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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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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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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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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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Characteristics of Precipitation-formed Polyethylene Glycol Microgels Are Controlled by Molecular Weight of Reactants
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Published on: December 23, 2013

Development of prednisone:polyethylene glycol 6000 fast-release tablets from solid dispersions: solid-state

Darío Leonardi1, María Gabriela Barrera, María Celina Lamas

  • 1Departamento Farmacia, Facultad de Cs Bioquímicas y Farmacéuticas, Universidad Nacional de Rosario, IQUIOS, CONICET, Suipacha 531, 2000, Rosario, Argentina.

AAPS Pharmscitech
|January 10, 2008
PubMed
Summary

This study developed fast-release prednisone tablets using solid dispersions with polyethylene glycol (PEG) 6000. Increasing PEG 6000 concentration significantly enhanced prednisone dissolution rates and tablet performance.

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science

Background:

  • Optimizing drug dissolution is crucial for oral fast-release formulations.
  • Prednisone's dissolution profile can be improved through advanced drug delivery systems.

Purpose of the Study:

  • To design and optimize oral fast-release polymeric tablets of prednisone.
  • To enhance prednisone dissolution by modifying carrier concentration in solid dispersions.

Main Methods:

  • Solid dispersions prepared using solvent evaporation at varying drug:polymer ratios.
  • Characterization via X-ray diffraction, infrared spectroscopy, and scanning electron microscopy.
  • Tablet formulation and dissolution testing.

Main Results:

  • Increasing polyethylene glycol (PEG) 6000 concentration significantly enhanced prednisone dissolution.
  • PEG 6000-based tablets showed 80% dissolution within 30 minutes, compared to <25% for conventional tablets.
  • Formulations demonstrated good disintegration and stability over 12 months.

Conclusions:

  • Polymeric solid dispersions, particularly with PEG 6000, are effective for improving prednisone dissolution.
  • Developed tablets offer a promising fast-release dosage form without superdisintegrants.
  • Prednisone remains stable within the PEG 6000 solid dispersion system.