Midterm #1 Flashcards

Question

Solutions & Solubility * Molarity * Normality * Molality * Mole Percent * Percent by weight * Percent by volume * Precent weight in volume

Answer 1

* Molarity * M * Moles solute in 1 L of _solution_ * Normality * N * Gram equivalent or equivalents of solute in 1 L of _solution_ * Molality * m * Moles of solute in 1000 g of _solvent_ * Mole percent * Moles of one constituent of a solution to the _total_ moles of all constituents expressed as a percent * Percent by weight * %w/w * Grams of solute in 100g of _solution_ * Percent by volume * %v/v * mL of solute in 100 mL of _solution_ * Percent weight in volume * %w/v * grams of solute in 100 mL of _solution_

Answer 2

* In chemistry, the equivalent concentration, or normality, of a solution is defined as the **molar concentration** divided by an **equivalence factor** * N, equivalent (Eq), milliequivalent (mEq), equivalent weight * N=equivalents (the number of equivalent weight) of solute in 1 L of solution * The number of equivalent weight of solute=mass of solute (g)/equivalent weight of solute. The unit of equivalent weight is g/Eq.

Answer 3

* Equivalent weight (q/Eq)=Atomic weight/# of equivalent per atomic weight (valence) * Ex: F and O * The number of equivalents per atomic weight is 1 for fluorine and 2 for oxygen * Ex: Mg * Number of equivalent per atomi weight of Mg is 2. Therefore, the equivalent weight is 24/2. this is 12 g/Eq * More than one valence, more than one equivalent weight. Depends on the reaction * Equivalent concentration is the **only** concentration unit that is dependent on the type of chemical reaction under consideration.

Answer 4

* Equivalent weight (g/Eq) = MW (g/mole)/equivalents per mole * Ex: 58.5 g NaCl in 1 L H₂O * 58.5g/(58.5g/mol)=1M * Is 1 equivalent per mole, so 58.5/1=58.5 g/Eq * 58.5/58.5=1N * Ex: 35 g MgCl₂in 1 L H₂O * 35g/(95.3g/mol)=0.37 M * 2 Eq per mole * 95.3/2=47.65 g/Eq * 35/47.65=0.74 N * Ex: equivalent weight K₃PO₄ * 3 Eq per mole * MW/3, 212/3=70.7 g/Eq * Ex: (0.1 Eq)\*(70.7 g/Eq)=7.07 g in 1 L water * Ex: Ca₃(PO₄)₂ * 6 Eq per mole * 310/6=51.7 g/Eq

Answer 5

* Normality is often used in pharmacy to calculate the content of individual ions * For example, n electrolyte replacement therapy, concentrations of electrolytes are ordinarily expressed as equivalets/L or mEq/L

Answer 6

* solvent-solvent * solvent-solute * solute can dissolve in a solvent because the solvent-solute interaction\>solvent-solvent interactions

Answer 7

* Ion-ion * Ion-dipole

Answer 8

* water has a permanant dipole * Unequal sharing of electron pairs between atoms due to a difference in electronegativity of atoms. * Net result of such interactions lead to polarization of molecules * if the center of negative charges does not perfectly overlap with the center of positive charges in a molecule * Electron charge is assymetric * Longer distance between negative adn positive charge center, the greater the polarity (D value, dipole moment)

Answer 9

* Van Der Waals * temporary dipole * non specific attractition when two atoms are 3-4 angstrom apart * at any time, electron charge distribution around the atom is not perfectly symmetric * transient asymmetric charge distribution around one atom encourages a similar asymmetric distribution of charge around its neighbooring atoms * weak attractive force between atoms

Answer 10

* Weak chemical interaction * H and O, F, N and acidic carbon (electronegative elements)t * Hydrogen bonds are formed between charged and uncharged molecules. In this bond, a hydrogen atom is shared by two other atoms (donor and acceptor, usually oxygen or nitrogen) * The atom in which the hydrogen is tightly linked is the donor * Acceptor has partial negative charge that attracts the hydrogen * H bonds strongest when the three atoms are in a straight line * The shorter the length between the proton donor and acceptor, the greater the hydrogen bond

Answer 11

* induced dipole

Answer 12

* e.g., NaCl * solvent molecules orient around the ions of solute

Answer 13

* e.g., methanol and glucose solutions * H-bonds are formed between the solvent and the solute * polarity of solvent and solid must match

Answer 14

* e.g., cyclosporine (very hydrophobic) dissolved in a non-polar solvent such as polyoxyethylated castor oil

Answer 15

* e.g., H₂O * Due to high dielectric constant, reduce ionic attractions between oppositely charged inons, thus breaking ionic bonds of strong electrolytes * Ex: water and salt * Results in dissociation * Interact with molecules through hydrogen bond * D\>50

Answer 16

* e.g., ketones, alcohols * can induce polarity in non-polar solvent molecules * often used as a co-solvent * D between 20-50

Answer 17

* e.g., vegetable oil, mineral oil and hydrocarbons * Dissolve non-polar compounds through induced dipole interactions * D lower than 20

Answer 18

Van't Hoff Equation R=gas constant, 1.99 cal/mol/Kelvin T=absolute temperature delta H= heat of solution (cal/mole) or change in enthalpy during solubalization Enthalpy is teh thermodynamic potential, which is a measure of internal energy of the solution J=constant Ks= solubility in mole/L * If delta H is positive, then increasing temperature increases solubility * because Ks proportional to logKs proportional to -1/T * if delta H is negative, then increasing temperature decreases solubility * because Ks proportional to logKs proportional to 1/T * if delta H is zero, there is no temperature effect on solubility * logKs=J

Answer 19

* Temperature * Salts * "salting out effect" for non-electrolytes i.e. glucose * competition between salt and glucose for solvent * salt and water=electrostatic interaction * salt and glucose=hydrogen bond * pH * weak bases * Low pH: ionization: high solubility * High pH: un-ionized: low solubility * weak acids * Low pH: un-ionized: low solubility * High pH: ionization: high solubility * Solvent polarity * polar-polar; nonpolar-nonpolar * Other factor such as **surfactants** (increase solubility of hydrophobic drugs) and **particle size** (smaller are more water soluable)

Answer 20

* Temperature increase/decrease * not practical *in vivo* * Adjust pH * not practical *in vivo* * Chemical modifications * phosphates and succinates

Answer 21

* Salts of organic acids or bases are more soluble in H₂O than the parent compound

Answer 22

* Mixed solvents to form a solvent system of favorable polarity * Note: These D values of solvents are approximate * Human toxicity: chloroform, octane, benzene

Answer 23

* Definition: To form a solvent system at optimum polarity to dissolve the solute * Such solvents must be miscible

Answer 24

* D_A+B+...=(f_A\*D_A)+(f_B\*D_B) * f_A, f_B-volume fraction of each solvent * (25\*0.2)+(80\*x)+(46\*(0.8-x))=47 * X=0.15

Answer 25

* Measure of differential solubility of a compound or a drug in two solvents * log ratio of the concentrations of the compounds in the solvents at equilibrium * Octanol and water * LogP is indidcation of lipophilicity or hydrophobicity * related to absorption * *Shake Flask* method * P=[s in octanol]/[s in water]

Answer 26

* different forms of crystal=polymorph * arise through packing of the molecules in different arrays within the crystal or by differences in the orientation or conformation of molecules at lattice sites

Answer 27

1. Cubic 2. Tetragonal 3. Orthorhombic 4. Monoclinic 5. Triclinic 6. Trigonal 7. Hexagonal

Answer 28

* Same chemical structure * Different physical properties * density, melting point, solubility * Often intentionally choose the polymorph that has a higher solubility so that its absorbtion can be increased

Answer 29

* Drug dissolution rate is dependent on drug solubility 1. may change as function of pH 2. may change based on formulation factors (salt form, polymorphic form, particle size, addition of surfactants) * Permeation is dependent on 1. partitioning from the GI fluid into the GI membrane, which is favored by high logP, of the non-ionized drug molecule 2. Fraction ionized (pKa/pH consideration). Entry into the GI membrane is favored by large fraction non-ionized 3. Entry into the GI membrane is favored by low molecular weightt (below 500)

Answer 30

* At any T and P, only one crystal form is stable * other polymorphs convert to stable form * Conversion rate weeks-years * "metastable" * high energy, higher aqeous solubility than stable form * **Higher solubilty** means **Less Stable **

Answer 31

* Amporphous * e.g., powder * E.g., crystalline novobiocin poorly soluable, amorphous novobiocin readily soluable * usually, drug solubility increases with decreasing particle size (largely due to increase in surface area of drug particles in contact with solvent)

Answer 32

* add surfactants

Answer 33

* Substances whose aqueous solutions conduct electricity * e.g., inorganic acids, inorganic bases and salts

Answer 34

* Acid: any species that will donate H⁺ * Base: any species that will donate OH^-

Answer 35

* Acid: a substance, charged or uncharged, which is capable of donating protons * Base: a substance, charged or uncharge, which is capable of accepting a proton

Answer 36

* Acid: a substance capable of accepting a share in an electron pair made available by another substance called base * Base: a substance capable of donating a share in an electron pair to another substance called an acid

Answer 37

* Formulate efficacious and stable preparations * Detect and understand incompatibilities *in vitro* and *in vivo* * *in vitro*-phenytoin (weak acid) * *in vivio*- sodium bicarbonate and tetracycline (amphoteric compounds) * either acid or base depending on pH * pH change solubility of drug

Answer 38

Since water almost in large excess, assume that it remains constant

Answer 39

* Strong Acid * K_a large * pK_a small * Strong Base * K_b large * pK_b small

Answer 40

* Strong electrolyte completely ionized in pH 0-14 * Weak electrolytes as incompletely ionized in pH 0-14

Answer 41

* pH=pKa+log(b/a) * a=b\*10^(pka-pH)

Answer 42

* is a chemical equilibrium phenomenon * only for weak acids * ((b)/(a+b))\*100=(100/(1+(10^(pKa-pH))) * pKa=pH; 50% * pH\>\>\>pKa; ~100% * pKa\>\>\>pH; ~0% * For weak base, (pKa+pH-pKw)

Answer 43

* Weak Acid * formic acid, acetic acid, trichloroacetic, hydrofluoric, hydrocyanic, hydrogen sulfide, water, conjugate acids of weak bases * Weak Base * ammonia, trimethyl ammonia, pyridine, ammonium hydroxide, water, conjugate bases of weak acids

Answer 44

* As % ionization increases, solubility increases * solubility can be altered by adjusting pH * e.g., phenytoin weak acid (pKa=8.1)

Answer 45

* Function as both acids and bases * e.g., amino acids and proteins * pH 3-9 glycine exists as + on NH3 and - on COO * Zwitterion * pH when + and - only equal each other is called the isoelectric point. At this point, there is not net charge in the solution. * Many drugs are amphoteric, e.g., tetracycline

Answer 46

* One compound or mixture of compounds that, by their presence in solution, resist chagnes in pH upon addition of small quantities of acid or alkali * E.g., human blood maintains pH 7.4 due to buffers present in plasma (natural buffer system which consits of physiological electrolytes at certain concentrations) * albumin, carbonic acid, and bicarbonate tears-pH 7.4

Answer 47

* to maintain optimal pH of the formulated product within a certain range upon addition of various additives * to maintain pH on storage * e.g., glass is alkaline

Answer 48

pH=pKw-pKb+log(base/salt)

Answer 49

* is the point where titrant added is stoichiometrically equal to the amount of moles of substance present in sample * the smalles amount of titrant that is sufficent to fully neutralize or react with the analyte * buffering zone is area before "acceleration" on graph

Answer 50

* Sufficient but not excessive * max capacity at pH=pKa * e.g., Ac pKa=4.76, so pH range is 4 to about 6 for buffer * C_buffer is defined as the total concentration of a buffer which is equal to the concentration of salt plus the concentration of the weak acid or weak base`

Answer 51

* buffers used widely in formulating drugs, especially opthalic solutions * e.g, pilocarpine eye drops, phenyl ephrine eye drops * pharmacists should consider: 1. pH-solubility, stability and activity 2. buffering capacity-sufficient but not excessive 3. volume of buffered product to be used relative to volume body fluid with which it will come into contact * parenteral sln (do not go through GI) not buffered/buffered to low capacity * Injection/infusion should minimally affect the body's natural buffering system

Answer 52

* if solution is buffered to a high capacity at a different pH other than physiological pH, infusion at a large volume of such sln may change physiologcial pH * Even if the solution has the same pH as the blood, a highly buffered solution means that the solution may posses a high total buffer concentration. Since the **natural buffering system of blood is maintained by the prescence of physiological electrolytes** at certain concentrations and concentration ratios, infusion of a large volume of highly buffered solution could still affect the natural buffering system by **changing** **concentration** and **concentration ratios.**

Answer 53

* The colligative properties of a solution are those that depend ONLY on _the number of solute particles_ in solution, irrespective of whether they are molecules, ions, large or small and of their chemical nature

Answer 54

1. Lowering vapor pressure (Raoult's Law) 2. Boiling point elevation ("ebulioscopy") 3. Freezing point depression ("cryoscopy") 4. Osmotic Pressure

Answer 55

* Osmotic Pressure: The force per unit area required to prevent passive diffusion of solvent molecules across a semipermeable membrane * Passive Diffusion: Movement of particles or molecules by internal kinetic motion down a concentration gradient * Semipermeable Membrane: Thin, porous film that selectively allows the passage of substances based on particle size. Typically solvent may pass and solute may not

Answer 56

* the molarity of solute particles in solution * measure of osmotic pressure * 1 Osmolar=1mol/L=(6.02\*10^23)particles/L * glucose = 1 osmolar * NaCl= 2 osmolar

Answer 57

* The passage of solvent molecules across a semipermeable membrane which maintains a solute concentration gradient across itself; direction is from low to high solute concentrations; driven by; * solvent concentration gradient (high to low X_w) * vapor pressure gradient of solvent (P_w=P_w⁰\*X_w) * Free energy gradient of solvent (µ_w=µ_w⁰+RTlnX_w)

Answer 58

Tonicity: the effective osmotic pressure of a solution when compared to a physiological body fluid or tissue. COMPARATIVE TERM Isotonicity: The quality of possesing and maintaining an uniformed _tone_ or tension across a physiological barrier. An isotonic solution is a solution that has the same osmotic effect as the physiological body fluid

Answer 59

* Hypertonic: osmotic pressure of the solution is higher than that of the body fluids. Net loss. Shrink * Isotonic: osmotic pressure of the solution is the same as body fluids * Hypotonic: osmotic pressure of the solution is lower than that of body fluids. Net gain. Blow up.

Answer 60

* 0.9% NaCl solution is isotonic. Its osmolarity is 308 mOsm/L

Answer 61

* Isoosmotic means having the same osmotic pressure * Isotonic means having the same tonicity as teh body/tissue fluid with which contact is made * Might be same, depends on what body/tissue fluid with which the solution contacts * Ex: RBC in 1.9% boric acid * overtime penetrate cell and cell swell * Isotonic for lens of eye, but hypotonic for RBC

Answer 62

* 1 Osmol: amount of particles in a solution * Osmolality: Osmol concentration based on weight; a 1 Osmolal solution= 1 Osmol/1000g water * Osmolarity: Osmol concentration based on volume; a 1 Osmolar solution 1 Osmol/L solution * Osmolarity is the measure of number of dissolved particles in solution. It is independent of the nature of solute * Clinical laboratory osmolality determinations are made by freezing point analysis; normal serum freezes at -0.52⁰C, and the "osmolarity" is approximately 308 mOsmol/L * USP requires that solutions for injection be labeled with the osmolar concentration

Answer 63

1. Some medical solutions are administered specifically for their osmotic effect * Mannitol IV as diuretic used to promote excretion of urine. Increases osmotic pressure of the tubular filtrate. Therefore, pulling more water into the tubules and increasing diuresis * Mg Citrate as laxative. Increases osmotic pressure for the luminal contents of the intestinal tract, water fills and evacuation is promoted 2. Perdominate consideration is to minimize osmosis. Generally, all medical solutions intended to come in contact with tissues other than G.I. tract are formulated to have the same osmotic pressure as the tissues contacted * opthalmics: iotonicity= 0.5-1.8% NaCl * parenterals: 0.8% NaCl for IV

Answer 64

* Definiton of V-value: The volume of sterile water to be added to 0.3 g of a drug to make it isotonic. * Make isotonic 30 mL of a 1% solution of homatrotopine hydrobromide * Amount of drug need=30\*(1/100)=0.3g * Weigh out 0.3g, add 5.7 mL H₂O=5.26% * Dilute with 0.9% NaCl to 30 mL * Mixing one isotonic solution with another isotonic solution still results in an isotonic solution

Answer 65

* Definition of Sodium Chloride Equivalent (E value): The weight in grams of NaCl which has the same osmotic effect as one gram of the drug prepared as an isotonic solution; expressed as an E-value in units of grams of NaCl per gram of drug. * Ex: 5% cocaine, 120 mL isotonic solution * E value of cocaine=0.14 (g NaCl/1g drug) * 1st: Calculate amount of NaCl * 120mL of 0.9% NaCl * 120mL(0.9/100)=1.08 g NaCl * 2nd: Amount cocaine for 120 mL of 5% cocaine * 120 mL (5/100)=6 g cocaine * 3rd step Isotonic effect of cocaine * 6g\*(0.14)=0.84 g NaCl * Amount NaCl = 1.08-0.84=0.24 g NaCl * Weigh out 0.24 g NaCl and 6 g cocaine add water to 120 mL

Answer 66

* Solution: a homegeneous mixture of two or more substances * Solute: a drug substance * Solvent: Alcohol, water, diluted alcohol, glycerin, propylene glycol

Answer 67

* Contains standards for medicines, dosage forms, drug substances, excipients, medical devices and dietary supplements * Info found in monographs

Answer 68

* Sterile sln that are suitably compounded for instillation into eye * Prescription, OTC, contact lens sln products: * Treat surface/intraocular conditions * bacterial, fungal, viral infections * allergic/infectious conjuctivitis or inflammation * dry eye

Answer 69

* tear volume is 7 µL * eye drops range from 50-70 µL * can result in brief contact between the medication and absorbing surfaces

Answer 70

* Sterility * Isotonicity * Buffering for stability and comfort * Clarity * Particulates * Antimicrobial preservatives * Viscosity * Stability (e.g., oxidation and hydrolysis)

Answer 71

* absolute requirement * steam (autoclave) container must be compatible * Gas (ethylene oxide) * Filtration * preferred under USP, container must be pre-sterilized * microbial contaminated=ulcers and blindness * *Staph *and *Pseudomonas* * Complete blindness in 24-48 hours * Sterilization standards set by USP 797

Answer 72

* Most multi-dose opthalmic solutions contain effective anti-microbials * Preservatives vary in solubility * Preservative vary in effectiveness * **Benzalkonium chloride, Benzethonium chloride, Cetylpyridium chloride** has slow action * 7 minutes for bacterial count to be decreased by 50% * quarternary ammonium compounds * lytic action on membrane * 0.004-0.02%, 0.01% most common * Incompatible with soap, anionic materials, salicylates, nitrates * **Phenylmercuric Acetate, Phenylmercuric Nitrate, Thiomerosal, ** * organic mercurials * denaturation of enzymes by combining thiol groups * 0.001%-0.01% * Incompatible with F, Br, Cl and phenylmercuric acetate * **Methylparaben, Propylparaben** * ** **Benzoic acid, boric acid, and parahydroxy benzoate esters (parabens) * denaturation of proteins * Max 0.1% * Incompatibilies: Adsorption by macromolecules; marginal activity (highly protien bounded) * Ineffective at pH greater than 5, good against fungi * **Chlorobutanol** * substituted alchol * lytic and denaturation action on membranes * 0.5% * close to max solubility, hard to prepare * stabilty is pH dependent

Answer 73

1. safety 2. efficacy 3. stability 4. compatibility 5. comfort

Answer 74

* absolute requirement * free from foreign particles * usually through filtration * filtration equip must be clean * filtration and sterilization can be in same step

Answer 75

* Total product stability depends on chemical nature of drug substance, solution pH, solution prep method (temp), solution additives, packaging/storage (light, metal ions, heat) * Compromise sometimes needed * 2-3 yr shelf life is common

Answer 76

* For comfort * Improved stability * balance contribution to the pH of all the ingredients * improve solubility of active drug substance * to maximize the effectiveness of the preservative

Answer 77

* pH of tears is about 7.4 * sufficient but not excessive buffer capacity * ~0.01-0.1M * eyes appear to be less sensative to alkaline buffering compared to acidic buffering * 7.4 goal, seldom acheived * many drug active ingredients are salts of weak bases and are most stable at acidic pH * optimum pH is a compromise (**stability, comfort, capacity**)

Answer 78

* Osmotic pressure considerations are important * Eye is tolerant of some tonicity variation (0.5-1.8% NaCl) * isotonicty for comfort, not overriding concern

Answer 79

* prolong contact * drug absorption and activity * increase ease of use * polymers for visocity agents * **methylcellulose ** * more units means higher viscosity * **hydroxypropylmethylcellulose** * **polyvinyl alchol **

Answer 80

* oxidants:loss of an electron or an increase in oxidation state of a molecule, atom, or ion; iorganic oxidation often involves electron transfer * Organic oxidation doest not actively involve electron transfer * involves addition of oxygen * series of free radical chain * antioxidant need to interfere intiation/propogation or participate in termination

Answer 81

* Oxygen scavenger, easily oxidized * **sodium bisulfite** * **sodium metabisulfite** ****known to cause allergic reactions * Reducing agents, reduce oxidized drugs * **ascorbic acid** * ****Chelating agents tie up metal * Fe, Cu, Co, Ni, Mn, unshared electron in outer shell * **EDTA, citric acid, tartaric acid** * Drugs in terminating step * **Vitamin E** * provide H atoms and free radicals, not sustain chain rxn * Storage issues (amber vial)

Answer 82

* in water or water-cosolvent system * additives for palatability, stability, aesthetic appeal * flavor agents * sweeting agents * coloring agents * buffers * antioxidants * preservatives * no isotonicity requirement

Answer 83

* purified water * alcohol * glycol * glycerin * internal and external uses * propylene glycol * internal and external uses * polyethylene glycol (PEG) * water soluble * decrease as MW increase * 900\>=waxy at RT * lot of things b/c of solubility and compatibility

Answer 84

* concentrated aqueous prepartions of sugar or sugar substitue w/ or w/o medicine * simple syrup * sucrose 850 mg * purified water q.s. 1000 mL * correctly prepared is self-preserving * fully saturated * 85% w/v or 65% w/w * clear and colorless * also **sorbital** sln

Answer 85

* clear and pleasantly flavored, sweetend hydroalcholic liquid inteded for oral use (0-23% alcohol) *

Answer 86

Aromatic waters are clear, saturated aqueous solutions of volatile oils or other volatile substances (sometimes referred to as medicated waters) * *Peppermint Water**, USP * *Stronger Rose Water**, USP

Answer 87

* Spirits are alcoholic or hydroalcoholic solutions (usually contain 50-90% alcohol) of volatile substances (sometimes referred to as essences) * Some used internally for medicinal value, some for inhalation, and some as flavoring agents * Historically, Brandy (Spiritus Vini Vitus) and Whisky (Spiritus Frumenti) were in the official compendia (USP or NF) as medicinal agents

Answer 88

* Used to restore fluid and electrolyte balance after severe diarrhea and/or vomiting * Contain sodium, potassium, bicarbonate, and glucose with reduced osmolarity (e.g. ~245 mOsm/L). * Pedialyte® for children

Answer 89

* Combination of electrolytes (sodium, chloride, bicarbonate, potassium) and high molecular weight nonabsorbable polyethylene glycol (PEG 3350); (GoLightly®) * Available as a solid product. When reconstituted, it becomes an iso-osmotic large volume fluid for preparation of the bowel for colonoscopy to prevent net loss of water or electrolytes as the bowel is evacuated. Colonoscopy is a diagnostic procedure to exam GI disorders such as colon cancer.

Answer 90

* Small volume parenterals: Injection of small volumes: (concept of bolus vs. infusion) * into a vein (intravenous, IV) or artery (intra-arterial, IA) * under the skin (subcutaneous, SC, sub-Q, SQ, hypodermic, hypo) * into the skin (intradermal, ID, intracutaneous) * into the muscle (intramuscular, IM) * into spinal fluid (intrathecal) * into spinal column (intraspinal) * into the joint space (intra-articular) or synovial fluid of the joint (intra-synovial) * into the heart (intracardiac) * Large volume parenterals: Infusion of large volumes: * into veins (intravenous, IV) or arteries (intra-arterial, IA)

Answer 91

* Purified Water, USP * contains ≤ 1 mg solids/100 mL * Not suitable for direct injection use * Must be filtered or autoclaved before use * Water for Injection, USP * Must be pyrogen free * Pyrogens = fever-producing organic substances arising from microbial contamination * Used in manufacturing pharmaceuticals (therefore not required to be sterile, sterilization occurring during manufacture of injectible) * Sterile Water for Injection, USP * No additives (can be used for neonates [1st 4 weeks], pediatrics) * Must be pyrogen free (some endotoxin is allowed) * Available as single dose containers not greater than 1 liter (not for infusion because it has no tonicity) to be used to prepare injections by aseptic technique * Bacteriostatic Water for Injection, USP * Use in small volumes only (because of the antimicrobial agent) * NOT FOR USE IN NEONATES (NEWBORNS)

Answer 92

* **Sterility** is the absence of viable organisms. * **Pyrogenicity** is the presence of pyrogens which are materials which when injected into a patient (therefore bypassing usual “defense mechanisms”) will cause a rise in body temperature because of an immunoresponsive reaction (pyrexia). * Normally the products of microbial growth * Most commonly encountered pyrogens are thought to be endotoxins * Endotoxins are the lipopolysaccharides that comprise the major part of the cell wall of gram-negative bacteria * Bacterial cells may be pyrogenic even when they are dead and when they are fragmented, so a solution that passes a test for sterility will not necessarily pass a pyrogen test. On the other hand, a solution that passes a pyrogen test may not pass a sterility test either. This is because: * A pyrogen test just detects bacterial cell wall materials. Even if there are no viable bacteria in the product that allows it to pass the sterility test, there still may be dead bacteria which will give a positive reaction in the pyrogen test. * A sterility test always tests bacterial growth. A product that passes a pyrogen test may have just a few bacteria at a level that does not have enough cell wall materials to cause a detectable pyrogen reaction. However, with the 14 day sterility test, bacteria may grow sufficiently to show growth observed as turbidity or a lack of clarity in the growth media. * Both tests can have interferences so that each test has to be carefully validated for the formulation prior to use for product quality assurance.

Answer 93

* Sodium Chloride Injection, USP * Isotonic (0.9% NaCl) * Bacteriostatic Sodium Chloride Injection, USP * Contains benzyl alcohol * Labeled: NOT FOR NEONATES (NEWBORNS) * Small volume (\< 5 ml) even for adults * Ringer’s Injection, USP * NaCl + KCl + CaCl2 * An electrolyte replenisher and plasma volume expander * Concentrations of salts are comparable to those in physiological body fluids * D5W IV * 5% w/v dextrose (glucose) in water * used to supply water and calories to the body. * also used as a mixing solution (diluent) for other IV medications

Answer 94

* Ethyl alcohol * Polyethylene glycol * Propylene glycol * Glycerin Cosolvents typically used

Answer 95

* Usually for formulations to be administered IM * Fixed vegetable oils: peanut, corn, cottonseed, sesame, castor, olive * Ethyl oleate * Isopropyl myristate * Dimethyl acetamide

Answer 96

* Antibacterial preservatives (the same as in ophthalmics). * **No coloring agents are allowed.** * Buffers (citrate, acetate, and phosphate acid salts) with low capacity. * Antioxidants (sulfites, EDTA, sulfur dioxide) * Sometimes also add solubilizers * Agents for isotonicity * Air in container above the injectible solution is frequently replaced with nitrogen or argon to prevent oxidation. * Sterilization is required (steam, dry heat, **filtration**, gas [ethylene or propylene oxide], or ionizing radiation)

Answer 97

* liquid preparations containing pyroxylin (a nitrocellulose) in a mixture of ethyl ether and ethanol * may be made more flexible by addition of camphor and castor oil * New Skin; Compound W for warts (add 10% salicylic acid)

Answer 98

* solutions or mixtures of various substances in oil, alcoholic mixtures of soap, or emulsion (may contain preservatives) * used for their counterirritant, mildly astringent (toughen and shrink tissues) and penetrating effects

Answer 99

* solutions containing medicinally active portions of plant or animal tissue separated from the inactive portions by extraction with solvent * Examples: * Tincture: alcoholic or hydroalcoholic solutions prepared from vegetable materials or from chemical substances * Tincture of Iodine * Thimerosal * Paregoric, USP (camphorated tincture of opium) * Opium Tincture, USP (laudanum, much more potent than Paregoric, USP)

Answer 100

* Concentrated acids (e.g., HCl) are often labeled % w/w with specific gravity; Determine mass in a given volume by multiplying volume (mL) by specific gravity (g/mL) and by percent strength (as decimal). * M = VSF * M = mass of solute in grams * V = volume of the solution in mL * S = specific gravity of the solution in g/mL * F = % strength w/w

Answer 101

mg/100mL total _solution_

Answer 102

The state of being exact; the extent to which a given set of measurements of the same sample agree with their mean. * perform something the same way each time

Answer 103

The state of being correct; the extent to which a given measurement agrees with the standard value for that measurement. * agreement between data and true value * hitting the bullseye

Answer 104

The difference between the observed value and the true value in a set of data. * true value-observed value

Answer 105

* The error (see C above) expressed as a percent. In pharmacy error should be ≤ 5%.

Answer 106

The state of being constructed to indicate, measure, or be affected by small amounts or small changes in amount. * not only is affected by very small change in amount, but one that can detect change

Answer 107

The measurement of the gravitational force acting on a body; proportional to its mass and expressed in terms of standard weights which exactly balance the body to equilibrium.

Answer 108

1 pound(lb) = 16 ounces(oz) = 7000 grains (gr)

Answer 109

* 1 pound = 12 ounces = 5760 grains * 1 ounce = 8 drams = 24 scruples

Answer 110

* 1 gr (grain) = 65 mg or 60 mg * e.g. Aspirin V gr can be 325mg or 300mg * 1 oz = 28.35 grams or round it up to 30.00 grams * 1 lb = 454 g * 2.2 lbs = 1000 g = 1 kg

Answer 111

The maximum change in load that will cause a specified change, one subdivision on the index plate, in the position of rest of the indicating element of the balance

Answer 112

1. % error =_(Sensitivity Requirement) \* 100%_ Amount Weighed

Answer 113

_Sensitivity Requirement) \* 100%_ Allowed Percentage of Error

Answer 114

Use when the desired amount of drug to be weighed is less than the least amount weighable. 1. Weigh excess drug in some amount equal to or greater than the least amount weighable. 2. Add enough diluent to make a mixture that has some convenient total weight from which a part or aliquot can be weighed which contains the desired amount of drug. 3. Weigh the aliquot of the mixture that contains the desired amount of drug.

Answer 115

1. Accuracy is limited by the interval size of the graduations. 2. Readings are made at the bottom of the meniscus for aqueous and alcoholic liquids. 3. Small volumes (\< 1.5 ml) should be measured with a pipet (in our lab, use a syringe)

Answer 116

* 1 gallon (gal) = 4 quarts (qt) = 8 pints (pt)=4 L * 1 pt = 16 fluid ounces (fl oz) * 1 fl oz = 8 fluidrachms or drams = 480 minims

Answer 117

* 1 pint = 2 cups * 1 tablespoonful (tbp) = 3 teaspoonfuls (tsp)= ½ fl. oz=15 mL

Answer 118

* 1 fl oz = 29.57 ml or 30.00 ml * 1 pt = 473 ml=480 mL * 1 gal = 3785 ml or 4000 ml

Answer 119

1 tsp. = 5 ml

Answer 120

use a graduated cylinder that has a capacity greater or equal to the volume to be measured

Answer 121

* IV solutions are liquid substances suitable for administration via intravenous route. * Intravenous means “within a vein”--\>directly into the vein * The intravenous route is the fastest way to deliver fluids and medications throughout the body. Some medications, as well as blood transfusions, can only be given intravenously.

Answer 122

- To correct disturbances in electrolyte balance. - To replace body fluids loss.--\>in dehydration, bleeding - To provide basic nutrition.--\>TPN - To use as vehicles for other drug substances--\>use in mixing IV antibiotics, IV electrolytes or other meds..

Answer 123

* Extracellular fluids : interstitial fluid and blood plasma. 25% of body water is outside the cells with 7.5% found in theintravascular space and 17.5% found in the interstitial space. Interstitial fluid fills the spaces between most of the cells of the body. * Intracellular fluids: 75% of all the body water. Liquids within cell membranes, containing dissolved solutes essential to fluid and electrolyte balance and metabolism. * Most of the materials in the IC fluid and EC fluid are the same, but differ in proportions * (e.g. Potassium in IC \>Potassium in EC).

Answer 124

Sodium (Na+): regulates water distribution, transmission of nerve impulses

Answer 125

Potassium (K+): transmits electrical impulse

Answer 126

Calcium (Ca++): major role in muscle contraction and nerve impulse

Answer 127

Magnesium (Mg++): important for biochemical processes in the body

Answer 128

Chloride (Cl-): fluid balance and renal function

Answer 129

Bicarbonate (HCO3-): neutralizes acids in the body

Answer 130

Phosphate (HPO4-): buffer and regulation of energy received from metabolism

Answer 131

* salts and sugars in water. * Contain no proteins or other high molecular weight solutes. * Remain in the intravascular space for a short time before diffusing across the capillary wall into the tissue. * Examples: normal saline, lactated ringers. * \*\*\*one liter of Normal saline 0.9% contains 154 mEq Na+\*\*\*

Answer 132

* contain large molecules such as protein that do not readily pass through the capillary membrane. * Remain in the intravascular space for an extended period. * Increase osmotic pressure, causing fluid to move from the interstitial and intracellular space to the intravascular space. * “Volume expanders”. * Examples: albumin, steroids. * Uses: reduce edema --\> Albumin pulls water outside of cells

Answer 133

* close to the same osmolarity as serum. They stay inside the intravascular compartment, thus expanding it. * Helpful in hypotensive or hypovolemic patients. * Risk of fluid overloading, e.g. CHF, hypertension. * Examples: Lactated ringers, Normal saline (fyi: 154 meq Na+/L)

Answer 134

* less osmolarity than serum. * Water is pulled from the vascular compartment into the interstitial fluid compartment. * As the interstitial fluid gets diluted, its osmolarity decreases, which draws water into the cells. * Helpful when cells are dehydrated. * Harmful because it can cause cardiovascular collapse or increased intracranial pressure in some patients. * Examples: 0.45% normal saline, 2.5% dextrose

Answer 135

* higher osmolarity than serum --\> generally infused via central IV (for dilution) line not peripheral IV line * Pulls fluid and electrolytes from the intracellular and interstitialcompartments into the intravascular compartment. * Helpful in reducing edema, stabilizing blood pressure. * Dangerous in the setting off cell dehydration. * Examples: 3% sodium chloride, Total Parenteral Nutrition (TPN)

Answer 136

Short catheters inserted through the skin into a peripheral vein.

Answer 137

Catheters with its tip inserted into a large vein, usual the superior vena cava, or into the right atrium of the heart. Subclavian : long into --\>chemotherapy Hickman: for chemo, surgeon put in, more permanent Portacath: see buton--\>stay longer than into elbow PICC: Peripheral Inserted Central Catheter: ultrasound guided Advantages: fluids and medications that are irritating to peripheral veins. * Vancomycin, * Dopamine * high concentration of Potassium Medications can reach the heart immediately and are quickly distributed to the rest of the body. Provide multiple lumens within the catheter, so multiple medications can be delivered at once.

Answer 138

1. Infection: Break in the skin can cause Staph infections, fungal infections such as Candida albicans or other infections caused by contaminated equipment, needles, tubings, catheter left in for too long. 2. Phlebitis: inflammation/irritation of the vein caused not by infection but from the presence of a foreign body (catheter, IV fluids, medications) 3. Infiltration: extravasation --\> catheter gets out of the vein or pokes through the vein causing fluids leaking out to surrounding tissues. 4. Fluid overload: more than the body can absorb or excrete --\> heart failure, pulmonary edema. 5. Electrolyte imbalance: 6. Embolism: life threatening, blood clot or other solid mass or air bubble blocking the blood vessel. Risk is less with peripheral line because the catheter is smaller and shorter.

Answer 139

1. Physical: can be observed most easily, can be detected by the changes in appearance of the admixture, can be predicted by knowing the chemical characteristics of the drugs. Calcium and Phosphorus --\> Calcium Phosphate --\> white precipitate 2. Chemical: decomposition of drug substances resulting from combination of parenteral dosage forms, from hydrolysis, oxidation, reduction or complexation and can only be detected with an analytic method. Therapeutic: most difficult to observe because the combination results in undesirable antagonistic or synergistic pharmacologic activity. **This is rare.**

Answer 140

- checking with reference texts: Handbook of Injectable Drugs by Trissel, Micromedex - changing to other routes of administration - mixing less additives together

Answer 141

Ingredients include gelatin, sugar, water, and usually titanium oxide as an opacity agent and one or more colorants. b. If too dry becomes brittle. If moist decomposes due to microbial growth c. Soluble in hot water. Relatively insoluble in cold water. Absorbs water and gets soft. Use desiccant when storing. d. Composed of two parts, body and cap. e. Brand names 1. ) KapsealsÒ - Park-Davis. eg. Dilantin (Phenytoin) **colored band to seal seam of cap** 2. ) PulvulesÒ - Eli Lilly. e.g. Ceclor (Cefaclor) **body has tapered ends** 3. ) SpansulesÒ - Smith, Kline, Beechman. Eg. Compazine (Prochlorperazine) 4. ) Coni-SnapÒ - Warner-Lambert Co.

Answer 142

Soft gelatin capsules are useful to seal in liquid drugs, volatile drugs, or drugs susceptible to deterioration in the presence of air. a. Made soft by addition of glycerin or some polyhydric alcohol such as sorbitol. b. Rarely used in compounding. **heat sealed**

Answer 143

1. Lactose 2. Microcrystalline cellulose - poorly soluble in H2O - good binding and disintegrant properties. 3. Pregelatinized starch - granule of corn, wheat or potato; processed such that the granules are ruptured making the starch more easy to compress and flowable

Answer 144

the bigger number capsule size, the smaller the capsule actually is

Answer 145

**Dry substances composed of finely divided poweder** **into, Tablet, capsule, liquids, suspensions**

Answer 146

Dissolution rate of drug dosage form is increased on decreasing particle size. Micronized particles give rise to higher drug concentration more rapidly in the blood, e.g. insulin and glyburide. Increasing dissolution rate is not always desirable e.g. nitrofurantoin

Answer 147

* The larger the seizer #, the finer the particles * Fine: all through #60 and not more than 40% through #100

Answer 148

* Prepared at the time in response to current need. * Compounding a prescription order in the pharmacy.

Answer 149

The mechanical process of reducing the size of particles or aggregates to fine powders

Answer 150

The process of mixing two or more powders in a mortar with a pestle or reducing the particle size of a drug

Answer 151

With the aid of additional material which can be easily removed following the procedure. e.g. ethanol with camphor.

Answer 152

With the aid of a nonsolvent that remains in final product. e.g. incorporating drug into ointments to prevent feeling of grittiness. Paste of drug in a nonsolvent (levigating agent) is made and then triturated to reduce particle size and than added to the ointment. e.g. mineral oil with sulfur powder.

Answer 153

coarser surface, easier to reduce particle size of hard crystals and large lumps of material. Porous, stains easily.

Answer 154

Semi-coarse surface, makes less fine particles. Glazed and therefore less porous.

Answer 155

Smooth surface makes coarse particles; best for preparing solutions, suspensions, ointments. Does not stain easily.

Answer 156

Pestles usually made of the same material as the mortar do not interchange pestles from different mortars. A pair of pestle and mortar are specifically designed to fit together.

Answer 157

Method of mixing solids whereby a small portion of one substance is added to an equal portion of another substance and mixed; the process is repeated serially until the total amount has been mixed; also referred to as geometric dilution. Makes well mixed product when drug is present in small quantity and the diluent quantity is large.

Answer 158

camphor, menthol, essential oils require air tight packaging.

Answer 159

Combination of two or more substances of low intermolecular attractive forces such that their combined melting point is less than room temperature, resulting in a product that softens and liquefies. a. Occurs with aldehydes, ketones, phenols, and alcohols. e.g. camphor and menthol. b. Prevented by separation of the crystalline components by trituration with inert powders such as magnesium carbonate, magnesium oxide, lactose, or starch.

Answer 160

Never triturate strong oxidizing agents (potassium permanganate, potassium chlorate, nitrates) with strong reducing substances (powdered acacia, powdered sugar, tannic acid, charcoal).

Midterm #1 Flashcards

(189 cards)