T1 - Exam 1 Flashcards
Route in mouth (swallowed)
Oral
Route under the tongue
Sublingual
Route between the cheek and gums
Buccal
Route in rectum
Rectal
Route in vagina
Vaginal
Route in nasal cavity
Intranasal
Route in mouth (inhaled)
Pulmonary
Route on eye surface
Ophthalmic
2 routes on epidermal surface
Topical and Transdermal
Route in veins
Intravenous injection or infusion
Route in striated muscles
Intramuscular injection
Route in subcutaneous fat
Subcutaneous injection
Route in peritoneal cavity
Intraperitoneal infusion
Route in spinal cord
Intrathecal injection or infusion
Route outside of the dura mater of the spinal cord
Epidural injection or infusion
Route in synovial space of joints
Intrasynovial injection
Route in bone marrow
Intraosseous injection or infusion
Route in vitreous humor of the eyeball
Intravitreal injection
What are the two common sites for measuring drug amount and concentration?
Plasma and urine
What is the difference between qualitative and quantitative measurements?
Qualitative is personal accounts and description, quanitative is numerical data
Give an example of quantitative measurements
Blood pressure and cholesterol
Give an example of qualitative measurements
Subjective in regards to mesure of pain
Define bioavailability
The proportion of an administered dose of unchanged drug that reaches the systemic circulation
Define clearance
The volume of plasma cleared of drug per unit of time
What is half-life?
The time required for plasma concentration of drug to decrease by 50%
What is volume of distribution?
An indicator of how well a drug is distributed
Describe the components of LADME
- Liberation: release of the drug from its dosage form
- Absorption: into the bloodstream
- Distribution: to various parts of the body
- Metabolism: by enzymes
5: Excretion: through the kidneys or other routes
What can be found on a USP/NF?
The standards of drugs including: strength, purity, quality, packaging, and labeling
What is a Schedule I drug?
Drugs with no accepted medical use or other substances with high potential for abuse
Examples of Schedule I drugs
LSD, Marijuana, Mescaline, Peyote, Methaqualone
What is a Schedule II drug?
Drugs with accepted medical use with high potential for abuse that may lead to severe psychologic or physical dependence
Examples of Schedule II drugs
Morphine, Cocaine, Methamphetamine, Amobarbital
What is a Schedule III drug?
Drugs with accepted medical use with a potential for abuse that may lead to severe psychologic or physical dependence if abused
Examples of Schedule III drugs
Codeine, butalbital, testosterone
What is a Schedule IV drug?
Drugs with accepted medical use with low potential for abuse that may lead to limited psychologic or physical dependence if abused
Examples of Schedule IV drugs
Difenoxin, Diazepam, Oxazepam
What is a Schedule V drug?
Drugs with accepted medical use with low potential for abuse that may lead to limited psychologic or physical dependence relative to schedule IV drugs
Examples of Schedule V drugs
Dihydrocodeine, diphenoxylate
What are the components of an NDC number?
1st segment: Drug’s manufacturer
2nd segment: Product
3rd segment: Packaging (size and quantity)
What is the FDA’s stance on dietary supplements?
Acts 1994 and 2006, Congress addressed the regulation of supplements. The product is not intended for curing or treat any diseases. Supplements are manufactured according to quality standards and must be submitted to the FDA.
What are the three classes of drug recalls?
Class I: Drug will cause serious adverse health consequences
Class II: Drugs may cause temporary or medically reversible adverse health consequences
Class III: Drug will not likely cause adverse heath consequences
What act reduced the risks of tampered and mislabeled drugs from secondary sources?
Prescription Drug Marketing Act of 1987 and Prescription Drug Amendments of 1992
What act established refills on prescriptions and created ‘Rx Only” or legend drugs and OTC products?
Durham-Humphrey Amendment of 1951
What act created an Investigational New Drug Application that must be approved before NDA can start?
Kefauver Harris Amendments of 1962
What act allowed drugs intended for the treatment of rare diseases and conditions may be designated orphan drugs to help promote research on rare diseases?
Orphan Drug Act of 1983
What are the FDA’s characteristics of a new drug?
- Combination products
- New dosage form
- New indication, route of administration or dosage schedule
- A change to the formulation of an existing dosage form
Explain what an IND is
Investigational New Drug Application: where drug is to be submitted to the FDA before human trials. Company must wait 30 days to be approved for trials. FDA clinically hold on studies if it has concerns. The preliminary process.
Explain what an NDA is
New Drug Application: the drug successfully demonstrate is sufficiently safe and statement of proposal shifts to the marketing of the product.
Explain what a SNDA is
Supplemental New Drug Application: an application to change a drug or formulation. The new drug must add or strengthen its predecessor.
Explain what an ANDA is
Abbreviated NDA: Omits clinical investigations and lab studies of drug products previously approved by the FDA except for those pertaining to the drug’s bioavailability.
What is a Treatment IND?
Permits the use of an investigational drug in the treatment of patients who are enrolled in clinical trials but who have life-threatening conditions for which there is no satisfactory alternative therapy
What is an orphan drug?
A treatment IND that the FDA provides grants to support and given to a patient to extend life
What are the elements for drug labeling?
- Precautions
- Adverse reactions
- Drug abuse and dependence
- Overdosage
- Dosage and administration
- How it’s supplied
Describe phase 0 of clinical trials
Phase 0: less than 15 patients are microdosed and screen within 7 days exposure
Describe phase 1 of clinical trials
20-100 patients are tested for up to 1 year. Purpose is for safety. 70% success
Describe phase 2 of clinical trials
100-500 patients tested between several months - 2 years. Purpose is for short-term safety and effectiveness. 35% success
Describe phase 3 of clinical trials
1000-5000 patients tested for 1-4 years. Purpose is for safety, effectiveness and dosage. 25-30% success
Describe phase 4 of clinical trials
Evaluates mechanism or scope of action indicating possible new therapeutic uses for the drug. This will finalize additional dosage, strength, dosage forms, and routes of administration. Reveals additional side effects and drug interactions.
What is the difference between intramolecular and intermolecular forcers?
Intra: within a molecule
Inter: between molecules
What is the difference between cohesive and adhesive?
Cohesive: between like/same molecules
Adhesive: between different molecules
Explain the potential energy diagram
Molecules at a sufficient distance between one another and have no potential energy (PE) linkage will be 0. As the get closer, PE with drop as attraction grows. When they are tightly pressed, PE spikes causing a repulsive attraction. Repulsive and attraction forces can equilibrate reaching the collision diameter.
How are van der Waal forces formed?
By weak forces called a dipole that involve the dispersion of charge across a molecule (partially + and -)
How are hydrogen bonds formed?
An interaction between a molecule containing a H+ and an electronegative atom forming an electrostatic type of union.
How are ion-dipoles formed?
The interaction between polar molecules with molecules having positive or negative charges
How are hydrophobic interactions?
The interaction between nonpolar atoms in water driving them together
List the characteristics of the solid state
- Nearly incompressible due to strong intermolecular forces
- Volatile enough to have a sublimation point
- Atoms vibrate in fixed positions
- Fixed shape, particle size, and melting point
List the properties of crystalline solids
- Arranged in repetitive 3-D lattice units
- Have defined melting point
What are the 7 crystalline solid substances?
- Cubic
- Tetragonal
- Orthorhombic
- Rhombohedral
- Hexagonal
- Monoclinic
- Triclinic
Which crystalline solids has the most symmetry? The least?
Cubic and Triclinic
What is the difference between homomeric and heteromeric?
Regarding crystalline solids
Homomeric: composed of identical molecules or atoms
Hetermeric: composed of more than one type of molecule or atom
What is the difference between hydrates and anhydrates?
Anhydrates lack free water molecules, while hydrates have them.
What is the difference between salts and co-crystals?
Salts are formed by opposing ions. Co-crystals interact non-ionically.
An ion that has an opposite charge than the ion its associated with?
Counterion
Define solvate.
When a solvent is incorporated into the lattice.
What is the ability for a substance to crystallize into another crystalline form?
Polymorphism
List the properties of amorphous
- Hard glassy to rubbery state and does not possess a definite melting point
- Less stable than crystalline solids due to weak intermolecular forces
- More soluble than crystalline materials because they require less energy
Which has more stability amorphous or crystalline solids and why?
Amorphous because they have relatively high humidity and heat
What are polymers?
Large molecules formed by the covalent assembly of smaller molecules into a chain or network of repeating structural units
What are polymers typically used for on a chemical scale?
Stabilize amorphous drugs
How do polymer properties change?
The molecular weight determines their use
List the characteristics of the liquid state
- Occupies a definite volume
- Denser than gas
- Possess less kinetic energy than gas
- Less compressible than gas
- Possess vapor pressure and surface tension
Define vapor pressure
The pressure where vapor and liquid states reach equilibrium
What is surface tension?
The energy to expand the liquids surface area. When molecules at the surface are pulled downward and sideways by other molecules, but not upward away from the surface.
What happens if liquid has high vapor pressure?
Weaker intermolecular forces and lower boiling point
What happens if a liquid has a low vapor pressure
Harder for molecules to escape the liquid allowing stranger intermolecular forces and higher boiling point
List the characteristics of the gaseous state
- High compressibility
- Very low density
- Rapid diffusion
- High speed random collision of molecules with each other and container wall
What is the ideal gas law?
R = PV/T
Explain the relationship between partial pressure and the concentration of gas
They are directly proportional
What is the process where solid changes into liquid?
Melting
What is the process where solid changes into gas?
Sublimation
What is the process where gas changes into liquid?
Condensation
What is the process where liquid changes into solid?
Freezing
What is the process where liquid changes into gas?
Vaporization
What is a eutectic system?
Homogenous mixture of substances which either melts or solidifies at a single temperature lower than the melting point of any of the constituents
What is the lowest temperature at which eutectic mixtures melt?
Eutectic point
How do polymorphs arise?
- Changes in intermolecular bonding patterns
- Conformational changes in the molecule
- Molecular orientations with neighbors
