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Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

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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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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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Factors Influencing Drug Absorption: Physicochemical Parameters01:22

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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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Drug design is a dynamic field that involves discovering and developing new medications based on specific biological targets. This process heavily relies on structure-activity relationships (SAR) and quantitative structure-activity relationships (QSAR) to guide the design and optimization of efficient drugs.
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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).
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Optimizing paracetamol-ascorbic acid effervescent tablet characteristics: a quality by design approach  .

Nur Tasnim Adlina Mazdi1, Nur Aisyah Mior Mat Zin1, Muhammad Aiman Khairul Hisham1

  • 1Department of Pharmaceutical Technology, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Pahang, Malaysia.

Drug Development and Industrial Pharmacy
|April 20, 2025
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Summary

Optimized paracetamol-ascorbic acid effervescent tablets using Quality-by-Design. Key factors like binder concentration and granulation time were identified to improve tablet hardness, disintegration, and dissolution rates for better drug delivery.

Keywords:
Effervescent tabletsascorbic acidcritical quality attributesparacetamolquality-by-design

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Area of Science:

  • Pharmaceutical Sciences
  • Formulation Development
  • Quality by Design (QbD)

Background:

  • Effervescent tablets offer rapid drug release and improved bioavailability.
  • Optimizing formulation parameters is crucial for consistent product quality and performance.
  • Paracetamol-Ascorbic Acid (PCM-AA) combination requires careful formulation to ensure stability and efficacy.

Purpose of the Study:

  • To optimize paracetamol-ascorbic acid (PCM-AA) effervescent tablet characteristics using a Quality-by-Design (QbD) approach.
  • To investigate the impact of critical process parameters on tablet hardness, disintegration, and dissolution.
  • To establish an optimized formulation for PCM-AA effervescent tablets.

Main Methods:

  • Implementation of QbD principles, including identification of Critical Quality Attributes (CQAs) and Critical Material Attributes (CMAs).
  • Risk assessment using Ishikawa diagrams and risk estimation matrices.
  • Response Surface Methodology (RSM) with a Central Composite Design (CCD) to study the effects of binder concentration, granulation time, and effervescent agent ratio.
  • Characterization of optimized tablets for physical properties and drug content.

Main Results:

  • Identified binder concentration, granulation time, and effervescent agent ratio as key factors influencing tablet properties.
  • Achieved optimized tablets with acceptable hardness (45±20 N), disintegration (<5 min), and dissolution (<10 min) for both PCM and AA.
  • Validated the formulation model, showing no significant difference (p>0.05), confirming consistent results.

Conclusions:

  • The QbD approach successfully optimized PCM-AA effervescent tablets.
  • Granulation time, binder concentration, and effervescent agent ratio significantly impact tablet quality attributes.
  • This study provides a robust framework for the development and optimization of effervescent tablet formulations.