Tablet Problems

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 among particles

By pre-compression, Reducing final compression, Minimizing tableting rate

2.

Deformational properties of formulation during and after compression

Increasing stress relaxation time

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: Ø Concave edges of punches turning claw shaped Ø Greater radius of curvature of punch face Ø Dies developing a wear ring shape Ø Improper adjustment of sweep off blade Ø Less rise of lower punch during ejection of tablet

Proper tooling: Ø Checking of punches and replacing them Ø Proper checking and replacing them Ø Turning the die over so that compression occurs in an unworn area above ring Ø Proper setting of sweep off blade & lower punch rise

6.

Poor compressibility observed during direct compression technique

Relative compressibility is to be maintained

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

PICKING AND STICKING

Picking:-

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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

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Poor flow

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Poor mixing

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

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Punch variation

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Hardness variation

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

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DOUBLE IMPRESSION

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