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Related Concept Videos

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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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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Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules01:18

Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules

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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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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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Bioavailability Enhancement: Drug Stability Enhancement and GI Retention01:05

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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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Drug Dissolution: Requirements and Profile Comparison01:14

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The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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Thermal Analysis by Structural Characterization as a Method for Assessing Heterogeneity in Complex Solid

Muqdad Alhijjaj1,2, Mike Reading3, Peter Belton4

  • 1School of Pharmacy, University of East Anglia , Norwich, Norfolk, United Kingdom , NR4 7TJ.

Analytical Chemistry
|October 3, 2015
PubMed
Summary

A new thermo-optical technique, thermal analysis by structural characterization (TASC), offers spatially resolved insights into pharmaceutical product heterogeneity. TASC provides rapid, sensitive analysis, outperforming traditional methods like differential scanning calorimetry (DSC).

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Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Analytical Chemistry

Background:

  • Pharmaceutical products often exhibit heterogeneity, complicating formulation design and quality control.
  • Conventional thermal analysis techniques like differential scanning calorimetry (DSC) provide averaged data, lacking spatial resolution.
  • Understanding phase distribution is crucial for drug efficacy and stability.

Purpose of the Study:

  • To introduce and evaluate a novel thermo-optical technique, thermal analysis by structural characterization (TASC), for analyzing pharmaceutical heterogeneity.
  • To demonstrate TASC's capability for providing spatially resolved thermal transition information.
  • To compare TASC's sensitivity and speed against conventional DSC.

Main Methods:

  • Utilizing hot stage microscopy combined with a novel algorithm to acquire and analyze thermal transition images.
  • Applying high heating rates for rapid sample screening (3-5 minutes per sample).
  • Comparing TASC's detection of metastable forms with DSC using polyethylene glycol (PEG) as a model.

Main Results:

  • TASC successfully provides spatially resolved information on thermal transitions in pharmaceutical formulations.
  • The technique is demonstrated to be low-cost and relatively rapid.
  • TASC exhibited higher sensitivity in detecting the metastable form of PEG compared to DSC.

Conclusions:

  • TASC is a valuable new tool for characterizing inter- and intrasample heterogeneity in solid and semisolid materials.
  • Its speed and sensitivity make it suitable for both research and quality control applications.
  • TASC offers a promising alternative or complementary method to existing thermal analysis techniques.