Tablets 123456789101000000888884454.pptx

TABLET

1. SOLID DOSAGE FORMS (TABLET PROBLEMS) PABITRA SUBEDI

2. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking

3. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Capping is the partial or complete separation of the top or bottom crowns of a tablet. Lamination is the separation of tablet into two or more distinct layers . May be apparent immediately. Or appear later. Friability test is the quickest method. Deep concave punches- capping. Too dry granules- lamination or capping.

4. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Due to deformational properties during compression. Particles undergo sufficient plastic deformation to produce die-wall pressures greater than can be relieved by elastic recovery. Die-wall pressure falls to zero during ejection. The emerging portion expands. Confined portion cannot. Sheer stress is concentrated at the edge of the die. Break develops. Rapid decompression causes fracture.

5. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Shape of die and punch can also be a cause. Concave or beveled edges can form a claw. Due to curve formed by wear and tear. Greater the curve, greater the force on the edges. Force at the centre will be less. Die can form a ring too due to wear and tear. Ring is larger than the other parts of die. Constriction caused can cause capping or lamination during ejection.

6. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Another reason is incorrect set-up. Lower punch must rise to optimum set height. If lower, tablet is not fully ejected. Sweep-off blade cannot function properly. Tablet exposed is swept. Tablet in the die is stuck. Only upper part will be swept. This can cause capping.

7. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Causes: Lack of sufficient moisture content. Incorrect adjustment of scraper blade and lower punch. Improper flashing of lower punch during ejection. Insufficient compression time . Remedies: Proper moisture level. (Avoid excessive drying) Proper adjustment of tableting machine. Adjust lower punch for optimum ejection force. Proper binder and lubricant.

8. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Causes: Improper adjustment of tableting machine. Improper flashing of lower punch during ejection. Improper binder and lubricant. High moisture content. Air entrapment. Remedies: Reduce moisture content. (Avoid excessive drying) Ensure a ir is removed.

9. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Picking is the removal of tablet surface material by a punch . Sticking is the adherence of tablet material to die wall . Picking is of particular concern for punches with: Engraving Embossing At extremes, picking can obliterate tip designs. Additional force is required to overcome sticking. Due to friction between tablet and die wall. Serious sticking can lead to chipping of tablets.

10. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Sticking can also damage punches. Does not allow lower punches free movement. Various remedies include: Lettering should be as large as possible or enlarge tablet. Plating punch face with chromium. Colloidal silica in formulation acts as polishing agent. Change of binder or additional binder. Mix low m. p. substance with high m. p. substance. Reduce moisture level.

11. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Causes: High moisture content. Improper use of lubricant and adherent. Broken edges or rough punch and die. Abrasive engravings. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to prevent adhesion.

12. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. C auses: High moisture content. Improper use of lubricant and adherent. Broken edges or rough punch and die. Abrasive engravings. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to pr event adhesion.

13. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to prevent adhesion. The uneven distribution of colour . Distinct light or dark areas on an otherwise even tablet surface. Caused due to: Colour differences between API and excipients. Degradation products with different colours . Mottling in direct compression due to: Dye not well dispersed Particle size difference

14. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to prevent adhesion. Dye can cause mottling. May migrate to surface of granules during drying. Remedies include: Change solvent system Change binder system Reduce drying temperature Reduce particle size Coloured adhesive gels may not mix well with powders. Gel must be heated.

15. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to prevent adhesion. Powder mixture is cooler. Adhesive precipitates and carries along most of the solution. Further wetting is required. Can lead to increased disintegration times. Better practice: Incorporate fine powder adhesives before adding granulating fluid. Acacia and tragacanth Disperse a dry colour additive during powder blending step.

16. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to prevent adhesion. Causes: Improper adjustment of scraper blade and lower punch. Improper binder and lubricant. High moisture content. Remedies: Proper adjustment of tableting machine. Proper binder and lubricant selection. Optimum moisture content. (Avoid excessive drying )

17. PROCESSING PROBLEMS Capping Lamination Mottling Double impression Cracking Picking Chipping Sticking Remedies: Reduce moisture content. (Avoid excessive drying) Ensure air is removed. Remedies: Optimum moisture content. Proper lubrication. Washing punch and die and ensuring they are smooth. Use of colloidal silica to prevent adhesion. Remedies: Proper adjustment of tableting machine. Proper binder and lubricant selection. Optimum moisture content. (Avoid excessive drying) The faulty print/embossing on tablet surface . Occurs for punches with engraving or embossing. Usually occurs when tableting machine setting is wrong. Uncontrolled upper punch can rotate during compression. Double compression occurs. Botches impressions on the tablet. Ejection is not smooth. Due to too much lubrication.