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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

203
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.
203
Model Approaches for Pharmacokinetic Data: Compartment Models01:14

Model Approaches for Pharmacokinetic Data: Compartment Models

557
Compartmental analysis is a widely adopted approach to characterizing drug pharmacokinetics. It uses compartment models that conceptualize the body as a collection of reversibly communicating compartments, each representing a group of tissues exhibiting similar drug distribution characteristics. The movement rate of the drug between these compartments is typically described by first-order kinetics.
Two primary types of compartment models are recognized: mammillary and catenary. The more...
557
Model Approaches for Pharmacokinetic Data: Physiological Models01:15

Model Approaches for Pharmacokinetic Data: Physiological Models

274
Physiological models in pharmacokinetics are instrumental in understanding the distribution and elimination of drugs within the body. These models describe the drug concentration within target organs, influenced by factors such as drug uptake, tissue volume, and blood flow. Drug uptake is governed by the partition coefficient, which signifies the drug concentration ratio in tissue to that in the blood. The blood flow rate to a specific tissue is expressed as Qt, and the rate of change in tissue...
274
Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis00:59

Model-Independent Approaches for Pharmacokinetic Data: Noncompartmental Analysis

329
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...
329
Model Approaches for Pharmacokinetic Data: Distributed Parameter Models01:06

Model Approaches for Pharmacokinetic Data: Distributed Parameter Models

250
Pharmacokinetic models are mathematical constructs that represent and predict the time course of drug concentrations in the body, providing meaningful pharmacokinetic parameters. These models are categorized into compartment, physiological, and distributed parameter models.
The distributed parameter models are specifically designed to account for variations and differences in some drug classes. This model is particularly useful for assessing regional concentrations of anticancer or...
250
Analysis Methods of Pharmacokinetic Data: Model and Model-Independent Approaches01:14

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

537
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...
537

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Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface
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A big data approach to pharmaceutical flow properties.

Andrew J Megarry1, Sadie M E Swainson2, Ron J Roberts3

  • 1Pharmaceutical Technology and Development, AstraZeneca, Pepparedsleden 1, Mölndal SE-431 83, Sweden.

International Journal of Pharmaceutics
|November 25, 2018
PubMed
Summary

Pharmaceutical materials

Keywords:
Formulation designOral solid dosage formsPowder flowProcess developmentShear cell

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Area of Science:

  • Pharmaceutical sciences
  • Materials science
  • Chemical engineering

Background:

  • Flowability is critical for oral solid dosage form development.
  • Limited literature exists on typical pharmaceutical material flow properties.
  • Understanding flow is essential for process optimization and product quality.

Purpose of the Study:

  • To analyze historical shear cell data to understand pharmaceutical material flow properties.
  • To establish typical flow characteristics for different material types (APIs, excipients, blends, granules).
  • To develop a process flow map for guiding future formulation development.

Main Methods:

  • Analysis of 3909 experiments from a shear cell apparatus.
  • Extraction and evaluation of historical data spanning nearly a decade.
  • Categorization of data by material type: Active Pharmaceutical Ingredients (APIs), excipients, blends, and granules.

Main Results:

  • Active Pharmaceutical Ingredients (APIs) exhibit poor flow properties (flow consistency index, ffc <2).
  • Excipients, blends, and granules generally demonstrate good flowability.
  • A process flow map was created by correlating material flow data with process parameters and drug load.

Conclusions:

  • This study enhances the understanding of typical pharmaceutical material flow properties.
  • The findings provide a basis for predicting and managing flow behavior in formulation development.
  • The developed process flow map aids in optimizing development strategies and focusing future research efforts.