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Pharmaceutics III Lect 3

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alchemist04's version from 2016-04-25 21:54

Section

Question Answer
Requirements of a injectable Dosage Form includes(1) Sterile (2) Pyrogen Free (3) Free from particulates (4) make the drug Isotonic
What is the temperature for Autoclaving?120 C
How do you sterilize protein?Protein is not sterilized, it is too unstable for sterilization. Hence filtration
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Question Answer
LVP examplesTPN, Lyposyn, Intralipid
D5W5% DextroseCarbohydrate
D10W10% Dextrose Carbohydrate
D5, 0.5NS5% Dextrose and 0.45% NS
Plasma ExpanderLVP, 6% Dextran 70 in 0.9% NS
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Question Answer
SVP examplesFamotidine, Heparin, Cimetidine
Types of SVPSolutions, Suspensions, Emulsions, Lyophilized powders.
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What are the importance of co-solvents (water miscible vehicle)enhance drug solubility and to enhance drug stability.
Polyethylene glycol (Peg)Co-solvent, water miscible vehicle
Propylene glycolCo-solvent, water miscible vehicle
Ethyl AlcoholCo-solvent, water miscible vehicle
Laxolin injectionCo-solvent, water miscible vehicle
Taxol InjectionCo-solvent, water miscible vehicle
Valium injectionCo-solvent, water miscible vehicle
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Question Answer
What are the uses of Non-Aqueous vehicles?(I) to solubilize lyphophilic drugs (II) to stabilize drugs that degrade in aqueous solution
Examples of non-aqueous vehicles are(1) soybean (2) Castor oil (3) Sesame (4) Peanut (5) Corn
Examples of products with non aqueous vehicle is(1) Haloperidol Decanoate (2) Sesame oil (3) Progesterone (4) Depo-testesterone
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Question Answer
Something interesting about Antimicrobials (Excipients) (1)They are preservatives
Something interesting about Antimicrobials (Excipients) (2)required in multidose vials
Something interesting about Antimicrobials (Excipients) (3)FDA limit concentration for safety
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Question Answer
Why is buffer important in parenteral (1)to maximize solubility
Why is buffer important in parenteral (2)To maximize stability
Why is buffer important in parenteral (3)To resist pH changes during storage
Why is buffer important in parenteral (4)To minimize irritation
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Question Answer
Acetic AcidBuffer
CarbonateBuffer
Citric AcidBuffer
GlycerinBuffer
HClBuffer
Sodium AcetateBuffer
Sodium CitrateBuffer
Sodium phosphateBuffer
TromethamineBuffer
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Question Answer
Tonicity Agentsuse to ensure that Parenterals are Isotonic so as to avoid shrinkage, swelling, irritation,hemolysis or tissue damage
Why shd Parenterals be isotonic?to minimize tissue damages, irritation, and hemolysis
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Question Answer
Typical tonicity agents (1)Sodium Chloride
Typical tonicity agents (2)Dextrose
Typical tonicity agents (3)Mannitol
Typical tonicity agents (4)Sorbitol
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Question Answer
Solubilizing agents are used toenhance solubility of the drug vehicles
Examples of Solubilizing agents(1) Surfacants (2) Complexation agents
Surfacants are used asvehicle to deliver lipophilic drugs
Types of Surfacants (1)Polysorbarate 80 (Tween 80)
Types of Surfacants (2)Polysorbarate 20 (Tween 20)
Types of Surfacants (3)Lecithin
Types of Complexation agents (1)Cyclodextrins = sugar molecules in a ring
Types of Complexation agents (2)Polyvinylpyrolidone (PVP)
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Question Answer
Antioxidantsto inhibit oxidative processes/degradation or remove residual oxygen. Hence, maintain drug stability.
Water soluble antioxidant (1)Ascrobic Acid (Vitamin C)
Water soluble antioxidant (2)Sodium bisulfide
Water soluble antioxidant (3)Sodium Metabisulfite
Water soluble antioxidant (4)Sodium Sulfite
Oil Soluble Antioxidant (1)BHT = Butylated Hydroxytoluene
Oil Soluble Antioxidant (2)BHA = Butylated hydroxyanisole
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Question Answer
Chelating AgentsBind to trace metals in solution to render them into a non-ionized form. Work synergically with antioxidants (bc metals catalyze oxidative degradation).
Example of Chelating agentEDTA (Ethylenediamine tetra-acetic acid)
Drug with "Injection" meansready to use, needs no manipulation
"For injection" meansthis needs to be manipulated.
"Injectable suspension" meanssolid particles suspended in a medium e.g Methylprednisolone Acetate injectable suspension
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Question Answer
One thing about "Injectable suspension" (1)Contraindicated for IV use
One thing about "Injectable suspension" (2)Use only for IM or SC
One thing about "Injectable suspension" (3)Used to achieve sustained release (SR)
One thing about "Injectable suspension" (4)Can be aqueous base or oil based but water is primary
For Injectable suspensionA dry powder that is reconstituted immediately prior to use
Bacteriostatic containsantimicrobial agents like 0.9% Benzyl Alcohol
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Question Answer
Something important about Formulation of injectable Protein Drugs (1)Use sugar as excipient
Something important about Formulation of injectable Protein Drugs (2)Employ surfactant like Polysorbate 80 to reduce adsorption and prevent aggregation during storage
Something important about Formulation of injectable Protein Drugs (3)Formulation is lyophilized in vail
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Question Answer
Something important about Administration of Recombinant Protein products (1)Majority are manufactured and stored as vials in lyophilized material
Something important about Administration of Recombinant Protein products (2)Majority are dosed parenterally.
Something important about Administration of Recombinant Protein products (3)May cause aggregation if the solution is agitated
Something important about Administration of Recombinant Protein products (4)When reconstituting lyophilized formulations of recombinant protein, direct the stream of diluents down the side of the vial
Something important about Administration of Recombinant Protein products (5)Do not shake any biotech (recombination protein or mAb) formulation.
Something important about Administration of Recombinant Protein products (6)Gently roll (swirl) the vial to mix contents
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