problem name problem definition cause solution

upper or lower segment of the tablet separates horizontally either air entrapment during compression and subsequent fines by 100 to 200 mesh screen/ binder/ dry
partially or completely from the body and comes off as a cap,during expansion of tablet on ejection hygroscopics e.g.sorbitol, methyl cellulose or PEG-4000
Capping ejection or handeling compress at room temperature
Use flat punches /make proper setting of lower punch adjust
sweep-off blade correctly.
separation of a tablet into two or more distinct horizontal layers Air- entrapment due to turret speed mixing process adsorbent or absorbent lubricant
Laminating compression pressure /turret speed Use tapered dies(outward
(Lamination) taper of 3 to 5 )
breaking of tablet edges during ejection , handling or coating Incorrect machine settings,specially mis-set ejection Dry lubricant moisture of granules to plas cize
Chipping take-off. hygroscopic binder concavity of punch (at punches) Polish die
to make it cylindrical polish punch edges
Small,fine cracks on the upper and lower tablet surface or rapid expansion of tablets,especially when deep granule size nes moisture binder granula on
Cracking very rarely on the side concave punches are used. compress at room temperature Use taperd die use
special take-off
tablet materials (not the whole tablet) adhere to the die wall (not the moisture > 2% (Improperly dried granules ) Dry binder lubricant humidity
Sticking punch) lubricant (improperly lubricated granules ) absorbent concavity (concave tab = weak) pressure
speed mixing me (uniform destribu on of ingrediants)
slow form of sticking ; due to sticking of successive tablets, a film that granulation
Filming cover the whole die wall is formed
tablet materials adhere to the punch (not the die wall ) moisture > 2% (Improperly dried granules ) Dry binder lubricant pressure
more prevalent on the upper punch than on the lower engraving or embossing letters on punch tips add high melting point material ( endure the machine heat)
Picking Temp. (refrigerate granules and the entire tablet press) / Polish
punch/ plate punch with chromium

the whole tablet adhere,seize or tear in the die A moisture > 2% (Improperly dried granules ) Dry lubricant granule size nes ( surface area H2O
film is formed in the die and ejection of tablet is hindered lubricant (improperly lubricated granules ) worn absorption) Temp. (the mel ng point of all ingrediant must be
Binding binding = tablet crack or crumble dies known) clearance ( punch diammeter) pressure Polish dies

unequal colour distribution with light or dark spots coloured drug differs from excipients colour colourant solvent par cle size ( segrega on)
Mottling chemical reaction (incompitability)e.g. miller rxn par cle size +mixing =homogenous color distribu on /
drying temperature ( ch. Rxn speed)
Double only punches with monogram or engraving on them Free rotation of upper punch or lower punch during Insert key = fits the punch = No punch rotation.
impression ejection anti-turning devices in Newer presses = No punch rotation
gases entrapment in or underneath the film overheating :outer most layer of the coat dry before drying condi ons
Blistering
inner most layer so air fail to escape
Chipping breaking of tablet edges during ejection , handling or coating a ri on molecular weight grade of polymer = lm hardness
localized disintegration of the core and coat disruption penetration of the coating solution into the tablet spray applica on rate (give me to dry)
Cratering surface often at the crown where the surface is more drying conditons
porous ( convex tablet)
pits on surface temperature of tablet core > melting point of tablet preheating before coating
Pitting
materials drying (inlet air)temperature
Blooming dull film concentra on & molecular wt of plas cizer concentra on and molecular weight grade of plas cizer
Whitish specks due to polymer precipitation coa ng temperature at or above the thermal drying air temperature NO
Blushing
gelation temperature of the polymers sorbitol + cellulose derivatives (hygroscopic sub. require temp to
(Haziness)
remove absorped H2O)
improper mixing or uneven spray pattern insufficient Geomtric mixing mild drying conditions
Colour variation
coating or migration of soluble dyes plsticizers
bubble/foam formation during air spraying of a polymer solution use smaller spray nozzle = finer atomization = no bubble pass
Infilling Add alcohol = surface tension = bubble pops

Orange peel inadequate spreading of the coating solution before drying viscosity of coa ng solu on
(Roughness)
Cracking internal stresses in the film >> tensile strength of the film molecular wt polymers or polymeric blends molecular weight polymers or polymeric blends
 name cause solution
high soluble salts high soluble e.g Br , Cl , I = rapid release = conc in localized area = gastric irrita on
mechanical impact cap-body interference control internal forces generated in the capsule
cracking
hygroscopic material = H2O content in gelatin > 10% = gelatin dimentional changes =brittle shell thickness in the shoulder area humidity
capsule size to use 000 (largest ) , 00 , 0 , 1 , 2 , 3 , 4 , 5 (smallest) powder = tapped density **pellets /granules =bulk density Capacity
???!! chart (text books)
moisture-senstive drugs (moisture content in gelatin capsule = 13 -16 %) HPMC capsules = moisture content (4-6%) PEG400
unsuitable
hygroscopic material = H2O content in gela n > 10% = gela n dimen onal changes =bri le (plasticizer) capsule (add 1-2 % only) compatibility study
formulations
pellets /granules par cle size dierences
pellets /granules pellets/granules Agglomera on
volumetric filling owability
difference level of pellets in the supply hopper
Electrosta c charge =retards the transfer from the dosing chamber to the capsule body
filling machine dosing system & feeder abrading the functional coat = affect the release profile.
pellet mixture blend of high and low dose pellet groups = segregation during the feeding or encapsulation. New filling machines w pellet feeding system; feed separately
empty capsules ::: Temp. cycles of & Temp. Unsupported wall = damage easily 15 -25 C + 35-55 % RH No freezing
storage
filled capsules::: depend on product stability profile temperature mapped warehouse monitor temp.
gela n ner pellet/granule coat a ri on
product recovery from No fill material grinding validation of recovered product use
capsule separator/recovery unit that mechanically seprate cap
(milling/seiving = ineffective)