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66 Cards in this Set
- Front
- Back
Surface tension and why it’s important
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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
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Correlation between contact angle and wetting process
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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. |
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Adhesion and cohesion forces
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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. |
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Surfactant structure, function and its mechanism of action
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- 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 |
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5. Surfactant concentration and its aggregation into micelles
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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 |
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6. Dispersion systems; oil in water, water in oil and multiple dispersions
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- 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 |
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7. Dispersion stability and instability causes
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Two problems with stability
- Creaming- reversible but not desirable (emulsion) - Settling-reversible or irreversible (suspensions) - Both due to density differences |
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8. Suspension instabilities (sedimentation, caking,..)
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- Instabilities
o Coagulation – strong particle aggregation o Flocculation-(clay) loose particle aggregation |
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8. Suspension , challenges,
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- Challenges
o Desired particle size o Cakeing of small particle o Fast settling of course particles o Particle shape |
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8. Suspension properties,
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- 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 |
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9. Particle sedimentation and factors affecting its rate
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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 |
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10. Emulsion stability, instabilities (creaming, breaking,..), stabilizers
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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) |
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11. Hydrophilic-Lipophilic Balance (HLB)
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o Griffin
o 20 x [MW(hydrophilic portion)/ MW(whole molecule)] Range is 0-20 Hydrophilic = 20 Hydrophobic = 0 Like dissolves like |
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2. pH-sensitivity of polymers and their drug delivery application
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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 |
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3. Thermogelling and importance of hydrophilicity and lipophilicity of the structure
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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 |
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4. Basic understanding of hydrogels and methods of hydrogel formation
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Can be Chemically and Physically Cross-linked
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5. Chain aggregation, hydrophobic association and ionic complexation
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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. |
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6. Micelle and liposome, definition, advantages and disadvantages
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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 |
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7. Swelling forces and swelling applications in drug delivery
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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 |
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8. Basics of microencapsulation, coacervation (simple versus complex)
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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 |
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9. Basics of conventional versus controlled delivery
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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 |
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10. Monolithic versus reservoir drug delivery systems
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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 |
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11. Role of swelling and biodegradation in pharmaceutical dosage forms
12. Erosion mechanisms (surface versus bulk) |
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 |
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1. State the main intention of cGMP or GMP
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Gov’s quality control standards intended to protect public from unsafe and harmfull drugs, med devices, food, and cosmetics
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2. Identify the general provisions – scope and definition of cGMP
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• 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 |
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3. Recognize the seven expectations of all GMP
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• 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 |
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4. Differentiate between compounding and manufacturing
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• 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 |
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5. Describe reasons for the increase in preparation of patient-specific medications (compounding)
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• 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) |
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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
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It allows pharmacist to compound by exempting them from certain laws
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7. Describe how the USP/NF helps prepare pharmacies for compounding
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• Starting a compounding accreditation board
• Set standards and guidelines |
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8. What institution promulgated the Good Compounding Practices and develops documents and recommendations for these type of practices (similar to cGMP)
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National Assoc of Boards of Pharmacy
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1. Define Disperse systems
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• 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 |
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2. Differentiate between dispersion classification
• True Solution |
o < 0.001 Microns
o Molecular dispersion o Invisible particles even w/ electorn microscope o Pass through filter paper and semi-permeable membranes |
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2. Differentiate between dispersion classification
• Colloid Dispersion |
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) |
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2. Differentiate between dispersion classification
• Coarse Dispersion |
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 |
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4. Recognize colloidal terminology based on how colloidal particles react with the dispersion medium
• Lyophilic Colloids |
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 |
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4. Recognize colloidal terminology based on how colloidal particles react with the dispersion medium
• Lyophobic Colloids |
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 |
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4. Recognize colloidal terminology based on how colloidal particles react with the dispersion medium
o Association Colloids |
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 |
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5. Describe and distinguish between the properties of colloids
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o Kinetic Properties
Brownian Movement o Optical Properties Tyndall Effect o Diffusion o Sedimentation o Viscosity o Electrolyte properties |
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6. Understand Fick’s and Stoke’s law general relationship
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• 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 |
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7. Define Zeta potential, Tyndall effect and other associated optical and electrochemical charges.
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• 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. |
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1. Explain how pharmacists utilizes biopharmaceutic analysis to the benefit of the patient
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• Determines drug, metabolites, and related substances in formulas and biological fluids
• Help with clinical pharmaco kinetics • Bioavailablity and bioequivalence |
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2. Differentiate the terms sensitivity and selectivity requirements for analysis of drug substances
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• 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 |
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3. Define the term trace analysis and give the common name for drug concentrations (10-9, 10-12, 10-15 g)
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• 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 |
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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)
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• If it is influnced by biotransformations the analysis will be scqued.
• Assay must be able to distinguish drug form metabolite |
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6. Cite and discuss considerations involved in the selection of an appropriate organic solvent for solvent extraction
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• Liquid-Solid extraction
o Adsorbed • Liquid-Liquid Extraction o Pertains to the partion coefficient |
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7. Define: (1) chromatography, (2) mobile phase, (3) stationary phase
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• 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! |
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8. List and define the types of chromatography
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• Thin layered Chromo (TLC)
• Gas Chromo • High Proformance Liquid Chromo (HPLC) • Gel permeation chromo • Ion exchange Chromo |
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9. Define: (1) tr , (2) Rf
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• Tr and Rf are retention values
o Rf = distance compound moved / solvent front moved o tr = retetion time ? |
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10. Name the essential components of gas and liquid chromatography
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• 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 |
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11.Compare detectors in terms of usefulness
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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 |
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13. Distinguish between external, internal and standard addition methods
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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 |
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1. Define the preformulation process and specific timing
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• 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 |
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2. Identify the objectives of preformulation
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• 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 |
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3. Cite reasons for molecular optimization
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• Molecular Chemist
• Moleu;ar Mod improves o Stability o Soluability Ex. Water soluable drugs o Absorption o Changing Crystallinity, taste, odor, etc Ex. EES |
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4. Explain the different tests use for bulk characterization
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• Crystalinity
• Hygroscopicity • Fine particle Characterization • Bulk Density • Powder Flow Properties • Mechanical Properties |
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5. Understand the difference between crystallinity, polymorphism and amorphous materials
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• 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 |
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6. Identify the techniques use for determining polymorphism
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• Thermal Methods (DSC)
o MP • X-Ray Diffraction o Determine Crystal structure • IR-Spectroscopy o ID groups • Solid State NMR o Structure |
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7. Distinguish between hygroscopicity and deliquescent
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• Hygroscopicity
o Tendency to absorb atmospheric moisture • Deliquescent o Material absord sufficient water to dissolve completely |
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8. Recognize the parameters and methods use for particle characterization
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• 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 |
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9. Explain the difference between densities and how to calculate their values
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• 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 |
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10. Recognize the rationale of powder flow
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• Free Flow
o Prefered • Non-free Flow o Cohesive |
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11. Understand the evaluation of mechanical properties of powders
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• 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. |
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12. Discuss the concept of solubility analysis and why they are used
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•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 |
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13. Describe the reasons for stability analysis and the typical setup
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• Compatability
• Packaging o Usually done at 25/ 60% RH o Accelerated conditions Higher temp/humidity Light and temp exposer |
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14. Relate how physicochemical properties such as solubility and crystallinity modification influence bioavailability
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More soluable better bioabaliitly and crystal structure effect soluablity
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