P1 Cuetics Final

Front 1

Surface tension and why it’s important

Back 1

Surface Tension- ability of molecules to stick together form elastic layer on surface of a liquid. used by trees suck water up. measured dyne/cm @ 25 C

Front 2

Correlation between contact angle and wetting process

Back 2

Wetting when contact angle is less than 90.
smaller angle wetter surface.
Contact angle depends on ratio of adhesion forces to cohesion forces, the higher adhesion the smaller angle.

Front 3

Adhesion and cohesion forces

Back 3

Cohesion between similar materials,
Adhesion between different materials.
Higher Cohesion forces like Mercury and glass you get a Convex top.
If you have higher adhesion forces like with H2O and glass you get Concave top.

Front 4

Surfactant structure, function and its mechanism of action

Back 4

- Polar Head with Ionic.
- Non-Polar Tail-
- Functions- can exsist in two phases and make aggregates(micelles)
- Mech of Action-(repulsion) Electrostatic interactions and Steric Repulsion

Front 5

5. Surfactant concentration and its aggregation into micelles

Back 5

Critical Miscelle Concenration- is concentration at which self aggregation happens
- Anionic Surfactant is better in High pH
- Cationic Surfactant is better in Low pH
- Zwitterionic Surfactant is ok in any pH
- Non-Ionic Surfactant it’s properties depend on the N value

Front 6

6. Dispersion systems; oil in water, water in oil and multiple dispersions

Back 6

- Matrix that dispesion is in is Continous (major) Phase (Internal)
- Whats dispersed is Dispertion ( minor) phase (external)
- Exist in two phases.
- Liquid in Liquid is Emulsion
- Solid in Liquid Is Suspension
- Gas in Liquid is Foam
- Liquid in gas is Cloud
- Soild in Gas is smoke(aerosol)
- Oil in Water is Suspension or Emulsion
- Water in Oil is Inverse susp/Emul
- Multiple emulsion. W/O/W or O/W/O
o Protein Delivery usually used

Front 7

7. Dispersion stability and instability causes

Back 7

Two problems with stability
- Creaming- reversible but not desirable (emulsion)
- Settling-reversible or irreversible (suspensions)
- Both due to density differences

Front 8

8. Suspension instabilities (sedimentation, caking,..)

Back 8

- Instabilities
o Coagulation – strong particle aggregation
o Flocculation-(clay) loose particle aggregation

Front 9

8. Suspension , challenges,

Back 9

- Challenges
o Desired particle size
o Cakeing of small particle
o Fast settling of course particles
o Particle shape

Front 10

8. Suspension properties,

Back 10

- Suspension Properties
o Therapeutic Efficacy
o Chem Stability
o Permanency of Prep
o Esthetic Prep
o Slow settling, readily re-dispersed
o No Particle growth
o Easy dispensing

Front 11

9. Particle sedimentation and factors affecting its rate

Back 11

o Sedimentation Rate (Stokes equation
o Dx / dt = d2 ( pi – pe) g /18η
 d2 =Particle size(diameter), Increase size increase sedimentation rate
 η = Medium Viscosity, Increased visc will decrease sedmentaion rate
 pi = Particle density
 pe = medium density
 g= force of gravity

Front 12

10. Emulsion stability, instabilities (creaming, breaking,..), stabilizers

Back 12

o Emulsion Instabilities
o Coalescences (Emulsion Breaking) – Irreversible
o Creaming – Is reversible
o Freezing and Thawing- Cant repeat otherwise you lose stability properties change. Must make it resistant to freezing and thawing
o Emulsion Stablilzers
o Surfactants
o Hydrocolloid- Acacia, Gelatin, Lecithin
o Fine solids- Colliod Clays( bentonite, magnesium hydroxide)

Front 13

11. Hydrophilic-Lipophilic Balance (HLB)

Back 13

o Griffin
o 20 x [MW(hydrophilic portion)/ MW(whole molecule)]
 Range is 0-20
 Hydrophilic = 20
 Hydrophobic = 0
 Like dissolves like

Front 14

2. pH-sensitivity of polymers and their drug delivery application

Back 14

Enteric Coating
o Resistant to stomach acid, drug will be released at neutral pH of small intestine.
o Anionic Methylcrylics
o Delivery to Intestine
o Anionic Polymers
Reverse Enteric
o Material resistant to neutral pH, Drug will be released at lower pH of stomach
o Cationic Methacrylics
o Protective Coating
o Delivery to stomach
o Cationic Polymer
Sustained Release
o Not effected by pH

Front 15

3. Thermogelling and importance of hydrophilicity and lipophilicity of the structure

Back 15

o Hydroxypropyl Substituions are more hydrophilic
o Increase substation increase the temp at which thermogelling occurs
o Methyl Substitutions are more hydrophobic
o By decreasing substitutions will increase temp at which Thermogelling occurs

Front 16

4. Basic understanding of hydrogels and methods of hydrogel formation

Back 16

Can be Chemically and Physically Cross-linked

Front 17

5. Chain aggregation, hydrophobic association and ionic complexation

Back 17

o Chain Aggregation
o Random coil to chain-> double helix->aggregate (gel)

o Hydrophobic Association
o Aggreagting of Hydrophobic region

o Ionic Complexation
o When an ion such as Ca is introducted the G-block of material (eg, Aligate gelation) Interacts to form Egg-box causeing it to be form gelatin

o Hydrogen bonding
o between what your mixing. Individually they are H2O soluable but when mixed gel with each other.

Front 18

6. Micelle and liposome, definition, advantages and disadvantages

Back 18

Micelle
o Aggregate of Surfactants
o Smaller than Liposome
o Need specific [C] CMC (Critical Micelle Concentration)
o No bilayer or internal aqueous core
Liposomes
o Not [C] dependent
o Microscopic Phos Lipid Bilayer
o Internal aqueous compartment

o Pros
 Incorporate insoluable and soluable drugs
 Biodegradable
 Non-toxic
 Improve Pharmacokinatic props of drug

o Cons
 Stability-Physical and Chem instablty in liquid state
 Efficiancy is low
 Scale up is hard
 Sterilization is hard
 Weak mechanical properties cause drug leakage

Front 19

7. Swelling forces and swelling applications in drug delivery

Back 19

o Swelling Forces
o Polymer-Solvent
o Electrostatic Forces
o Osmotic Forces
o Elastic Forces
o Swelling App in Drug Delivery
o Superdisntegrants-help to disintegrates properly/quickly
o Ion Exchange Resins
 Taste Mask
 Drug Stablization
 Tablet Disintegration
 Sustained Release

Front 20

8. Basics of microencapsulation, coacervation (simple versus complex)

Back 20

o Coacervation-Process of making Microcapsules
o Simple
 One polymer component
 Induced by physical or chemical change
o Temp
o Solubility
o Ionic Strength
o [C]
 Complex
o More than one component
o Attraction of oppositely charged polyelectorlytes
o this causes gel to come out of solution

Front 21

9. Basics of conventional versus controlled delivery

Back 21

o Conventional delivery
o No Control on delivery
o Controlled delivery
o Can change the rate of release of a drug
o Types of Controlled delivery
 Instant Release
 Sustained- Fast onset with slow decline
 Constant- long plateau
 Delayed

Front 22

10. Monolithic versus reservoir drug delivery systems

Back 22

o Monolithic
o Drug distributed throughout polymer matrix
o Relased by diffusion
 Dependent of drug [C] and relaxation of Matrix

o Reservoir
o Drug release controlled by a permeable membrane
 Non Porous- Diffuses through membrane
 Porous- diffuses through porous
• Facillitated- force helps
• Simple
 Tortuosity (filler Orientation)- filler hinders release changing direction of filler changes release properties

Front 23

11. Role of swelling and biodegradation in pharmaceutical dosage forms

12. Erosion mechanisms (surface versus bulk)

Back 23

o Erosions
o Polymer erosion controls release
o Happen By
 Biodegradation- exsistance of hydrolizable sites
• Suface- as one layer removed it exposes next
• Bulk- Hydrolze all sites at the same time
o Porous matrix helps gives access to water
 Swelling-gel on outside swell causeing drug to go thru which takes time
• Extended release
• Can achieve zero order kinetics
o Extra Stuff
o Osmotic tablet
 Has orifice with osmotic agent
 Causes constant release
 One a day tablet
o Osmotic Pump
 Year long deliver
o Solvent evaporation

Front 24

1. State the main intention of cGMP or GMP

Back 24

Gov’s quality control standards intended to protect public from unsafe and harmfull drugs, med devices, food, and cosmetics

Front 25

2. Identify the general provisions – scope and definition of cGMP

Back 25

• Organization and personel
• Building and facilities
• Equipment
• Production and process controls
• Packaging and labeling controls
• Holding and distribution
• Laboratory control
• Records and reports
• Returned salvaged drug products
Really just Facility, Personel, Labelling, Manufacturing

Front 26

3. Recognize the seven expectations of all GMP

Back 26

• Protect from contaimination
• Prevent mix ups
• Know what your doing before you do it
• Strive for consistency and control
• Document all activities
• Have independent group make final decisions on documents,product release, and quality issues
• Learn from mistakes minitor and continually improve

Front 27

4. Differentiate between compounding and manufacturing

Back 27

• Compounding
o Directed toward one script
o Regulated by FDA
o Pharmacy, hospital engaged in manufatureing, repackageing, or relabelig drugs
• Manufacturing
o Large scale
o Labeling requirments
o CGMP controlled
o More regulated

Front 28

5. Describe reasons for the increase in preparation of patient-specific medications (compounding)

Back 28

• Drug dosage not commercially available
• Pediactric meds need to be prepared more kid friendly
• Meds not stable and require prep and dispensing every few days
• Reported in literature but not manufactured or approved yet
• Physicians want to used drug in innovated ways
• Most not available for vet use
• Home health care
• Allergy to excipients (lactose allergy)

Front 29

6. Recognize the purpose of the specific section of the Food and Drug Modernization Act (Section 127)and how it exempts pharmacy compounding from several government regulatory requirements

Back 29

It allows pharmacist to compound by exempting them from certain laws

Front 30

7. Describe how the USP/NF helps prepare pharmacies for compounding

Back 30

• Starting a compounding accreditation board
• Set standards and guidelines

Front 31

8. What institution promulgated the Good Compounding Practices and develops documents and recommendations for these type of practices (similar to cGMP)

Back 31

National Assoc of Boards of Pharmacy

Front 32

1. Define Disperse systems

Back 32

• Is a system containing one or more constituents distributed throughout a homogeneous medium
o Classifed into 3 categories
 True Solutions - Less than 0.001 Microns
 Colloids – 0.001 to 0.5 microns
 Coarse Dispersion – greater than 0.5 microns

Front 33

2. Differentiate between dispersion classification
• True Solution

Back 33

o < 0.001 Microns
o Molecular dispersion
o Invisible particles even w/ electorn microscope
o Pass through filter paper and semi-permeable membranes

Front 34

2. Differentiate between dispersion classification
• Colloid Dispersion

Back 34

o 0.001 to 0.5 microns
o Intermediat state between true solution and suspension
o Particle only seen with electron microscope
o Can pass through filter paper, but NOT semi permeable membrane
o Diffuse slower (Size durrrrr)

Front 35

2. Differentiate between dispersion classification
• Coarse Dispersion

Back 35

o > 0.5 microns
o Know as Emulsions or Suspensions
o Particle visible with naked eye
o No pass through filter paper or semi-permeable membrane
o Used extensively in pharm products

Front 36

4. Recognize colloidal terminology based on how colloidal particles react with the dispersion medium

• Lyophilic Colloids

Back 36

o Reaciton w/ dispersion medium are said to be solvent loving
 Strongly attracted to solvent medium
 Attraction so strong not differentiation between colloid and dispersion medium
o Essentially one phase
o Lyophilic Colloid distinguish based on dispersion medium
 Hydrophilic
 Lipophilic
 Have to distinguish like this because it may be a Lyophilic colloid in one medium but NOT in another
 EX. Hydrophilic colloid Mucilages, used as viscosity inducing agents in suspensions and emulsions

Front 37

4. Recognize colloidal terminology based on how colloidal particles react with the dispersion medium

• Lyophobic Colloids

Back 37

o Solvant Hating
 No attraction between solvent and dispeion medium
 Also named based on medium they hate
• Hydrophobic etc
• Hydrophobic colloids usually dispersion of inorganic solvents or insoulable drug particles

Front 38

4. Recognize colloidal terminology based on how colloidal particles react with the dispersion medium

o Association Colloids

Back 38

 Amphiphilic Colloids
 Are surface activate agent because it has two sections
• Hydrophilic/ polar portion
• Lypophilic/ non- polar portion
 This cause them to form monomolecular films on surface of water to cause reduction in surface tension
o Peptization (deflocculation)
 Sponaneous dispersion of a colloidal precipitate onn the adtion of small amounts of third substance
 Third substance may be dispersion medium but is usually an electrolyte

Front 39

5. Describe and distinguish between the properties of colloids

Back 39

o Kinetic Properties
 Brownian Movement
o Optical Properties
 Tyndall Effect
o Diffusion
o Sedimentation
o Viscosity
o Electrolyte properties

Front 40

6. Understand Fick’s and Stoke’s law general relationship

Back 40

• Fick’s Law
o Amount that diffuses across a give Plane area is DIRECTLY proportional to change in [C] with distance
• Stokes Law
o Rate of Sedimentation is proportional to particle size and inversely proportional to viscosity of dispesion medium

Front 41

7. Define Zeta potential, Tyndall effect and other associated optical and electrochemical charges.

Back 41

• Zeta Potential
ocharge difference between outer edge of Particle and body of liquid
o Colloid have fixed zeta potential (critical potential) above is stable
• Below colloid no longer repel flocculation
• lower Zeta potential by adding ion of opposite charge or colloid of opposite charge.
• Tyndall Effect
o Beam of light through true solution not a visible cone
o Light scattered by colloid
o Used to visualize colloid particle
o Don’t actually see particle just bright spot

• Nernst Potetial
o Potential on the surface of the particle.

Front 42

1. Explain how pharmacists utilizes biopharmaceutic analysis to the benefit of the patient

Back 42

• Determines drug, metabolites, and related substances in formulas and biological fluids
• Help with clinical pharmaco kinetics
• Bioavailablity and bioequivalence

Front 43

2. Differentiate the terms sensitivity and selectivity requirements for analysis of drug substances

Back 43

• Sensitivity- Lowest level of drug that can be measured
o Shows drug and/or metabolite
• Selectivity- ability to distinguish the drug from the metabolite and other substanced

Front 44

3. Define the term trace analysis and give the common name for drug concentrations (10-9, 10-12, 10-15 g)

Back 44

• Trace level – parts per million or less [C] of drugs
o 1 microgram – ppm
o 1 nanogram – ppb
o 1 pictogram – ppt
o 1 femtogram – ppq

Front 45

4. Explain why the pharmaceutical analyst must be cognizant of the metabolism scheme for a drug(s) when analyzing a biological sample containing the drug(s)

Back 45

• If it is influnced by biotransformations the analysis will be scqued.
• Assay must be able to distinguish drug form metabolite

Front 46

6. Cite and discuss considerations involved in the selection of an appropriate organic solvent for solvent extraction

Back 46

• Liquid-Solid extraction
o Adsorbed
• Liquid-Liquid Extraction
o Pertains to the partion coefficient

Front 47

7. Define: (1) chromatography, (2) mobile phase, (3) stationary phase

Back 47

• Chromatogrophy
o Seperation technique based on differing affinities or a mixture of solutes between two phases
o Physical separation of components results
o Stationary is stationfuckinary
o Mobile Phase- Moves!

Front 48

8. List and define the types of chromatography

Back 48

• Thin layered Chromo (TLC)
• Gas Chromo
• High Proformance Liquid Chromo (HPLC)
• Gel permeation chromo
• Ion exchange Chromo

Front 49

9. Define: (1) tr , (2) Rf

Back 49

• Tr and Rf are retention values
o Rf = distance compound moved / solvent front moved
o tr = retetion time ?

Front 50

10. Name the essential components of gas and liquid chromatography

Back 50

• Gas Chromo
o Mobile Phase is Gas
o Pump in helium or whatever used
• Liquid Chromo
o Mobile Phase is Liquid
o Has solvent supply

Front 51

11.Compare detectors in terms of usefulness

Back 51

o Spectrophotometer
o Use uv/ visible absorption
o Frequently used for detetion

Flame Ionization detector
o Frequently used for detection
o Common for organics

Mass Spec
o Tell the material
o Used in forensic application where you don’t know the material

Front 52

13. Distinguish between external, internal and standard addition methods

Back 52

o Internal
o P-C behavior similar to metabolite
o Response ratio is determined
o External
o Multiple samples with increasing [C]
o Standard Addtion
o Always the same sample size

Front 53

1. Define the preformulation process and specific timing

Back 53

• Preformulation –Stage or process by which the physical, chemical, and mechanical properties of drug substance are determined by themselves and with common excipients
• Specific timing
o Very early stages ( prior to formulation) Usually
o But can last long after final formulation

Front 54

2. Identify the objectives of preformulation

Back 54

• To determine that the drug product is safe and effective
o Select most stable drug
o ID compatibale excipients
o Provide knowledge that can be used in manufacture of dosage form
• Main Preformulation parameters
o Molecular Optimization
o Bulk Characterization
o Soluability analysis and related properties
o Stability

Front 55

3. Cite reasons for molecular optimization

Back 55

• Molecular Chemist
• Moleu;ar Mod improves
o Stability
o Soluability
 Ex. Water soluable drugs
o Absorption
o Changing Crystallinity, taste, odor, etc
 Ex. EES

Front 56

4. Explain the different tests use for bulk characterization

Back 56

• Crystalinity
• Hygroscopicity
• Fine particle Characterization
• Bulk Density
• Powder Flow Properties
• Mechanical Properties

Front 57

5. Understand the difference between crystallinity, polymorphism and amorphous materials

Back 57

• Crystalinity- Repeating spacing of constituents atoms or molecules in a 3D array
• Amorphous- Having atoms or molecules randomly placed in a liquid
o Higher thermodynamic energy than corresponding crystalline form
• Polymorphism- ability of a compound to exist as more than one distinct crystalline species
o this will effect soluablity, intrinsic dissolution, hygroscopicity

Front 58

6. Identify the techniques use for determining polymorphism

Back 58

• Thermal Methods (DSC)
o MP
• X-Ray Diffraction
o Determine Crystal structure
• IR-Spectroscopy
o ID groups
• Solid State NMR
o Structure

Front 59

7. Distinguish between hygroscopicity and deliquescent

Back 59

• Hygroscopicity
o Tendency to absorb atmospheric moisture
• Deliquescent
o Material absord sufficient water to dissolve completely

Front 60

8. Recognize the parameters and methods use for particle characterization

Back 60

• Parameter
o Size
o Shape
o Surface Area
• Methods
o Microscopy,Sieving
o Microscopy
o Brunauss,Emmet, and Teller (BET)
o Method are in same respective order

Front 61

9. Explain the difference between densities and how to calculate their values

Back 61

• Bulk Density
o M/initial Vol
o Used for storage purposes
• Tap(Apperent,packed) Denisty
o Used in capsule choices
o M/ vol after several taps to consistent vol
• True Denisty
o Used to determine how much of particle is filled with air
o Use gas like helium

Front 62

10. Recognize the rationale of powder flow

Back 62

• Free Flow
o Prefered
• Non-free Flow
o Cohesive

Front 63

11. Understand the evaluation of mechanical properties of powders

Back 63

• Important for tablet formation
• Compressiblity
o How reduced you can get the volume
o % compressibility = [Tap Density – Initial Bulk Density / Tap denisity] x 100
• Compaction
o Stay in final form
o Powders that form hard compacts under applied pressure w/o cap or chip can be considered compact.

Front 64

12. Discuss the concept of solubility analysis and why they are used

Back 64

•Determine pKa
o Ionizing properties
o Acid in acid unionized
o Base in base Unioinzed

• Parton Coefficient
oMeasure Lipophilic characteristics
oPreferance for lipophilic or hydrophilic for drug
o@ equallibrum and constant temp
o K= Cu/ CL..Upper hydrophobic
o Uses
 Extract of crue drug
 Absorption

•Temperature Effect
o Endo thermic require energy
 Increase temp increase soluability
o Exothermic
 Give off energy
 Decrease temp increase soluablilty

Front 65

13. Describe the reasons for stability analysis and the typical setup

Back 65

• Compatability
• Packaging
o Usually done at 25/ 60% RH
o Accelerated conditions
 Higher temp/humidity
 Light and temp exposer

Front 66

14. Relate how physicochemical properties such as solubility and crystallinity modification influence bioavailability

Back 66

More soluable better bioabaliitly and crystal structure effect soluablity