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In Vitro Drug Dissolution: Compendial Testing Models I01:13

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Compendial dissolution methods are standardized procedures defined by pharmacopeias to evaluate the rate at which a drug dissolves in a specific medium. These methods ensure batch-to-batch consistency, enable quality control, and support the prediction of drug bioavailability. They are critical for both immediate and modified-release drug products.The apparatuses used for dissolution testing differ in their design and mechanical function, but all aim to simulate the physiological environment of...
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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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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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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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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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Solventless amorphization and pelletization using a high shear granulator. Part I; feasibility study using

Keita Kondo1, Thomas Rades2

  • 1Department of Pharmacy, University of Copenhagen, Universitetsparken, 2, Copenhagen 2100, Denmark; Faculty of Pharmacy, Meijo University, 150, Yagotoyama, Tempaku-ku, Nagoya 468-8503, Japan.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|November 18, 2022
PubMed
Summary

This study demonstrates a solventless method for creating amorphous drug pellets using high shear granulation. This technique enhances drug dissolution rates and offers a feasible alternative to traditional solvent-based processes.

Keywords:
Amorphous drug-layered pelletsDrug pelletizationHigh shear granulatorIndomethacinMicrocrystalline cellulose spheresSolventless amorphization

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Area of Science:

  • Pharmaceutical Technology
  • Materials Science

Background:

  • Solvent-based methods for amorphous drug formulation are common but pose environmental and safety concerns.
  • Developing solventless techniques is crucial for sustainable pharmaceutical manufacturing.

Purpose of the Study:

  • To investigate the feasibility of solventless amorphization and pelletization using a high shear granulator.
  • To produce amorphous drug-layered pellets from drug crystals and inactive spheres without solvents or heating.

Main Methods:

  • Indomethacin crystals were mixed with microcrystalline cellulose spheres (1:10 ratio) in a high shear granulator.
  • Particles were characterized using solid-state, particle analytical, and pharmaceutically relevant tests.
  • Investigated effects of processing time, jacket temperature, and sphere size on amorphization.

Main Results:

  • Solventless amorphization and pelletization were achieved, with amorphization increasing with processing time and decreasing temperature.
  • Larger spheres (414 and 649 μm) enhanced amorphization rates, leading to drug-layered pellets.
  • Pellets showed supersaturation and faster dissolution than amorphous indomethacin powder, though with lower physical stability.
  • Polyvinylpyrrolidone K-25 stabilized the amorphous form, inhibiting recrystallization.

Conclusions:

  • Solventless amorphization and pelletization using high shear granulation is a feasible technique for producing amorphous drug-layered pellets.
  • This method offers improved dissolution profiles and a potentially greener manufacturing process.
  • Co-processing with stabilizers like polyvinylpyrrolidone K-25 is effective in enhancing the physical stability of the amorphous drug form.