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Related Experiment Videos

Amlodipine besylate-excipients interaction in solid dosage form.

A Abdoh1, M M Al-Omari, A A Badwan

  • 1The Jordanian Pharmaceutical Manufacturing Co., Naor, Jordan.

Pharmaceutical Development and Technology
|March 6, 2004
PubMed
Summary

Amlodipine besylate stability in solid formulations is crucial. Lactose and magnesium stearate can cause amlodipine besylate degradation, suggesting lactose-free formulations are recommended for improved quality and efficacy.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation
  • Chemical Stability

Background:

  • Amlodipine besylate is a widely used antihypertensive medication.
  • Understanding drug-excipient compatibility is essential for stable solid dosage forms.
  • Previous studies have highlighted potential interactions with common pharmaceutical ingredients.

Purpose of the Study:

  • To evaluate the compatibility of amlodipine besylate with various pharmaceutical excipients in solid formulations.
  • To identify factors influencing amlodipine besylate stability.
  • To recommend optimal formulation strategies based on stability data.

Main Methods:

  • High-performance liquid chromatography (HPLC) was employed to assess amlodipine besylate stability.
  • Binary (1:1) and multicomponent mixtures with excipients were subjected to stress conditions (65°C and 40°C/75% RH).

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  • HPLC coupled with mass spectrometry (HPLC-MS) was used to identify degradation products.

    • Main Results:

    • Amlodipine besylate demonstrated stability in binary mixtures with most excipients under tested conditions.
    • Mixtures containing lactose, magnesium stearate, and water induced significant instability.
    • Amlodipine besylate glycosyl was identified as the major degradation product, consistent with the Maillard reaction.

    Conclusions:

    • Lactose is a key excipient that can compromise amlodipine besylate stability due to the Maillard reaction.
    • Magnesium stearate and water also contribute to amlodipine besylate degradation.
    • Lactose-free amlodipine besylate formulations are recommended to ensure safety, quality, efficacy, and process efficiency.