Module 5 Lesson 2 Flashcards
Flat or biconvex discs of unit dosage forms containing one or more active ingredients, compressed along with necessary aditives
tablet
Ingredients used in tablet formulations
API & excipients
Excipients properties
-Must be non-toxic and physiologically inert
- must be free from microbial contamination
- do not alter bioavailability of drug
excipients
-Binder and adhesives
-Disintegrants
-glidants
-antiadherants
-lubricants
These Materials are added either dry or in wet form to form granuels
binders and adhesives
Example of binders and adhesives
Acacia, tragacanth, cellulose derivatives, starch paste,hydroxy propyl methyl cellulose
-to promote breakup of the tablets
disintegrants
To promote rapid release of the drug
disntegrants
Reducing friction between particles
glidants
To improve the flow properties of the granulations
glidants
Prevent adherence of the granules to the punch faces and dies
antiadherants
Examples of antiadherants
Talc, corn starch
To redue the friction during tablet ejection
lubricants
Examples of lubricants
Stearic acid, magnesium stearate, talc, PEG, surfactants
Organoleptic agents
Sweetening agents, coloring agents, flavoring agents
Sugar, mannitol, saccharine
Sweetening agents
500 times seeter than sucrose
Saccharine (artificial)
Use of colors and dyes in a tablet
Coloring agents
Purpose of coloring agents
Mask of off color drugs
Product identification
Production of more elegant product
does particle size of granulation affect the average tablet wright, weight variation, disintegration time, friability, granule flow ability
y
yes
Coloring agents
FD & C, yellow 6-sunset yellow, FD & C yellow 5-Tartrazine
Mostly used in chewable tablets
Flavoring agents
Flavoring agents
Flavor oils
TRUE OR FALSE
The dissultion of a drug depends on surface area of powder materials or granules
true
for the movement of granules from hopper to die cavity sufficient flow properties are essential
true
official tests
weight variation, disintegration, dissolution, drug content
non official tests
hardness, fribality, general appearance
crown thickness of individual tablets may be measured with
micrometer
uses a spring applies diametrically to a tablet
stokes hardness tester
force produced by a manually operated air pump
string cobb hardness tester
makes use of hand pliers
pfizer tester
makes use of hand pliers as aid
erweka tester
horizontally positioned, eliminated operator variance
schleuniger
acceptable hardness of ordinary compressed tablet
4-a0 kgf
acceptable hardness of buccal tablet
7-10 kgf
acceptable hardness of chewable tablet
2-3 kgf
acceptable hardness of sublingual tablet
2-3 kgf
acceptable hardness of sustained release tablet
10-20 kgf
the tendency of tablets to powder, chip, or fragment which can affect the elegance appearance of the tablet
friability
these tests can be performed to give indication of how well a tablet will hold up in its specified package and shipping container during shipment
friability
friablity additional tests:
vibration test
drop tesst
incline plane tests
breakdown of the tablet into smaller particles or granules a process known as
disintegration
a physiochemical process by which a solid substance enters the solvent phase to yield a solution
dissolution
apparatus 1
basket
apparatus 2
paddle
apparatus 3
reciprocating cylinder
apparatus 4
flow through cell
apparatus 5
paddle over disk
apparatus 6
rotating cylinder
apparatus 7
reciprocating holder
