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Related Concept Videos

Drug Product Stability01:16

Drug Product Stability

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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Bioavailability Enhancement: Drug Stability Enhancement and GI Retention01:05

Bioavailability Enhancement: Drug Stability Enhancement and GI Retention

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Body:Improving a drug's stability in the gastrointestinal (GI) tract is paramount for enhancing its bioavailability and therapeutic effectiveness. Various strategies are employed to protect the drug from the harsh gastric milieu and to ensure its release and absorption at the desired site within the GI tract.Polymer coatings are one such method used to shield drugs from the stomach's acidic environment. By preventing premature drug release, these coatings improve the bioavailability of unstable...
193
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

397
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinically Relevant Drug Product Specifications: Methods of Establishment01:29

Clinically Relevant Drug Product Specifications: Methods of Establishment

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Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
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Novel Production Protocol for Small-scale Manufacture of Probiotic Fermented Foods
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Probiotic Development Strategy Centered on Stability and Regulatory Considerations.

Hye Kim1, Ariful Haque1, Abdur Razzak1

  • 1Department of Food Science and Technology, Texas A&M University, College Station, Texas, USA.

Comprehensive Reviews in Food Science and Food Safety
|January 6, 2026
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Developing effective probiotics requires bridging lab findings with industrial needs. Standardized evaluation and regulatory harmonization are key for commercializing next-generation probiotics safely and efficiently.

Keywords:
microencapsulationprobioticsregulatory frameworksstabilitystrain development

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Area of Science:

  • Microbiology and Biotechnology
  • Food Science and Technology
  • Regulatory Science

Background:

  • Probiotic strain development faces challenges in translating laboratory efficacy to industrial-scale stability and performance.
  • Consumer demand and health benefits drive significant academic and industrial research in probiotics.
  • A gap exists between demonstrated functional outcomes and the requirements for commercialization, hindering market entry.

Purpose of the Study:

  • To critically review the probiotic development pipeline, from strain screening to regulatory frameworks.
  • To examine the impact of production stressors on probiotic strain viability and the effectiveness of resilience-enhancing strategies.
  • To compare global regulatory systems and highlight the need for harmonized evaluation frameworks.

Main Methods:

  • Literature review of studies on probiotic strain screening and resilience strategies.
  • Analysis of production stressors (heat, oxygen, digestion) on strain viability.
  • Comparative analysis of regulatory frameworks in the US, EU, Japan, Korea, and China.

Main Results:

  • Adaptive strategies like heat shock and microencapsulation show variable improvements in strain survival (up to 31-fold and 100-fold, respectively), highlighting strain specificity and reproducibility issues.
  • Production stressors significantly impact probiotic viability, necessitating targeted resilience strategies.
  • Heterogeneity in global regulations for classification, safety, and functional substantiation complicates international market access.

Conclusions:

  • Harmonized evaluation frameworks integrating scientific validation, industrial performance, and regulatory compliance are crucial for developing next-generation probiotics.
  • Sustained collaboration among academia, industry, and regulatory bodies is essential for balanced progress in probiotic efficacy, safety, scalability, and economic feasibility.
  • Standardized approaches are needed to overcome the commercialization gap for probiotics.