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Related Concept Videos

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Preclinical challenges for developing long acting intravitreal medicines.

Sahar Awwad1, Christin Henein1, Nkiruka Ibeanu1

  • 1UCL School of Pharmacy, 29-39 Brunswick Square, London WC1N 1AX, United Kingdom; National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London EC1V 9EL, United Kingdom.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|May 24, 2020
PubMed
Summary

Developing longer-acting intraocular therapies requires understanding vitreous physiology. In vitro models can accelerate preclinical development, improving long-acting intravitreal medicines for retinal diseases.

Keywords:
Drug deliveryIntravitrealOcularPharmacokineticsPosterior segmentVitreous

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Area of Science:

  • Ophthalmology and Pharmaceutical Sciences
  • Drug Delivery and Preclinical Development

Background:

  • Intravitreal injections revolutionized treatment for chronic retinal diseases like wet age-related macular degeneration (wAMD), diabetic retinopathy (DR), and choroidal neovascularization (CNV).
  • Current intravitreal injection protocols necessitate frequent administration, highlighting the need for longer-acting intraocular therapies.
  • Preclinical development of intraocular medicines heavily relies on animal models, which present significant limitations in predicting human ocular responses.

Purpose of the Study:

  • To address the limitations of animal models in developing longer-acting intraocular formulations.
  • To emphasize the importance of understanding vitreous physiology for effective preclinical development strategies.
  • To explore the potential of in vitro models for accelerating the optimization of long-acting intravitreal medicines.

Main Methods:

  • Review of current preclinical strategies for intraocular medicine development, including reliance on animal models.
  • Analysis of anatomical and physiological differences between animal and human eyes impacting drug translation.
  • Proposal for utilizing in vitro models analogous to those used for other administration routes to develop in vitro-in vivo correlations (IVIVCs).

Main Results:

  • Animal models inadequately represent human ocular physiology, leading to challenges in translating preclinical data for long-acting protein formulations.
  • Preclinical strategies often fail to account for vitreous changes due to aging or vitrectomy.
  • In vitro models, incorporating intraocular mass transfer, can estimate pharmacokinetic profiles and accelerate formulation optimization.

Conclusions:

  • A comprehensive understanding of physiological, pharmaceutical, and regulatory factors is crucial for developing effective long-acting intravitreal medicines.
  • In vitro models offer a promising approach to accelerate preclinical development and establish in vitro-in vivo correlations (IVIVCs).
  • Advancements in this field are establishing long-acting intravitreal medicines as a distinct and evolving pharmaceutical discipline.