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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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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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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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In precipitation gravimetry, the precipitating agent should react specifically or selectively with the analyte. While a specific reagent reacts with the analyte alone, a selective reagent can react with a limited number of chemical species.
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Method to Produce Durable Pellets at Lower Energy Consumption Using High Moisture Corn Stover and a Corn Starch Binder in a Flat Die Pellet Mill
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Differences in characteristics of pellets prepared by different pelletization methods.

Adam Häring1, David Vetchý, Lucie Janovská

  • 1Department of Pharmaceutics, Faculty of Pharmacy, University of Veterinary and Pharmaceutical Sciences, Brno, Czech Republic. aminah@seznam.cz

Drug Development and Industrial Pharmacy
|March 26, 2008
PubMed
Summary

Extrusion/spheronization and rotoprocessor agglomeration produced oral pellets. Extrusion/spheronization yielded denser pellets with better size control and higher yield, indicating its pharmaceutical manufacturing advantage.

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Area of Science:

  • Pharmaceutical Technology
  • Drug Delivery Systems
  • Particle Engineering

Background:

  • Oral pellets are a widely used dosage form for drug delivery.
  • Various techniques exist for pellet production, each with unique characteristics.

Purpose of the Study:

  • To compare extrusion/spheronization with rotoprocessor agglomeration for pellet preparation.
  • To evaluate the impact of these methods on pellet properties and yield.

Main Methods:

  • Pellets were prepared using extrusion/spheronization and rotoprocessor agglomeration.
  • Theophylline was used as the model drug, with lactose monohydrate and microcrystalline cellulose as excipients.

Main Results:

  • Both methods produced pellets with suitable shape and mechanical integrity.
  • Extrusion/spheronization resulted in pellets with higher density, hardness, and lower friability.
  • Extrusion/spheronization also yielded a narrower particle size distribution and a greater yield of desired pellet sizes.

Conclusions:

  • Extrusion/spheronization is a superior method for producing high-quality oral pellets compared to rotoprocessor agglomeration.
  • This technique offers advantages in terms of physical properties, uniformity, and production efficiency for pharmaceutical applications.