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Related Concept Videos

Biopharmaceutical Factors Influencing Drug Product Design: Overview01:22

Biopharmaceutical Factors Influencing Drug Product Design: Overview

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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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Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

251
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...
251
Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems01:22

Bioavailability Enhancement: Determination and Conceptual Approaches in Overcoming Bioavailability Problems

42
Body:Bioavailability is a critical pharmacological concept that measures the extent and rate at which an active drug ingredient or therapeutic moiety enters the systemic circulation, remaining unchanged. It's a pivotal factor in determining a drug's efficacy and safety.The Biopharmaceutics Classification System (BCS) plays an essential role in drug development by categorizing drugs into four classes based on their solubility and permeability. This classification aids in understanding drug...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

63
As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Related Experiment Video

Updated: Nov 9, 2025

Process Optimization using High Throughput Automated Micro-Bioreactors in Chinese Hamster Ovary Cell Cultivation
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Particle engineering principles and technologies for pharmaceutical biologics.

Dongmei Cun1, Chengqian Zhang2, Hriday Bera1

  • 1Wuya College of Innovation, Shenyang Pharmaceutical University, Wenhua Road No. 103, 110016 Shenyang, China.

Advanced Drug Delivery Reviews
|April 12, 2021
PubMed
Summary

Pharmaceutical biologics are often injections due to poor oral absorption. Particle engineering technologies create nano- and microparticles to improve biologic drug delivery, stability, and patient compliance.

Keywords:
MicroparticlesNanoparticlesParticle engineeringParticulate delivery systemPharmaceutical biologics

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Area of Science:

  • Pharmaceutical Science
  • Biotechnology
  • Materials Science

Background:

  • The global market for pharmaceutical biologics has grown substantially.
  • Biologics are crucial in modern medicine, but often require injections due to low oral bioavailability.
  • Particulate delivery systems offer non-invasive administration and prolonged action for biologics.

Purpose of the Study:

  • To review particle engineering technologies for pharmaceutical biologics.
  • To discuss formulation and process parameters influencing critical quality attributes.
  • To present commercialized biologic products using particle engineering.

Main Methods:

  • Review of bottom-up particle engineering principles.
  • Analysis of formulation and process parameters.
  • Compilation of commercialized particulate biologic products.

Main Results:

  • Particle engineering enhances biologic stability, bioavailability, and patient compliance.
  • Various nano- and microparticle technologies are applicable to biologics.
  • Mathematical models can predict critical quality attributes.

Conclusions:

  • Particle engineering is vital for developing advanced biologic drug delivery systems.
  • Addressing challenges in particulate system development is key for future biologics.
  • Optimized particle design improves therapeutic outcomes and patient experience.