PHA 327-Aerosols

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PHA 327-Aerosols
2013-05-11 17:14:55
PHA 327 Aerosols

PHA 327-Aerosols
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  1. Pulmonary Drug Delivery Systems is what?
    Any procedure or device which allows a drug to be administered into the respiratory tract
  2. What are inhalations?
    Drug or Drug solutions administered nasally for local or systemic effects
  3. What is an example of an inhalation given in class?
    Stadol NS (Butorphenol tartate, an opiod pain medication)
  4. What are aerosols?
    Pressurized product that releases the active ingredient when the valve system is activated
  5. What are examples of aerosols?
    Ventoilin/Proventil (Albuterol sulfate, Bronchospasms)
  6. What are the advantages of Pulmonary drug delivery systems?
    • Mechanical irritation of topical applications is reduced
    • May replace injection
    • Maintains stability- protected from 02, moisture, light and unsterile conditions
    • Facilitates self-administration
    • Delivers drugs to the appropriate location in the correct form
    • Faster action than oral
    • Larger absorption area
    • Avoids GI destruction
  7. What does hermetic mean?
    Sealed airtight
  8. What are the disadvantages of Pulmonary delivery systems?
    • Volatility of propellants may cause irritating cooling effect
    • Fluorinated hydrocarbons may exhibit cardiotoxic effects when used repeatedly or rapidly
  9. What are aerosols?
    Suspensions of fine solids or liquids in air or gas
  10. What factor controls aerosol ejection?
    The power/pressure of the liquefied or pressurized gas
  11. When did aerosols come into use?
  12. What is the most common type of pulmonary drug delivery system?
  13. What does the future of aerosol development depend on?
    Development of new propellants
  14. Explain how a two phase aerosol system works:
    • Gasket seals access to the nozzle off
    • When the nozzle is pressed, it penetrates the gasket and, creating a passage out of the container
  15. What three physical properties of aerosol contents allows for ejection of the drug product?
    • Equilibrium between liquefied and aerosolized drug product
    • Vapor exerts pressure on the container and liquid form of product
    • Actuation of the valve, allows pressure relief, expelling the contents
  16. What happens to the drug after it is ejected from the aerosol?
    It evaporates immediately
  17. What happens in the aerosol container as the product is being released?
    The equilibrium of the aerosolized and liquid product reestablishes
  18. How does an aerosol product maintain even pressure and release rate?
    By maintaining the equilibrium between aerosolized and liquefied product within the container
  19. Under what condition will pressure and propulsion drop dramatically in an aerosol?
    When the liquid reservoir is depleted
  20. What are the four main components of an aerosol delivery system?
    • Propellant
    • Containers
    • Product concentrate
    • Valve assembly
  21. What is the product concentrate?
    The active ingredient mixed with required adjuncts
  22. What are examples of the required adjuncts of the product concentrate?
    • Solvents
    • Surface active agents
    • Antioxidants
  23. What is the "Heart of the aerosol"?
    The propellant
  24. What is the purpose of the propellant?
    To develop the proper pressure to the expel contents when the valve is open
  25. What determines if an aerosol is a spray or a foam?
    The Propellant
  26. What type of propellant cannot be used as a solvent for the active ingredient?
    Compressed gas propellants
  27. What are the two classes of propellants?
    • Liquefied gas propellants (includes fluorinated hydrocarbons and hydrocarbons)
    • Compressed gas propellants
  28. What are the two types of Liquid gas propellants?
    • Fluorinated hydrocarbons
    • Hydrocarbons
  29. What three examples of Compressed gas propellants were given in class?
    Carbon Dioxide, Nitrous oxide and Nitrogen
  30. What type of propellants are Nitrous oxide, Carbon dioxide and Nitrogen?
    Compressed gas propellants
  31. What are three examples of Fluorinated hydrocarbon propellants given in class?
    • Trichloromonofluoromethane (Propellant 11)
    • Dichlorodifluoromethane (Propellant 12)
    • Dichlorotetraflouromethane (Propellent 114)
  32. What is Propellent 114?
    • Dichlorotetrafluoromethane
    • Liquid gas propellant
  33. What is Propellant 12?
    • Dichlorodifluoromethane
    • Liquid Gas propellant
  34. What is propellant 11?
    • Trichloromonofluoromethane
    • Liquid Gas propellant
  35. What type of Propellant is used in aerosols for oral and inhalation uses?
    Fluorinated hydrocarbon liquid gasses
  36. What type of propellant would you use for topical purposes?
    Hydrocarbon Liquid gasses
  37. What three examples were given in class for hydrocarbon liquid gas propellants?
    • Butane
    • Isobutane
    • Propane
  38. What category of propellants are Propellant 11, 12 and 114?
    Fluorinated hydrocarbon liquid gasses
  39. What category of propellants are isobutane, butane and propane?
    Hydrocarbon liquid gasses
  40. What category of propellants are carbon dioxide, Nitrogen and Nitrous oxide?
    Compressed gas propellants
  41. What are the five general characteristics of fluorinated hydrocarbon propellants?
    • Deplete the ozone
    • Chemically inert
    • Non-toxic
    • Flammable
    • Expensive
  42. What six general characteristics were given in class for Hydrocarbon propellants?
    • Chemically stable
    • Inflammable
    • Inexpensive
    • No hydrolysis
    • Environmentally safe
    • Low order of toxicity
  43. What are four general characteristics of Compressed gas propellants?
    • Produces a less stable foam than liquid gas propellants
    • No cooling effect
    • Low expansion power
    • Used for food and non-food products that need to be dispensed in the original form
  44. What example products were given that are make use of compressed air propellants?
    • Dental creams
    • Hair products
    • Ointments
    • Germicidal aerosols
    • Antiseptics
  45. What equations would you use to determine the vapor pressure of a mixture of propellants?
    • Dalton's law
    • Raoult's law
  46. Summarize Dalton's law:
    The total pressure of the system = The sum of all the partial pressures
  47. Summarize Raoult's law:
    • The depression of the vapor pressure of a solvent with the addition of a solute = The mole fraction of the solute molecules in solution
  48. What are examples of mixtures that create a negative deviation from Raoult's law?
    • Chloroform and acetone
    • Water and ethanol
  49. What is an example of a mixture that strictly follows Raoult' law?
    Ethylene chloride and Benzene
  50. What characteristics must an aerosol container have?
    • Able to withstand pressures of 140-180 psi
    • Must be able to reach 103 degrees F
  51. What are the three types of aerosol containers?
    • Metal
    • Synthetic resins or Plastics
    • Glass
  52. What types of glass are suitable for aerosols?
    Uncoated or coated
  53. What type of Metals are suitable for aerosols?
    • Tin plated
    • Stainless steel
    • Aluminum
  54. What are the five considerations in aerosol container selection?
    • Aesthetics/Design
    • Adaptability to production methods
    • Ability to withstand pressure and heat
    • Compatibility with product
    • Cost
  55. What is the function of the Valve assembly of an aerosol?
    • Enables the product to be expelled
    • In a desired form
    • At a desired rate
    • In the proper amount
  56. What three components related to expelling the drug do valves regulate?
    • The rate of delivery
    • The amount delivered
    • The Form delivered
  57. What is the actuator of the valve assembly?
    The button that the consumer uses to open the valve
  58. What is the purpose of the valve assembly dip tube?
    Brings formulation form the container to the valve
  59. What is the purpose of the valve assembly Spring?
    • The component that closes the valve after the actuator is released
    • Prevents leakage when the valve is closed
  60. What is the purpose of the valve assembly Housing?
    Links the stem of the actuator and the dip tube
  61. What is the purpose of the valve assembly Stem?
    The mechanical piece that retracts when the actuator is released, closing the valve
  62. What is the mounting cusp?
    The area around the valve that holds it in place
  63. What is the purpose of the gasket in a valve assembly?
    To prevent leakage when the valve is closed
  64. What are the requirements for aerosol valves?
    • Must dispense the correct amount
    • Must dispense the correct form
    • Must be easily opened and closed
  65. What are the two classifications of Aerosol valves?
    Metered and non-metered
  66. What is a metered valve?
    One that dispenses a certain amount
  67. What are the types of actuators?
    • Spray
    • Foam
    • Solid Stream
    • Specialty for eye nose and throat delivery
  68. What two things does the actuator aid in?
    • Easy opening and closing
    • They type of product discharged
  69. What are the aerosol formulation parts?
    • The product concentrate
    • The propellant
  70. How many propellants can be used in an aerosol?
    One or more
  71. What are the four type of aerosol formulation systems?
    • Water based
    • Solutions
    • Suspension-dispersion
    • Foam systems
  72. What are the two processes for aerosol production?
    • Cold process
    • Pressure Process
  73. Summarize the cold process of aerosol production:
    • The propellant, product concentrate and container are cooled to -30 or -40 degrees F
    • The propellant and concentrate are placed into the container
    • Liquid gas is overlayed in the container
    • The valve assembly is added and crimped into place
  74. How is air expelled from the container in the cold process of aerosol assembly?
    The liquid gas overlay is heavier and pushes the air out during assembly
  75. Summarize the pressure process of aerosol manufacturing:
    • The product concentrate is added t the container
    • The valve is crimped into place
    • The air is removed by vacuum
    • The propellant is added through the valve assembly utilizing the vapor pressure force
  76. How is air removed from the container in the pressure process of aerosol manufacturing?
    By vacuum after the valve has been crimped into place
  77. What process is used for most aerosol manufacturing?
    The pressure process
  78. What are the advantages of The pressure process of aerosol manufacturing?
    • Less risk of moisture contamination
    • Less propellant loss during manufacturing
  79. What type of propellants were used before 1978?
    Fluorinated Hydrocarbons
  80. What type of fluorinated Hydrocarbons were not banned in the 1970s?
    Those for inhalation/nasal or oral use
  81. What are the alternatives to fluorinated hydrocarbon propellants?
    • Compressed gasses
    • Hydrocarbons
    • Mechanical pumps
  82. What are the two most common types of containers used for aerosols?
    Glass and Metal
  83. What should be carefully considered prior to packaging in aluminum?
    Alcohol (due to chemical reactivity)
  84. What type of aerosol products should be used in glass?
    • No more than 15% propellant
    • no more than 25 psi
  85. What type of aerosol products need special attention when choosing a container?
    Acids and soaps
  86. What factors contribute to the selection of Valves and actuators?
    • The size of the orifice
    • The application
    • Material used to construct it
  87. What factors contribute to the selection of aerosol applicators?
    The type of application (nasal, inhalation, etc)
  88. What 8 characteristics are used as indicators of stability for the aerosol product concentrate?
    • pH
    • Density
    • Viscosity
    • Vapor pressure
    • Assay of ingredients
    • Odor
    • Color
    • Total weight
  89. What is the aerosol container examined for in terms of stability?
    Corrosion during storage
  90. What stability measures are performed on aerosol valve assemblies?
    Function of the valve over time (satisfactory product dispensing, opening an d closing correctly, etc...)
  91. What two ways are aerosols tested for Flammability/Combustibility?
    • Flash test
    • Flame Projection
  92. What is the Flash point test for Aerosols?
    • The aerosol product is cooled to -25 degrees F
    • The product is placed in a ignition chamber
    • The temperature is raised until it ignites
  93. What is the Flash point (the point not the test)?
    The temperature at which an aerosol ignites
  94. Describe the Flame projection test for aerosols:
    • The product is sprayed for four seconds into a flame
    • The extension of the flame is measured by a ruler
  95. What would you measure using a pycnometer or hydrometer?
    The density
  96. What methods can be used to determine the moisture content of an aerosol?
    • Gas chromatography
    • Karl Fischer method
  97. What can be used to identify product contents of an aerosol?
    • IR
    • GC
  98. What would you use and artificial respiratory system for?
    To determine the amount of drug received by the patient
  99. How is the reproducibility of metered doses determined for an aerosol?
    By analysis of drug components
  100. What would you use to evaluate foam stability?
    • Visual = time it takes to penetrate the foam
    • Rotational viscometer
  101. What methods are used to determine the particle size of an aerosol product?
    • Light scatter decay method
    • Cascade impactor
  102. How does the Cascade impactor work?
    • Gas is projected through a series of nozzles and glass slides
    • Larger particles become impacted in earlier slides at lower velocities
  103. What two areas are considered when testing the Biological efficiency of aerosol products?
    • Therapeutic activity
    • Toxicity