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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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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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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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Ion Exchange01:17

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Ion exchange chromatography separates charged molecules from a solution by reversibly exchanging them with mobile, or 'active', ions associated with the oppositely charged stationary phase. This method can be used to separate ions, soften and deionize water, and purify solutions. The polymers comprising the ion-exchange column are high-molecular-weight and chemically stable polymers, crosslinked to be porous and essentially insoluble. They are also functionalized with either acidic or...
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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).
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The role of ionic vs. non-ionic excipients in APIs-based eutectic systems.

Mónia A R Martins1, Liliana P Silva1, Patrícia S Jorge1

  • 1CICECO - Aveiro Institute of Materials, Department of Chemistry, University of Aveiro, 3810-193 Aveiro, Portugal.

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
|October 12, 2020
PubMed
Summary

New eutectic mixtures were created using excipients like thymol and coumarin with active pharmaceutical ingredients (APIs). Thymol enhanced API liquefaction through strong molecular interactions, showing potential for drug pre-formulation.

Keywords:
COSMO-RSDrug formulationPhase diagramsQuaternary ammonium chloridesSolid-liquid equilibriumThymol

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Area of Science:

  • Pharmaceutical Science
  • Physical Chemistry
  • Materials Science

Background:

  • Drug pre-formulation is critical for developing stable and effective medications.
  • Understanding solid-liquid equilibrium (SLE) and molecular interactions is key to designing new drug delivery systems.
  • Eutectic mixtures offer a promising approach for improving the physical properties of active pharmaceutical ingredients (APIs).

Purpose of the Study:

  • To develop novel eutectic mixtures for drug pre-formulation by combining APIs with various excipients.
  • To investigate the solid-liquid equilibrium (SLE) and molecular interactions within these binary mixtures.
  • To evaluate the predictive capability of the Conductor-like Screening Model for Real Solvents (COSMO-RS) for SLE in mixtures with non-ionic excipients.

Main Methods:

  • Preparation and characterization of binary eutectic mixtures involving APIs (acetylsalicylic acid, acetaminophen, ibuprofen, ketoprofen, lidocaine) and excipients (thymol, coumarin, quaternary ammonium chlorides).
  • Measurement of solid-liquid equilibrium (SLE) phase diagrams for the developed mixtures.
  • Computational evaluation using the Conductor-like Screening Model for Real Solvents (COSMO-RS) to predict SLE and analyze molecular interactions.

Main Results:

  • Experimental SLE phase diagrams were successfully measured, revealing insights into potential phase separation and molecular interactions.
  • COSMO-RS demonstrated good quantitative agreement with experimental SLE data for mixtures containing non-ionic excipients, highlighting its utility in screening eutectic systems.
  • Thymol exhibited strong interactions with APIs, leading to negative deviations from ideality and favoring API liquefaction. Coumarin-based systems showed quasi-ideal behavior.
  • Ionic excipients (choline chloride, tetraalkylammonium chlorides) showed limited interactions with APIs, with no significant deviations from ideality observed.

Conclusions:

  • Eutectic mixtures containing APIs and non-ionic excipients, particularly thymol, show significant potential for drug pre-formulation due to favorable molecular interactions and enhanced API liquefaction.
  • COSMO-RS is a valuable computational tool for predicting SLE and screening potential eutectic systems involving APIs and non-ionic excipients.
  • The choice of excipient significantly influences the solid-liquid equilibrium and molecular interactions, impacting the suitability for drug formulation.