Pharmaceutics Exam 3

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Section 1

Question Answer
What is the main barrier to drug absorption?Stratum corneum
Hygroscopic meansabsoprtion of water
Keratinsulfur containg fibrous protein
Collagengives skin density
Elastinis formed in crosslinks, and is stringy
Systemicgets into the blood
Localstays where area is administered
Occlusive property meansbarrier property
Measure of drug transportFranz cells
Three types of permeation enhancerschemical agents, iontopheresis, and sonophoresis
Dermal clearanceThe rate of drug removal from the skin
Vasodilatorincreases blood supply to skin (raises dermal clearance)
Vasoconstrictordecreases blood supply to skin (lowers dermal clearance)
Cutaneous BiotransformationCatabolic enzyme activity in the dermis (e.g. w/patches)
What are good criteria for a drug delivery system?Small molecule size, small dose, hydrophobicity, and broad therapeutic index

Section 2

Question Answer
Oleaginous base (BEST occlusive barrier)Hydrocarbons, cocoa butter (CB), oils, waxes (petrolatum), usually NO water componment, and oil only
Absorption basew/o emulsions (aquaphor), closer to organic with water on the internal phase, and CANNOT wash out with water
Water-Removable baseo/w emulsions (hydrophilic ointment, USP), includes preservatives, closer to water with oil as internal phase, and CAN wash out with water
Water Soluble baseGreaseless (no oily components), polyethylen glycols (PEG)
Incorporation MethodNo heat, mainly levigation (particle size reduction).
Fusion MethodUse of heat. Melt the component with the highest melting point. Add volatile/heat labile components at the end.

Section 3

Question Answer
CreamsGenerally emulsions: o/w or w/o. Vanish quickly (o/w emulsions)
GelsUse of agent and a large amount of water. Agents include: carbomers, cellulose derivative, and natural gums. Preservatives are essential

Section 4

Question Answer
Vaginal Suppositoriespessaries
Uethral Suppositoriesbougies
Anorectal physiologyrectum: 150 mm (6 in) in length, and has NO villi/microvilli.
Which vein carries blood into the portal system?Upper hemorrhoidal vein
α-form This form melts at <30C. (bad for storage and administration)
β-formThis melts at ~35C (desirable).
PEGylationThe process of adding PEG chains to protein molecules to increase protein diameter.
PEG 400Liquid form of PEG
PEG 8000Solid form of PEG
Volume of Suppository basevolume of mold - volume of drug

Section 5

Question Answer
What is a solution?A mixture of two or more chemical entities at a MOLECULAR level
What is a dispersion?Mixture of two or more chemical entities at a PARTICULATE level
AlloySolid solution
Molarity moles of solute/L of solution
Molalitymoles of solute/Kg of solvent
Mole FractionThe ratio of the moles of solute to the total moles present in solution
Solute the solid or liquid that is dissolved in another liquid
SolventThe liquid containing the solute. Forms the bulk of the solution.
VehicleAnother name for a pharmaceutical solvent or solution used to dispense/carry drug. Example: syrup.
What is a mole? Weight in grams divided by molecular weight
What is a dipole? The separation of charges. If high, it can also dissolve ionic compounds.
What is the Dielectric Constant? It is the effectiveness of a medium to keep charged particles apart relative to vacuum. Similar to polarity.
What are buffers? Solutions that resist changes in pH

Section 6

Question Answer
Aromatic WatersLow concentrations, generally saturated. Aqueous, flavored vehicles (rose water, peppermint water, etc.)
MouthwashesRefreshing, deodorizing, antiseptic. Sodium borate, peppermint oil.
Nasal SolutionsSymptomatic relief; local irritation, or congestion. Ephedrine HCl, oxytocin nasal solution.
Otic SolutionsSymptomatic relief. Hydrocortisone (itching), neomycin or polymyxin.

Section 7

Question Answer
Simple Syrups ○ 85% w/v of table sugar in water. ○ Prepared by heating components or cold stirring ○ Density is approximately 1.3 g/mL. So concentration is 65.4% w/w.
Flavored Syrups○ Contain aromatics such as menthol ○ Used as vehicle
Medicated SyrupsVitamin syrups, antihistamine syrups

Section 8

Question Answer
Non-aqueous: Elixirs● Clear, flavored, sweetened, hydroalcoholic solutions ● Contain 10-70% v/v alcohol.
Glycerines ● Glycerine-water mixture with glycerine 50-100%. Generally used for ear drops. Ex: sod. bicarbonate glycerine ear drops. ● Sodium bicarb bubbles up used to loosen up the ear wax
Liniments ● Solutions of oils, alcohols, and/or soaps. ● External use only. Ex: calamine liniment.
Spirits ● Alcoholic or hydroalcoholic solutions of volatile oils. ● Internal or external use. Includes liquors such as whiskey and brandy.
Colloidons● Solutions of nitrocellulose in a mix. of ether and alcohol ● Very highly flammable ● Applied on skin; leave a thin layer of nitrocellulose.

Section 9

Question Answer
Hard Water Unsuitable for pharmaceutical purposes. Contains bicarbonates and sulfates of Ca and Mg
Soft/Deionized Waterobtained upon removal of above salts with ion exchange resins. Still not suitable for Pharmacy
Purified Water Deionized water that meets EPA standards. May be used for non-sterile purposes.
Distilled WaterFiltered hard or soft water. Some volatile organic matter and salts may be present.
Sterile WaterMicrobes destroyed, but toxins may be present. Not suitable for injections, but may be used for other purposes such as opthalmic preparations. May still have pyrogens left over
Pyrogen free Sterile Water may be used for large volume parenterals. Pyrogens removed by filtration or repeated distillation. Should not contain more than 0.25 USP units of pyrogen/10 mL. Should NOT contain preservatives. Do not want to use to make syrup solutions
Bacteriostatic Watermay be used for small volume parenterals. Similar to sterile water for injection, except that: (1) should not contain more than 0.5 USP units of pyrogen/10 mL, (2) contains preservatives to control microbial growth.

Section 10

Question Answer
Non electrolytes (do not dissociate in solution) ■ Volatile (menthol, ethylene chloride) ■ Nonvolatile (glucose, mannitol, sorbitol)
Electrolytes ○ Molecules that conduct electricity in solution (charged molecules). Ionization, dissociation of weak acids and bases
Van’t Hoff equation for non-electrolytesπV = nRT
Van’t Hoff equation for electrolytesπV = inRT

Section 11

Question Answer
Cul-de-sac● Area behind the lower eyelid and this is where the eye can hold a finite amount of volume behind the lower eyelid
Diabetic RetinopathyLeading cause of blindness among working-age Americans
Normal volume of tear fluid in cul-de-sac7-8 μL
Maximum volume in cul-de-sac30 μL
Optimal volume for an ophthalmic sol/suspension5-10 μL
Normal volume of a drop 50 μL
Residence time for eye drops 1-2 min
Normal pH of lacrimal fluid7.4

Section 12

Question Answer
Class I method for HYPOtonic solutionsSolution: add sufficient sodium chloride
Class II method for HYPERrtonic solutionsSolution: add sufficient water

Section 13

Question Answer
Surfactants (non-ionic)Tweens, Poloxamers, Pluronic F127
Chelating Agents EDTA 0.1%, Trisodium EDTA 0.25%
Enzymatic Cleaners Stabilized papain, Subtilisin A, Pancreatin (comes from pancreas and can digest some of the protein)
What preservative is linked to autism in children? Thimerosal

Section 14

Question Answer
Adult Nasal Cavity Capacity 20 mL
Adult Nasal Cavity Surface Area 180 cm2 due to presence of microvilli
What is a major problem in drug delivery to the brain?The Blood Brain Barrier
CerumenEar wax. May contain epithelial cells, fallen hair, dust, and other foreign bodies & is mainly hydrophobic.
Otic Surfactant Triethanolamine Polypeptide Oleate Condensate (TPOC)
Otitis Media An infection in the middle ear. This is the most common ear problem in children.

Section 15

Question Answer
Intravenous ● In the vein; large volumes possible ● Immediate blood levels; rapid action (no absorption needed) ● Continuous phase: aqueous (sterile, pyrogen free) usually give solution and not suspension because do not want to block arteries and veins ● Sterility ESSENTIAL, ● Immediate dilution of drug ● Possibility of hypotension/shock ● Thrombus and embolus formation. Needle may scrape the vein which could cause clotting which may lead to a stroke ● Dose cannot be retrieved in case of adverse reaction.
Intramuscular● In muscle, volume generally limited to 5mL ● Less rapid and longer lasting than IV ● Continuous phase: aqueous or oleaginous, solutions or suspensions ● Sterility ESSENTIAL, ● Avoid major nerves and blood vessels ● Neural damage, abscess, embolism, hematoma, scarring ● Dose cannot be retrieved in case of adverse reaction
Subcutaneous● In the subcutaneous fat tissue; volume generally limited to 1.5mL ● Less rapid and longer lasting than IM and IV ● Fastest onset of action is IV then IM then SC ● Longest duration of action is SC then IM then IV ● Continuous phase: aqueous or oleaginous, solutions or suspensions ● Sterility ESSENTIAL ● Can be self-administered by patient (ex: insulin) ● Ambulatory (mobile) s.c. infusion units are available (continuous subcutaneous insulin infusion pumps)
Intradermal● Below the epidermal skin layer; ● Volume generally limited to 0.1 mL ● Generally reserved for diagnostic purposes such as: allergy testing, desensitization, immunization.
IntraarterialCan be used to treat non-metastasized cancer (cancer that has not spread)
IntrathecalBypasses the Blood-Brain Barrier
Inplantable Infusion Pumps● Currently used in animals ● Alzet Osmotic Pumo ○ Has small polyethylene bag that contains the solution ○ Controlling how much water comes determines the about of drug that is going to be pumped out ○ These are implants that can be comparable to IV infusion used mostly in animals ○ There are infusion pumps for humans (ex. Insulin pump)
Potential for Controlled Release SC > IM > IV
Fastest Onset of ActionIV > IM > SC

Section 16

Question Answer
Steam○ Employs steam under pressure. Conducted in an “autoclave”. ■ 10 lb pressure – 115.5°C for 30 minutes ■ 15 lb pressure – 121.5°C for 20 minutes ■ 30 lb pressure – 126.5°C for 15 minutes
Dry Heat○ Usually carried out in ovens ○ Usually conducted at 150° to 170°C for not less than 2 hours
Filtration○ Physical removal of microorganisms ○ Useful for heat sensitive solutions CANNOT use dry heat or steam ○ Can remove the dead matter as well ○ Filters contain up to 80% porosity to permit high flow (pore-size 14 to 0.025mm)
Gas○ Heat sensitive and moisture sensitive materials and highly viscous materials ○ Exposure to ethylene oxide and propylene oxide ○ Approximately 4-16 hours of exposure
Ionizing Radiation○ Use of gamma rays and cathode rays ○ Mechanism of action: irreversible cellular destruction
Pyrogens Testing Limulus Ameobocyte Lysate (LAL) test

Section 17

Question Answer
Lidocaine hydrochlorideSkin anesthesia, trigeminal neuralgia
Calcium ChlorideMyopathy, myospasms, immobile joints
Copper SulfateFungus infection
Dexamethasome Sodium PhosphateArthritis
Gentamicin SulfateEar chronditis
Iron/Titanium OxideSkin pigmentation
Morphine Sulfateanalgesic

Section 18

Question Answer
Fast dissolving tablets target what segment of the GI tract?The buccal cavity
Enteric coating Cellulose Acetate Phthalate (CAP), Eudragit
Oral Adhesive SystemsStriant, Oradisc
Vaginal administrationIUD, crinone gel, Estring, Dinoprostone vaginal insert
Opthalmic InsertsLacrisert, pilocarpine
Liposomes ○ Site specific and targeted delivery ○ Useful for both hydrophilic and hydrophobic drugs ○ Protection of other tissues until drug is released from liposome
Stealth Liposomes Contain PEGmolecules in the exterior to avoid detection by reticuloendothelial system
PEGylated Dosage FormsAttaching PEG molecules to proteins to increase half-life and circulation times
NeulastaUse: reduce the risk of infection in certain cancer patients undergoing chemotherapy
PegasysUsed in patients with chronic infection with Hepatitis C
MicrocapsulesDrugs coateed with polymers
Gliadel Wafer ImplantTreats surgical cavity created when brain tumor is removed
Zoladex ImplantTreatment of endometriosis, advanced breast cancer, advanced carcinoma of the prostate.
Autoinjection systemsEpiPen and EpiPen JR for anaphylaxis
Safe-Needle systems Lovenox injection

Section 19

Question Answer
First product of biotechnologyrecombinant human insulin in 1982
What does recombinant DNA do?It prepares human proteins from nonhuman cells (such as E.coli ).
Antibodies produced by B lymphocytes in response to antigens
Monoclonal Antibodies derived from the culture of a single ancestral B cell
Polyclonal Antibodies obtained from the blood of an immunized animal
Gene Therapy Exogeneous genetic material is transferred into somatic cells to correct inherited or acquired gene defect.
Sense Sequence Sequence on a nucleotide chain that contains information for protein synthesis
Peptide Technology screening polypeptide molecules that can mimic larger proteins

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