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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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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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Drug absorption within the gastrointestinal (GI) tract is a complex process influenced by several critical factors, including the site pH, the drug's dissociation constant (pKa), and the drug's lipophilicity. The GI tract exhibits a pH gradient, with an acidic environment in the stomach and a more alkaline environment in the small intestine. This pH variation directly affects the ionization state of drugs.
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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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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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Toward Biopredictive Dissolution for Enteric Coated Dosage Forms.

J Al-Gousous1, G L Amidon2, P Langguth1

  • 1Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz , Staudinger Weg 5, 55099 Mainz, Germany.

Molecular Pharmaceutics
|May 4, 2016
PubMed
Summary
This summary is machine-generated.

A novel phosphate buffer dissolution method accurately predicts enteric-coated drug release and pharmacokinetic performance, outperforming established USP and FaSSIF methods for improved biopredictivity.

Keywords:
IVIVCaspirinbiopredictive dissolutionenteric coatingpharmacokinetics

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Pharmacokinetics

Background:

  • Enteric-coated formulations require dissolution methods that accurately predict in vivo performance under fasted conditions.
  • Existing methods like USP and FaSSIF have limitations in predicting drug release profiles and pharmacokinetic parameters for these formulations.

Purpose of the Study:

  • To develop an improved phosphate buffer dissolution method for enteric-coated drugs.
  • To enhance biopredictivity for fasted conditions, focusing on lag time and drug release characteristics.
  • To compare the novel method's performance against USP and FaSSIF methods.

Main Methods:

  • Developed a phosphate buffer dissolution method incorporating a pH and molarity gradient.
  • Tested two enteric-coated aspirin products (Aspirin Protect, Walgreens Aspirin).
  • Compared dissolution profiles and convoluted them using GastroPlus for pharmacokinetic prediction, validated by a human volunteer study.

Main Results:

  • The novel method accurately predicted the lag time differences between the two aspirin formulations.
  • Both the new method and blank FaSSIF showed potential for predicting Cmax and AUC0-24 (within 20% error).
  • The new method demonstrated superior prediction of the Cmax/AUC0-24 ratio, outperforming USP and FaSSIF.

Conclusions:

  • The developed phosphate buffer dissolution method offers improved biopredictivity for enteric-coated formulations under fasted conditions.
  • The novel method accurately predicts the onset of drug release and relative performance of different formulations.
  • This method represents a significant advancement over existing dissolution testing protocols for regulatory applications.