibility of a respirable powder, administrable by inhalation, is increased by including a pharmaceutically acceptable water-soluble polypeptide.

Abstract: According to the present invention, methods and compositions are provided for spray-dried, interferon-based dry powder compositions, particularly interferon-beta. The compositions are useful for treating conditions in humans that are responsive to treatment with interferons. In particular, the methods of the present invention rely on spray drying to produce stable, high-potency dry powder formulations of interferons, including but not limited to IFN-beta. Surprisingly, it has been found that IFN can be prepared in high potency, dry powder formulations by spray drying. Such dry powder formulations find particular utility in the pulmonary delivery of IFN.

Abstract: In a composition which has an amorphous, undercooled, glassy phase containing a water-soluble or water-swellable substance in an amorphous form, a sugar, which is capable of existing as a crystalline hydrate, is used as an agent to dehydrate the amorphous phase by crystallization therefrom, and thereby enhance the glass transition temperature of the residual amorphous phase.

Abstract: A composition comprises an agent to be delivered through a body surface and an electrotransport enhancer having a hydrophobic tail and a polar head of specific characteristics. An electrotransport delivery device is also provided having a reservoir comprising the agent to be delivered and the electrotransport enhancer of the invention. The electrotransport enhancers increase the electrotransport delivery rate of the agent through the surface while reducing the electrical resistance of the surface during electrotransport of the agent.

Abstract: A method of laser drilling a delivery port (37) in a beneficial agent dispenser (30) is disclosed. A dispenser (30) has a compartment (32) formed by a wall (31) for containing a beneficial agent (33) to be delivered. A laser beam is employed for burning at least partially through the wall (31). The laser beam and the dispenser (30) are positioned relative to one another such that the laser beam is aimed at a predetermined port site (35) on the dispenser (30). The laser beam is turned off (unenergized) during the positioning period. The laser beam is then energized and moved relative to the dispenser (30) for scribing a delivery port (37) proximate the port site (35). The scribing motion moves the laser beam from the port site (35) along a course (37). Preferably the course (37) is closed. The scribing motion causes the burning of the wall (31) by the laser beam to scribe the delivery port (37). The positioning motion and the scribing motion are controlled by a scanning system (16).

Abstract: A drug delivery device is disclosed for delivering a drug to the intestine and the colon. The device comprises external means for delaying the delivery of drug in the stomach, and hydrophobic means for preventing the passage of fluid through the delay means.

Abstract: A selectively permeable membrane (14) is positioned between the agent reservoir (15) and the electrode (11) of a donor electrode assembly (8) in an iontophoretic delivery device (10). Optionally, an electrolyte reservoir (13) is positioned intermediate the electrode (11) and the agent reservoir (15). In certain embodiments, the membrane (14) is permeable to species of less than a predetermined molecular weight and substantially less permeable to species of greater than the predetermined molecular weight. The agent is capable of dissociating into agent ions and counter ions.

Abstract: The present invention provides compositions and systems for the transdermal administration of a drug together with glycerol monolinoleate as a permeation enhancer. An example of a delivery system of the invention is a system (20) having a drug reservoir (22) containing together a drug to be delivered and glycerol monolinoleate permeation enhancer. Reservoir is sandwiched between a backing layer (24) and an in-line contact adhesive layer (28).

Abstract: A device for the transdermal administration of a drug comprising a microporous tie layer located between the drug reservoir and the contact adhesive. The tie layer eliminates blooming and delamination and has no appreciable adverse effect on either the drug flux or release rate from the device.

Abstract: A hormone replacement composition, a hormone replacement dosage form, and a method of hormone replacement are disclosed and indicated for the management of hormone replacement therapy.

Abstract: This invention is directed to a novel formulation for effectively utilizing hydrophobic permeation enhancers for the increased permeability of active agents through the skin or mucosa along with reduction of the lag time between application of the active agent and attainment of a therapeutically effective agent flux, with little or no irritation to the host. The invention is directed to compositions containing a hydrophobic permeation enhancer, which permeation enhancer has been micronized and stabilized in an inert carrier such as water. These compositions can be combined with a biologically active agent to provide enhanced permeability of the active agent to the skin or mucosa.

Abstract: An electrotransport delivery device utilizing reservoir buffering at a select pH ranges in order to reduce skin irritation and skin resistance is provided. Cathodic reservoirs are buffered to a pH of less than about 4, preferably to a pH in the range of about 2 to 4, while anodic reservoirs are buffered to a pH above about 4, preferably to a pH in the range of about 4 to 10. Another electrotransport delivery device utilizes a potassium sensor to monitor potassium efflux from the skin. Potassium efflux above a certain predetermined level has been found to be a precursor to skin irritation/erythema. Operation of the device is modified (eg, terminated) when the predetermined potassium efflux level is sensed.

Abstract: Compositions and methods for the oral administration of drugs and other active agents are provided. The compositions comprise an active agent carrier particle attached to a binding moiety which binds specifically to a target molecule present on the surface of a mammalian enterocyte. The binding moiety binds to the target molecule with a binding affinity or avidity sufficient to initiate endocytosis or phagocytosis of the particulate active agent carrier so that the carrier will be absorbed by the enterocyte. The active agent will then be released from the carrier to the host's systemic circulation. In this way, degradation of degradation-sensitive drugs, such as polypeptides, in the intestines can be avoided while absorption of proteins and polypeptides from the intestinal tract is increased.

Abstract: An electrically powered transdermal iontophoretic delivery device (10, 20) and a method of making same is provided. The device utilizes electrode assemblies (8, 9 ) composed of a substantially homogenous blend of a polymeric matrix containing about 5 to 50 vol % of a conductive filler which forms a conductive network through the matrix, and up to about 50 vol % of the agent to be iontophoretically delivered through the skin. In the case of the donor electrode assembly, the agent is typically a drug and preferably a water soluble drug salt. In the case of the counter electrode assembly, the agent is typically an electrolyte salt. The homogenous blend eliminates the need for separate electrode and agent containing layers which require lamination.

Abstract: A dosage form is disclosed for delivering pentoxifylline to a patient in need of pentoxifylline therapy. A method is discussed for delivery pentoxifylline to a patient at a dosage form controlled rate over an extended period of time.

Abstract: A process is disclosed and claimed for preparing a therapeutic composition comprising asteroid or a dosage form comprising the composition, which therapeutic composition or dosage form is indicated for human administration.

Abstract: A therapeutic tablet comprising morphine, poly(alkylene oxide) and poly(vinylpyrrolidone) encased by a composition comprising a cellulose polymer.

Abstract: The invention disclosed comprises a method for administering the antidiabetic drug glipizide to a patient in need of glipizide in need of antidiabetic therapy.

Abstract: A dry-state iontophoretic drug delivery device (10, 30) is provided. The device has drug and electrolyte reservoirs (15, 16) which are initially in a non-hydrated condition. In one embodiment of the invention, a sealed liquid-containing pouch (21, 22) is provided in each electrode assembly (8, 9). Water or other liquid (20) is released from the pouch (21, 22) by pulling a tab (27, 28) attached to a portion (25, 26) of the pouch (21, 22) which is capable of being torn or ripped in order to hydrate the drug and electrolyte reservoirs (15, 16) and activate the device (10, 30). In another embodiment, the device (30) is held in a package (32). The device (30) has pouches (21, 22) which release their liquid contents automatically upon removal of the device (30) from the package (32). In yet another embodiment, the device (40) is held in a package (42) having a compression zone (46). The pouches (21, 22) must be moved through the compression zone (46) when removing the device (40) from the package (42).