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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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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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Alternative drug dissolution methods include the rotating bottle, intrinsic dissolution test, peristalsis, and the Franz diffusion cell method. The rotating bottle method involves meticulously rotating tightly capped controlled-release beads in a temperature-controlled bath. Periodic decanting of samples allows for residue assay, followed by refilling with fresh medium and testing at various pH levels to emulate the gastrointestinal tract conditions.In contrast, the intrinsic dissolution test...
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Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry01:20

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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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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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Disintegrant Selection in Hydrophobic Tablet Formulations.

Sonja Bauhuber1, Gernot Warnke1, Alberto Berardi2

  • 1Technical Competence Center, JRS PHARMA GmbH & Co. KG, 73494 Rosenberg, Germany.

Journal of Pharmaceutical Sciences
|November 12, 2020
PubMed
Summary

Croscarmellose sodium (CCS) is the most effective disintegrant for hydrophobic tablets, ensuring rapid disintegration even after storage. Sodium starch glycolate (SSG) and crospovidone (XPVP) showed reduced performance, especially under stress conditions.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Formulation Science

Background:

  • Hydrophobic drugs often exhibit delayed tablet disintegration, impacting bioavailability.
  • Selecting appropriate disintegrants is crucial for overcoming formulation challenges in poorly soluble drugs.

Purpose of the Study:

  • To evaluate the efficacy of different disintegrants (sodium starch glycolate, croscarmellose sodium, crospovidone) in hydrophobic tablet formulations.
  • To assess the impact of storage conditions and compression force on tablet disintegration.

Main Methods:

  • Tablets were formulated with diluents, hydrogenated vegetable oil, and one of three disintegrants.
  • Disintegration times were measured immediately and after storage at 40°C and 75% RH.
  • Physical properties of pure disintegrants, including settling volume and liquid uptake, were analyzed.

Main Results:

  • Tablet disintegration was negatively affected by storage and increased compression force, particularly at low disintegrant concentrations (1%).
  • The performance order of disintegrants was croscarmellose sodium (CCS) > sodium starch glycolate (SSG) > crospovidone (XPVP).
  • Croscarmellose sodium demonstrated superior disintegration (≈3 min) compared to SSG (≈12 min) and XPVP (≈69 min) after two months of storage at 1% concentration and 20 kN compression.

Conclusions:

  • Croscarmellose sodium (CCS) is recommended for hydrophobic tablet formulations due to its consistent rapid disintegration across varying compression forces and storage conditions.
  • The reduced performance of crospovidone (XPVP) is attributed to its limited expansion and altered behavior upon storage.
  • Optimizing disintegrant selection is vital for ensuring the performance of challenging hydrophobic drug formulations.