Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.

Abstract: Disclosed are compositions that stabilize (e.g., thermo-stabilize) biological agents, such as mRNA. Also disclosed are methods of administering and using said compositions.

Abstract: Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.

Abstract: Microparticulate compositions and methods for delivery and pulsatile release of one or more sting agonists and/or receptors have been developed. The compositions include polymeric microdevices formed from biodegradable and biocompatible polymers or co-polymers thereof including a shell and compartment(s) or discrete regions in the compartment(s) formed by an additive process such as micromolding, three dimensional printing and lithography. The compositions include microdevices that release individual doses of incorporated STING agonist and/or receptors at defined times, for example, in pulses up to several months after administration with essentially no leakage between releases.

Abstract: Microdevices with complex three-dimensional (3D) internal and external structures are described. The microdevices are made by a method combining micromolding and soft lithography with an aligned sintering process. The microfabrication method, termed StampEd Assembly of polymer Layers (SEAL), generates microdevices with complex geometries and with fully-enclosed internal cavities containing a solid or liquid. The microdevices are useful for biomedical, electromechanical, energy and environmental applications.

Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Methods of encapsulating microorganisms, or components thereof, for targeted enteric delivery to an animal host have been developed. In particular, the encapsulation provides a prolonged survival, extended retention and a pH-sensitive release of the encapsulated microorganisms or antigenic components thereof at targeted sites within the gastrointestinal tract. The formulations are useful for diagnostic, therapeutic and prophylactic purposes and can alter a host's microbial composition associated with a condition or a disease state.

Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Particulate formulations containing one or more micronutrients such as iron supplements such as ferrous sulfate, fat or oil soluble vitamins such as vitamin A, D, and E, water soluble vitamins such as B vitamin family, and other micronutrients have been developed. These formulations resist oxidation and loss of bioactivity during processing, storage and cooking. The particles include one or more enteric polymers such as pH-sensitive polymers. To prevent oxidation, the iron supplements are encapsulated by a polymer such as hyaluronic acid (“HA”), preferably in a ratio of iron:HA of between 1:4 and 1:10), or mixed with a compound such as vitamin C. The resulting mixture is then dispersed in a solution of a enteric polymer, and manufactured using techniques such as spray drying or spinning disc atomization into particles into particles.

Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Microdevices with complex three-dimensional (3D) internal and external structures are described. The microdevices are made by a method combining micromolding and soft lithography with an aligned sintering process. The microfabrication method, termed StampEd Assembly of polymer Layers (SEAL), generates microdevices with complex geometries and with fully-enclosed internal cavities containing a solid or liquid. The microdevices are useful for biomedical, electromechanical, energy and environmental applications.

Abstract: Microneedle patches have been developed that can be used to deliver therapeutic, prophylactic, diagnostic agents and/or dyes to the skin. The microneedles encapsulate the agent(s) to be delivered. These are formed of a biodegradable polymer that dissolves upon insertion into skin or tissue, so that the microneedles break off from the substrate forming the patch, remaining in the skin/tissue at the site of insertion. The patches are used to create a tattoo or to deliver therapeutic, prophylactic or diagnostic agent in combination with a tattoo. In one embodiment, the microneedle patch contains both vaccine and dye pigments to administer vaccine and record such administration in one application of the microneedle patch.

Abstract: Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.

Abstract: Methods of encapsulating microorganisms, or components thereof, for targeted enteric delivery to an animal host have been developed. In particular, the encapsulation provides a prolonged survival, extended retention and a pH-sensitive release of the encapsulated microorganisms or antigenic components thereof at targeted sites within the gastrointestinal tract. The formulations are useful for diagnostic, therapeutic and prophylactic purposes and can alter a host's microbial composition associated with a condition or a disease state.

Abstract: Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.

Abstract: Emulsion-based and micromolded (“MM”) or three dimensional printed (“3DP”) polymeric formulations for single injection of antigen, preferably releasing at two or more time periods, have been developed. Formulations are preferably formed of biocompatible, biodegradable polymers. Discrete regions encapsulating antigen, alone or in combination with other antigens, adjuvants, stabilizers, and release modifiers, are present in the formulations. Antigen is preferably present in excipient at the time of administration, or on the surface of the formulation, for immediate release, and incorporated within the formulation for release at ten to 45 days after initial release of antigen, optionally at ten to 90 day intervals for release of antigen in one or more additional time periods. Antigen may be stabilized through the use of stabilizing agents such as trehalose glass. In a preferred embodiment for immunization against polio, antigen is released at the time of administration, and two, four and six months thereafter.

Abstract: Salt formulations, which are resistant to moisture and cooking conditions, are described herein. The formulations provide particles of micronutrients and vitamins encapsulated within heat resistant pH-sensitive water-insoluble polymers, which are packaged within a salt shell. The pH-sensitive, water-insoluble, thermally stable materials stabilize the micronutrients, particularly at high temperatures, such as during food preparation and cooking, and release the micronutrients at the desired locations such as the stomach, small intestine, etc. Preferred pH-sensitive polymers release at a low pH, less than the pH present in the stomach. The particles can be used to deliver daily-recommended doses of micronutrients simultaneously with salt, eliminating the need for vitamin pills. This is particularly important in populations suffering from severe malnutrition.