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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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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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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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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Excipient variability and its impact on dosage form functionality.

Vivek S Dave1, Suprit D Saoji, Nishikant A Raut

  • 1St. John Fisher College, Wegmans School of Pharmacy, Rochester, New York, USA.

Journal of Pharmaceutical Sciences
|January 7, 2015
PubMed
Summary
This summary is machine-generated.

Pharmaceutical excipient variability, though unavoidable, can be minimized. Understanding and controlling these variations is crucial for ensuring drug product performance and quality.

Keywords:
Quality by design (QBD)excipientsformulationphysical characterizationphysicochemical propertiesprocess analytical technology (PAT)

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Pharmaceutical excipients are critical inactive ingredients in drug formulations.
  • Excipient variability, originating from various sources, can impact drug product performance.
  • Ensuring consistent excipient quality is vital for predictable drug delivery.

Purpose of the Study:

  • To highlight the significance of excipient variability in pharmaceutical formulations.
  • To emphasize the need for understanding how excipient properties affect critical quality attributes.
  • To introduce modern approaches for managing excipient variability.

Main Methods:

  • Review of excipient variability sources and their impact on drug products.
  • Discussion of advanced analytical techniques for excipient characterization.
  • Application of Quality-by-Design (QbD) principles and Process Analytical Technology (PAT).

Main Results:

  • Excipient variability can originate from raw material sourcing, manufacturing processes, and formulation steps.
  • Variations in excipient properties directly influence the functionality and performance of the final dosage form.
  • Modern analytical tools and QbD/PAT approaches aid in characterizing and controlling excipient variability.

Conclusions:

  • Minimizing and understanding excipient variability is essential for robust pharmaceutical manufacturing.
  • A risk-based approach, incorporating QbD and PAT, is recommended for excipient management.
  • Adherence to International Pharmaceutical Excipients Council (IPEC) guidelines supports the appropriate use of excipients.