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Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

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Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Designing a dosage regimen, which refers to the manner of drug administration, is a complex process involving the selection of drug dose, route, and frequency. This process is underpinned by pharmacokinetic parameters derived from tests and population averages. These parameters are then tailored to patient-specific variables such as diagnosis, demographics, and allergy status. Once therapy commences, therapeutic response monitoring is critical and achieved through clinical and physical...
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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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Ecodesign approach for pharmaceutical packaging based on Life Cycle Assessment.

Fabiana Bassani1, Carla Rodrigues2, Pedro Marques2

  • 1University of Coimbra, ADAI, Department of Mechanical Engineering, Coimbra, Portugal; Federal Institute of Education, Science and Technology of Pará - IFPA, Conceição do Araguaia, Brazil.

The Science of the Total Environment
|November 11, 2021
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Summary

This study introduces a Life Cycle Assessment (LCA) approach for pharmaceutical packaging ecodesign. It offers recommendations to reduce environmental impact through material reduction and sustainable transportation.

Keywords:
BlisterBottleElectric vehiclesEnvironmental impactMedicineSachet

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Area of Science:

  • Environmental Science
  • Sustainable Packaging
  • Pharmaceutical Industry

Background:

  • Pharmaceutical packaging significantly impacts environmental performance.
  • Ecodesign strategies are crucial for mitigating these impacts.
  • Life Cycle Assessment (LCA) provides a robust framework for evaluating environmental footprints.

Purpose of the Study:

  • To present a novel ecodesign approach for pharmaceutical packaging based on LCA.
  • To assess opportunities for improving packaging environmental performance.
  • To provide actionable ecodesign recommendations for the pharmaceutical sector.

Main Methods:

  • Investigated representative pharmaceutical packaging (blister, bottle, sachet).
  • Applied LCA to evaluate ecodesign strategies: material reduction, alternative packaging, and transport optimization.
  • Modeled cradle-to-gate impacts, including transport to pharmacies, considering various production locations and transport modes.

Main Results:

  • Identified significant environmental impact reductions through material and volume optimization.
  • Highlighted the benefits of selecting lower-impact transportation modes and optimizing production locations.
  • Quantified environmental benefits of specific ecodesign solutions, such as reduced packaging size and empty space.

Conclusions:

  • The LCA-based ecodesign approach effectively quantifies environmental impacts across the pharmaceutical packaging lifecycle.
  • Ecodesign recommendations focus on material efficiency, sustainable logistics, and optimized distribution.
  • This methodology supports informed decision-making for enhancing the environmental performance of pharmaceutical packaging.