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