Exam 3

Question 1

what is a gel

Answer 1

semi solid dosage form

Question 2

what does a gel consist of structure wise

Answer 2

a matrix formed by hydrogen bonds between..

1. gel base/ gel base
2. gel base/ active ingredient
3. micelle/ micelle
4. viscosity primarily due to hydrogen bonds not molecular weight

Question 3

Can the organic matrix be altered? if so, by what

Answer 3

1. temporarily by heat

2. permanently by alcohol

Question 4

purpose of gels

Answer 4

1. vehicle for topical, transdermal, IM or oral preparations

2. achieve high viscosity with low molecular weights

Question 5

gel solubility

what should it be able to do
what is the exception

Answer 5

must be soluble in body fluids or able to melt @ body temp.

exception: hemostatic gelatin

Question 6

examples of internal used gel

Answer 6

Amphojel tab/capsule

Question 7

example of vaginal gel

Answer 7

metrogel (metronidazole)

Question 8

examples of topical gels

Answer 8

hemostatic gelatin

americaine/ hurricaine (benzocaine)

campho-phenique (camphor/ phenol)

erygel (erythromycin)

Question 9

examples of transdermal gels

Answer 9

clonidine, gabapentin, ketamine, lidocaine

indomethacin

prochlorperazine

scopolamine

Question 10

examples of gels used topically for local effect

Answer 10

ketoprofen (PLO)

Question 11

Transdermal gel dosing

should have what

Answer 11

should have..
1. specific dose
2. by volume (mg/mL)
3. metering device
4. instructions should read ....
ex: apply 1 mL to chest did orrr
apply contents of1 syringe bid
5. CAREGIVER SHOULD WEAR GLOVES

Question 12

Considerations for gel preparations

non organic based gels

Answer 12

1. order of incorporation

2. topical

Question 13

Considerations for gel preparations

organic based gels

Answer 13

1. order of incorporation (lipo/hydro phase)
2. shear forces
3. micelles
4. transdermal

Question 14

(googled)

what is a PLO gel

Answer 14

Pluronic lecithin organogels (PLO gels) are lecithin-based organogels widely used in compounding pharmacies as a vehicle for enhancing the transdermal permeability of many therapeutic drugs.

Question 15

when rx says to make PLO gel, what ingredients must you use

Answer 15

1. drug prescribed (ofc.)
2. Pluronic F127 (gel)
3. Lecithin/ Isopropyl palmitate solution (oil/solution)

Question 16

UBSOP policy for compounding transdermal gels

Answer 16

when compounding semi solid UNIT DOSE preparations, 1 extra dose of compound may be prepared

Question 17

volume of deadspace in syringes for transdermal preparations we have to account for

Answer 17

1. 0.1 mL x2 for the headspace of the syringes
2. 0.1 mL of headspace in the syringe-to-syringe adapter

0.1+0.1+0.1=0.3

Question 18

how to determine volume of Lecithin/ Isopropyl palmitate Solution to use when compounding transdermal gels

Answer 18

22% w/v

Question 19

how to determine volume of plutonic F127 gel to be used when compounding transdermal gels

Answer 19

it is the qs media.

once mixing drug with the lecithin/ isopropyl palmitate solution. expel remaining air and note volume. subtract from total volume to DISPENSE, NOT total volume to prepare (which includes the deadspace volume

will end up with f127 volume needed to compound.

Question 20

notes from transdermal gel compounding calculations

Answer 20

1. calculate total volume to prepare ): prescribed volume + 1 extra +deadpsace volume
2. calculate how many doses to prepare: total volume to prepare in proportion to 1mL/dose
3. calculate drug amount
4. calculate lecithin/ isopropyl palmitate solution: 22% w/v
5. calculate F127 volume by subtracting volume of drug/ lecithin mix from TOTAL VOLUME TO DISPENSE (NOT PREPARED).

Question 21

how to ensure tip contents transferred to main body of an ampule

Answer 21

1. gentle tapping against work surface
2. swirling
3. gentle finger snap

Question 22

how to safely handle ampule when using one

Answer 22

1. ensure tip contents transferred to main body
2. swab neck with alcohol swab
3. wrap neck with alcohol swab or gauze pad when breaking
4. use filter star or filter needle to withdraw
   either pre filter or post filter

Question 23

needles to use when using ampules

Answer 23

use a 0.5 micron filter needle when drawing liquid from ampule. then use switch needle to ensure filtered stuff doesn’t get back into the IV bag

Question 24

pros and cons of ampules

Answer 24

pros: do not require preservatives
cons: contamination by glass shards upon opening, filtration required

Question 25

# define ophthalmic preparations USP definition

Answer 25

essentially free from foreign particles, suitably compounded and packaged for installation into the eye (and ocular tissue surrounding the eye) note: USP 797 "pharmaceutical compounding-sterile preparations" mentions ophthalmic preparations should be sterile "...which include but are not limited to... inhalations, injections, powers for injection, irrigations, metered sprays, and ophthalmic and otic preparations"

Question 26

purpose of ophthalmic preparations

Answer 26

administration of medication to the eye lubrication cleansing

Question 27

local vs systemic effect of opthalmic preparations

Answer 27

local effect only? yes systemic absorption: always undesired GI coupling: gets absorbed into nasolacrimal gland epithelial absorption

Question 28

capacity of the eye for ophthalmic preparations

Answer 28

1 gtt/ eye 50 mg/ eye (for ophthalmic ung.)

Question 29

administration of opthalmic medication

Answer 29

1-2 drops (liquid) | 1/4"-1/2" (semisolid)

Question 30

ophthalmic preparaion dosage forms

Answer 30

1. solution (aq.) ex: atropine 1% w/v 2. ointments: white petrolatum or mineral oil ex: tetracycline HCL 3% w/v 3. suspensions: suspending agets ex: prednisolone 1% (Pred Forte) 4. Gels ex: timolol 0.25-0.5% (timoptic XE) * a solution which forms a gel upon administration

Question 31

special considerations for opthalmic preparations

Answer 31

1. PH: 7.4 (IDEAL) 2. tonicity: ~277 mmol-isotonic (ideal) 3: sterility? YES! USP 797 4. preservation: maybe

Question 32

A. tolerable range for pH of opthalmic preparations B. what happens if not in tolerable range

Answer 32

A .6.5-8.5 pH of 7.4 is ideal, but optimum pH is not always attainable due to concerns of drug stability. discomfort/ stinging

Question 33

colligative property that tonicity dictates also note about colligative properties

Answer 33

osmotic pressure freezing point depression boiling point elevation vapor pressure *note: colligative properties depend only upon the number of solute particles in solution, not the size of the particles

Question 34

freezing point

Answer 34

the temperature at which a liquid freezes

Question 35

freezing point depression

Answer 35

the number of centigrade degrees below the freezing point of water (0 C) at which a liquid freezes

Question 36

freezing point depression example what is the freezing point of a solution containing 700 g dextrose QS'd to a final volume of 1000mL

Answer 36

1. convert mass to moles using MW 700g/ (180g/mol)=3.888 moles 3.888 mol x 1.86 C/mol=7.23 C degrees. then that would mean the freezing point of this solution is -7.23 degrees C NOTE: for water: freezing point is depressed 1.86 centigrade degrees for every mole of particle per liter of solution,

Question 37

another freezing point depression example what is the freezing point depression of 5% w/v of dextrose in water

Answer 37

(5g/100 mL)=(Xg/1000mL) X=50 g (50g/Xmol)= (180 g/mol) X= 0.278 mol 0.278 mol (1.86c degrees/mol)=0.517 centigrade degrees (freezing point depression freezing point =-0.52 degrees centigrade

Question 38

even though the optimal tonicity for ophthalmic preparations is 277 mM, why may hyper/hypo tonicity be unavoidable

Answer 38

drug stability issues therapeutic dosing concerns

Question 39

tolerable tonicity range : may cause what

Answer 39

200-600 mM may cause: discomfort, stinging TISSUE DAMAGE

Question 40

Dextrose 5% w/v is isotonic. show the math to prove it

Answer 40

5g/100mL=X/1000mL X=50g 50g/Xmol=180.16 g/mol X=0.277 mols or 277 mM 277mM is isotonic. checks out just fine

Question 41

problems with calculating tonicity traditionally with ionic solutions

Answer 41

must use I Value (dissociation factor) when calculating

Question 42

I values for ``` non electrolytes 2-ion electrolytes 3-ion electrolytes 4--ion electrolytes 5-ion electrolytes ``` exception

Answer 42

``` non electrolytes: 1.0 2-ion electrolytes: 1.8 3-ion electrolytes: 2.6 4--ion electrolytes: 3.4 5-ion electrolytes: 4.2 and so forth ``` exception (zinc sulfate =: I=1.4 (not expected 1.8)

Question 43

how to find tonicity of ionic compound ex:

Answer 43

find the moles of solute (moles of solute) x (the I value)= moles of particles in solution

Question 44

what is the SCE method

Answer 44

sodium chloride equivalent method used to find the equivalent concentration of sodium that yields the same tonicity as concentration of a given substance

Question 45

what is the SCE value of a substance

Answer 45

value factor for a given substance that converts its tonicity to the equiv. tonicity of sodium

Question 46

how to calculate SCE value if not given experimental one

Answer 46

divide the molar concentration of a substance (in mM) by 277mM

Question 47

examples of how to find SCE value if not given experiemental find sce value of 9 g of dextrose (MW: 180.16g/mol)

Answer 47

find sce value of 9 g of dextrose (MW: 180.16g/mol) 9 g/X mol=180.16 g/mol X=0.05 mol I value = 1: so 0.05molx1=0.05 mol 0.05mol= 50 mM 50mM/277mM=0.181 (SCE value) 9g x 0.181=1.629 g of NaCl

Question 48

examples of how to find SCE value if not given experiemental find sce value of 9 g of potassium cl (MW: 74.55g/mol)

Answer 48

9 g/Xmol= 74.55 g/mol X= 0.121 mol 0.121 (1.8 {I Value})=0.217 mol 0.217 mol= 217 mM 217mM/277mM= 0.783 {SCE value} 9g x 0.783=7.047 g

Question 49

what is the experimental SCE for KCl and what does that tell us

Answer 49

~0.76 represents an approx 3% diff in calculates SCE value we should use reliable experimental data whenever possible rely on calculated sce value when he I value is known to be accurate

Question 50

example of how to determine how much substance needed to make a solution isotonic 1. how much KCl would be required to compound 30 mL of an isotonic solution containing 0.35% w/v NaCl?

Answer 50

how much KCl would be required to compound 30 mL of an isotonic solution containing 0.35% w/v NaCl? 1. find out how much NaCl would be in 30 mL of a 0.35% w/v solution 0.35g/ 100 mL= Xg/30mL X= 0.105 g 2. now calculate how much NaCl is in 30 mL of NS. (because NS is isotonic, conc of NaCl in that solution will be an isotonic concentration we can compare our value to) 0.9 g/100 mL=Xg/30 mL X=0.27 g * as we can see, the amount of sodium we need in our solution is less than the amount calculated to make 30 mL of an isotonic solution. now calculate how much more sodium we would need to get the isotonic sodium value for our volume 0. 270g-0.105 g= 0.165 g or 165 mg we would need 0.165 g more sodium to make the solution isotonic. however, the solution only intended to have 0.35% w/v in sodium. that means that we have to find the equivalent mass of KCl to yield that tonicity must use the SCE value of KCL: 165mg / 0.76 {KCl SCE value}=217 mg of KCl

Question 51

how much Nacl would be required to compound 15 mL of an isotonic solution of 1% atropine sulfate monohydrate (SCE value =0.12)

Answer 51

how much Nacl would be required to compound 15 mL of an isotonic solution of 1% atropine sulfate monohydrate (SCE value =0.12) 1. 1g/100mL=Xg/15mL X=0.15g Atropine 2. 0.15g x0.12 {SCE value}=0.018g 3. 0.9g/100mL=Xg/15mL x=0.135g 4. 0.135g-0.018g=0.117 g or 117 mg

Question 52

what is the freezing point of a solution containing 20 mg/mL caffeine and 3% NaCL w/v. NaCL: MW= 58.44 g/mol I value: 1.8 Caffeine: 194.19 g/mol 2 ways to get this answer

Answer 52

1. find out conc of each in a liter 2. find out molar concentration of each 3. add them together 4. multiple by freezing point depression value caffeine: 20 mg/ 1 mL= Xmg/1000mL X=20,000 mg or 20 g 20g/Xmol=194.19g/mol X= 0.103 mol NacL: 3g/100mL=Xg/1000mL X= 30 g 30g/Xmol=58.44 g/mol X=0.513 mol 0.513 mol x 1.8{I value}=0.924 mol 0. 103 mol+0.924 mol=1.03 mol 1. 03 mol x 1.86 C degrees =1.92 C degrees THIS IS THE FREEZING POINT DEPRESSION THE FREEZING POINT IS -1.92 degrees C second way: consider %NACL (or equiv.) NaCl: 3% caffeine: 20 mg/ml= Xg/100 mL X= 2000 mg or 2 g of caffeine. sooo 2% w/v 2% x 0.17 {SCE value}=0.34% 3%+0.34%=3.34% Ratio 0.9%/ 0.52 C degrees (freezing point depression of NS)=3.34%/ X C degrees X=1.93 C degrees freezing point =-1.93 degrees C

Question 53

basic steps of SCE method

Answer 53

***pH not an issue 1. determine and weigh required amount of drug 2. calculate amount of NaCL in an isotonic volume equiv to compounded volume 3. multiply calculated drug mass by SCE value 4. subtract step4 from 3. weigh this amount of Nacl 4. place nail and drug in beaker. dissolve in minimal amount of H2O, quantitatively transfer to a GC, qs to final volume with h20. mix by pouring 7. cold filter sterilize, transfer to dispensing container

Question 54

OU vs OS vs OD rx abréviation meaning

Answer 54

OU: both eyed OD: right eye OS: left eye

Question 55

benzalkalonium chloride

Answer 55

preservative for eyedrops

Question 56

what do you do if you have to weigh a volume that is below minimal weighable quantity

Answer 56

make a dilution. use judgement as to what volume dilution is reasonable.

Question 57

what should you do if you have to measure a volume that we can technically measure given our volume instruments but is small ex: measure 1.5 mL

Answer 57

divide the volumeinto 2 and measure that volume twice. 1.5/2= 0.75 mL measure this volume twice

Question 58

what are the 3 methods of ophthalmic compunding considered in this course

Answer 58

1. SCE method 2. USP method 3. Sorensen Phosphate Buffer Method

Question 59

USP method what is"theorem A" when does it not hold true

Answer 59

if you add an isotonic solution (of any volume ) to a second isotonic solution (of any volume), the resulting solution will be isotonic ``` does not hold true if these occur... precipitation drug degredation chemical reaction and solutions must be miscible ```

Question 60

USP method V-value

Answer 60

the amount of H2O required for the dissolution of 300 mg of drug which results in an isotonic solution

Question 61

USP method what is the assumption of the USP method

Answer 61

1, contribution of the solute ott he overall solution volume is negligible concentration: 300 mg/V-value.

Question 62

how to us USP method in Rx ex: Rx atropine sulfate 1.125% Nacl qs H2O: qs ad 15 mL (Atropine v value: 4.3 mL)

Answer 62

make a 300 mg/4.3 mL atropine solution 1. atropine 1.125g/100 mL=Xg/15 mL X=0.169 g or 169 mg 300mg/4.3 mL= 169mg/XmL X=2.42 mL of you would put 2.42 mL of atropine solution in a GC, then QS to 15mL with NS.

Question 63

Is there a difference between resulting ingredient compositions when using the SCE or USP method?

Answer 63

NO.

Question 64

does the USP method take pH into account?

Answer 64

no

Question 65

Sorensen Phosphate Buffer Method basic steps

Answer 65

1. pH is an issue 2. Pharmacist has direct control over product pH 2. prepare an excess buffered stock solution of appropriate proportion to yield desired pHh in final product. 3. calculate and weigh required amount of drug 4. multiple mass by SCE value 5. determine NACL required volume of product with out drug content 6. subtract nacl mass equiv. from total nail equiv. to yield NacL required. 7. place drug and nail in beaker, dissolve. qs to final volume with buffered stock solution. mix by pouring, etc. 8. sterilize, transfer to dispensing container, label, dispense

Question 66

how to determine volumes of sodium diphosphate and sodium phosphate to make buffer solution

Answer 66

look at sorensen phosphate buffer chart. look at required percentages of each solution for required pH. Use to make solution for required compounding volume

Question 67

in the sorensen method, how to determine amount of Nacl in an isotonic solution for required compounding volume if it only contained Nacl. how does this differ from the SCE mthod

Answer 67

must use the NacL required for isotonicity from the sorensen method chart for that specific pH value. different cause in the SCE method, you find the requiredNaCL by using the concentration of NS

Question 68

how to convert between C and F

Answer 68

1.8C=F-32

Question 69

freezing point of D10W

Answer 69

1. 10g/100 mL= Xg/1000mL X= 100g 2.100g/X mol=180g/mol X= 0.556 mol 3. 0.556 mol(1.86 C degrees)= 1.03 C degrees (freezing point depression) Freezing point: -1.03 degrees C