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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

121
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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Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis00:59

Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis

47
Noncompartmental analyses offer an alternative method for describing drug pharmacokinetics without relying on a specific compartmental model. In this approach, the drug's pharmacokinetics are assumed to be linear, with the terminal phase log-linear. This assumption allows for simplified analysis and interpretation of the drug's behavior in the body.
One important characteristic of noncompartmental analyses is that drug exposure increases proportionally with increasing doses. This...
47
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry

177
Orally administered drugs primarily enter the systemic circulation via passive diffusion through the intestinal membranes. The drug's absorption is influenced by drug stability in the gastrointestinal GI tract, membrane permeability, the surface area available for absorption, luminal drug concentration, and residence time in the lumen. Drug permeability can be enhanced by adjusting the lipophilicity, polarity, or molecular size of the drug, promoting its passive transport across intestinal...
177
Methods for Studying Drug Absorption: In situ01:09

Methods for Studying Drug Absorption: In situ

206
In situ experiments, such as the Doluisio method and Single-Pass Perfusion technique, provide critical insights into drug uptake by simulating in vivo conditions for drug absorption.
The Doluisio method involves perfusing a prepared segment of a rat's small intestine with a solution of radiolabeled drug and a non-absorbable marker. This helps to differentiate between absorbed and non-absorbed drug concentrations. The intestinal segment is connected at both ends using tubing and syringes,...
206
Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches01:14

Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches

89
Drug disposition in the body is a complex process and can be studied using two major approaches: the model and the model-independent approaches.
The model approach uses mathematical models to describe changes in drug concentration over time. Pharmacokinetic models help characterize drug behavior in patients, predict drug concentration in the body fluids, calculate optimum dosage regimens, and evaluate the risk of toxicity. However, ensuring that the model fits the experimental data accurately...
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Noncompartmental Analysis: Miscellaneous Pharmacokinetic Parameters00:54

Noncompartmental Analysis: Miscellaneous Pharmacokinetic Parameters

65
The noncompartmental approach is a widely used method in pharmacokinetics to assess drugs' behaviors in the body. It considers several factors, including clearance, bioavailability, and total volume of distribution.
One key aspect of the noncompartmental approach is determining a drug's total clearance. This can be done by dividing the drug dose by the area under the concentration-time curve from zero to infinity. The area under the concentration-time curve represents the drug's...
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Related Experiment Video

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Nondestructive techniques for pharmaceutical drug product characterization.

Sarwar Beg1, Kailash Ahirwar2, Waleed H Almalki3

  • 1Department of Pharmaceutics, School of Pharmaceutical Education and Research, Jamia Hamdard, New Delhi 110062, India.

Drug Discovery Today
|November 23, 2024
PubMed
Summary

This review explores nondestructive analytical techniques for pharmaceutical quality control. These methods ensure product consistency and aid in identifying counterfeit drugs, aligning with modern regulatory standards.

Keywords:
Analytical characterizationCritical quality attributesNondestructive techniquesPharmaceutical qualitySpectroscopy

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Area of Science:

  • Pharmaceutical Science
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Pharmaceutical product development is complex, leading to variability in raw components, manufacturing, and environmental conditions.
  • Ensuring consistent batch-to-batch quality is challenging, with current end-product testing having limitations.
  • Intermediate quality checks are often restricted, necessitating advanced monitoring solutions.

Purpose of the Study:

  • To review modern regulatory perspectives on utilizing nondestructive tools for pharmaceutical quality monitoring.
  • To highlight the importance of in-line quality checks and real-time data in drug manufacturing.
  • To discuss the role of handheld devices in ensuring pharmaceutical product integrity.

Main Methods:

  • Review of current literature on nondestructive analytical techniques.
  • Discussion of terahertz, near-infrared, X-ray, and Raman spectroscopy applications.
  • Analysis of regulatory viewpoints on implementing these technologies.

Main Results:

  • Nondestructive techniques offer robust solutions for in-line quality assessment and real-time data acquisition.
  • Handheld devices utilizing these technologies are effective for identifying counterfeit pharmaceutical products.
  • The integration of these tools aligns with evolving regulatory expectations for pharmaceutical quality.

Conclusions:

  • Nondestructive analytical techniques are crucial for enhancing pharmaceutical quality control and ensuring product robustness.
  • Regulatory bodies are increasingly supportive of adopting advanced nondestructive tools in pharmaceutical manufacturing.
  • These technologies improve batch consistency, facilitate real-time monitoring, and combat drug counterfeiting.