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[Not Available].

D W Holt1, A Johnston

  • 1Analytical Unit, St George's Hospital Medical School, London, England.

Biodrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
|March 1, 1997
PubMed
Summary
This summary is machine-generated.

A new cyclosporin formulation (Neoral®) offers improved oral bioavailability and reduced absorption variability compared to the original (Sandimmun®). This leads to more predictable drug exposure and potentially easier dosage stabilization in transplant patients.

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Area of Science:

  • Pharmacology and Drug Development
  • Transplantation Medicine
  • Immunosuppression Therapy

Background:

  • The original cyclosporin formulation (Sandimmun®) exhibits poor and highly variable oral bioavailability, impacting therapeutic efficacy.
  • Variability in cyclosporin absorption is linked to suboptimal treatment outcomes, even with trough concentration monitoring.

Purpose of the Study:

  • To evaluate a new cyclosporin formulation (Neoral®) designed to enhance oral bioavailability and minimize absorption variability.
  • To compare the pharmacokinetic profiles and clinical implications of the new formulation against the original.

Main Methods:

  • Comparative pharmacokinetic studies in healthy volunteers and transplant recipients (renal, liver).
  • Analysis of dose-linear kinetics, relative bioavailability, time to maximum concentration, and drug exposure (area under the concentration-time curve).

Related Experiment Videos

  • Long-term (over 1 year) clinical evaluation in renal transplant patients assessing dosage, stability, and toxicity.

    • Main Results:

    • The new formulation (Neoral®) demonstrated more dose-linear pharmacokinetics and consistently higher relative bioavailability.
    • Neoral® showed a shorter, more reproducible time to maximum concentration and a stronger correlation between trough levels and total drug exposure.
    • In renal transplant patients, Neoral® required 10-15% lower total doses for comparable or increased exposure, with easier dosage stabilization. Toxicity did not appear to be a significant issue, though closer monitoring during conversion is advised.

    Conclusions:

    • The new cyclosporin formulation (Neoral®) offers significant pharmacokinetic advantages, including improved and more predictable absorption.
    • These advantages extend to various transplant settings (renal, liver) and autoimmune indications, with particular benefits for liver transplant patients and those with cystic fibrosis.
    • While clinical efficacy gains are not definitively established, preliminary data suggest a trend towards reduced graft rejection. Pharmacokinetic improvements may allow for reduced monitoring frequency, but careful conversion is necessary.