Preformulation

Question 1

define preformulation

Answer 1

first step in developing dose form by gathering information regarding drug properties which may have a bearing on product formulation

Question 2

what must formulator develop in preformulation

Answer 2

detailed procedure and specification of API, excipients, and finished product

Question 3

define organoleptic

Answer 3

description of drug including taste, color, and odor

Question 4

how do you fix bad colors

Answer 4

coating or coloring agent

Question 5

how do you fix bad odors

Answer 5

aromatic excipient or coatin

Question 6

how do you fix objectional taste

Answer 6

flavouring agent, coating, insoluble form

Question 7

what are the colors

Answer 7

off white
tan
cream yellow
shiny

Question 8

what are the odors

Answer 8

pungent 
sulfurous
fruity
aromatic 
odorless

Question 9

what are the tastes

Answer 9

acidic 
bitter 
bland 
intense
sweet tasteless

Question 10

what is required for metal impurities

Answer 10

excipients like EDTA

limit test development

Question 11

what dooes micrometrics include

Answer 11

particle size shape and surface area

Question 12

what does small particle size do

Answer 12

increase surface area for excipient , oxygen, and moisture

Question 13

what are some problems of milling

Answer 13

agglomeration
polymorph formation
static electricity

Question 14

what must a drug do before absorption

Answer 14

dissolve in GI fluids

Question 15

at what solubility percent are drugs considered to not have dissolution problems

Answer 15

1%

Question 16

what is the risk associated with HCl oral salts

Answer 16

common ion effect with gastric HCl

Question 17

if drug not ionizable what are other means of increasing solubility

Answer 17

use of metastable polymorph
use of complexes
solid solution techniques
incorporation of surfactants 
micronization

Question 18

if dissolution rate slower than absorption what would happen if you changes the dissolution rate

Answer 18

it would change the absorption rate bc dissolution is the rate limiting step

Question 19

what does a larger log p value indicate

Answer 19

more affinity for organic phase than aqueous

Question 20

what are properties of crystallin sunstances

Answer 20

definite shape
stable
can form polymorphs

Question 21

what are properties of amorphous substances

Answer 21

no definite shape
more soluble
better dissolution

Question 22

if absorption is dissolution rate limited what might be one way to speed it up

Answer 22

use metastable polymorph

Question 23

what are the forms of a polymorph

Answer 23

only one stable form and metastable forms convert over time to stable , unless in a solution it no longer differs

Question 24

when can you justify use of metastable polymorph

Answer 24

when it exhibits sufficient chemical and physical stability

Question 25

what stability studies are done on tablets

Answer 25

drug alone
drug with excipients
drug in solution

Question 26

what factors influence stability

Answer 26

pka 
solubility
melting point
crystal habit/form
equilibrium moisture content

Question 27

what are the most common factors for instability

Answer 27

light
heat
oxygen
moisture

Question 28

how are high humidity levels for testing achieved

Answer 28

using saturated solutions of various salts

Question 29

what are ways to pull samples stored at elevated temperature

Answer 29

TLC
HPLC
DTA

Question 30

what other factors are inportant to formulator

Answer 30

density
flow
hygroscopy
compressibility

Question 31

how does density affect formulation

Answer 31

excipients must have similar density or segregation will occur
affects flow properties

Question 32

why must moisture content be know

Answer 32

may affect flow and compression properties

Question 33

how do flow properties affect formulation

Answer 33

need good flow for blending, granulation, compression

assessed by angle of repose

Question 34

whats a good angle of repose

Answer 34

25-45

smaller = better flow

Question 35

what is compressibility

Answer 35

powder forms hard uniform contact under moderate pressure