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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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Factors Affecting Dissolution: Polymorphism, Amorphism and Pseudopolymorphism01:21

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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).
Some polymorphic crystals possess lower aqueous solubility than their amorphous counterparts, leading to incomplete absorption. For instance, the oral suspension of Chloramphenicol, which...
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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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Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Unlike ionic or small covalent molecules, polymers do not form crystalline solids due to the diffusion limitations of their long-chain structures. However, polymers contain microscopic crystalline domains separated by amorphous domains.
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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

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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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Rational excipient selection for co-amorphous formulations.

Ossi Korhonen1, Katja Pajula1, Riikka Laitinen1

  • 1a School of Pharmacy , University of Eastern Finland , Kuopio , Finland.

Expert Opinion on Drug Delivery
|June 9, 2016
PubMed
Summary
This summary is machine-generated.

Stabilizing amorphous solid forms of drugs is crucial for improving bioavailability. This review explores technologies for stabilizing co-amorphous formulations and highlights the need for predictive computational tools in excipient selection.

Keywords:
Co-amorphousinteraction parameterinteractionsmiscibilitymolecular modelingsolubility parameterstability

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Drug Delivery

Background:

  • Amorphous solid state forms of small molecule drugs offer improved solubility and bioavailability.
  • However, amorphous forms are high-energy, unstable states requiring effective stabilization strategies.
  • Co-amorphous formulations represent a key technology for stabilizing amorphous drug substances.

Purpose of the Study:

  • To review technologies used for stabilizing amorphous states in co-amorphous formulations.
  • To emphasize the critical role of appropriate stabilizing excipient selection.
  • To focus on the underlying mechanisms of stabilization in these systems.

Main Methods:

  • Literature review of existing technologies and research on amorphous stabilization.
  • Analysis of excipient selection criteria and stabilization mechanisms.
  • Discussion of current research limitations and future directions.

Main Results:

  • Various technologies are employed to stabilize amorphous states within co-amorphous formulations.
  • The selection of stabilizing excipients is paramount for successful formulation.
  • Current research often adopts inefficient case-by-case approaches.

Conclusions:

  • A systematic and predictive approach to selecting stabilizing excipients is needed.
  • Modern in silico tools, chemometrics, and advanced statistical methods should be utilized.
  • Further research with larger datasets is essential for developing more efficient screening strategies for co-amorphous formulations.