Pharmaceutics Exam 1 cont.

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Pharmaceutics Exam 1 cont.
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2010-02-03 11:54:00
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Parenteral Formulations
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Parenteral Formulations
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  1. Injex
    • Needle Free
    • delivers up to 1 ml of liquid
    • Reusable injection device with a single use ampule
    • long-term or frequent injections
    • SubQ injection
  2. 5 official types of injections
    • ___ injection
    • Sterile ___
    • ___ for injection
    • Sterile ____ Suspension
    • Sterile ____ for suspension
  3. _____ Injection
    • Suitable for Injection
    • Solution
  4. Sterile ____
    • Raw Material (dry solid or liquid)
    • Solution
    • No buffers or diluents added
  5. _____ for Injection
    • Needs solvent of vehicle
    • Solution
    • contains buffers, diluents or other added substance
  6. Sterile _____ Suspension
    • Solid suspended in suitable fluid vehicle
    • Not for IV or IS
  7. Sterile _____ for suspension
    • Dry Solid
    • add suitable vehicle
  8. Criteria for non-aqueous vehicles for parenteral formulations
    • Non-irritating, non-toxic and non-sensitizing
    • High BP(121 C) and Low VP
  9. Water miscible solvent
    • Cosolvents for barb, cardiac glycosides and antihistamines:
    • Glycerin
    • PEG
    • Propylene Glycol
    • Ethyl Alcohol
  10. Water Non-miscible Solvent
    • Cosolvent in formulations containing steroids, vitamins and hormones
    • Ethyl oleate
    • Cottonseed Oils
    • Fixed Oils
    • Soybean
    • Peanut
    • Sesame
  11. Ampho B is suitable for injection without any further manipulation (T/F)
    False
  12. Wich of the following ions are present in the plasma which account for at least 5% of the total ions?
    Na+, Cl-, bicarb
  13. Sterile Ampicillin sodium can be made into the injectable ready formulation by mixing with PEG (T/F)
    False
  14. Sterile Ampicillin sodium can be made into the injectable ready formulation by mixing with aqueous solution (t/f)
    False
  15. Sterile ampicillin sodium can be made into inj ready soln. by mixing with aqueous soln. and other necessary additives. (t/f)
    True
  16. Plasma Cations
    • Na = 142
    • K = 5
    • Ca = 5
    • Mg = 2
  17. Plasma Anions
    • Cl = 103
    • HCO3 = 27
    • HPO4 = 2
    • SO4 = 1
    • Organic Acids = 5
    • Proteinate = 16
  18. Interstitial Anions
    • Cl = 144
    • HCO3 = 30
    • HPO4 = 2
    • SO4 = 1
    • Organic Acids = 8
    • Proteinate = 0
  19. Interstitial Cations
    • Na = 146
    • K = 5
    • Ca = 3
    • Mg = 1
  20. Intracellular Cations
    • Na= 15
    • K= 150
    • Ca= 2
    • Mg= 27
  21. Intracellular Anions
    • Cl = 1
    • HCO3 = 10
    • HPO4 = 100
    • SO4 = 20
    • Organic Acids = -
    • Proteinate = 63
  22. Purified Water
    pharmacological solvent
  23. Water for Injection
    • Pyrogen free
    • Single dose container
    • Preparation of parenterals that will be sterilized
  24. SWFI
    • Pyrogen free
    • Sterile
  25. Bacteriostatic Water
    • Pyrogen free
    • sterile
    • Bacteriostatic agents
  26. Preservatives
    • Benzyl alcohol
    • Methy and propyl parabens
    • Phenol
    • Thimerosal
  27. Buffers
    • Citrates -acidic
    • Phosphates -neutral
    • Carbonates -basic
    • Lactates - acidic
  28. Solubilizers/Cosolvents
    • Alcohol
    • Glycerine
    • Propylene glycol
    • polysorbate 20 and 80 - wetting agent
    • sodium benzoate
    • benzyl benzoate
    • lecithin/ethylene diamine
  29. Antioxidants/stabilizers
    • Sodium bisulfite
    • Ascorbic Acid
    • Monothioglycerol
    • Amino acids
  30. Tonicity agents
    • mannitol
    • sorbitol
    • dextrose
    • lactose
    • glycerin
    • sodium chloride
  31. chelating agents
    edetate disodium
  32. Wetting agents
    • prevent caking
    • polysorbate 20 and 80
    • may present physical or chemical instability
  33. Parenteral formulations containting barbituates can be prepared by glycerin and can be administered through IS route. (T/F)
    False
  34. Lactose acts as _____ in parenteral products.
    tonic agent
  35. Sterility
    free from all living organisms and particulates
  36. Methods of Sterilization
    • Thermal
    • Chemical
    • Radiation
    • Filtration
  37. Thermal Sterilization
    Moist Heat
    • Most reliable
    • Autoclave
    • 121C for 20 min
    • Surgical instruments, glassware and solutions
    • not used for products containing oils or fats
  38. Thermal Dry Heat Sterilization
    • Autoclaves
    • 140-120C for 2 hr
    • Heat stable powders and oily materials
  39. Chemical sterilization
    • Safety issue
    • specialized autoclaves
    • Ethylene oxide - toxic
    • enzymes and antibodies
  40. radiation sterilization
    • Most potent
    • highly specialized equipment
    • used for food not drugs
  41. Filtration
    • Most widely used (least expensive)
    • No special equipment
    • Particulate (0.45mM)
    • Microbial (0.22 mM)
    • Used for products that can't withstand other methods
  42. Quality control
    regulatory processes though which industry measures actual quality performance, compares it with standards and act on the difference.
  43. Types of quality control
    • Raw material control - materials
    • In Process control - procedures
    • Product control - final product

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