Lab 2

Question 1

Drugs are formulated as suspension dosage forms based on…..

Answer 1

their properties (insolubility, stability, taste) and other specific patient needs (age, route of administration)

Question 2

excipients to improve product appeal, stability, and storage of suspension dosage forms are selected based on……

Answer 2

the same principles as preparing solutions

Question 3

true or false

parenteral and sterile suspension dosage forms have the same requirements for sterility and pyrogenicity

Answer 3

true

Question 4

___ and ____are required to ensure controlled flocculation and prevent caking

Answer 4

suspending agents and viscosity enhancers

Question 5

name 4 common vehicles for suspensions

Answer 5

simple syrup
cherry syrup
sorbitol
glyceirn

Question 6

name 4 common preservatives for suspensions

Answer 6

methylparaben
propylparaben
sorbic acid
sodium benzoate

Question 7

name 6 suspending agents for suspensions

Answer 7

tragcanth
acacia
colloidal silicone dioxide
sodium carboxymethylcellulose
methylcellulose
carbomer resins

Question 8

the particle size of suspensions must be sufficiently small to ensure…….
and to avoid…….

Answer 8

to ensure uniformity of dose, prevent erratic absorption, bioavailability, stability, and to avoid a COARSE FEELING in the mouthq

Question 9

smaller particle size ensures ____ of the suspension and reduces ____ rate

Answer 9

ensures uniformity and reduces the sedimentation rate

Question 10

true or false

increased particle size decreases surface area and potential bioavailability

Answer 10

FALSE – increases

Question 11

extremely fine powders may tend to….. due to…..

THIS MAY INCREASE ____

Answer 11

extremely fine powders tend to DEFLOCCULATE due to an INCREASE IN SURFACE CHARGE and DECREASE in wettability of the powder

THIS MAY INCREASE CAKING

Question 12

extremely fine powders have a _____ in surface charges and a _____ in wettability of the powder

Answer 12

INCREASE in surface charges and a DECREASE in wettability of the powder

Question 13

extremely fine powders can increase or decrease caking?

Answer 13

increase

Question 14

significant differences in the physical properties of the suspended ingredients can result in…..

Answer 14

different sedimentation rates and caking of individual ingredients

Question 15

as mentioned, significant differences in physical properties of the suspended ingredients can result in different sedimentation rates and caking of individual ingredients.

how are these formulation issues dealt with?

Answer 15

through the addition of appropriate excipients

Question 16

true or false

the suspension must be both physically and chemically stable

Answer 16

true

Question 17

the pH of the suspension must be compatible with…..

Answer 17

active ingredients and excipients

Question 18

the containers of suspensions must ensure ____

Answer 18

stability

Question 19

name 3 indicators of microbial stability

Answer 19

growth
color
odor

Question 20

name 3 indicators of chemical stability

Answer 20

pH
degradation of the active ingredient
viscosity change

Question 21

name 7 indicators of physical stability

Answer 21

appearance/color/odor/taste
viscosity and sp gravity
particle size (microscope)
uniform drug distribution
pH
sedimentation rate and volume
compatibility with container and cap

Question 22

true or false

suspensions do not have to resist microbial growth

Answer 22

FALSE – they do.

Question 23

“free water”

Answer 23

the non-preserved water content (available for microbial growth)

Question 24

when formulating a suspension, what 5 things must be considered when determining if preservatives are needed

Answer 24

-the source of the ingredient and its potential for microbial contamination
-pH
-“free water” content
-storage conditions
-shelf life

Question 25

the preservative concentration is based on what?

Answer 25

the non-preserved water content in the suspension

Question 26

ingredients from _____ are more likely to have microbial issues as compared to _____

Answer 26

ingredients from NATURAL SOURCES are more likely to have microbial issues as compared to SYNTHETIC PRODUCTS

Question 27

name 5 examples of ingredients from natural sources (more likely to have microbial issues)

Answer 27

aluminum hydroxides trisilicates magnesium oxides carbonates bentonite

Question 28

when hydrated ingredients are used in suspensions, what must be considered?

Answer 28

their water content must be included in the free water calculation

Question 29

true or false Simple Syrup NF (85% w/v sucrose) is self preserving and is a preservative

Answer 29

FALSE simple syrup is self preserving, but syrups are NOT PRESERVATIVES. syrups may require preservation due to their hygroscopic nature (readily takes up moisture)

Question 30

can refrigeration slow microbial growth?

Answer 30

YES, but it can create other issues such as precipitation, or an increase in viscosity

Question 31

slight ___ improves taste

Answer 31

SLIGHT ACIDITY IMPROVES TASTE

Question 32

many excipients require specific ___ to be effective

Answer 32

pH

Question 33

____ and ____ are used to adjust pH. for oral preparations, ___ and ____ are preferred to maintain the pH

Answer 33

HCl and NaOH sodium citrate and citric acid are preferred for oral preparations

Question 34

true or false appropriate colors and flavors may be added for oral suspensions

Answer 34

true

Question 35

the effectiveness of an antacid is determined how?

Answer 35

by its ability to neutralize gastric acid

Question 36

the endpoint or pH of the neutralization should be compatible to function of....

Answer 36

the stomach (digestion)

Question 37

in the formula: total mEq = (30*NHCl) - (VNaOH *NNaOH) what does total Meq mean?

Answer 37

number of mEq of acid consumed by the antacid formula

Question 38

powders are pulverized either by ___ or ___

Answer 38

using a mortar and pestle (small scale) or grinders and mills for large scale

Question 39

when mixing fine powders or semisolids in unequal amounts, (particularly when the quantity of the ingredients is large), pharmacists use ____ to ensure ____

Answer 39

GEOMETRIC DILUTION to ensure HOMOGENEITY of the mixture

Question 40

explain how geometric dilution works

Answer 40

involves slowly combining the ingredients, a small portion at a time -arrange pulverized ingredients in ascending order by weight -place API in mortar (smallest quantity) -add quantity of diluent approximately equal to quantity in mortar and mix thoroughly using pestle

Question 41

suspensions must include ___ on the label, besides the standard labeling requirements

Answer 41

"SHAKE WELL BEFORE USE"

Question 42

when transferring and measuring significantly affect accuracy, ____ is used to measure the final volume

Answer 42

a pre-calibrated container

Question 43

in suspensions, errors may occur when measuring and transferring. why?

Answer 43

due to the sedimentation of suspension products

Question 44

explain how the calibration of container bottles works

Answer 44

the volume of water is weighed and the level of water is marked on the container the mark is used to measure the final product volume

Question 45

a base ____ is used to neutralize an acid ____ in titration. the endpoint (____) is measureed using a ____ and/or a ____

Answer 45

NaOH is used to neutralize HCl in titration the endpoint (pH) is measured using a pH indicator and/or pHmeter