PROCESSING PROBLEMS 1.

Capping

ILLUSTRATION

DEFINITION Capping is a complete or partial separation of the upper or lower surface of the tablet horizontally, when the tablet comes out of the die. When the air is entrapped in between the tablet material in a die, and when the material gets compressed between the two punches, the air entrapped also gets compressed, but when the pressure is released on the tablet I.e. when the two punched move apart and the tablet ejects out of the die, the compressed sir expands and leads to capping.

REMEDY Friability test can reveal these problems Pre-compression: reduce final compression, Minimize tableting rate Increase stress relaxation time Better use of flat punches Maintain moisture levels using hygroscopic level Maintain relative compressibility Use 100-200 mesh screens Dry granules properly Increase amount of binder or adding dry-binders Increase or change the lubricant Compress at room temperature Polish dies properly Proper settling of lower punch Modify mixing process Add absorbent or adsorbent Lessen or change the lubricant Use tapered dies Pre-compression step: reduce turret speed and final compression pressure

2. Lamination

It is similar to capping but here the tablet gets separated into layers. It can once again occur due to the air entrapment or due to the high speed of turret

3. PICKING

Adherence of the tablet material from the surface of a tablet by a punch Picking happens when a part of the tablets gets sticks to the punch surface and gets eroded from the tablet surface This mostly happens with the upper punch. And if this is left unchecked then this may lead to weight variation too.

4. 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

5. CRACKING

Small, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the sidewall are referred to as Cracks.

Dry properly the granules, determining optimum limit Increase lubrication; use of colloidal silica Add high-melting point materials Refrigerate granules and entire tablet press Compress at room temperature Cool before compression Reduce amount of binder Use of dry binders 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 Use lower molecular weight polymers Add plasticizer type and concentration Use appropriate colorants Change solvent system Change binder Reduce drying temperature Use smaller particle size Mix properly Use dry color additive

6. MOTTLING

Mottling is uneven distribution of the color on the surface of the tablet, with dark and light patches on it. It is mainly due to different coloration of the excipient or the degradation product of the tablet is colored.

7. PEELING

Coating peels away from the tablet surface Coating solution did not lock with the tablet surface Defect in coating solution, over-wetting, high moisture content

Do not over-wet Lessen moisture content

8. ORANGE PEEL ROUGHNESS

Inadequate spreading of coating solution before drying causes a bumpy or orange-peel effect

Use mild drying conditions Use additional solvent to reduce viscosity of solution Increase plasticizer content or change plasticizer type

9. LOGO BRIDGING

Occurs when coating fills in the logo/lettering on the tablet Typically caused by improper application of the solution, poor design of tablet embossing, high coating viscosity, improper atomization pressure Term of two tablets that stick together A common problem for capsule-shaped tablet

10. TWINNING

Balance pan speed and spray rate Modify tooling, changing the radius

# 22- Odd Group Liwag, James Timothy L Processing Problems = Numbers 1-10 Sources (URLs): http://formulation.vinensia.com/2011/05/coating-tablet-defects-cause-and.html http://www.slideshare.net/venkybunnyt/theories-of-solubulisation-11429763 http://www.pharmainfo.net/tablet-ruling-dosage-form-years/problems-tablet-manufacture-and-related-remedies http://www.pharmainfo.net/gate-quizzes/processing-problems-of-tablets http://www.pharmainfo.net/rajapicta1023/blog/problems-associated-tablet-manufacturing

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