SBIR-STTR Award

This overall goal of this project is to develop a scalable process for fabricating oil encapsulated particles with uniform sizes and physical characteristics that contain oil as a vehicle for delivering hydrophobic drugs. Poorly water soluble active pharmaceutical ingredients (APIs) represent 40% of all new chemical entities discovered by the pharmaceutical industry, but investigators often discard them in the R&D phase because their insolubility renders them difficult to formulate, which translates to low and/or variable bioavailability and effectiveness in vivo. Solubility problems also decrease the efficacy of a significant portion of products on the market, including many pain relievers and antibiotics. Our novel Precision Particle Fabrication (PPF) technology is a flexible, single-step process for fabricating oil-containing particles with finely tuned sizes and physicochemical characteristics that enable improved control over drug encapsulation and release. We hypothesize that a scaled version of this technology will produce dried, oil-filled microcapsules (size <100 5m) at a rate of at least 10 kg/min, more than adequate for industry needs. Phase I research will demonstrate the feasibility of scaling PPF technology for broad use by pharmaceutical companies. Our research team will develop several scaled prototypes of the existing PPF technology to meet a range of varying microcapsule specifications (Aim 1). We will also integrate the technology with current Good Manufacturing Practice guidelines given by the FDA (Aim 2) and design a monitoring mechanism and fluid recycling for the process to decrease material waste (Aim 3). Successful scaling of the PPF technology for drug delivery will improve the biological performance of existing pharmaceutical products and enable production of new therapeutic solutions using APIs previously discarded in the drug development process.

Public Health Relevance:
Development of effective delivery mechanisms for pharmaceutical products is just as important as the drugs themselves for treatment of disease. However, pharmaceutical companies have yet to discover a reliable, scalable process for consistently fabricating drug particles with controlled physical properties and release profiles. This project aims to test the feasibility of expanding a novel method for fabricating particles with well-defined and tunable properties from the laboratory setting to the broader marketplace by leveraging encapsulated oil as a delivery vehicle for poorly- soluble drugs.

Thesaurus Terms:
Alimentary Canal; Antibiotic Agents; Antibiotic Drugs; Antibiotics; Aspiration, Mechanical; Beds; Beverages; Bioavailability; Biologic Availability; Biological; Biological Availability; Businesses; Characteristics; Chemicals; Childhood; Development; Development And Research; Digestive Tract; Disease; Disorder; Dose; Drainage, Suction; Drug Controls; Drug Delivery; Drug Delivery Systems; Drug Industry; Drug Targeting; Drug Targetings; Drugs; Effectiveness; Encapsulated; Equipment; Flr; Failure (Biologic Function); Filtration; Fractionation, Filtration; Funding; Future; Gi Tract; Gastrointestinal Tract; Gastrointestinal Tract Structure; Gel; Goals; Grant; Guidelines; Gustation; Health; Human; Human, General; Hydrogen Oxide; Industry; Industry, Pharmaceutic; Investigators; Laboratories; Liquid Substance; Man (Taxonomy); Man, Modern; Manufacturer; Manufacturer Name; Marketing; Masks; Mechanics; Medication; Methods; Microcapsules Drug Delivery System; Microencapsulations; Miscellaneous Antibiotic; Monitor; Morphology; Nutrient; Oils; Pain; Painful; Particle Size; Patients; Performance; Pharmaceutic Preparations; Pharmaceutical Agent; Pharmaceutical Industry; Pharmaceutical Preparations; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Phase; Physiologic Availability; Position; Positioning Attribute; Practice Guidelines; Process; Production; Property; Property, Loinc Axis 2; R & D; R&D; Recycling; Research; Research Personnel; Researchers; Solubility; Solutions; Solvents; Stream; Suction; System; System, Loinc Axis 4; Taste; Taste Perception; Technology; Testing; Translating; Translatings; Validation; Vitamin E; Water; Alimentary Tract; Base; Bioavailability Of Drug; Controlled Release; Cost; Design; Designing; Digestive Canal; Disease/Disorder; Drug Development; Drug/Agent; Experience; Failure; Flexibility; Fluid; Improved; In Vivo; Industry Partner; Innovate; Innovation; Innovative; Language Translation; Liquid; Meetings; Microcapsule; New Therapeutics; Next Generation Therapeutics; Novel; Novel Therapeutics; Particle; Pediatric; Physical Property; Product Development; Prototype; Public Health Relevance; Research And Development; Scale Up; Wasting

This overall goal of this project is to develop a scalable process for fabricating oil encapsulated particles with uniform sizes and physical characteristics that contain oil as a vehicle for delivering hydrophobic drugs. Poorly water soluble active pharmaceutical ingredients (APIs) represent 40% of all new chemical entities discovered by the pharmaceutical industry, but investigators often discard them in the R&D phase because their insolubility renders them difficult to formulate, which translates to low and/or variable bioavailability and effectiveness in vivo. Solubility problems also decrease the efficacy of a significant portion of products on the market, including many pain relievers and antibiotics. Our novel Precision Particle Fabrication (PPF) technology is a flexible, single-step process for fabricating oil-containing particles with finely tuned sizes and physicochemical characteristics that enable improved control over drug encapsulation and release. We hypothesize that a scaled version of this technology will produce dried, oil-filled microcapsules (size <100 5m) at a rate of at least 10 kg/min, more than adequate for industry needs. Phase I research will demonstrate the feasibility of scaling PPF technology for broad use by pharmaceutical companies. Our research team will develop several scaled prototypes of the existing PPF technology to meet a range of varying microcapsule specifications (Aim 1). We will also integrate the technology with current Good Manufacturing Practice guidelines given by the FDA (Aim 2) and design a monitoring mechanism and fluid recycling for the process to decrease material waste (Aim 3). Successful scaling of the PPF technology for drug delivery will improve the biological performance of existing pharmaceutical products and enable production of new therapeutic solutions using APIs previously discarded in the drug development process.

Public Health Relevance:
Development of effective delivery mechanisms for pharmaceutical products is just as important as the drugs themselves for treatment of disease. However, pharmaceutical companies have yet to discover a reliable, scalable process for consistently fabricating drug particles with controlled physical properties and release profiles. This project aims to test the feasibility of expanding a novel method for fabricating particles with well-defined and tunable properties from the laboratory setting to the broader marketplace by leveraging encapsulated oil as a delivery vehicle for poorly- soluble drugs.

Public Health Relevance Statement:
PROJECT NARRATIVE Development of effective delivery mechanisms for pharmaceutical products is just as important as the drugs themselves for treatment of disease. However, pharmaceutical companies have yet to discover a reliable, scalable process for consistently fabricating drug particles with controlled physical properties and release profiles. This project aims to test the feasibility of expanding a novel method for fabricating particles with well-defined and tunable properties from the laboratory setting to the broader marketplace by leveraging encapsulated oil as a delivery vehicle for poorly- soluble drugs.

Project Terms:
Alimentary Canal; alimentary tract; analgesia; Analgesic Agents; Analgesic Drugs; Analgesic Preparation; Analgesics; Anodynes; Antibiotic Agents; Antibiotic Drugs; Antibiotics; Antinociceptive Agents; Antinociceptive Drugs; Aspiration, Mechanical; base; Beds; Beverages; Bioavailability; bioavailability of drug; Biologic Availability; Biological; Biological Availability; Businesses; Characteristics; Chemicals; Childhood; controlled release; cost; design; designing; Development; Development and Research; digestive canal; Digestive Tract; Disease; disease/disorder; Disorder; Dose; Drainage, Suction; Drug Controls; Drug Delivery; Drug Delivery Systems; drug development; Drug Industry; Drug Targeting; Drug Targetings; drug/agent; Drugs; Effectiveness; Encapsulated; Equipment; experience; failure; Failure (biologic function); Filtration; flexibility; FLR; fluid; Fractionation, Filtration; Funding; Future; Gastrointestinal Tract; Gastrointestinal tract structure; Gel; GI Tract; Goals; Grant; Guidelines; Gustation; Health; Human; Human, General; Hydrogen Oxide; improved; in vivo; Industry; industry partner; Industry, Pharmaceutic; innovate; innovation; innovative; Investigators; Laboratories; language translation; liquid; Liquid substance; Man (Taxonomy); Man, Modern; Manufacturer; Manufacturer Name; Marketing; Masks; Mechanics; Medication; meetings; Methods; microcapsule; Microcapsules drug delivery system; Microencapsulations; Miscellaneous Antibiotic; Monitor; Morphology; new therapeutics; next generation therapeutics; novel; novel therapeutics; Nutrient; Oils; particle; Particle Size; Patients; pediatric; Performance; Pharmaceutic Preparations; Pharmaceutical Agent; Pharmaceutical Industry; Pharmaceutical Preparations; Pharmaceuticals; Pharmacologic Substance; Pharmacological Substance; Phase; physical property; Physiologic Availability; Position; Positioning Attribute; Practice Guidelines; Process; product development; Production; Property; Property, LOINC Axis 2; prototype; public health relevance; R & D; R&D; Recycling; Research; research and development; Research Personnel; Researchers; scale up; Solubility; Solutions; Solvents; Stream; Suction; System; System, LOINC Axis 4; Taste; Taste Perception; Technology; Testing; Translating; Translatings; Validation; Vitamin E; wasting; Water