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Tablet Problems

The document discusses various issues that can occur during tablet manufacturing processes like capping and lamination, picking and sticking, weight variation, mottling, and double impression. Potential causes of each issue are outlined along with recommended remedies to address the problems and prevent defective tablets. The key information provided relates to maintaining proper moisture levels, granule size, mixing, compression parameters, and tooling to optimize tablet quality.

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Anup Bajracharya
Copyright
© Attribution Non-Commercial (BY-NC)
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Download as PDF, TXT or read online on Scribd
4K views

Tablet Problems

The document discusses various issues that can occur during tablet manufacturing processes like capping and lamination, picking and sticking, weight variation, mottling, and double impression. Potential causes of each issue are outlined along with recommended remedies to address the problems and prevent defective tablets. The key information provided relates to maintaining proper moisture levels, granule size, mixing, compression parameters, and tooling to optimize tablet quality.

Uploaded by

Anup Bajracharya
Copyright
© Attribution Non-Commercial (BY-NC)
Available Formats
Download as PDF, TXT or read online on Scribd
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Anup Bajracharya

QA Officer, Quest Pharmaceuticals (P)Ltd


[email protected]

CAPPING AND LAMINATION

S.No Reasons Remedies


1. Air entrapment in the tablet among granules or By pre-compression, Reducing final
among compression, Minimizing
particles tableting rate

2. Deformational properties of formulation during Increasing stress relaxation time


and after
compression

3. Improper/Deep concave punches Better to use flat punches


4. Over dried granules (Due to lack of cohesion) By maintaining moisture levels using
hygroscopic materials
like MC (Methyl Cellulose), Sorbitol, PEG 4000
(Polyethylene glycol) etc.
5. Improper tooling: Proper tooling:
Ø Concave Ø Checking of punches and replacing them
edges of punches turning claw shaped Ø Proper checking and replacing them
Ø Greater radius of curvature of punch face Ø Turning the die over so that compression
Ø Dies developing a wear ring shape occurs in an
Ø Improper adjustment of sweep off blade unworn area above ring
Ø Less rise of lower punch during ejection of Ø Proper setting of sweep off blade & lower
tablet punch rise

6. Poor compressibility observed during direct Relative compressibility is to be maintained


compression
technique
Anup Bajracharya
QA Officer, Quest Pharmaceuticals (P)Ltd
[email protected]

PICKING AND STICKING

Picking:-

!
" !
" #!
"

$!
" %!

& " '

(
)

Sticking:-

Adherence of tablet material to the die walls resulting in chipping of tablet


edges producing rough edges and causing the lower punches uneasy to move resulting
in damage of cam tracks and punch faces
:
• Presence of low melting point substances in the formula ex. stearic
acid, PEG (Polyethylene glycol) etc , which gets soften due to compressive heat
• Excessive moisture in the granules
:
• Partial or complete substitution of low melting point components with
high melting point materials in the formula
• Proper drying of the granules to remove excessive moisture
Anup Bajracharya
QA Officer, Quest Pharmaceuticals (P)Ltd
[email protected]

WEIGHT VARIATION

Granule size and size distribution

* "

) ' +
, - '

Poor flow

0 "

'

Poor mixing

* /

* 1 /
Anup Bajracharya
QA Officer, Quest Pharmaceuticals (P)Ltd
[email protected]

/ 1 /

Punch variation

) 1

'

Hardness variation

MOTTLING

) 1

2 + -
#

3
)
Anup Bajracharya
QA Officer, Quest Pharmaceuticals (P)Ltd
[email protected]

(
/
*

4 '

DOUBLE IMPRESSION

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