Unit14PharmaceuticsI

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Unit14PharmaceuticsI
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2010-12-06 01:29:36
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Unit14PharmExcipientsSolvents
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  1. Excipient:
    A usually inert substance that forms a vehicle
  2. Excipient Examples:
    • Solvents
    • Preservatives
    • Antioxidants
    • Buffers
    • Viscosity inducers
    • Surfactants and emulsifying agents
    • Colors, flavors, sweeteners, and scents
  3. —Water
    Most commonly used and most desirable solvent-vehicle for liquid drug products and preparations for all uses
  4. —Other solvent-vehicles
    • Alcohol, Isopropyl Alcohol, Glycerin, Propylene Glycol, and Polyethylene Glycol 400
    • Oils as solvents
    • Ether, chloroform
  5. —Solubility – ability of a substance to dissolve
    Concentration of solid in the solvent must be at, or below the solubility for the solid in that solvent
  6. Miscibility
    • Capable of mixing in any ratio without separation of the two phases
    • i.e. alcohol/ water
  7. How are solubilities given?
    • In gram of solute per milliliter of solvent (not per mL of solution)
    • Solubility of Boric Acid is 1 g/ 15mL water
  8. Describing solubility – per USP
    • Soluble
    • Slightly soluble
    • Sparingly soluble
  9. Basic starting ingredient for all USP water items:
    Potable water
  10. USP <1231>:
    “Water used in the production of drug substances or as source or feed water for the preparation of various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) issued by the U.S. Environmental Protection Agency (EPA)”
  11. USP-NF Water Articles:
    • Purified Water USP
    • Sterile Purified Water USP
    • Water for Injection USP
    • Sterile Water for Injection USP
    • Sterile Water for Inhalation USP
    • Sterile Water for Irrigation USP
    • Bacteriostatic Water for Injection USP
  12. Purified Water USP Standards:
    • Bacterial endotoxins: no standard
    • Bateriologic purity: complies with EPA regulations for drinking water
  13. Purified Water USP is used:
    As a solvent-vehicle for the preparation of pharmaceutical dosage forms for internal or external use
  14. Purified Water USP is not used:
    When sterility is required unless it meets the requirements under USP Sterility Tests<71> or is first sterilized by filtration or autoclaving
  15. Purified Water USP must be:
    Protected from microbial contamination
  16. Purified Water USP is not used for:
    Making parenteral products unless it can be assured that it meets the requirements for sterility and bacterial endotoxins for parenteral administration
  17. Sterile Purified Water USP Standards:
    • Bacterial endotoxins: no standard
    • Bacteriologic purity: Meets requirements in Chapter<71> for sterility
    • pH: between 5.0 and 7.0
  18. Sterile Purified Water USP Labeling:
    Label with method of preparation and that this is not for parenteral use
  19. Sterile Purified Water USP is used:
    • It is used as a solvent-vehicle for the preparation of
    • pharmaceutical dosage forms for internal or external use
  20. Sterile Purified Water USP
    It is not for parenteral administration
  21. Water for Injection USP Standards:
    • Bacterial endotoxins: Not more than 0.25 USP Endotoxin Units per mL
    • All requirements of Purified Water
  22. Water for Injection USP
    Water for injection is a starting material for making parenteral products. It must be processed further either before use or during product preparation
  23. Sterile Water for Injection USP (SWFI) Standards:
    Bacterial endotoxins: not more than 0.25 USP Endotoxin Units per mL
  24. Sterile Water for Injection USP (SWFI) Labeling:
    Additional note: label that it is not suitable for intravascular injection prior to being made approximately isotonic
  25. Sterile Water for Inhalation USP Standards:
    • Bacterial endotoxins: not more than 0.5 USP Endotoxin Units per mL
    • pH: 4.5 – 7.5
  26. Sterile Water for Inhalation USP Labeling:
    For inhalation therapy only and not for parenteral use
  27. Sterile Water for Inhalation USP Uses:
    Note in USP: “Do not use Sterile Water for Inhalation for parenteral administration or for other sterile compendial dosage forms.”
  28. Sterile Water for Irrigation USP Standards:
    • Bacterial endotoxins: Meets the endotoxin test under Water for Injection
    • Bacteriologic purity: Meets requirements given for Sterile Purified Water
  29. Sterile Water for Irrigation USP Labeling:
    • No preservatives or other substance has been added
    • Additional labeling: “For irrigation only” and “Not for injection”
  30. Sterile Water for Irrigation USP Uses:
    Solvent for drugs to be administered by irrigation (local effect)
  31. Bacteriostatic Water for Injection USP Labeling:
    NOT FOR USE IN NEWBORNS
  32. Bacteriostatic Water for Injection USP Uses:
    It is not to be used when large volumes are needed for parenteral administration
  33. Alcohol
    All statements of percentages of alcohol refer to percentage, by volume of C2H5OH at 15.56o
  34. Ethyl EtOH: Ethanol; CH3CH2OH; C2H5OH; C2H6O; MW =
    46.07
  35. Ethanol: Alcohol USP Content:
    • >92.3% and < 93.8% (w/w), &
    • >94.9% and < 96.0% (v/v)
  36. Ethanol: Alcohol USP Description:
    Clear, colorless, mobile, volatile liquid; flammable; characteristic odor; bp = 78o
  37. Ethanol: Alcohol USP Solubility:
    Miscible with castor oil, but immiscible with other fixed oils and mineral oil
  38. Ethanol: Alcohol USP Packaging
    Tight containers, away from fire
  39. Ethanol: Alcohol USP Other:
    Solvent-vehicle for internal or external use. Effective antiseptic-disinfectant in concentrations > 60%
  40. Ethanol: Dehydrated Alcohol USP Description:
    Clear, colorless, mobile, volatile liquid; flammable; characteristic odor; bp = 78o
  41. Ethanol: Dehydrated Alcohol USP Packaging:
    Tight containers, away from fire
  42. Ethanol: Dehydrated Alcohol USP Other
    Use when “dehydrated” or “absolute” alcohol is designated in the formula
  43. Ethanol: Dehydrated Alcohol Injection USP Description:
    Clear, colorless, mobile, volatile liquid; flammable; characteristic odor; bp = 78
  44. Ethanol: Dehydrated Alcohol Injection USP Packaging:
    • Single-dose containers (Type I glass preferred)
    • Container headspace may have inert gas
  45. Ethanol: Dehydrated Alcohol Injection USP Other
    • Suitable for parenteral use
    • Meets requirements for parenteral products found in USP Chapter<1> Injections of the General Tests and Assays
  46. Ethanol: Diluted Alcohol USP Content:
    Mixture of alcohol and water.
  47. Ethanol: Diluted Alcohol USP Description:
    Clear, colorless, mobile liquid; characteristic odor
  48. Ethanol: Diluted Alcohol USP Packaging:
    Tight containers, away from fire
  49. Ethanol: Diluted Alcohol USP Other:
    • Made by mixing equal volumes of Alcohol USP and Purified Water.
    • Mixing 500 mL of each yields 970 mL of Diluted Alcohol USP
  50. Ethanol: Rubbing Alcohol Content:
    • 68.5 % to 71.5% (v/v) of Dehydrated Alcohol
    • May contain stabilizers, perfumes, or dyes
  51. Ethanol: Rubbing Alcohol Description:
    Like alcohol, except that it may be colored; Odor dependant on presence of additives.
  52. Ethanol: Rubbing Alcohol Other:
    • External use only
    • Effective antiseptic-disinfectant
  53. Isopropyl Alcohol: 2-Propanol; CH3CHOHCH3; C3H8O; MW =
    60.10
  54. Isopropyl Alcohol USP Content:
    >99.0%
  55. Isopropyl Alcohol USP Descritpion:
    Transparent, colorless, mobile, volatile, flammable liquid with characteristic odor
  56. Isopropyl Alcohol USP Packaging:
    Tight containers, away from heat
  57. Isopropyl Alcohol USP Other:
    • External use only; Solvent-vehicle for topical products;
    • Effective disinfectant at concentrations >70%
    • Superior to ethyl alcohol as an antiseptic.
  58. Isopropyl Rubbing Alcohol USP Content:
    • Alcohol: >68.0% and <72.0% by volume (v/v)
    • Other: water with or without stabilizers, perfumes, and color additives
  59. Isopropyl Rubbing Alcohol USP Description:
    Like Isopropyl Alcohol except that it may be colored; Odor dependant on additives
  60. Isopropyl Rubbing Alcohol USP Packaging:
    Tight containers, away from heat
  61. Isopropyl Rubbing Alcohol USP Other:
    External use only; Solvent-vehicle for topical products; Effective antiseptic-disinfectant
  62. Azeotropic Isopropyl Alcohol USP
    Like Isopropyl Alcohol
  63. Dihydroxy alcohols:
    • More than one site for hydrogen bonding
    • Higher water solubility
    • Higher boiling points (less volatile)
    • Vary greatly in their toxicities
    • Use only glycols approved for their intended purpose
  64. Glycols: Glycerin USP; Glycerol; C3H8O3; MW=
    92.01
  65. Glycols: Glycerin USP Description:
    • Clear, colorless, viscous liquid.
    • Practically odorless, hygroscopic, neutral pH
  66. Glycols: Glycerin USP Packaging:
    Tight containers
  67. Glycols: Glycerin USP Other:
    • Solvent-vehicle for internal and external use
    • Humectant and preservative properties
  68. Glycols: Glycerin Oral Solution USP Description:
    Like glycerin USP, except pH between 5.5 and 7.5
  69. Glycols: Glycerin Oral Solution USP Packaging:
    Tight containers
  70. Glycols: Glycerin Oral Solution USP Other:
    Solvent-vehicle for oral dosage forms
  71. Glycols: Glycerin Ophthalmic Solution USP Content:
    Other: May contain one or more suitable antimicrobial preservatives
  72. Glycols: Glycerin Ophthalmic Solution USP Description:
    Like Glycerin Oral Solution USP, except it is sterile
  73. Glycols: Glycerin Ophthalmic Solution USP Packaging:
    • Tight containers of glass or plastic
    • Volume<15mL and protected from light
    • Container is sealed and tamper-proof to ensure sterility
  74. Glycols: Glycerin Ophthalmic Solution USP Other:
    For ophthalmic use
  75. Glycols: Propylene Glycol USP; C3H8O2; MW=
    76.09
  76. Glycols: Propylene Glycol USP Description:
    Clear, colorless, viscous liquid. Practically odorless, hygroscopic
  77. Glycols: Propylene Glycol USP Other:
    • Solvent-vehicle for internal and external use
    • Humectant and preservative properties
  78. Glycols: Polyethylene Glycol NF (PEG) Labeling:
    • Number indicating average MW (200 to 8000)
    • PEGs 200 - 600 are liquid at room temp
    • Higher MW PEGs are waxy solids at room temp
  79. Glycols: Polyethylene Glycol NF (PEG) Solubility:
    • All PEGs are soluble in water
    • PEG 400
  80. Glycols: Polyethylene Glycol NF (PEG) Packaging:
    Recommended tight containers
  81. Glycols: Polyethylene Glycol NF (PEG) Other:
    PEG 400 is the most common liquid PEG. Used as a solvent-vehicle for internal and external use. Clear, colorless, slightly hygroscopic, viscous liquid with a slight odor
  82. 2 official solvent-vehicles:
    • Acetone /Methyl Isobutyl Ketone
    • Can dissolve anything bu limited usefullness because:
    • Volatile
    • Highly flammable
    • Toxic
  83. Acetone; CH3COCH3; C3H6O; MW=
    58.08
  84. Ketone: Acetone labeling:
    Flammable
  85. Ketone: Acetone Packaging:
    Tight containers; remote from fire
  86. Choice of solvent can affect the stability of a product's
    • pH
    • Solubility
    • Toxicity
    • Route of administration
    • Packaging and storage
  87. Antimicrobial preservatives
    Substances added to non-sterile dosage forms to protect them from microbiological growth or from microorganisms that are introduced inadvertently during or subsequent to the manufacturing process.
  88. Why sterile articles in multiple-dose containers:
    Added to inhibit the growth of microorganisms that may be introduced from repeatedly withdrawing individual doses
  89. Antimicrobial preservatives should not be used as
    a substitute for:
    • Good manufacturing practices
    • Good compounding practices
    • Good technique
  90. When is it not necessary to add a preservative?
    • The preparation will be used immediately
    • No water is present
    • The pH of the preparation is either < 3 or > 9
    • One or moreingredients have antimicrobial properties are already present
  91. When are preservatives contraindicated?
    • Neonates
    • Ophthalmic solutions intended for use during eye surgery, with not-intact corneas, or for intraocular injection
    • Parenteral products with volumes greater than 30 mL
  92. —So a preservative is needed, but contraindicated. What do you do? (i.e. neonate patient)
    • Prepare a single dose for immediate use
    • Prepare a limited (small) quantity
    • Use within a short time period
    • Store under refrigeration
    • Label with a short expiration date

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