Pharmaceutics 1 Exam 1 study guide
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97 Terms
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What is the prerequisite to absorption?
Dissolution
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Which form (physical state) is better for bioavailability?
Liquid (solution)
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Higher melting point means \____________ solubility.
lower
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Lower melting point means \___________ solubility.
higher
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Ex: When a gas goes to a liquid what is it called?
condensation
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When a liquid goes to a solid what is it called?
freezing
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When a solid goes to a liquid what is it called?
melting
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Which is more soluble? salt or amorphous solid
amorphous
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Why do we need salt?
Because of it's bioavailability and solubility
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What is BCS?
Classifies drugs by water solubility and permeability
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Ex: Which class would a drug with poor solubility and good permeability belong to?
Class II
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Ex: Which is not a factor affecting solubility?
A. Stereochemistry
B. Temperature
C. Quantity of the Solute
D. Ionization
A. Stereochemistry
B. Temperature
C. Quantity of the Solute
D. Ionization
C
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Ex: 8 mg/mL is considered good or poor solubility?
POOR (less than 10mg/ml is considered poor)
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Ex: What is a co-crystal is made of.
API and nonvolatile molecule
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Why do we use salts?
Better bioavailability
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What is the main advantage of using crystalline solid forms?
More stable
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What is dosage regimen?
They prescribe schedule of dosing
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What is the initial dose?
A dose given at the beginning of treatment to start getting the effect of a drug
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What is the priming/loading does
A larger than usual, initial dose
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What is the minimum effective concentration?
The minimum serum concentration of the drug that is able to produce the desired therapeutic effect
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What is the minimum inhibitory concentration?
This is the lowest concentration of an antimicrobial drug that prevents physical growth of a microorganism after incubation with media
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What is the minimum toxic concentration?
This is the best level of blood serum concentration that produces does related toxic effects
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What is median effective dose?
It is the amount that produces the desired intensity of the effect in 50% of the individuals
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What is median toxic dose?
It is the amount that produces toxic affects and 50% of individuals
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What is therapeutic index?
It is the ratio between a drugs, median, toxic dose and its median effective dose (TD 50/ED 50)
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What is the FDA definition of a drug?
Any product approved for use in the diagnosis, cure, treatment or prevention of disease and that is intended to affect structure or any function of the body
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What is a dosage form?
It is a physical form of a pharmaceutical formulation. It is also a vehicle for the convenient and safe delivery of the accurate and precise dose of an active pharmaceutical ingredient combined with inactive ingredients.
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What are some examples of pharmaceutical dosage forms
Tablets, capsules, suppositories, solutions, suspensions, ointments, creams, gels, aerosol
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What are examples of pharmaceutical excipients?
Size, shape, texture, taste/odor, appearance
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What are drug delivery systems?
Specialize dosage forms with a specific drug release rate and or a preprogrammed drug release site
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Why do drugs need to be in a different dosage forms?
Ensuring Bioavailability - the rate and extent to which an API is absorbed and becomes available at the site of action
Protection drug substances
Ensuring unit dose precision
Protection drug substances
Ensuring unit dose precision
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What are the three factors to consider in dosage form design?
Therapeutic considerations of the disease state and patients
Physical and chemical properties of the drug substance
Biopharmaceutical considerations
Physical and chemical properties of the drug substance
Biopharmaceutical considerations
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What’s the difference between enteral and parenteral?
Enteral - oral, rectal, sublingual
Parenteral - IV, IM, subcutaneous, pulmonary, transdermal, nasal, otic, ocular
Parenteral - IV, IM, subcutaneous, pulmonary, transdermal, nasal, otic, ocular
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What is oral route’s effect? Systemic or local
Systemic
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What is parenteral route’s effect?
Systemic
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What is pulmonary route’s effect?
Mainly local pulmonary
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What is topical route’s effect?
Local
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What’s transdermal route’s effect?
Typically systemic
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Which dosage form is the most bioavailabe?
Solutions, suspensions, capsules, uncoated tablets, coated tablets
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What is ADME?
Absorption, distribution, Metabolism, Excretion
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Where do IV injections get input to?
Circulatory system
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What is IM/SC injections input?
Tissues
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What is oral dosage form’s input?
GI tract
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What are some non-first pass routes
IV, IM, subcutaneous, sublingual, buccal, and transdermal
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What is the FDA’s perspective on a new drug?
Any drug that is not recognized as being safe and effective in the conditions recommended for its use, and the labeling among qualified experts. A new chemical entity, a new formulation or method of manufacture a new combination of two or more old drugs a new use a route of administration or dosage form for an established drug.
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What is the Wiley act?
The first food and drug law established in 1906
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What are some sources of new drugs?
Plants
Minerals and animals
Micro organisms
Organic synthesis (artificial)
Minerals and animals
Micro organisms
Organic synthesis (artificial)
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What is an advantage of drugs being synthesized in a laboratory?
High purity, less expensive and large scale production with a short time
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What are two ways to genetically engineer a drug
Recombinant DNA or monoclonal antibodies
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What is drug discovery?
To find active ingredients, or modify the chemical structures of existing active ingredients of drugs to form the basis of a new agent. Ideally, this process should result in a goal drug.
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What is a goal drug versus a leading compound?
A goal drug can produce a desired effect, can be administered by the most desirable route ,can be administered at a minimal dosage and frequency, shows optimal onset and duration of activity has no side effects, and after exerting unnecessary affect, it should be eliminated from the body effectively and without residual effects.
A lead compound is a prototype, having desired activity, the also undesirable characteristics. I.e. poor ADME profile
A lead compound is a prototype, having desired activity, the also undesirable characteristics. I.e. poor ADME profile
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What is the difference between drug activity and drug potency?
Drug activity is the particular biological affect
Drug potency is the strength of the biological affect
Drug potency is the strength of the biological affect
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What is a drug candidate?
A compound worthy of extensive biological pharmacological and animal testing
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What is a pro drug?
Pro drug is a compound that requires metabolic biotransformation after administration to produce the desired pharmacologically active compound
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What are four ways of drug discovery?
Drug metabolism studies
Clinical observations
Rational design
High throughput screening
Clinical observations
Rational design
High throughput screening
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What is the ratio of drugs that get approved by the FDA
One in every 10,000 compounds
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What is pre-clinical testing
Pre-clinical testing is an activity to assess the potential of Lead compounds as safe and effective therapeutic agents.
the key components of pre-clinical testing are toxicology studies, thermal, kinetic studies and material properties studies
the key components of pre-clinical testing are toxicology studies, thermal, kinetic studies and material properties studies
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What is the toxicology studies?
It deals with the adverse or undesired effects of drugs
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What is the therapeutic index?
The therapeutic index equals the safe drug concentration/effective drug concentration
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What is pre-formulation studies and what are the properties of interest in those studies?
Preformulation studies are performed to understand the physical and chemical properties of Lead compounds to enable the optimal formulation design.
The properties of interest are solubility, partition coefficient, dissolution rate, solid state form, particle size and morphology, and stability
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What is an IND application
IND application is an investigational new drug application, and it is the first step of application for FDA approval.
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What is phase 1 of clinical trials
Phase 1 is known as the human safety phase. It usually contains 20 to 80 participants and is several months long.
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What is phase 2 of clinical trials
Phase 2 is known as the effectiveness phase it contains 100 to 300 participants and can last up to two years
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What is phase 3 of clinical trials
Phase 3 is known as safety, effectiveness and dosage phase it usually contains 1000 to 3000 participants and it can last anywhere from 1 to 4 years.
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What is a NDA application?
A NDA application can be filed for if the three phases of clinical investigation show sufficient drug safety and therapeutic effects, this is to gain marketing permission for the new drug product in the US.
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What is phase 4 of clinical trials
Phase 4 is known as the post marketing surveillance phase. It is continue data collection for drugs after they are marketed.
it looks at long-term effectiveness and any serious or unexpected, adverse side effects or drug interactions.
it looks at long-term effectiveness and any serious or unexpected, adverse side effects or drug interactions.
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What is a ANDA application
ANDA applications grant a marketing approval of a generic duplicate drug product which is comparable to an innovative drug product in dosage form strength route of administration, quality, performance characteristics, and intended use.
Generally includes no pre-clinical, or clinical data to establish safety and effectiveness.
Generally includes no pre-clinical, or clinical data to establish safety and effectiveness.
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What is a BLA application
A BLA application, or Biologics license application, requests for the manufacture and marketing of Biologics.
These products include blood products, vaccines, toxins, cellular and genetic therapies.
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What is an orphan drug?
Orphan drug development is for the more than 5000 known rare diseases.
Orphan drug development requires two clinical trials, except for seizures conditions where there are no other therapies available.
Orphan drug development requires two clinical trials, except for seizures conditions where there are no other therapies available.
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Define powder as physical form
A dry substance composed of finely divided particles
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What is micromeritics and what are the properties?
The science of small particles,
Particle size and size distribution
Shape
Angle
True density
Bulk density
Porosity
Voids
True volume
Bulk volume
Bulkiness
Particle size and size distribution
Shape
Angle
True density
Bulk density
Porosity
Voids
True volume
Bulk volume
Bulkiness
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Why is particle size important/ how is it measured?
Equivalent sphere diameter used to describe size, r
May be measured by volume, surface area, mass, or linear dimension
Affects mixing and blending, dose uniformity, powder flow, aerosolization, dissolution, suspendability of suspensions
May be measured by volume, surface area, mass, or linear dimension
Affects mixing and blending, dose uniformity, powder flow, aerosolization, dissolution, suspendability of suspensions
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What is the USP classification for fine particles?
\#60 sieve = 250um
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What is equivalent sphere diameter?
The size of a sphere can be described by a single number, r
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What is the difference between true/bulk density?
True density = density of the particles
P=m/v
Bulk density = density of powder
Pa= m/Vbulk
P=m/v
Bulk density = density of powder
Pa= m/Vbulk
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What is the difference true/bulk volume?
True volume = V
Space occupied by the powder, microscopic
V = mass/ density
Bulk volume = Vbulk
Volume occupied by the selected weight of a powder, macroscopic
True volume + porosity
Space occupied by the powder, microscopic
V = mass/ density
Bulk volume = Vbulk
Volume occupied by the selected weight of a powder, macroscopic
True volume + porosity
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What is porosity?
Void as a percent instead of decimal ratio
Void x 100
Porosity = (Vbulk - V)/Vbulk x 100
Void x 100
Porosity = (Vbulk - V)/Vbulk x 100
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What is bulkiness?
B = 1/Pa
(ML/g)
Reciprocal of bulk (apparent) density
(ML/g)
Reciprocal of bulk (apparent) density
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What is angle of repose?
Used to estimate the flow properties of a powder
Measured by allowing a powder to flow through a funnel and fall freely onto a surface
The lower the angle or repose more freely powder flows
Tan q = h/r
Measured by allowing a powder to flow through a funnel and fall freely onto a surface
The lower the angle or repose more freely powder flows
Tan q = h/r
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What is wettability of powders?
The ability of a liquid to spread over a solid surface
The contact angle q = a measure of the wettability
The contact angle q = a measure of the wettability
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What is a common measurement of wettability of powders?
Young’s equation
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What is the relationship between the powder wettability and contact angle?
Young’s question, relates surface free energies to contact angle
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What are pharmaceutical implications of wetting phenomena?
Good wetting required for dispersion of powders in liquid media and for the penetration of liquid into tablets.
Wetting problems can often be solved by the inclusion of surfactants into formations
Wetting problems can often be solved by the inclusion of surfactants into formations
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What is void?
The ratio of the space to volume
Void - Vbulk - V/ Vbulk
Void - Vbulk - V/ Vbulk
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What are the 3 main classifications of solids
Crystalline, amorphous, polymeric
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What are examples of single- component crystals?
Polymorph 1 and polymorph 2
Made of packed active molecules
Made of packed active molecules
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What are examples of multicomponent crystals?
Solvate - made of active molecules and solvent molecules
Salt- made of protonated active molecules and deprotonated acid molecules
Co- crystal - active molecule and non-volatile moelcules
Salt- made of protonated active molecules and deprotonated acid molecules
Co- crystal - active molecule and non-volatile moelcules
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What are classifications of crystalline solids?
Polymorphs, hydrates/ solvates, and salts/ cocystals
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What are the classifications of amorphous?
Amorphous and amorphous dispersions
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What are the characteristics of class 3 in the BCS?
Good solubility and poor permeability
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What are the characteristics of class 1 in the BCS?
Good solubility and good permeability
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What are the characteristics of class 4 in the BCS?
Poor solubility poor permeability
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What key factors affect solubility?
Molecular structure
Molecular weight
Crystal structure
Stereochemistry
ionization
Temperature
Molecular weight
Crystal structure
Stereochemistry
ionization
Temperature
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At what angle is a good wettability?
0 degrees
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At what angle is not good wettability?
90 degrees or more
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What is the recombinant DNA technique?
Ability to selectively hydrolyze a population of DNA molecules and then join two different DNA molecules
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What is the monoclonal antibodies technique?
Laboratory produced copies of a specific protein (antibody) produced within cells of higher animals. They can be designed specifically to only target a certain antigen.
Note 
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