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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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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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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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 pharmacologically...
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PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
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Pelletization processes for pharmaceutical applications: a patent review.

Stavros N Politis1, Dimitrios M Rekkas

  • 1Faculty of Pharmacy, Dept. of Pharmaceutical Technology, University of Athens, Panepistimiopolis Zografou, Athens, Greece.

Recent Patents on Drug Delivery & Formulation
|December 15, 2010
PubMed
Summary

This review highlights innovations in pharmaceutical pelletization processes and their novel applications. It focuses on recent literature and patents, showcasing pellets as versatile drug delivery systems.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Materials Science

Background:

  • Pellets are a highly advantageous dosage form in pharmaceuticals.
  • Numerous processes and materials enable versatile pellet configurations.
  • Pellets offer flexibility and adaptability as drug delivery systems.

Purpose of the Study:

  • To review recent literature on pelletization processes for pharmaceutical applications.
  • To focus on awarded and pending patents in pelletization technology.
  • To explore innovations and novel applications of pharmaceutical pellets.

Main Methods:

  • Literature review of scientific publications.
  • Patent analysis of awarded and pending intellectual property.
  • Categorization of pelletization innovations.
  • Evaluation of novel pellet applications.

Main Results:

  • Overview of recent innovations in pelletization processes.
  • Identification of key patented technologies in pellet manufacturing.
  • Summary of emerging and novel applications for pharmaceutical pellets.
  • Demonstration of the versatility and configurability of pellet technology.

Conclusions:

  • Pelletization processes continue to evolve with significant innovation.
  • Patents reflect ongoing advancements in pellet technology.
  • Novel applications are expanding the utility of pellets in drug delivery.
  • Pellets remain a crucial and adaptable dosage form in pharmaceutical development.