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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
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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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Levothyroxine Sodium Pentahydrate Tablets - Formulation Considerations.

Navpreet Kaur1, Raj Suryanarayanan1

  • 1Department of Pharmaceutics, College of Pharmacy, University of Minnesota-Twin Cities, 9-177 WDH, 308 Harvard Street Southeast, Minneapolis, MN 55455, United States.

Journal of Pharmaceutical Sciences
|August 13, 2021
PubMed
Summary
This summary is machine-generated.

Levothyroxine sodium pentahydrate recalls persist due to sub-potency. Problem excipients causing drug instability in tablets are linked to hygroscopicity and acidity, affecting drug form and assay accuracy.

Keywords:
Drug product stabilityExcipientsLevothyroxine sodiumTablets

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Stability
  • Formulation Development

Background:

  • Levothyroxine sodium pentahydrate tablets, marketed since 1955, face ongoing recalls for sub-potency.
  • Excipient properties, specifically hygroscopicity and microenvironmental acidity, are implicated in levothyroxine instability.
  • The drug's pentahydrate form can degrade to monohydrate or free acid, impacting efficacy.

Purpose of the Study:

  • To comprehensively review factors affecting levothyroxine sodium pentahydrate stability in solid oral dosage forms.
  • To identify 'problem excipients' contributing to drug instability.
  • To understand the influence of drug physical form on chemical stability and assay methods.

Main Methods:

  • Compilation and analysis of marketed levothyroxine formulation compositions.
  • Identification of excipient properties (hygroscopicity, acidity) linked to instability.
  • Review of drug degradation pathways (dehydration, salt disproportionation).

Main Results:

  • Hygroscopicity and microenvironmental acidity of excipients identified as key drivers of levothyroxine instability.
  • Degradation pathways include dehydration to levothyroxine sodium monohydrate and salt disproportionation to levothyroxine free acid.
  • The standard USP assay method (HPLC) is insensitive to these different physical drug forms.

Conclusions:

  • Excipient-induced instability is a significant issue for levothyroxine sodium pentahydrate solid dosage forms.
  • Understanding and controlling excipient properties are crucial for ensuring drug stability and potency.
  • Current USP assay methods may not accurately reflect the drug's actual physical state and potency in marketed products.