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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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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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Bioavailability Enhancement: Drug Solubility Enhancement01:16

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Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...
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Factors Affecting Dissolution: Drug pKa, Lipophilicity and GI pH01:21

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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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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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Optimizing Particle Size of pH Modifiers Enhances Dissolution of Weakly Basic Drugs.

Kejia Wu1, Yupeng Feng1, Zherui Zhang1

  • 1Department of Pharmaceutics, School of Pharmacy, Shenyang Pharmaceutical University, 103 Wenhua Road, Shenyang , 110016, Liaoning, People's Republic of China.

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|April 17, 2026
PubMed
Summary
This summary is machine-generated.

Citric acid concentration enhances carvedilol dissolution, but its particle size effect is pH-dependent. Fine particles improve release at mid-pH, while coarse particles sustain release at high pH.

Keywords:
CarvedilolCitric acidPH microenvironmentParticle sizeWeakly alkaline drug

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems
  • Physical Chemistry

Background:

  • Carvedilol, a BCS Class II drug, exhibits pH-dependent solubility.
  • Understanding dissolution is crucial for optimizing drug formulation and bioavailability.
  • Citric acid is explored as a dissolution enhancer for weakly basic drugs.

Purpose of the Study:

  • To investigate the pH-dependent dissolution of carvedilol.
  • To examine the influence of citric acid concentration and particle size on carvedilol release.
  • To elucidate the role of microenvironmental pH modification in drug dissolution.

Main Methods:

  • Dissolution studies were performed across a simulated gastrointestinal pH range (1.2-7.8).
  • The effects of citric acid concentration (3% and 9%) and particle size (fine vs. coarse) were evaluated.
  • Microenvironmental pH was monitored to assess its impact on drug solubility.

Main Results:

  • Carvedilol solubility was high and unaffected by citric acid particle size at low pH (1.2-1.6).
  • Fine citric acid particles created an acidic microenvironment (pH 3.5±0.2) in the mid-pH range (3.8-6.5), enhancing carvedilol solubility and dissolution.
  • The particle size effect was less pronounced at higher citric acid concentrations and diminished at high pH (6.8-7.8).

Conclusions:

  • Citric acid concentration universally improved carvedilol dissolution.
  • The particle size of citric acid significantly impacts carvedilol release in a pH-dependent manner.
  • Coarse citric acid particles demonstrated a sustained release effect at higher pH values.