SBIR-STTR Award

Topical Microparticle Delivery for Burn Pain Control
Award last edited on: 8/13/15

Sponsored Program
SBIR
Awarding Agency
NIH : NIGMS
Total Award Amount
$223,944
Award Phase
1
Solicitation Topic Code
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Principal Investigator
Joseph C Salamone

Company Information

Rochal Industries LLP

12000 Network Boulevard B200
San Antonio, TX 78249
   (210) 375-9349
   absalamone@aol.com
   www.rochalindustries.com
Location: Single
Congr. District: 20
County: Bexar

Phase I

Contract Number: 1R43GM114857-01
Start Date: 6/1/15    Completed: 11/30/15
Phase I year
2015
Phase I Amount
$223,944
There is a critical need for improved treatments for pain associated with burn injury. Pain control after burn injury is a major challenge from the initial point of care through rehabilitation. The overall objective of this project is to develop a easily-applied topical delivery system based on analgesic microparticles that can be used for treatment of pain associated with deep partial thickness burns. One of the critical barriers to progress is that current therapies are administered systemically with concomitant side effects in addition to often insufficient pain relief - no topical treatments are available to treat burn pain This new topical treatment approach is designed to target pain at the source, lowering usage of systemic opioids or other treatments, thus reducing unwanted side effects associated with the current systemic treatments and enhancing the effectiveness of burn pain relief. A key focus of this research is to determine which microparticle topical delivery system has the highest potential for burn pain relief. The application of peripherally-acting analgesics has been designed to provide effective, simple-to-use, easily and painlessly applied treatment of pain associated with burn injury. This topical microparticle delivery technology has the potential to lead to a marketable product and the proposed technology will improve current treatment methodologies for burn injury and pain. The first specific aim is to incorporate therapeutic agents into the topical delivery system. The second aim is to evaluate drug release characteristics ex vivo using a bioartificial dermis system. The third specific aim is to select th formulation for in vivo testing utilizing a team of clinical burn and scientific pain experts. The fourth specific aim is to evaluate the efficacy of the optimized delivery system in vivo using a rodent burn model. The resulting product is being designed to be a unique topical delivery system that can be used to painlessly apply analgesic treatment for burn pain. The impact of this research is to help the millions of victims, many of whom are children and wounded warriors, who have debilitating acute and chronic pain resulting from burns.

Public Health Relevance Statement:


Public Health Relevance:
Pain control is a major challenge from the initial point of care after burn injury through rehabilitation. Burn pain is the most difficult form of acute pain to tret due to extensive tissue damage combined with the invasive nature of standard burn medical care, as well as the resulting difficult chronic pain post-burn closure due to peripheral neuropathy. A topical treatment is critically needed to minimize the undesirable side effects associated with current systemic pain treatments and to better modulate burn pain at the source of injury.

Project Terms:
Acute Pain; Adverse effects; Affinity; Analgesics; Bandage; base; Burn injury; Burning Pain; Caring; Characteristics; Child; chronic pain; Clinical; commercial application; controlled release; Dermis; design; Drug Delivery Systems; Drug Formulations; Effectiveness; Encapsulated; Evaluation; Exhibits; Family; Future; Government; improved; in vivo; Industry; Injection of therapeutic agent; injured; Injury; innovation; Intravenous; Investigation; Ketoconazole; Lead; Liquid substance; Medical; Methodology; Modeling; Nature; Nerve; Nordihydroguaiaretic Acid; Opioid; Oral; Pain; Pain management; Pain Origin; Painless; Penetration; Peripheral Nervous System Diseases; Persons; Pharmaceutical Preparations; Phase; point of care; Polymers; Process; Property; public health relevance; receptor; Rehabilitation therapy; Research; Rodent; Rodent Model; Silicones; Site; Solutions; Solvents; Source; standard of care; Surface; Surface Tension; System; technological innovation; Technology; Testing; Therapeutic; Therapeutic Agents; Thick; Tissues; Topical application; Treatment Efficacy; Treatment Protocols; wound

Phase II

Contract Number: ----------
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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Phase II Amount
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