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Developing a Parenteral Formulation of MetolazoneAward last edited on: 2/3/20
Sponsored Program
SBIRAwarding Agency
NIH : NIDDKTotal Award Amount
$158,460Award Phase
1Solicitation Topic Code
-----Principal Investigator
John C SombergCompany Information
Academic Pharmaceuticals Inc
21 Skokie Valley Road Suite G3
Lake Bluff, IL 60044
Lake Bluff, IL 60044
(847) 735-1170 |
N/A |
N/A |
Location: Single
Congr. District: 10
County: Lake
Congr. District: 10
County: Lake
Phase I
Contract Number: 1R43DK121641-01Start Date: 6/1/19 Completed: 5/31/20
Phase I year
2019Phase I Amount
$158,460Public Health Relevance Statement:
Project Narrative Metolazone orally is an effective diuretic in patients with severe edema, congestive heart failure and diuretic resistance to loop diuretics.(1,2,3,4) Diuretic resistance to loop diuretics occurs frequently with large doses administered to patients with severe HF. An IV formulation of metolazone would be useful to treat patients with severe heart failure, and patients with loop diuretic resistance. We had previously developed an IV formulation at pH 9.5 to 10, but the formulation was venous irritating, limiting its utility. A newly developed lipid emulsion formulation at pH 7.4, we believe, will be less phlebitic and effective in diuretic resistant states. The studies proposed aim to characterize the formulation and evaluate the diuretic effects, as well as demonstrating the lack of venous irritation (phlebitis), all requisite steps in the development of a viable product for both adult and pediatric populations.
Project Terms:
absorption; Adult; Animal Model; Animals; Blood; Canis familiaris; Childhood; Chronic; Clinical Research; comparative; Congestive Heart Failure; Development; Diuretics; Dose; Ear; Edema; efficacy study; Emulsions; Erythrocytes; Evaluation; Excretory function; FDA approved; Formulation; Furosemide; Grant; Heart failure; Hemolysis; Human Volunteers; In Vitro; Intravenous; irritation; Limb structure; Lipids; man; Measures; Metolazone; Modeling; Oral; Oryctolagus cuniculus; Output; Patients; Peripheral; Pharmaceutical Preparations; Pharmacology; Phlebitis; Population; Preparation; Quinazolines; Resistance; Site; Solubility; Sulfonamides; synergism; thiazide; Urine; Veins; Venous
Phase II
Contract Number: ----------Start Date: 00/00/00 Completed: 00/00/00