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Biphasic testosterone delivery profile observed with two different transdermal formulations

A Misra1, R Pal, S S Majumdar

  • 1National Institute of Immunology, Aruna Asaf Ali Marg, New Delhi, India. amit@nii.ernet.in

Pharmaceutical Research
|November 5, 1997
PubMed
Summary

Two novel testosterone (T) formulations were developed for pulsatile delivery. Both formulations demonstrated biphasic pharmacokinetics in animal models, indicating potential for controlled T release.

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Area of Science:

  • Pharmacology
  • Drug Delivery Systems
  • Endocrinology

Background:

  • Testosterone (T) exhibits biphasic pharmacokinetics and skin permeation.
  • Pulsatile T delivery requires advanced formulation strategies.

Purpose of the Study:

  • To develop and evaluate two distinct formulations for pulsatile testosterone delivery.
  • To assess the pharmacokinetic profiles of these formulations in animal models.

Main Methods:

  • Formulation 1: T/polymer blend solution in isopropanol, applied topically to form an in situ film.
  • Formulation 2: Adhesive-dispersion patch.
  • In vitro release studies using flow-through cell HPLC.
  • Pharmacokinetic evaluation in castrated Wistar rats and gonadotropin-releasing hormone-immunized bonnet monkeys.

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Main Results:

  • Both formulations produced biphasic serum concentration-time profiles in animal models.
  • Distinct "burst" and "sustained" release phases were observed.
  • The magnitude and timing of the two peaks varied between the formulations.

Conclusions:

  • Both tested formulations achieve biphasic testosterone pharmacokinetics in vivo.
  • The formulation approach significantly influences the pulsatile release characteristics.
  • These findings support the development of controlled testosterone release systems.