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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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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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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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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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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...
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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...
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Formation of Dispersible Taohong Siwu Tablets
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Predictive Approach to Understand and Eliminate Tablet Breakage During Film Coating.

William R Ketterhagen1, Jeffery Larson2, Kevin Spence3

  • 1Drug Product Development, AbbVie Inc., R4SW, Bldg. AP31-4, 1 N Waukegan Road, North Chicago, Illinois, 60064, USA. bill.ketterhagen@abbvie.com.

AAPS Pharmscitech
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Summary

This study introduces a hybrid approach combining discrete element method (DEM) modeling and experiments to predict and prevent pharmaceutical tablet breakage during coating. The method helps optimize coating processes and equipment to reduce tablet damage.

Keywords:
discrete element methodfilm coatingpredictive approachtablet breakage

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Area of Science:

  • Pharmaceutical manufacturing
  • Mechanical engineering
  • Computational modeling

Background:

  • Pharmaceutical tablets risk damage like chipping and fracture during coating.
  • Process parameters, equipment design, and tablet characteristics influence damage severity.

Purpose of the Study:

  • To develop a predictive approach for identifying conditions causing tablet breakage during coating.
  • To virtually test modifications for mitigating tablet fracture in coating processes.

Main Methods:

  • Utilized a hybrid predictive approach integrating discrete element method (DEM) modeling.
  • Conducted lab-based tablet impact experiments to validate models.
  • Employed in silico analysis to explore equipment and process condition modifications.

Main Results:

  • Successfully identified conditions leading to tablet breakage events.
  • Demonstrated the ability to virtually test and propose modifications to coating equipment and processes.
  • Validated the predictive approach for understanding and mitigating tablet damage.

Conclusions:

  • The hybrid DEM and experimental approach enhances understanding of tablet coating processes.
  • It enables the identification of optimal process conditions to minimize tablet breakage.
  • This method de-risks future tablet coating batch manufacturing by predicting and preventing damage.