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Pharmaceutics Exam 1 Study Guide
Study Guide
100
Science
Professional
09/21/2013

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Term
Karl Wilhelm Scheele (1742-1786)
Definition
Discovered lactic acid, citric acid, tartaric acid and arsenic acid. Identified glycerin, invented new methods of preparing calomel and benzoic acid and discovered oxygen
Term
Friedrich Serturner (1783-1841)
Definition
German pharmacist who isolated morphine from opium which prompted a series of isolations of other active materials for medicinal plants
Term
Joseph Caventou and Joseph Pelletier
Definition
Combined their talents and isolated quinine and cinchonine from cinchona and strychnine and brucine from nux vomica
Term
USP and NF
Definition
Created in 1820 to ensure quality and uniform standards. Pharmacopeia was written with high degree of clarity and specificity

- Adopt standards for drugs, pharmaceutical ingredients and dosage forms
- Reflect the best current practices of medicine
- Provides information on tests and assay procedures for demonstrating compliance with these standards
- For individual components not combinations
Term
Food and Drug Act of 1906
Definition
Required that "drugs marketed interstate comply with claimed standards for strength, purity and quality" No more false claims and declared products misbranded
Term
Food, Drug and Cosmetic Act of 1938
Definition
Sulfanilamide was used as an elixir containing diethylene glycol which killed 100 people before it was removed from the market. As a result, all new drugs had to be tested for safety and submitted to the NDA for marketing approval. They also need to be adequately labeled with directions and the FDA is now authorized to conduct surprise inspections
Term
Kefauver-Harris Amendment of 1962
Definition
Created as a result of thalidomide and requires manufacturers to prove that drugs are safe and effective before FDA market approval. All drugs must be accurately labeled, whether OTC or Rx. Prescription drugs must be clearly labeled Rx and "Caution: federal law prohibits dispensing without prescription"
Term
Durham-Humphrey Amendment of 1952
Definition
No refills without a valid prescription. Clarified dispensing obligations of pharmacists. Defined drugs that cannot be used safely without proper medical supervision.
Term
Comprehensive Drug Abuse Prevention and Control Act of 1970
Definition
Established 5 schedules for classification and control of drug substances particularly those that were more likely to be abused.

Schedule I and II: High potential for abuse
Schedule III: Moderate potential for abuse
Schedule IV & V: Low potential for abuse
Term
Frances Kelsey
Definition
Recent graduate who got hired to work for the FDA. She received the thalidomide case and refused to approve it for market use even though it was already being widely used throughout Europe. She was recognized and given a medal from President Kennedy when it was proven that thalidomide causes birth defects. As a result, the laws were strengthened by the FDA.
Term
Source of morphine
Definition
Opium poppy
Term
Source of quinine
Definition
Cinchona bark
Term
Source of digitalis
Definition
Foxglove
Term
Source of belladonna
Definition
Deadly night shade
Term
Vinca rosea
Definition
Vinblastine and vincristine are extracted from this plant and used as drugs for leukemia and Hodgkin's lymphoma
Term
Drug solubility
Definition
Less than 10 mg/ml is considered poorly soluble
Term
Partition coefficient
Definition
Preference for lipid verses preference for aqueous phase
Term
Dissolution rate
Definition
speed at which a drug substance dissolves in a medium
Term
Physical form
Definition
Crystal versus amorphous versus powder, etc. Will alter the rate and extent of absorption
Term
Stability
Definition
Retention of drug substances within dosage form
Term
Lead compound
Definition
Closet agent to the goal drug possessing the fundamental desired biologic or pharmacologic activity. It may not contain all of the properties of the desired compound, and so medicinal chemists often modify the lead compound
Term
CDER
Definition
Cancer of Drug Evaluation assesses the benefits and risks of the drug. Also decides if the drug gets approved, what are the other issues of the drug, is it a high priority drug?
Term
Investigational New Drug Application
Definition
Protects the rights and safety of subjects and makes certain that the research objectives stated can be achieved with the investigational plan. The IND is then assigned to a CDER official
Term
IND Phase 1
Definition
20 - 100 patients; less than 1 year; purpose is to determine toxicology, metabolism and pharmacologic actions. Application contains: the plan for the study, chemical structure, animal testing results and manufacturing information
Term
IND Phase 2
Definition
100 - 300 patients; determines compound's effectiveness; the patients have the disease that the drug is intended to heal; extensive pharmacologic, toxicological and pharmacological testing
Term
IND Phase III
Definition
1000-3000 patients; to determine long term safety and efficacy of drug product; carried out several years. How well does the drug treat the disease or condition? What are the short term side effects and risks associated with drug use in patients whose health is impaired? Investigational drug will be used in several randomized, controlled studies in various research facilities.
Term
Minimum effective concentration
Definition
MEC; The minimum dose required to get a desired effect
Term
Minimum toxic concentration
Definition
MTC; Administering drugs above this level will produce dose related toxicities
Term
Median effective dose
Definition
MED; This dose will produce a desired intensity of a drug effect in 50% of the individuals tested
Term
Age
Definition
Neonatal, pediatric and geriatric patients
Term
Body weight
Definition
Milligrams (of drug)/per kilogram of body weight
Term
Body surface area
Definition
1 mg/M^2 BSA - nomogram
Term
Sex
Definition
Men and woman have different responses to certain drugs due to biochemical and physiologic factors
Term
Pathologic state
Definition
Disease state
Term
Times of administration
Definition
Before or after meals
Term
Tolerance
Definition
Ability to endure influence of a drug
Term
Batch
Definition
A specific quantity of a drug of uniform specified quality produced according to a single manufacturing order during the same cycle of manufacture
Term
Batchwise control
Definition
The use of validated in process sampling and testing methods in such a way that results prove that the process has done what it purports to do for the specific batch concerned
Term
Certification
Definition
Documented testimony by qualified authorities that a system qualification, calibration, validation or revalidation has been performed appropriately and that the results are acceptable
Term
Compliance
Definition
Determination through inspection of the extent to which a manufacturer is acting in accordance with prescribed regulations, standards and practices
Term
Component
Definition
Any ingredient used in the manufacture of a drug product, including those that may not be present in the finished product
Term
Drug product
Definition
A finished form that contains an active drug and inactive ingredients. The term may also include a form that does not contain an active ingredient, such as a placebo
Term
Inactive ingredient
Definition
Any component other than the active ingredients in a drug product
Term
Lot
Definition
A batch or any portion of a batch having uniform specified quality and a distinctive identifying lot number
Term
Lot number, control number or batch number
Definition
Any distinctive combination of letters, numbers, or symbols from which the complete history of the manufacture, processing, packaging, holding and distribution of a batch or lot of a drug product may be determined
Term
Master record
Definition
Record containing the formulation, specifications, manufacturing, procedures, quality assurance requirements, and labeling of a finished product
Term
Quality assurance
Definition
Provision to all concerned the evidence needed to establish confidence that the activities relating to quality are being performed adequately
Term
Quality audit
Definition
A documented activity performed in accordance with established procedures on a planned and periodic basis to verify compliance with the procedures to ensure quality
Term
Quality control
Definition
The regulatory process through which industry measures actual quality performance, compares it with standards and acts on the difference
Term
Quality control unit
Definition
An organizational element designated by a firm to be responsible for the duties relating to quality control
Term
Quarantine
Definition
An area that is marked, designated or set aside for the holding of incoming components prior to acceptance testing and qualification for use
Term
Representative sample
Definition
A sample that accurately portrays the whole
Term
Reprocessing
Definition
The activity whereby the finished product or any of its components is recycled through all or part of the manufacturing process
Term
Strength
Definition
The concentration of the drug substance per unit dose or volume
Term
Verified
Definition
Signed by a second individual or recorded by automated equipment
Term
Validation
Definition
Documented evidence that a system does what it purports to do
Term
Process validation
Definition
Documented evidence that a process does what it purports to do
Term
Validation protocol
Definition
A prospective experimental plan to produce documented evidence that the system has been validated
Term
Written documentation is required to make sure that each drug product has
Definition
Correct identity, strength, quality and purity
Term
FDA modernization act of 1997
Definition
Ensured patients access to compounded products; prevented unnecessary FDA regulation of health professional (pharmacy) practice, but did not exempt the drug manufacturing company
Term
Which container is better and why? Plastic or glass
Definition
Glass because it won't change in container material over time, there is no absorption of drug to container, no leaching of constituents of container and no change in permeability
Term
What needs to be included on a prescription label?
Definition
Name and address of pharmacy, serial number of prescription, date of prescription, name of the prescriber, name of patient, directions for use
Term
What needs to be included on an OTC label?
Definition
Product name, net quantity of contents, pharmacologic category, cautions and warnings, sodium content, storage conditions
Term
Storage conditions (temperatures) defined by the USP
Definition
Cold: 8 C
Cool: 8 - 15 C
Room temp: 20 - 25 C
Warm: 30 - 40 C
Excessive heat: above 40 C
Term
Melting point
Definition
A characteristic of a pure substance is a defined melting point. If not pure, the substance will exhibit a change in melting point. Commonly used to determine the purity of a drug substance and in some cases, the compatibility of various substances before inclusion in the same dosage form
Term
Phase diagram
Definition
Represents the melting point as a function of composition of 2 or 3 component systems. Starting from the extremes of either pure A or pure B, as the second component is added, the melting point of the pure component decreases. Equal amounts of both could result in a eutectic point where a minimum melting point occurs. Never stay at this position for too long before it becomes disastrous
Term
pH
Definition
Measure of a substances acidity; can be adjusted to enhance solubility
Term
Other techniques used to adjust pH
Definition
Co-solvents, micronization, dispersion, emulsion
Term
Dissolution
Definition
Time it takes for a drug to dissolve in fluids at the absorption site. The rate limiting step in the absorption process.

Absorption rate will increase with decrease in particular size
Dissolution will increase with increase in solubility
Dissolution can influence duration of therapeutic effect
Term
Fick's law of diffusion
Definition
Transfer of drugs from an area of high concentration (c1) to an area of low concentration (c2).

dQ/dt=DA/h(c1-c2)
dQ/dt : rate of drug diffusion
D : diffusion coefficient for drug
A : surface are across which transfer occurs
h : thickness of the region through which diffusion occurs
Term
Partition coefficient
Definition
Optimal balance between water and lipid solubility

P = conc. of drug in octanol / conc. of drug in water
Term
Zero order reactions
Definition
C = -k(t)+c
Term
First order reactions
Definition
lnC = -k(t)+lnc
Term
Powder
Definition
A drug substance composed of finely divided particles or a type of pharmaceutical preparation, a medicated powder intended for internal or external use
Term
Trituration
Definition
The process of rubbing, crushing, grinding or pounding materials
Term
Levigation
Definition
The process of reducing the particle size and grittiness
Term
Levigating agent
Definition
A small amount of some liquid added to the powder to form a paste
Term
Spatulation
Definition
A spatula moves through powders on a sheet of paper or ointment tile

-Not recommended for large quantities
-Ideally suited for mixing solid substances that form eutectic mixtures when in close and prolonged contact with one another
-Mixing agents are phenol, camphor and menthol
Term
Trituration 2
Definition
May be employed to comminute and mix powders. Glass mortar is preferred if no need for comminution. During geometric dilution an inert color is added to ensure uniform distribution
Term
Sifting
Definition
Powders are mixed by passing them through sifters. Not acceptable for incorporation of potent drugs into a diluent powder
Term
Tumbling
Definition
Another method of mixing; powder enclosed in a rotating container. Special blenders mix/blend powders by tumbling motion. Most widely used in the pharmaceutical industry
Term
Medicated powders
Definition
Internal and external use; external use are dusted on affected area from a sifter-type container or applied from a powder aerosol. Oral use intended for local effects (laxatives) or systemic effects (analgesics). Oral powders have faster rates of dissolution for systemic use than solid forms.
Term
Granules
Definition
Prepared agglomerates of smaller particles of powder. Usually 4 - 12 sieve size range. Prepared when blended powders are moistened and passed through a screen or special granulator. Dried until pasty mass is formed.
Term
Very coarse
Definition
No. 8
Term
Coarse
Definition
No. 20
Term
Moderately coarse
Definition
No. 40
Term
Fine
Definition
No. 60
Term
Very fine
Definition
No. 80
Term
Dissolution rate or particles
Definition
Micronization of particles can increase the rate of drug dissolution and its bioavailability
Term
Suspendability
Definition
Particles intended to remain undissolved but uniformly dispersed in a liquid vehicle
Term
Penetrability
Definition
Particles intended to be inhaled for deposition deep in the respiratory tract (1 - 5 microns)
Term
Nongrittiness
Definition
Solid particles in dermal ointments, creams and ophthalmic preparations (50 - 100 microns)
Term
Sieving
Definition
Particles pass through a series of sieves of known successively smaller sizes: 40 - 9500 micron
Term
Microscopy
Definition
Calibrated grid background is used to measure particle size: 0.2 - 100 micron
Term
Sedimentation rate
Definition
Velocity of particles through a liquid medium in a gravitational or centrifugal environment: 0.8 - 300 micron
Term
Light scattering
Definition
Reduction in the amount of light reaching the sensor as the particle dispersed in liquid or gas passes through the sensing zone range: 0.02 - 2000 micron
Term
Laser holography
Definition
Pulsed laser is fired through an aerosolized particle spray and photographed in three dimensions with a camera: 1.4 - 100 micron
Term
Cascade impaction
Definition
Driven by airstream impacts on a surface in its path, particles are then separated into various size ranges by successively increasing velocity of the airstream: no specific size range
Term
Effervescent granules
Definition
Granules (coarse to very coarse powders) containing medicinal agent in a dry mixture composed of sodium bicarbonate, citric acid and tartaric acid
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