Abstract: A multi-layered microcapsule containing one or more active ingredients and process for preparing the same is disclosed. The multi-layered microcapsule comprises an inner solid microparticle core, typically composed of a biodegradable polymer, and having one or more alternating layers of polymer, active ingredient or polymer/active ingredient mixtures to produce a multi-layered microcapsule wherein the polymer or active ingredient in each layer may be the same or different or have the same or different concentration of the polymer or active ingredient in other layers.

Abstract: Methods and compositions to induce opioid drug independence in opioid drug dependent individuals comprising administering opioid agonists and/or antagonists encapsulated in biodegradable polymer microspheres in a dosage formulation.

Abstract: A novel method of producing biodegradable microparticles is disclosed. Inorganic calcium salts are mixed with water to form a slurry. The slurry is then added to an oil bath which is then mixed to form an emulsion. The mixing continues for a period of time sufficient to form hardened microparticles. The hardened microparticles are then retrieved and characterized. Biologically active agents may be added to the slurry prior to emulsification, or they may be added to the hardened microparticles after production. The microparticles may be injected into a human being whereby they act as controlled release drug delivery vehicles.

Abstract: A transdermal drug delivery system useful for the controlled, for example zero order release of one or more drugs to a selected skin area of a user, which system comprises an impervious backing sheet and a face membrane, the backing sheet and membrane secured together to form an intermediate reservoir. The face membrane is a macroporous membrane which has pores of sufficient size to avoid any rate control of the drug to be transdermally delivered to the user. The reservoir contains a viscous liquid base material selected to exude from the membrane to form a film and to occlude the skin of the user to force hydration of the stratum corneum with water from the lower layers of the epidermis of the user and a plurality of solid microparticles generally uniformly dispersed and suspended in the liquid base material. The microparticles containing an effective therapeutic amount of the drug for transdermal delivery, such as the contraceptive steroid.

Abstract: A transdermal drug delivery system useful for the controlled, for example, zero order, release of one or more drugs to a selected skin area of a user, which system comprises a reservoir containing a transdermal delivery composition. The reservoir contains a composition which comprises a base material, which is a solid but which melts or liquefies upon contact with the skin of a user and selected to occlude the skin of the user to force hydration of the stratum corneum with water from the lower layers of the epidermis of the user and a plurality of solid microparticles, generally uniformly dispersed and suspended in the base material, the microparticles containing an effective, therapeutic amount of the drug for transdermal delivery, such as the contraceptive steroid.

Abstract: A transdermal drug delivery system which system comprises an impervious backing sheet and face membrane, the backing sheet and membrane secured together to form an intermediate reservoir. The face membrane is a macroporous membrane which has pores of sufficient size to avoid any rate control of the drug to be transdermally delivered to the user. The reservoir contains a viscous liquid base material selected to exude from the membrane to form a film and to occlude the skin of the user to force hydration of the stratum corneum with water from the lower layers of the epidermis of the user. The liquid base material contains an effective, therapeutic amount of the drug for transdermal delivery, such as the contraceptive steroid, which drug is highly soluble in the liquid base material.

Abstract: A vehicle which provides rapid release of a drug and prolonged release of a drug is disclosed.

Abstract: A transdermal drug delivery system useful for the controlled, for example zero order release of one or more drugs to a selected skin area of a user, which system comprises an impervious backing sheet and a face membrane, the backing sheet and membrane secured together to form an intermediate reservoir. The face membrane is a macroporous membrane which has pores of sufficient size to avoid any rate control of the drug to be transdermally delivered to the user. The reservoir contains a viscous liquid base material selected to exude from the membrane to form a film and to occlude the skin of the user to force hydration of the stratum corneum with water from the lower layers of the epidermis of the user and a plurality of solid microparticles generally uniformly dispersed and suspended in the liquid base material. The microparticles containing an effective therapeutic amount of the drug for transdermal delivery, such as the contraceptive steroid.

Abstract: A transdermal drug delivery system useful for the controlled, for example zero order, release of one or more drugs to a selected skin area of a user, which system comprises an impervious backing sheet and a face membrane, the backing sheet and membrane secured together to form an intermediate reservoir. The face membrane is a macroporous membrane which has pores of sufficient size to avoid any rate control of the drug to be transdermally delivered to the user. The reservoir contains a viscous liquid base material selected to exude from the membrane to form a film and to occlude the skin of the user to force hydration of the stratum corneum with water from the lower layers of the epidermis of the user and a plurality of solid microparticles generally uniformly dispersed and suspended in the liquid base material. The microparticles containing an effective therapeutic amount of the drug for transdermal delivery, such as the contraceptive steroid.

Abstract: A process for preparing coated microparticles, which process comprises preparing a solvent solution of an active ingredient to be encapsulated and a film-forming polymer, removing the solvent to provide a dry, composite, uniform admixture of the active ingredient and the polymer material, reducing the composite admixture to a defined smaller particle size distribution, coating the reduced composite core particles in a fluidized bed, with a uniform defined wall thickness of the same or substantially the same film-forming polymer material to provide composite core coated microparticles.

Abstract: A process for preparing coated microparticles, which process comprises preparing a solvent solution of an active ingredient to be encapsulated and a film-forming polymer, removing the solvent to provide a dry, composite, uniform admixture of the active ingredient and the polymer material, reducing the composite admixture to a defined smaller particle size distribution, coating the reduced composite core particles in a fluidized bed, with a uniform defined wall thickness of the same or substantially the same film-forming polymer material to provide composite core coated microparticles.

Abstract: A wearable medicator suitable for controlled subcutaneous dispensing of a liquid medication into a patient. The medicator utilizes a unique arcuate syringe means to provide a small compact medicator that can be easily worn by the patient. The medicator can provide controlled release of insulin for the treatment of diabetes.

Abstract: A system is disclosed for demand-based administration of insulin which utilizes a change in a physical property of a patient's body fluid as an indicator that a change in the body fluid glucose level has occurred and that an appropriate amount of insulin should be supplied to the patient. Body fluid osmolality or one of its colligative properties are particularly suitable for this purpose. A second sensor for measuring such properties as electrical conductivity may be added to detect changes in osmolality caused by such factors as dehydration. Insulin can be delivered to the patient from an extracorporeal source by means of a dual lumen catheter. One lumen of the catheter provides a passageway for the insulin dose and the other lumen provides a passageway through which a replaceable sensors can be introduced into or removed from the patient's body. In the alternative, the entire insulin administration system can be implanted into the patient.

Abstract: A body cavity access device for supplying a hormone to a patient including an implantable housing placed in the body and having an impermeable extracorporeal segment and a semipermeable subcutaneous segment. A hormone source such as live, hormone-producing cells, e.g., pancreatic islet cells is then removably positioned in the housing to provide a hormone supply to the patient. A sensor can be located within the subcutaneous segment and operably associated with a dispenser to release medication into the housing and to the patient.

Abstract: An artifical endocrine gland for supplying a hormone to a patient including an implantable housing placed in the body and having an impermeable extracorpeal segment and a semipermeable subcutaneous segment. A replaceable envelope containing live hormone-producing cells such as pancreatic islet cells is then removably positioned in the housing to provide hormones to the patient.

Abstract: A system is provided for the administration of a medicament, such as insulin, to a patient in small, controlled doses over an extended period in response to a continuously generated force. The force may be maintained continuously on a reservoir of the medicament in intermittent communication with a site in the body of the patient through a flexible and compressible tube. A constrictor about the tube keeps it normally closed except when a separate force is exerted to open the constrictor and permit the medicament to flow through the tube for a predetermined period. Alternatively, the continuously generated force may be applied intermittently to the medicament reservoir through the action of an escapement mechanism.