Abstract: Temperature-stable, gastric-resistant formulation suitable for oral and sustained delivery of proteins, including insulin, and for nucleic acids (e.g., DNA, RNA), and related methods of making and use are described. In an embodiment, The thermostable and acid-stable pharmaceutical composition includes an inclusion complex, where the inclusion complex includes a lipophilic active pharmaceutical ingredient-carrier ionic association complex encapsulated in a ?-cyclodextrin or derivative thereof. In an embodiment, the pharmaceutical composition ion-pair complex encapsulated in the ?-cyclodextrin or derivative thereof is in the form of a convenient dissolvable tablet dosage form.

Abstract: The present disclosure provides nanostructures (e.g., monolayer or bilayer nanostructures) comprising porphyrins with cobalt chelated thereto such that the cobalt metal resides within monolayer or bilayer in the porphyrin macrocycle. The nanostructures can have presentation molecules comprising epitopes from microorganisms with a histidine tag attached thereto, such that at least a part of the his-tag is within the monolayer or bilayer and coordinated to the cobalt metal core and the presentation molecules are exposed to the outside of the nanostructures. The nanostructures can further comprise a cargo. The nanostructures can be used to deliver the cargo to an individual.

Abstract: The present disclosure provides nanostructures (e.g., monolayer or bilayer nanostructures) comprising porphyrins with cobalt chelated thereto such that the cobalt metal resides within monolayer or bilayer in the porphyrin macrocycle. The nanostructures can have presentation molecules with a histidine tag attached thereto, such that at least a part of the his-tag is within the monolayer or bilayer and coordinated to the cobalt metal core and the presentation molecules are exposed to the outside of the nanostructures. The nanostructures can further comprise a cargo. The nanostructures can be used to deliver the cargo to an individual.

Abstract: This disclosure is directed to compositions that combine the polysaccharide-specific antibody protection afforded by the conventional vaccines through carrier effects provided by one or more pneumococcal common T-cell antigen(s) together with Streptococcus pneumoniae-specific Th-17 responses elicited by the pneumococcal carrier common T-cell antigen. The disclosed compositions are useful for pan-serotypic protection against NP carriage, and antibody responses against common pneumococcal virulence factors, potentially useful for pan-serotype protection against Streptococcus pneumoniae invasive diseases.

Abstract: A female condom is provided that includes a pouch of resilient membranous material and a hydrophilic cling mechanism. According to an embodiment of the invention, the cling mechanism includes three or more foam cling elements attached to an outer surface of the pouch. Upon insertion, the foam cling elements cling lightly to vaginal walls proximate a transition zone between the vagina's introitus and its rugated internal tissue. The foam cling elements may be shaped to permit them to nestle into a user's rugated internal vaginal tissue. An inserter may be coupled to the pouch for facilitating insertion of the condom. The inserter may retain a distal portion of the pouch in a collapsed form. The cling mechanism may be contained within the dissolvable inserter. The inserter may be dissolvable in the presence of vaginal moisture. Methods are also provided for collapsing the pouch and compressing it into an insertion package.

Abstract: A contraceptive or non-contraceptive diaphragm having a rim surrounding a thin membrane, the membrane having a cervical dome extending downwardly from a posterior portion of the membrane. The rim has a spring member having non-uniform bending characteristics. The shape of the spring member can be contoured to provide a rim that curves slightly upwardly at the anterior end of the diaphragm and slightly downwardly at its posterior end.

Abstract: Employing the known “tensegrity” principle, a female condom is configured such that when the condom is inserted into a woman's vagina, the woman's introitus acts on a proximal section of an elongated pouch extending between internal and external biasing members (e.g., rings) of the condom. Inward compressive forces exerted by the introitus on the inner ring of the condom cause the inner ring to be pushed distally within the vaginal canal, and the proximal pouch section to become a tension member pulling against the external ring. This causes a “tenting” of the proximal pouch section against the introitus. The resulting interaction of compression and tensile forces (a tensegrity effect) serves to provide the condom with a high degree of internal and external stability, including resistance to twisting and slippage.

Abstract: A female condom is provided that includes a pouch of resilient membranous material and a hydrophilic cling mechanism. According to an embodiment of the invention, the cling mechanism includes three or more foam cling elements attached to an outer surface of the pouch. Upon insertion, the foam cling elements cling lightly to vaginal walls proximate a transition zone between the vagina's introitus and its rugated internal tissue. The foam cling elements may be shaped to permit them to nestle into a user's rugated internal vaginal tissue. An inserter may be coupled to the pouch for facilitating insertion of the condom. The inserter may retain a distal portion of the pouch in a collapsed form. The cling mechanism may be contained within the dissolvable inserter. The inserter may be dissolvable in the presence of vaginal moisture. Methods are also provided for collapsing the pouch and compressing it into an insertion package.

Abstract: In a needle cannula extraction device, an engagement stroke moves one engagement member toward another engagement member so as to first engage a needle cannula inserted therebetween. Movement of at least one of the engagement members during a subsequent extraction stroke maintains a generally constant spacing between the engagement members that generally corresponds to a thickness of the needle. The extraction stroke pulls the needle cannula from its hub or other attachment structure, which is held in position. In first and second embodiments, the two engagement members first come together to grip the cannula, and then move together as a unit (with the engaged needle cannula) away from the retained attachment structure. In third and fourth embodiments, a first engagement member is pivotable toward a second engagement member, provided in the form of a backing member, and then away from the retained attachment structure.

Abstract: A unit dose injection cartridge (e.g., needleless injection cartridge) includes an elongated chamber, a sealable discharge outlet (e.g., nozzle orifice) and a piston seal slidable within the chamber from a proximal end region to a distal end of the chamber. The piston seal is movably securable at a first position within the proximal end region, wherein the chamber is fillable with medicament by way of a passageway extending past the piston seal from a proximal side to a distal side thereof. During filling, air is allowed to escape from the chamber through the same passageway used for filling, or a second similarly arranged adjacent passageway. Once a unit dose of medicament is metered into the chamber, the piston seal may be moved slightly distally to a second position within the proximal end region, whereby the chamber is sealed-off from the passageway by the piston seal.

Abstract: A disposable medicine delivery unit for use in a needleless hypodermic injector is configured to allow economical replacement, after each injection, of a patient contact surface and the entire injection flow-path of the medicament, to thereby ensure sterility with less need for repeated equipment cleaning and sterilization procedures. The delivery unit includes a piston seal configured to prevent improper reuse. The piston seal deforms and sticks in a conical end of the medicine delivery chamber at the end of its injection stroke. A push-only connection between the piston seal and a piston drive rod of the injector ensures that the latter cannot be used to retract the former. Preferably, the piston seal also includes a protruding nipple which enters and destroys the injection orifice following an injection, to further disable the delivery unit.

Abstract: A contraceptive diaphragm having a rim surrounding a thin membrane, the membrane having a cervical dome extending downwardly from a posterior portion of the membrane. The rim has two curvilinear bands joined together at their respective ends and encased in a coil spring. The shape of the bands creates a rim which curves slightly upwardly at the anterior end of the diaphragm and slightly downwardly at its posterior end. The rim is formed with a curvilinear profile which provides an advantageous fit. A small dome projects upwardly from an anterior portion of the membrane which is grasped by the wearer to remove the diaphragm.

Abstract: The assay device of this invention provides for very simple assay procedures leading to rapid, sensitive, specific detection of an analyte in a solution. The device is inexpensive and easily manufactured, particularly if automated manufacturing processes are used. The assay device is a test strip having an elongated support sheet of solid non-porous material attached to a similarly shaped sheet of absorbent material. The absorbent sheet has perforations, preferably of circular shape, forming sample receiving wells. Forming the bottom of the sample receiving wells is one surface of the support sheet, and attached to this surface are moieties which specifically bind the analyte (anti-analyte moieties). A liquid sample for assay is placed in the wells, and the liquid is drawn into the absorbent material. As the liquid is absorbed, it flows tangentially across the surface of the support sheet, and across binding moieties specific for the analyte which are attached to the bottom of the wells.

Abstract: An improved injection port (1) for a single-use syringe is described. One embodiment of the injection port has a one-way valve system for making it more difficult to reuse the syringe (2). The one-way valve system has a flap or diaphragm valve (6) housed in a valve chamber (11) at the proximal end of port cylinder (45). When the valve (6) is seated against valve seat (51) on valve cap (5), refilling of the syringe is blocked. During injection, the valve (6) unseats and moves toward radial ribs (7), allowing flow of medicament into the proximal end of a needle (2). Another embodiment of the injection port (1) includes longitudinal grooves (8) on the interior surface of the chamber (12) at the distal end of cylinder (45). The grooves (8) vent pressure from a Luer syringe inserted in the distal end of the cylinder (45).

Abstract: A single-use disposable syringe. In the syringe, a reservoir is formed of two sheets of thermoplastic material having expanded central portions that form a pair of convex domes. Both of the domes are compressible, and a connecting member spaces apart the domes. In response to complete compression of both of the central portions together, the reservoir substantially collapses and each of the domes becomes concave to prevent the reservoir from being reformed and to prevent reuse of the syringe. After partial compression of both of the central portions together and partial collapse of the reservoir, the central portions expand to reform the reservoir and draw fluid into the reservoir, thereby aspirating a hypodermic needle.

Abstract: A single use, single dose injection administering device including a drug or vaccine containing body and a needle wherein the sidewalls have memory causing at least one sidewall to collapse into the other during the administration of the vaccine.