LUBRICANTS USED IN TABLET MANUFACTURING

How tablets are prepared with lubricants

1. NETAJI SUBHAS CHANDRA BOSE INSTITUTE OF PHARMACY CHAKDAHA, NADIA, 741222 LUBRICANTS USED IN TABLET MANUFACTURING PRESENTED BY- SAYANTAN JANA B.PHARM , 6 TH SEM

2. CONTENT 1. INTRODUCTION Lubricant Role of Lubricant Characteristics Classification 2. MECHANISM 3. SOME LUBRICANTS AND THEIR USES IN TABLET PREPARATION 4. ADVANTAGES 5. DISADVANTAGES 6. REFERENCE

3. . INTRODUCTION Lubricants are intended to reduce the friction during tablet ejection between the walls of tablet and walls of die cavity in which the tablet was formed. One of the most challenging steps in tablet manufacturing is identifying the correct lubricant level for producing defect free tablets within a specific hardness range. Examples: Steric acid, Magnesium sterate , Talc etc.

4. Role of Lubricant : True Lubricant Role: To decrease friction at the interface between a tablets surface and the die wall during ejection and reduce wear on punches & dies. 2. Anti adherent Role: Prevent sticking to punch faces or in the case of encapsulation ,Lubricants prevents sticking to machine dosators , tamping pins , etc . 3 . Glidant Role: Enhance product flow by reducing interparticulate friction.

5. . CHARECTERISTICS: Low Shear strength ,Want the lubricant to hear during blending ,not the granulator other excipient in the formulation . Non toxic Able to form a “durable layer” over the surface covered. Chemically inert Unaffected by process variables

6. CLASSIFICATION OF LUBRICANT 1.Water Soluble 2.Water insoluble

7. WATER SOLUBLE LUBRICANT: Examples Concentration Range(%W/W) 1.Boric acid 1 2.Sodium Benzoate 5 3.Sodium Olete 5 4.Sodium Acetate 5 5.Sodium Lauryl Sulphate 1-5 6.Magnessium Lauryl Sulphate 1-2

8. Examples Concentration (%W/W) 1.Sterate 0.25-1 2.Talc 1-2 3.Waxes 1-5 4.Sterowet 1-5 5.Glyceryl behapate 1-5 6.Liquid paraffin upto5 WATER INSOLUBLE LUBRICANT

9. MECHANISM 1.Fluid Lubrication In this type of lubrication is done in those cases where liquid lubricants having minimum viscosity under working conditions. 2.Boundary Lubrication It happens when a shaft starts moving from rest . The Speed is very low. The load is very high . viscosity of this lubricant is too high.

10. SOME LUBRICANTS AND THEIR USES IN TABLET PREPARATION: Magnesum Stearate Application: Used as anti adherent in the manufacture of medical tablets. Used to bind sugar in medical candies like mints. B. Talc Application: sued in tablet preparation as dissolution retardant in the development of controlled release product. Magnesium sterate Talc

11. C. Polyethylene Glycol 4000 -6000 (PEG ): Application: Has been used as a water-soluble lubricant for some water soluble and effervescent tablet formulations. D. Sodium Lauryl Sulphate (SLS ): Application: Effective at reducing ejection forces but does not help much for sticking to punch faces. Therefore, it must be used in conjunction with an anti-adherent . Sodium lauryl sulphate PEG (4000-6000)

12. E. Sodium benzoate: Application: It is also used in tablet preparation as a lubricant and it also worked as flavouring agent and anti microbial agent. Other lubricants that are used in Tablet preparations are: Glyceryl Palmitostearate  ( Precirol ) & Glyceryl ) Behenate  ( Compitrol 888). Sodium Stearyl Fumarate ( Pruv ).

13. ADVANTAGES: Prevent the adhesion of tablet. Reduce interparticulate friction. Improve the rate of flow of tablet granulation. High viscosity index eg.Vegetable oil. High resistance of detoriation in storage. Highly stable eg.temperature radiation.

14. DISADVANTAGES: lubricants is the production of oil spots.eg steric acid salts and derivatives. Talc samples are found to contain trace quantities of iron. P oor self healing property. Poor heat dissipation eg . polymers. Higher coefficient frication.

15. REFERENCE: Miller T.A, York P. Pharmaceutical tablet lubrication. Int. J. Pharm. 1988; 41; 1–19. Lapeyre F, Cuine A, Chulia D, Verain A. Quantitative evaluation of tablet sticking anti-adherent properties of some tablet lubricants. STP Pharma 1988; 4; 106–110. Ertel K.D, Carstensen J.T. Chemical, physical, and lubricant properties of magnesium stearate. J. Pharm. Sci. 1988; 77; 625–629. Lachman / Lieberman’s. Industrial pharmacy. 4th edition; 2013; 463-464 .