Materials Science in Pharmaceutical Industry
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Questions and Answers

What is a material, according to the text?

  • A solid intended for certain applications (correct)
  • A liquid intended for certain applications
  • A mixture of different phases for certain applications
  • A gas intended for certain applications

    • What is the significance of understanding the 'character' of a material for its application?

  • It helps in determining the physical state of the material
  • It ensures that the material meets the required specifications for its intended use (correct)
  • It determines the molecular weight of the material
  • It helps in analyzing the chemical composition of the material

    • What are some common terms related to pharmaceutical materials mentioned in the text?

  • Gases, liquids, and solids
  • Catalysts, oxidants, and reductants
  • Excipients, diluents, and fillers (correct)
  • Acids, bases, and salts

    • How are crystalline solids defined in the text?

    <p>Solids with long-range orderliness in atom arrangement</p> Signup and view all the answers

    What property results from the long-range orderliness in crystalline solids?

    <p>Sharp melting point</p> Signup and view all the answers

    How many possible geometries for the unit cell are mentioned in the text?

    <p>7 Bravais lattices</p> Signup and view all the answers

    What is the purpose of Dynamic Vapour Sorption (DVS) in the pharmaceutical industry?

    <p>Analysis of moisture interactions with pharmaceutical solids</p> Signup and view all the answers

    Which technique is best suited for determining crystal structure in crystalline solids?

    <p>Powder X-ray Diffraction (PXRD)</p> Signup and view all the answers

    What does Infrared Spectroscopy primarily identify within a molecular structure?

    <p>Functional groups</p> Signup and view all the answers

    What is a key indicator of the stability of colloidal dispersions?

    <p>Zeta potential</p> Signup and view all the answers

    Which technique is used for measuring the change in sample mass as a function of temperature and/or time?

    <p>Thermogravimetric Analysis (TGA)</p> Signup and view all the answers

    Which parameter does Particle Size influence in pharmaceuticals?

    <p>Dissolution rate</p> Signup and view all the answers

    What characterizes Amorphous solids in thermal analysis techniques?

    <p>Lack of a clear melt peak and presence of Tg</p> Signup and view all the answers

    Which technique is NOT commonly used for particle size measurements in the pharmaceutical industry?

    <p>UV/VIS spectroscopy</p> Signup and view all the answers

    What is the main application of Vibrational Spectroscopy techniques such as Infrared Spectroscopy and Raman Spectroscopy in pharmaceutical analysis?

    <p>Fingerprinting identification of known scans</p> Signup and view all the answers

    What type of polymorphs does Nifedipine exhibit?

    <p>Crystallographic polymorphs</p> Signup and view all the answers

    Which type of solid has an ability to exist in two or more crystalline forms?

    <p>Polymorphic solids</p> Signup and view all the answers

    Why is inattention to polymorphic forms of an Active Pharmaceutical Ingredient (API) considered harmful and expensive for pharmaceutical companies?

    <p>It can result in differences in bioavailability and physical properties</p> Signup and view all the answers

    Which pharmaceutical industry form usually exhibits a random molecular arrangement with a high degree of disorder?

    <p>Amorphous form</p> Signup and view all the answers

    Why does the amorphous form of a drug usually have higher solubility than the crystalline form?

    <p>It exhibits a random molecular arrangement</p> Signup and view all the answers

    Which technique would be most appropriate for evaluating the crystal form of a pharmaceutical substance?

    <p>Powder X-ray diffraction (XRD)</p> Signup and view all the answers

    Which property is usually higher in the amorphous form compared to the crystalline form?

    <p>Solubility</p> Signup and view all the answers

    Which type of polymer is formed from bi-functional and tri-functional monomers and contains strong covalent bonds between various linear polymer chains?

    <p>Cross linked or Network polymers</p> Signup and view all the answers

    What is the melting point of the most stable form of a certain polymer discovered in 1998?

    <p>125 °C</p> Signup and view all the answers

    Which of the following is a semi-synthetic polymer?

    <p>Cellulose acetate (rayon)</p> Signup and view all the answers

    Which type of polymerisation reaction results in the elimination of small molecules such as water, alcohol, hydrogen chloride, etc.?

    <p>Condensation polymers</p> Signup and view all the answers

    Which natural polymer is a polyaminosaccharide derived from the N-deacetylation of chitin?

    <p>Chitosan</p> Signup and view all the answers

    Which type of polymer is known for its strong intramolecular H-bonding between hydroxyl and amino groups, making it thermo-stable?

    <p>Chitosan</p> Signup and view all the answers

    Which type of polymer is formed by linking together a large number of small molecules (monomers)?

    <p>All of the above</p> Signup and view all the answers

    Which type of polymer is not classified based on its source?

    <p>Classifications Based on Molecular Forces</p> Signup and view all the answers

    Which type of polymer is used for developing smart delivery systems?

    <p>Chitosan</p> Signup and view all the answers

    Which natural polymer is composed of glucose monomers joined in α 1,4 linkages and is typically derived from corn or potato?

    <p>Starch</p> Signup and view all the answers

    Study Notes

    Temperature and Heat Flow

    • Endothermic and exothermic processes occur in chemical reactions, involving heat absorption or release
    • DSC (Differential Scanning Calorimetry) measures heat flow vs. temperature, providing information on melting points, crystallization, and phase transitions

    DSC Applications

    • Conversion of a monohydrated form of a drug compound to its anhydrous form
    • Quantitative determination of the monohydrate and anhydrous forms in a mixture
    • Calibration curve for quantitative determination of the monohydrate and anhydrous forms

    Amorphous Solids

    • Lack of a clear melt peak in DSC
    • Presence of a Tg (glass transition temperature), indicating an endothermic process
    • Amorphous solids have no long-range ordering of molecules, resulting in a high degree of disorder

    Thermogravimetric Analysis (TGA)

    • Measures the change in sample mass as a function of temperature and/or time
    • Applications:
      • Changes in mass due to decomposition, oxidation, evaporation, or combustion
      • Absorbed moisture content
      • Volatilization rate of materials
      • Determination of processing or storage conditions

    Dynamic Vapour Sorption (DVS)

    • Interacts pharmaceutical solids with moisture, influencing material properties, processability, and stability
    • Applications:
      • Characterization of amorphous content
      • Characterization of hydrate formation
      • Characterization of glass transition and crystallization behavior

    Vibrational Spectroscopy

    • Infrared spectroscopy (IR) and Raman spectroscopy
    • Fingerprinting identification of known scans
    • Identifies functional groups within the molecular structure
    • Determines protein secondary structure
    • Identifies resins and opaque/coloured materials using photoacoustic scans

    Polymorphs

    • Nifedipine exists as three polymorphic forms: α, β, and γ
    • Degree of polymorphism is produced by the degree of conformational rotations within the large flexible Nifedipine molecule
    • IR spectra can show differences between polymorphic forms

    Powder X-ray Diffraction (PXRD)

    • An array of X-ray diffraction techniques exist for characterizing structural and chemical properties of crystalline solids
    • Applications:
      • Crystal structure determination
      • Compound identification
      • Determination of crystallographic orientation
      • Particle size analysis
      • Crystal strain measurement
      • Degree of crystallinity/crystal quality
      • Defect density and characterization

    Particle Sizing

    • Particle size influences physical and chemical properties
    • Applications:
      • Solubility
      • Dissolution rate
      • Bioavailability
    • Common techniques for particle size measurements include:
      • Sieving
      • Microscopy (with or without image analysis)
      • Electric stream sensing zone method (Coulter counter)
      • Laser diffraction
      • Sedimentation (by gravity or centrifugal)
      • Ultrasonic attenuation

    Particle Size and Zeta Potential

    • Dynamic light scattering (DLS) measures particle size and zeta potential
    • Applications:
      • Analysing wet emulsion, suspension, and bulk dry dispersion
      • Diverse sample types: abrasive, fragile, cohesive, or agglomerated

    Other Analysis Techniques

    • UV/VIS spectroscopy:
      • Determines characteristic absorption patterns
      • Used for qualitative detection, quantitative calculation, and kinetic analysis
    • NMR spectroscopy:
      • Solid-state characterization: crystal polymorphism, testing, and measuring polymorphic state
      • Impurity analysis
    • Mass spectrometry:
      • Quantitative elemental analysis
      • Molecular weight/formula evaluation
      • Unknown purity evaluation

    Polymorphism

    • The ability of a solid to exist in two or more crystalline forms
    • >50% of APIs in the pharmaceutical industry have polymorphs
    • Chemically identical but with significant differences in physical properties (solubility, dissolution rate, Tm, hygroscopicity, etc.)
    • Differences in bioavailability: low or high solubility
    • Inattention to polymorphic forms of an API can be harmful and expensive for pharmaceutical companies

    Multi-Tier Evaluation of API Candidates

    • Tier 1: Crystallinity, optical microscopy, and powder X-ray diffraction (XRD)
    • Tier 2: Thermal properties, differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and dynamic vapour sorption (DVS)
    • Tier 3: Polymorph and hydrate screening, XRD, Raman microscopy, and DSC
    • Tier 4: Humidity/temperature-induced changes in crystal form, powder XRD, DSC, and DVS

    Pharmaceutical Analysis

    • Molecular level: Fourier Transform Infrared (FT-IR), Nuclear Magnetic Resonance (NMR) spectroscopy, and mass spectrometry
    • Physical/Particulate/Morphology: thermal analyses, X-ray diffraction (XRD), and other techniques
    • Quantitative: HPLC, UV/VIS spectroscopy, and other spectrophotometry methods

    Solid Phase Transitions

    • Knowledge of solid form transitions is important for pharmaceutical product preparation
    • Processes may cause polymorph or amorphous form conversions
    • Multi-tier evaluation of API candidates is necessary for thorough characterization

    Polymer Classifications

    • Based on source: natural, semi-synthetic, and synthetic polymers
    • Based on structure: linear, branched, and cross-linked polymers
    • Based on pharmaceutical applications: polymers in conventional dosage forms, controlled release dosage forms, and drug packaging
    • Based on solubility: water-soluble and water-insoluble polymers

    Polymer Properties

    • Molecular weight
    • Composition
    • Mechanical/thermal properties
    • Rheology

    Pharmaceutical Applications of Polymers

    • Natural polymers: starch, chitosan, and others
    • Synthetic polymers: polythene, polyvinyl chloride, and others
    • Applications: tablet and capsule diluents, disintegrants, glidants, binders, and others

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    Description

    This quiz covers the fundamentals of material science and its importance in the pharmaceutical industry, including the review of material science, solids and their properties, and pharmaceutical analysis. Topics include the application of materials in pharmaceuticals and understanding the characteristics required for specific applications.

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