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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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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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In Vitro Drug Dissolution: Alternative Methods01:17

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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 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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Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
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Using containerless methods to develop amorphous pharmaceuticals.

J K R Weber1, C J Benmore2, K J Suthar3

  • 1MDI, Arlington, Heights, IL, USA; Argonne National Laboratory, Argonne, IL, USA.

Biochimica Et Biophysica Acta. General Subjects
|April 12, 2016
PubMed
Summary
This summary is machine-generated.

Containerless processing using acoustic levitation efficiently synthesizes pure amorphous drugs, overcoming solubility challenges for improved oral bioavailability. This method aids in developing stable, high-uptake pharmaceutical formulations for clinical use.

Keywords:
Acoustic LevitationAmorphous PharmaceuticalsContainerlessSpray Drying

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Area of Science:

  • Pharmaceutical Science
  • Materials Science
  • Chemical Engineering

Background:

  • Many pipeline drugs exhibit low solubility in crystalline forms, necessitating specialized dosage forms for enhanced oral bioavailability.
  • Amorphous pharmaceutical formulations significantly increase the solubility and uptake of active pharmaceutical ingredients.
  • Amorphous forms are increasingly vital for both pre-clinical and clinical applications in drug development.

Purpose of the Study:

  • To review and present data on methods for synthesizing amorphous pharmaceuticals.
  • To evaluate containerless processing (acoustic levitation) and spray drying techniques for amorphous drug production.
  • To investigate the stability and structure of amorphous materials for clinical formulation development.

Main Methods:

  • Amorphous drug synthesis via acoustic levitation (containerless processing) and spray drying.
  • In-situ high energy X-ray diffraction for structural analysis of synthesized products.
  • X-ray diffraction for assessing the stability of amorphous samples.

Main Results:

  • Containerless processing with acoustic levitation successfully produced phase-pure amorphous forms of challenging drugs.
  • The stability and structure of amorphous materials were characterized for formulation development.
  • Comparison of materials produced by spray drying and containerless synthesis.

Conclusions:

  • Amorphous compounds are crucial for developing oral drug delivery systems for poorly soluble drugs.
  • Containerless techniques offer efficient synthesis of pure amorphous forms for pre-clinical trials and clinical product optimization.
  • Addressing stability and bioavailability challenges is key for advancing amorphous pharmaceutical applications.