PHA 327 - Exam 2 - Preformulation 1

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kyleannkelsey
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214345
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PHA 327 - Exam 2 - Preformulation 1
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2013-04-19 09:51:53
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PHA 327 Exam Preformulation
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PHA 327 - Exam 2 - Preformulation 1
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  1. What is a drug?
    The active ingredient having pharmacological or therapeutic effect
  2. What components does a dosage form have?
    • Active ingredients
    • Inactive ingredient
    • (Purpose for using inactive ingredients is included)
  3. Give an example of a dosage form:
    • tablet
    • capsule
    • suspension
    • emulsion
  4. Give an example of a drug:
    • ibuprofen
    • asprin
    • hypdrocodone
  5. Describe an optimized drug product:
    One that has been designed to release drugs in a way that improves efficacy and reliability
  6. What charcteristics of a dosage form are accounted for by pharmaceutic indgredients?
    • appearance
    • texture
    • stability
    • taste
    • form
  7. What are pharmaceutic ingredients?
    • Dosage form components that contribute to the shape, form, taste, texture and stability of the product
    • stabilizers, bases, diluents, binders, etc.
  8. What is the general purpose of using surfactants as a pharmacutic ingredient?
    Solubilize
  9. What is the general purpose of using water as a pharmacutic ingredient?
    Dilute
  10. What five things should you consider what designing a dosage form?
    • Characteristics of the drug substance
    • Drug and formulation stability
    • drug release profile
    • prevention against microbes
    • Appearance
  11. What are therapeutic considerations for dosage form design?
    • Clinical effectiveness
    • Route of administration
    • Nature or disease
    • Age and condition of patient
  12. What are biopharmaceutic consideration of dosage design?
    • Biopharmaceutics
    • Bioavailability
  13. What is Pharmaceutics important?
    in-depth understanding of traditional pharmaceutical dosage forms as well as innovative new drug delivery systems
  14. What is preformulation?
    • process of optimizing a drug through the determination of its physical and chemical properties
    • including: the determination of any possible interactions in the final form
  15. What three properties need to be evaluated in preformulation studies?
    • chemical
    • physical
    • biological
  16. What are the chemical properties that need to be studied in preformulation?
    • structure
    • form
    • purity
    • reactivity
  17. What physical features need to be studied in preformulation?
    • microscopic and macroscopic properties
    • Drug and drug product stability
    • General : pKa, solubility, dissolution, polymorphism, partition coefficient
  18. What type of property is studied when you evaluate the pKa, partition coefficient, solubility, dissolution, and polymorphism of a drug product?
    Physical properties
  19. What biologic properties are studied during preformulation?
    • Ability to get to the site of action
    • Ability to elicit a response
  20. What are the five Macroscopic properties listed in class?
    • Color
    • Odor
    • Appearance
    • Density
    • Flow properties
  21. Color, odor, appearance, flow properties and density are what type of property?
    Macroscopic
  22. What are the three microscopic properties discussed in class?
    • Crystal habit
    • Particle size
    • Size distribution
  23. What type of property are: size distribution, particle size, and crystal habit?
    Microscopic properties
  24. What USP chapter describes federal obligations for Macroscopic properties?
    616
  25. What type of densities measurements exist?
    • True density
    • Bulk density
    • Tapped density
  26. What is true density?
    Density of the actual solid material
  27. What is bulk density?
    The mass of a powder divided by the volume (includes spaces between particles)
  28. What is the tapped density?
    Mass divided by the volume obtained by tapping a cylinder repeatedly (compressing the spaces between the particles)
  29. How is the true density obtained?
    • For Non-porous material = volume is obtained by displacement in an insoluble liquid
    • For porous material = volume is measured using a helium densitometer
  30. What would you use a helium densiometer for?
    To measure the volume of a porous substance to obtain the true density
  31. What type of density is obtained by dividing the bulk mass by the bulk volume (volume is inclusive of the spaces between particles)?
    Bulk density
  32. What is the angle of repose?
    • The angle of the side of a pile of drug powder/granule
    • The steepest angle of the dip of the slope relative to the horizonal
  33. What is the equation for the angle of respose?
    • tan (angle of repose) = us
    • us = coeff. of static friction
  34. What is the range of angles or repose?
    0-90 degrees

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