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Poly-Lactic Acid-Based Biopolymer Formulations Are Safe for Sustained Intratympanic Dexamethasone Delivery.

Francis Rousset1,2, Vivianne Beatrix Christina Kokje2, Marta Da Costa Coelho1,2

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A novel biodegradable HexPLA vehicle offers sustained intratympanic delivery of dexamethasone, improving treatment for sudden sensorineural hearing loss. This HexPLA drug delivery system demonstrates safety and efficacy in animal models.

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Area of Science:

  • Otolaryngology
  • Biomaterials Science
  • Pharmacology

Background:

  • Sudden sensorineural hearing loss (SSNHL) treatment relies on steroids, but systemic side effects and rapid drug clearance limit efficacy.
  • Intratympanic injections bypass the blood-cochlear barrier, reducing systemic exposure.
  • Existing slow-release carriers have suboptimal properties, necessitating improved drug delivery vehicles.

Purpose of the Study:

  • To evaluate the safety and efficacy of a novel hexyl-substituted-poly-lactic-acid (HexPLA) vehicle for sustained intratympanic dexamethasone delivery.
  • To assess the long-term residence time, biocompatibility, and drug levels in perilymph.
  • To investigate the impact on hearing thresholds and middle ear morphology.

Main Methods:

  • A guinea pig model of SSNHL was used, with animals receiving intratympanic injections of HexPLA vehicle, 5% dexamethasone-HexPLA, 5% dexamethasone suspension, or sham operations.
  • Vehicle residence time, biocompatibility, hearing thresholds (click and pure-tone), and perilymph dexamethasone levels were prospectively assessed.
  • Morphological changes in the middle ear and functional hearing were monitored up to 3 months post-injection.

Main Results:

  • HexPLA vehicle was present in the middle ear at 1 week post-injection.
  • Perilymph dexamethasone levels were significantly higher and sustained longer with 5% dexamethasone-HexPLA compared to dexamethasone suspension.
  • No significant adverse morphological or functional changes were observed up to 3 months, indicating good biocompatibility.

Conclusions:

  • Hexyl-substituted-poly-lactic-acid (HexPLA) is a safe, biocompatible, and effective vehicle for sustained high-dose intratympanic dexamethasone delivery for at least 1 week.
  • This HexPLA vehicle holds significant promise for treating SSNHL and other acute inner ear diseases.
  • The favorable properties of HexPLA allow for the loading of various drugs, expanding its potential for otological applications.