Distribution, Metabolism, and Excretion of a Novel Surface‐Active Agent, Purified Poloxamer 188, in Rats, Dogs, and Humans

Grindel, J M; Jaworski, Ted; Piraner, Olga; Emanuele, Rossella; Balasubramanian, M

doi:10.1002/jps.10190

Cited by 103 publications

(7 citation statements)

References 14 publications

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“…Several previous experimental studies have shown that bone wax inhibits bone healing and induces inflammation [3-5,10]. Similar findings in human studies have been reported but mostly as case reports and retrospective studies [2,6,13].…”

Section: Discussionsupporting

confidence: 76%

“…Ostene ® is used in the same way as bone wax to immediately ensure hemostasis by sticking to the bone surface and thus creating a physical barrier. The biocompatible polymers used in Ostene ® have been shown to be eliminated from the body and remain unchanged through renal clearance [10]. The properties of Ostene ® are claimed to mimic the ideal hemostatic properties of bone wax while avoiding the inherent risks of infection and impaired bone healing associated with the use of traditional bone wax.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Bone healing after median sternotomy: A comparison of two hemostatic devices

Vestergaard

Jensen

Vind-Kezunovic

et al. 2010

J Cardiothorac Surg

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BackgroundBone wax is traditionally used as part of surgical procedures to prevent bleeding from exposed spongy bone. It is an effective hemostatic device which creates a physical barrier. Unfortunately it interferes with subsequent bone healing and increases the risk of infection in experimental studies. Recently, a water-soluble, synthetic, hemostatic compound (Ostene®) was introduced to serve the same purpose as bone wax without hampering bone healing. This study aims to compare sternal healing after application of either bone wax or Ostene®.MethodsTwenty-four pigs were randomized into one of three treatment groups: Ostene®, bone wax or no hemostatic treatment (control). Each animal was subjected to midline sternotomy. Either Ostene® or bone wax was applied to the spongy bone surfaces until local hemostasis was ensured. The control group received no hemostatic treatment. The wound was left open for 60 min before closing to simulate conditions alike those of cardiac surgery. All sterni were harvested 6 weeks after intervention.Bone density and the area of the bone defect were determined with peripheral quantitative CT-scanning; bone healing was displayed with plain X-ray and chronic inflammation was histologically assessed.ResultsBoth CT-scanning and plain X-ray disclosed that bone healing was significantly impaired in the bone wax group (p < 0.01) compared with the other two groups, and the former group had significantly more chronic inflammation (p < 0.01) than the two latter.ConclusionBone wax inhibits bone healing and induces chronic inflammation in a porcine model. Ostene® treated animals displayed bone healing characteristics and inflammatory reactions similar to those of the control group without application of a hemostatic agent.

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Section: Discussionsupporting

confidence: 76%

Section: Introductionmentioning

confidence: 99%

Bone healing after median sternotomy: A comparison of two hemostatic devices

Vestergaard

Jensen

Vind-Kezunovic

et al. 2010

J Cardiothorac Surg

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“…As previously confirmed by other authors, the dissolution of the hydrogel occurs constantly and rapidly, that is, virtually 100% after 24 h [ 48 ]. This result is probably due to the high solubility of P407 in aqueous media and this is important for the design of an in situ gelling formulation because the dissolution properties modulate the drug leakage at the administration site [ 83 ]. Again, neither the rutin nor the ethanol influenced the dissolution rate of the P407-hydrogels ( Figure 9 and Figure 10 ).…”

Section: Resultsmentioning

confidence: 99%

Rutin-Loaded Poloxamer 407-Based Hydrogels for In Situ Administration: Stability Profiles and Rheological Properties

et al. 2020

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Rutin is a flavone glycoside contained in many plants, and exhibits antioxidant, anti-inflammatory, anticancer, and wound-healing properties. The main disadvantage related to the use of this molecule for pharmaceutical application is its poor bioavailability, due to its low solubility in aqueous media. Poloxamer 407-hydrogels show interesting thermo-sensitive properties that make them attractive candidates as pharmaceutical formulations. The hydrophobic domains in the chemical structure of the copolymer, a polymer made up of two or more monomer species, are useful for retaining poorly water-soluble compounds. In this investigation various poloxamer 407-based hydrogels containing rutin were developed and characterized as a function of the drug concentration. In detail, the Turbiscan stability index, the micro- and dynamic rheological profiles and in vitro drug release were investigated and discussed. Rutin (either as a free powder or solubilized in ethanol) did not modify the stability or the rheological properties of these poloxamer 407-based hydrogels. The drug leakage was constant and prolonged for up to 72 h. The formulations described are expected to represent suitable systems for the in situ application of the bioactive as a consequence of their peculiar versatility.

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“…P188 was first approved by the Food and Drug Administration as an anti-viscosity agent added to blood and has been previously tested in clinical trials for sickle cell anemia and MI 81, 103, 104, 105, 106, 107, 108, 109, 110. The pharmacokinetic profile of P188 in healthy males has been obtained in a cohort of volunteers, and it has been determined that elimination occurs primarily through renal clearance 111, 112. The formulation of P188 purified from small molecular weight impurities is well tolerated (113).…”

Section: Block Copolymers: First-in-class Synthetic Muscle Membrane Smentioning

confidence: 99%

Cardiac Muscle Membrane Stabilization in Myocardial Reperfusion Injury

Houang

Bartos

Hackel

et al. 2019

JACC: Basic to Translational Science

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Highlights In myocardial ischemia, the integrity of the cardiac sarcolemma is severely stressed in the critical earliest moments upon reperfusion. Bolstering sarcolemma integrity improves myocyte survival. This review focuses on cardiac sarcolemma stability and its role as a therapeutic target in ischemia-reperfusion injury. Synthetic block copolymers have been shown to interface with the muscle membrane to confer membrane stabilization during stress. Integrated multidisciplinary research teams, spanning cardiology, physiology, chemistry, and chemical engineering are essential to guide future mechanistic and translational studies of novel chemical-based membrane stabilizers for preserving viable heart muscle during ischemia-reperfusion injury in human patients.

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Distribution, Metabolism, and Excretion of a Novel Surface‐Active Agent, Purified Poloxamer 188, in Rats, Dogs, and Humans

Cited by 103 publications

References 14 publications

Bone healing after median sternotomy: A comparison of two hemostatic devices

Bone healing after median sternotomy: A comparison of two hemostatic devices

Rutin-Loaded Poloxamer 407-Based Hydrogels for In Situ Administration: Stability Profiles and Rheological Properties

Cardiac Muscle Membrane Stabilization in Myocardial Reperfusion Injury

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