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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
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Polymorphism and pseudopolymorphism of acyclovir.

Young Taek Sohn1, Sang Hee Kim

  • 1College of Pharmacy, Duksung Women's University, 419 Ssangmun-Dong, Dobong-Gu, Seoul 132-714, Korea. ytsohn@duksung.ac.kr

Archives of Pharmacal Research
|March 28, 2008
PubMed
Summary

Understanding acyclovir crystal forms is key. Form 1 showed the best dissolution, but Form 3 (hydrate) converted to Form 2 upon storage, impacting drug efficacy.

Area of Science:

  • Solid-state chemistry
  • Pharmaceutical sciences
  • Crystallography

Background:

  • Acyclovir is a vital antiviral medication.
  • Polymorphism significantly impacts drug bioavailability and stability.
  • Characterizing different acyclovir crystal forms is crucial for pharmaceutical development.

Purpose of the Study:

  • To isolate and characterize various crystal modifications of acyclovir.
  • To investigate the dissolution profiles of different acyclovir forms.
  • To assess the stability of acyclovir crystal forms under specific storage conditions.

Main Methods:

  • Recrystallization techniques were employed to isolate acyclovir crystal forms.
  • Powder X-ray diffractometry, differential scanning calorimetry, and thermogravimetric analysis were used for characterization.

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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism
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  • Dissolution studies were conducted in water at 37°C, and stability was assessed under low relative humidity (0% RH).

    • Main Results:

    • Four crystal modifications of acyclovir were identified, including a hydrate (Form 3) and an acetic acid solvate (Form 4).
    • Dissolution rates in water were highest for Form 1, followed by Form 2 and Form 3.
    • Acyclovir Form 3 transformed into Form 2 after 25 hours of storage at 0% RH and 20°C.

    Conclusions:

    • Different acyclovir crystal forms exhibit distinct physicochemical properties.
    • Form 1 demonstrates superior dissolution characteristics compared to Forms 2 and 3.
    • The stability of acyclovir Form 3 is compromised under low humidity, leading to transformation into Form 2, which has implications for formulation and storage.