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35 Cards in this Set
- Front
- Back
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Common preservatives added to prevent microbial activity
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Benzoic Acids
Sorbic acid Butyl Parabens |
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pH at which preservatives lose their antimicrobial activity and why
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pH 5, because it's not ionized
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Glycerin (3) and problem
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triol that does not have the same depressant effects as ethanol
mixes with propylene glycol, water, alcohol and PEG400 humectant and preservative problem: increased viscosity |
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Alcohol
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solvent
children under 6- 0.5% 6-12- 5% 12-adult- 10% |
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propylene glycol
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diol
miscible with water, alcohol, PEG 400 |
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Antioxidants (and 4 examples)
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preservative
ascorbic acid, sodium metabisulfate, alpha tocopheral, butylated hydroxytoluene |
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aspartame
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sweetener
do not use with patients who have phenylketonuria |
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sucrose
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sweetener
can cause GI upset to young and old patients (high osmotic load making a hyperosmotic solution) |
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vin marini
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cocaine laced drug in the 1880-1906 time period
caused the Pure Food and Drug act |
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diethylene glycol
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causes kidney failure; was used as solvent for sulfanilamide. caused 1938 food, drug, cosmetic act
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thalidomide
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birth defects; caused Kefauver-Harris amendment requiring safety and efficacy testing as well as teratogenicity tests in pre-clin
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investigational new drug application types (3)
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commercial (most common)
single investigator (for one physician at one study site- usually for dosing regimens of approved drug) Emergency/Compassionate- for incurable patients who don't meet requirements for ongoing treatment protocols |
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types of conventional solid dosage forms (4)
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lozenge
capsule tablet powders |
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common liquid forms (5)
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emulsion
elixir suspension syrup solution |
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dentifrice
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bulk powder, usually contains soap/detergent, anticariogenic agent (prevents cavities), and an abrasive
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effervescent granules
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contain sodium bicarbonate + citric acid or sodium biphosphate. releases CO2 and masks bitter medications
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enteric coated tablets
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pass through stomach to dissolve in GI (protects against stomach acid?)
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1888- what was established?
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national formulary
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some advantages of powders/granules (solid) 4
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easier to prepare big doses
faster dissolution flexible for compounding solids solids are more stable |
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disadvantages of powders/granules (5)
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not convenient to carry around
not good for drugs that are inactivated in stomach not suitable for dispensing hygroscopic drugs hard to mask unpleasant taste bulk powders not good for administering low doses of potent drug |
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advantages of compressed tablets (5)
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accurate doses can be administered simply
easy to transport in bulk more stable than liquid mass produced quickly release rate can be customized |
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disadvantages of compressed tablets (4)
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tablet coating hard to perfect
compression can change physical properties, particle size, crystal form tablet disintegration can be a rate limiting step if drug dose is large, big tablet is hard to swallow |
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advantages of hard capsule (4)
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Better bioavailability than tablets
Flexibility in formulation in comparison to tablets Bead type release products can be filled without problems associated with compression Ideal or clinical trials and widely used for preliminary drug trials |
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disadvantages of hard capsules (5)
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Number of suppliers of shells is limited
Filling equipment slower than tableting Generally more costly than tablets Not suitable for highly soluble salts – rapid release causes gastric irritation Hard gelatin capsules (and tablets) can become lodged in the esophagus |
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advantages of soft capsules (5)
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Liquid fill is metered resulting in higher degree of reproducibility
Higher degree of homogeneity Rapid release of liquid may result in better bioavailability Hermetically sealed as part of the process Wide variety of sizes and shapes available |
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disadvantages of soft capsules (4)
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Limited number of companies
Expensive compared to tablets Shell and liquid products in greater contact than solid contact – greater potential for interactions Drug might migrate into shell |
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advantages of liquids (7)
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homogeneous
ease of preparation can be sweetened/flavored dose is easily changed by adjusting volume easier to swallow KCl causes ulcerations in tablet form so need to use liquid can be used orally, parenterally, topicaly |
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disadvantages of liquids (6)
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susceptible more to degradation so shorter shelf life
some things taste/smell bad in solution bulk and fluidity (takes up lots of shelf space) need special storage (e.g. refrigerator) patient needs to be able to see susceptible more to microbes |
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parts of the FDA review team (6)
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medical- drug efficacy and safety
chemistry- manufacture ok? GMP? statistics- validate study design clin. pharm/biopharmaceutics- drug disposition, in vitro ADME tox/pharm- in vivo ADME, carcinogenicity, teratogenicity project management- interface between review staff and manufacturers |
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food drug and cosmetic act of 1938 (4)
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new drugs, therapeutic devices, and cosmetics must be shown to be safe before marketing
authorized factory inspections eliminate need to prove intent to defraud in misbranding added safe levels for unavoidable poisonous substnaces |
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type 1 NDA
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not available in US
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types 2 NDA
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derivative of active approved moiety in US
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type 3 NDA
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new formulation
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type 4 NDA
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new combination with other approved drug
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types 5 NDA
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new manufacturer
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