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Basic Salt Additives Modulate the Acidic Microenvironment Around In Situ Forming Implants.

Kelsey Hopkins1, Elizabeth Wakelin1, Natalie Romick1

  • 1Weldon School of Biomedical Engineering, Purdue University, Martin C. Jischke Hall (MJIS) Rm 3019, 206 S. Martin Jischke Drive, West Lafayette, IN, 47907, USA.

Annals of Biomedical Engineering
|December 1, 2022
PubMed
Summary
This summary is machine-generated.

Basic salts like magnesium carbonate and hydroxide can neutralize acidic conditions in in situ forming implants (ISFIs), improving protein drug stability and release. This enhances patient compliance and reduces healthcare costs.

Keywords:
Acidic microclimateAdditivesControlled releaseLong-acting injectableProtein releaseStabilization

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Area of Science:

  • Biomaterials Science
  • Drug Delivery Systems
  • Protein Therapeutics

Background:

  • Protein drugs require frequent injections due to poor oral bioavailability.
  • In situ forming implants (ISFIs) offer potential for reduced injection frequency and improved patient compliance.
  • Protein instability within ISFIs, caused by acidic microclimates, hinders biotherapeutic delivery.

Purpose of the Study:

  • To demonstrate the efficacy of basic salts in neutralizing ISFI acidification.
  • To evaluate the impact of basic salts on protein release and ISFI properties.
  • To improve protein stability and delivery of pH-sensitive biomolecules using ISFIs.

Main Methods:

  • Incorporation of basic salts (MgCO3, Mg(OH)2) into protein-releasing ISFIs.
  • Evaluation of pH, drug release, implant swelling, diffusivity, and erosion over 28 days.
  • Comparison of ISFIs with and without salt additives.

Main Results:

  • 3 wt% MgCO3 and Mg(OH)2 neutralized the acidic ISFI environment, maintaining pH around 6.5 compared to 3.7 without salts.
  • Salts increased initial solution uptake but delayed implant degradation and erosion.
  • Mg(OH)2 formulation showed improved drug release profile with reduced burst and increased slope.

Conclusions:

  • Basic salt additives effectively modulate the pH within ISFIs, enhancing protein stability.
  • This approach improves the capacity of ISFIs for delivering pH-sensitive biomolecules.
  • The developed platform offers a low-cost method to improve patient compliance and reduce healthcare burden.