pharmaceutics exam 3- what I did not know :) Flashcards
what is an example of Percolation of either the source of the medicating substance or the sucrose
Ex. Ipecac syrup
% of sugar in syrup
what are alternatives to sucrose in syrups
what you do not usually find in syrup
60% to 80%
can use Sorbitol, glycerin, and propylene glycol are all alternatives
do not find Solubilizing agents, thickeners, stabilizers
elixirs compared to syrup in sweetness or thickness
Are not as sweet or viscous (thick) as syrups.
who decides the formula of an elixir
USP monographs provide standards for preparing Elixirs, but NOT formulas. The individual manufacturer can decide on the formula
why does Cloudy final mixture occur in elixir
Cloudy final mixture often results from the separation of flavorant oils in the reduced alcoholic solution.
If this occurs, the mixture sits (typically for couple of hours) for the globules to coalesce. The formation of large globules makes for easier removal by filtration.
what is talc used for in elixirs
Talc is a frequently used filter which can absorb the excess amount of oils from the solution.
what can enhance stability in elixirs
Presence of glycerin, syrup, sorbitol and propylene glycol in elixirs can assist with dissolution of the solute, and enhance stability.
The downside is the additionally added components will slow down rate of filtration due to the increased viscosity resulting from the addition of the 4 different components.
what does the graph show between oral tablets and oral solutions
that an oral solution will go into the serum faster than an oral tablet
so oral solution absorbs faster than oral tablets
what do tinctures vary in
Vary in terms of method of preparation, strength of active ingredient, alcoholic content, and intended use in pharmacy
what are the ingredients of Vanilla Tincture, USP
*Vanilla, cut into small pieces
*Purified Water
*Alcohol
*Sucrose, in coarse granules
*Diluted Alcohol, a sufficient quantity
to make
what can an iodine tincture be used for
how much iodine is used
A tincture of iodine can be used to disinfect the area around an epidural catheter.
Usually, between 2 and 7% Iodine is used
what do sprays usually contain
Often contain antibiotics, antihistamines
what are Alcoholic based liniments
used for
Counter irritant or if penetrating action is needed
what can the solvent of oleaginous liniments be
The solvent may be almond oil, peanut oil, sesame oil or cottonseed oil, or some volatile substance (i.e., wintergreen) or a combination of oil & volatile substance
what is prepared first, Emulsion liniments or desired solvent
Emulsions are prepared first, and added to desired solvent
how are vaginal solutions prepared
Bulk powders are used by the teaspoonful or tablespoonful to prepared solution
A measured amount of powder is added to warm water, stirred and dissolved
what are special solutions?
these solutions have additional features so they can be better suited for ophthalmic, nasal or otic
how long must you apply pressure to your lacrimal sac to minimize systemic absorption?
3 to 5 minutes
how do you sterilize ophthalmic solutions?
bacterial filtration or by autoclave
what must be done if you add antimicrobial preservatives to ophthalmic solutions?
when is done
If antimicrobial preservatives are to be added, formulation stability, chemical and physical compatibility with other formulation components, and effectiveness must be determined.
done in preformulation stage
if antimicrobial preservatives are not added to the ophthalmic solution, what is done
If antimicrobial preservatives are not added they are generally packaged in single-use containers.
what is osmotic pressure?
: the pressure applied by a solution to prevent the inward flow of water across a semi-permeable membrane.
What antimicrobial preservatives are used for ophthalmic solutions
what is the caution with one of them?
Benzalkonium chloride, 0.004% to 0.01%
Benzethonium chloride, 0.01%
Chlorobutanol, 0.5%*
Phenylmercuric acetate, 0.004%
Phenyl mercuric nitrite, 0.004%
Thimerosal, 0.005% to 0.01%
Chlorobutanol, 0.5%* does not autoclave because it will turn to HCl
is sodium chloride hypo, iso, or hypertonic
what is tonicity in reference to
isotonic or isosmotic
in reference to blood
what buffering capacity to tears have
weak buffering capacity
what very acidic drugs can overwhelm the natural buffering capacity of tears?
pilocarpine hydrochloride
epinephrine bitartrate
what is the Optimal range for viscosity for ophthalmic solutions
15 to 25 cP
what solutions thickeners in ophthalmic solutions as well.
Hydroxypropyl methylcellulose and polyvinyl alcohol
what is used to administer sterile preparations via intravenous push or infusion systems
syringe
how are Ophthalmic solutions packaged?
Most are packaged in small plastic containers with a fixed built-in dropper.
what was introduced for the injection of sodium chloride and glucose
Hypodermic
so now we can inject insulin in the subq using hypodermic needles!
when are injections used
Used when rapid drug action is desired (use IV)
Used when patients are uncooperative or unconscious
Used when patients cannot tolerate medicine
Used when the drug is ineffective by other routes
Veins for IV
The superficial veins can be used for venipuncture, however basilic and cephalic veins on back of hand and dorsal forearm are best for peripheral veins for IV therapy
What is the size of IV containers
1000 ml containers of solutions for IV infusion used frequently
what kinds of injuries can occur from IM route?
., paralysis resulting from neural damage, scarring, abscess cysts)
needle size for IM
20 to 22 gauge needle is utilized.
needle size of subq
what is the needle size for insulin
[24 to 26] gauges
Insulin is administered using 25 to 30 gauge needles
site of injection for intradermal
needle size
volume
Usual site for intradermal injection is the anterior surface of the forearm
Needle size: 23 to 26 gauge
Volume injected: approximately 0.1 ml is the limit
Premixed IV delivery systems are available for product administration
what is an example of this
Ex. of solutions, Digoxin (cardiotoxin) given IM or IV with carefully monitored dosage- “ready-to-use systems”
for small volume parenterals
pH
disadvantages
pH can range between 4 to 10
disadvantage
Thawing of the frozen drug product
High-energy microwave — water bath—- room temperature for 1 hr
how are small vs large volume paranteral labled
small: 100mL or less
large: more than 100mL
what are large-volume parenterals used for
These are generally used for IV infusion to replenish body fluids or electrolytes or nutrition, and 100 ml to 1L is typically used.
for large-volume parenterals, what should you be aware of
Be aware of different issues with compatibilities.
- During compounding procedures
- During multiple infusions
what are the 5 general categories
of injectable materials
Injection
For Injection
Injectable emulsion
Injectable suspension
For injectable suspension
containers for “for injection, USP”
Water should be collected in sterile and pyrogen-free containers, and the containers are usually glass or glass lined.
WHAT IS Sterile water for injection, USP used for
Water is intended to be used as a solvent, vehicle or diluent for already sterilized and packaged injectable medications
Suitable injection: water is added directly to the medicinal substance such as with dry powders or granular substances
how is Bacteriostatic water for injection, USP packaged
Packaged in pre-filled syringes or in vials containing not more than 30 ml of water
when is sterile water for injection preferred over bacteriostatic water?
Large injected volumes of antimicrobial agents are toxic. For this reason, if volumes of more than 5 ml of solvent are required, sterile water for injection is preferred over bacteriostatic water
what should the label for bacteriostatic water have and why
“Not for use in newborns”
because of benzyl alcohol
example of nonaqueous solutions
Vegetable oil, glycerin, polyethylene glycols
what would Oleaginous injections via IV cause
pulmonary microcirculation
what can be used for dry heat sterilization and not steam sterilization
, oils, glycerin, mineral oil and heat-stable powders
what is the size of the filter in Sterilization by Filtration
This method involves the removal of all bacteria and spores with use of a 0.22 µm filter
Advantage & disadvantages of filter units
Advantages of filter units:
Speed in filtration, relatively inexpensive and complete removal of living and dead microorganisms
Disadvantage of filter units:
Proper inspection of the filter unit is necessary to avoid using systems that are ruptured or faulty in some other way.
Systems can be flawed during assembly
Handling and Disposal of Chemotherapeutic agents
Training and quality assurance programs needed
Minimize unnecessary exposure with these steps
Use laminar flow hoods or bacteriologic glove boxes for preparing the reconstitution of cytotoxic drugs
Wear a mask during the preparation
Use special waste containers
Periodic monitoring of personnel who handle cytotoxic drugs
Informing personnel handling cytotoxic drugs of risk to health
Specialized labeling of containers to ensure proper handling and disposal of cytotoxic drug agent
what can biologics include and what is another name for them
include antibiotics, hormones, vitamins and also know as immunobiologics
when was the
Inactivated Polio vaccine
Oral Polio virus (OPV)
Rubella vaccine
introduced
Inactivated Polio vaccine- introduced in 1955
Oral Polio virus (OPV)- introduced in 1960s
Rubella vaccine- introduced in 1969
what do T-lymphocytes and B lymphocytes do in acquired immunity
T-lymphocytes augment (make it greater) the activity of B lymphocytes primarily involved in humoral immunity and antibody production, which helps individuals to resist infections the next time they are exposed.
what about water do biologics have to be tested for
residual moisture
Refrigerators, cool air and biologics
Refrigerators should not be overstocked with products
cool air must have room to circulate
vaccines & expiration date
what temp should the fridge be
keep vax with shorter expiration dates to front of shelf
fridge (not freezer) should be between 35F to 46F, but aim for 40*F
Don’t for vaccines and fridge
no vaccine in drawers or on the floor of the refrigerator
no vax in solid plastic trays or containers
no vax in doors
no food in fridge
keep vax away from all cold air vents. The vents blow in very cold air from the freezer which can damage vax
Regardless of method the vaccine may be
expressed as what
- Total # of organisms
– Total protective units per milliliter or dose
– Micrograms of immunogen in each milliliter, or in each dose of vaccine.
what do cancer vax increase
The cancer vaccine increases antigen awareness of your immune cells
increase co-stimulatory signals that induce an immune response
what are the 3 immune system cells with natural antitumor activity?
what do cancer vax do to these cells
T cells
Lymphokine-activated killer cells
Natural killer cells
– Cancer vaccines stimulate these immune cells
tumor-killing cells recognize tumor-associated antigens (TAA) on tumor cell surface.
Tumor Vaccines: Autologous, Allogeneic, Gene Therapy
what is the result of Traditional vaccines constituted by inactivated whole cells
can cause unwanted side effects
Hypersensitivity-anaphylaxisisamajorconcern
– Bronchospasm
– Respiratory distress – Laryngeal edema
– Circulatory collapse – Death
Because hypersensitivity reactions are so rare, what is not clear for vaccines
Because hypersensitivity reactions are so rare it’s not clear whether patients are allergic to proteins that make up the active antigenic portion of the vaccine, or the excipients (i.e., neomycin, gelatin, aluminum gels).
what did children who took Thimerosol preservatives produce and what did it result in
methyl mercury and ethyl mercury resulting in neurotoxicity
for passive immunity what must the sera be free from
Must be free of hepatitis B antigen and antibodies to HIV
What needle size is used for BOTOX cosmetics
to draw up how much saline
21 gauge to draw up 0.5 to 2.5 ml of saline containing reconstituted material.
What are some potential problems associated with polymer use?
High molecular weight
Slow permeability
Delay excretion
Unfavorable Immunologic or toxic reactions
Expenses associated with preparation
In what ways are Long-Acting Parenteral Systems accomplished?
Slowly dissolving chemical complexes of drug entity
Slow erosion of drugs encapsulated in microspheres
Mechanically controlled-rate drug infusion pumps
how much polyanhydride copolymer and carmustine inn gliadel wafer
The wafers contain 192.3 mg of a biodegradable polyanhydride
copolymer and 7.7 mg of carmustine
Gliadel: Packaging, storage, handling
Wafers designed as a single-dose treatment box
Each box contains 8 individually pouched wafers
Each wafer is double-pouched in foil, Inner pouch is sterile
Must be stored at or below -20ºC (just like moderna)
what do liposomes deliver and to where
drugs, genes, proteins to target cells
how many carbons in liposomes
10 to 24
melting temp of lipids
Phospholipid head groups
Myristoyl: 20*C
Palmitoyl: 41*C
Stearyl: 55*C
Oleoyl: - 20*C
the more carbons, the higher the temp. except if it is with a kink then it has a much lower temp.
Head groups: PC, PG, PE, PS
Liposomal Therapeutics purpose
why was this done
To reduce toxic side effects of agents in sensitive organs such as heart and kidneys, and to target diseased tissues.
Potent medicinal substances are usually the most toxic and so there is an urgent need for effective drug delivery systems.
- Less than 5% of the injected drug accumulates at the target site, the remaining drug interacts with healthy host tissues.
lipoceutical vs conventional vehicle with free active
for lipoceuticals:
- permeation is greater with liposomal encapsulation
- eliminated irritation and optimized dosage
- greater concentration and residence time in the epidermis and dermis for prolonged release
- protects encapsulated material from metabolic degradation
- reduces systemic absorption
How are novel drug delivery systems administered?
Parenterally, topically, inhalation methods, orally or possibly by other routes.
what can we target in tumors rather than tumor cells
targeting tumor vessels is an effective alternative to targeting cancer cells in tissue
why is it called stealth
because it is longer circulating because the kidney, liver, and other eliminating organs cannot get to it
due to PEG
Liposomal Amphotericin B
Amphotericin B is an antifungal antibiotic. Because of the many well-known side effects and certain dose-limiting toxicities associated with conventional amphotericin B,
lipid-based formulations were developed to increase the tolerability (e.g., decrease nephrotoxicity) of the drug without compromising its antifungal effects.
