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Related Concept Videos

In Vitro Drug Dissolution: Compendial Testing Models I01:13

In Vitro Drug Dissolution: Compendial Testing Models I

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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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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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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Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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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Related Experiment Video

Updated: Nov 28, 2025

In situ Grazing Incidence Small Angle X-ray Scattering on Roll-To-Roll Coating of Organic Solar Cells with Laboratory X-ray Instrumentation
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Novel Coating Uniformity Models for Tablet Pan Coaters.

Michael Choi1, Stuart C Porter2, Betsy Macht3

  • 1PCTS, Inc., PCTS, Inc., 470 Boot Rd. #343, Downingtown, Pennsylvania, 19335, USA. michael.choi@particlecoating.com.

AAPS Pharmscitech
|November 26, 2020
PubMed
Summary
This summary is machine-generated.

New mathematical models predict tablet coating uniformity in batch and continuous pan coaters. These models offer accurate predictions for process optimization and manufacturing control.

Keywords:
acceptance valuecoating uniformitycontinuous manufacturingmanufacturing control strategyscale-up

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Area of Science:

  • Pharmaceutical Manufacturing
  • Process Engineering
  • Mathematical Modeling

Background:

  • Ensuring uniform tablet coatings is critical for drug efficacy and stability.
  • Existing models for predicting coating uniformity have limitations in scope or complexity.

Purpose of the Study:

  • To develop novel mathematical models for predicting inter-tablet coating uniformity.
  • To provide tools for analyzing and optimizing tablet coating processes in pan coaters.

Main Methods:

  • Developed models based on binomial coating spray and tablet movement distribution functions.
  • Incorporated tablet bed geometry into the model equations.
  • Validated model predictions against experimental data and existing models.

Main Results:

  • The developed models accurately predict coefficients of variation (CV) and acceptance values (AV).
  • Model results show good agreement with experimental data, empirical expressions, and complex computational models.
  • The models are applicable to both batch and continuous tablet pan coater operations.

Conclusions:

  • Novel mathematical models offer a robust and accessible method for predicting tablet coating uniformity.
  • These models are suitable for process analysis, optimization, scale-up, and manufacturing control.
  • The findings facilitate improved design and consistent manufacturing of coated tablets.