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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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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Factors Influencing Drug Absorption: Drug Dissolution01:27

Factors Influencing Drug Absorption: Drug Dissolution

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The pharmacokinetic journey of drugs from solid oral dosage forms into systemic circulation is multifaceted. It begins with disintegration, a prerequisite ensuring a solid dosage form's subdivision into minute particles. Dissolution occurs next as these granulated entities solubilize in gastrointestinal fluids. This solubilization is crucial for the succeeding stage, permeation, which describes the traversal of the drug across the intestinal membrane and its subsequent entry into the blood...
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Bioequivalence: Overview01:16

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism

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Polymorphism refers to the existence of a drug substance in multiple crystalline forms, known as polymorphs. Recently, this term has been expanded to include solvates (forms containing a solvent), amorphous forms (non-crystalline forms), and desolvated solvates (forms from which the solvent has been removed).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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Factors Influencing Drug Absorption: Physicochemical Parameters01:22

Factors Influencing Drug Absorption: Physicochemical Parameters

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The physicochemical characteristics of drugs play a crucial role in formulating stable and bioavailable drug products. The solubility of a drug, governed by the varying pH along the GI tract and its dissociation constant (pKa), is pivotal in determining its ionization state and absorption rate. Notably, weak acids and bases remain unionized and are absorbed more rapidly.
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Batch vs. continuous direct compression - a comparison of material processability and final tablet quality.

B Bekaert1, P H M Janssen2,3, S Fathollahi3

  • 1Laboratory of Pharmaceutical Technology, Department of Pharmaceutics, Ghent University, Ottergemsesteenweg 460, B-9000 Ghent, Belgium.

International Journal of Pharmaceutics: X
|January 18, 2024
PubMed
Summary
This summary is machine-generated.

This study compared batch and continuous direct compression, finding flow dynamics significantly impact tablet quality consistency. While continuous processing showed less variability, batch processing offered more consistent active pharmaceutical ingredient (API) concentration.

Keywords:
Continuous manufacturingDirect compressionExcipientsLactoseMaterial scineceMultivariate analysisRaw material characterization

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Area of Science:

  • Pharmaceutical Technology
  • Chemical Engineering
  • Materials Science

Background:

  • Direct compression is a key pharmaceutical manufacturing process.
  • Batch and continuous manufacturing offer distinct operational characteristics.
  • Understanding process-property relationships is crucial for tablet quality.

Purpose of the Study:

  • To conduct an in-depth comparison of batch versus continuous direct compression.
  • To evaluate material processability and final tablet quality.
  • To correlate material properties, process parameters, and tablet outcomes.

Main Methods:

  • Utilized similar compression setups for both batch and continuous direct compression.
  • Processed 20 formulations (10 low-dosed, 10 high-dosed) with 10 different fillers/combinations.
  • Employed multivariate data analyses to establish correlations.

Main Results:

  • Filler type, drug load, and process settings had similar impacts on both batch and continuous processes.
  • Flow dynamics (flow, compressibility, permeability) were key differentiators.
  • Continuous processing exhibited lower variability in tablet press (σCF) and quality (σMass, σTS) compared to batch.

Conclusions:

  • Flow dynamics are critical for differentiating batch and continuous direct compression outcomes.
  • Batch processing demonstrated superior active pharmaceutical ingredient (API) concentration consistency due to controlled blending.
  • Selecting appropriate excipients and process settings is vital for achieving desired outcomes in direct compression manufacturing.