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Related Concept Videos

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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In Vitro Drug Dissolution: Compendial Testing Models I01:13

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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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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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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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In Vitro Drug Dissolution: Alternative Methods01:17

In Vitro Drug Dissolution: Alternative Methods

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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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In Vitro Drug Dissolution: Compendial Testing Models II01:09

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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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A critical review on tablet disintegration.

Julian Quodbach1, Peter Kleinebudde1

  • 1a Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University , Duesseldorf , Germany.

Pharmaceutical Development and Technology
|May 16, 2015
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Tablet disintegrants, crucial for drug release, primarily act via swelling and shape recovery. Understanding these mechanisms and influencing factors is key for optimizing tablet formulations.

Keywords:
Disintegration mechanismsdisintegrantsexcipientsmanufacturing techniquessuperdisintegrants

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Tablet disintegration significantly impacts drug release kinetics.
  • Tablet disintegrants are excipients that modify disintegration, acting through various mechanisms.
  • Disintegrant efficacy is influenced by multiple factors, including formulation and processing.

Purpose of the Study:

  • To critically review existing literature on tablet disintegration.
  • To discuss potential disintegration mechanisms based on experimental evidence.
  • To analyze factors impacting the tablet disintegration process.

Main Methods:

  • Comprehensive literature search of Scopus and Web of Science databases.
  • Inclusion of keywords such as 'tablet disintegration', 'superdisintegrants', and 'disintegration mechanisms'.
  • Screening of references from identified publications.

Main Results:

  • Experimental data confirms swelling and shape recovery as primary disintegrant mechanisms.
  • The presence of other tablet excipients influences disintegration.
  • Manufacturing techniques significantly affect the disintegration process.

Conclusions:

  • Current knowledge on tablet disintegration is fragmented due to diverse methodologies.
  • A need exists for broader, systematic approaches to consolidate and advance research.
  • Standardized research methods are required for future investigations.