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CO-PROCESSED




 Presented by-            Under the guidance of
Mr. Bhaskar N. Bangar       Dr. N. H. Aloorkar
           EXCIPIENTS
     M. Pharm. (Sem. I)     (H.O.D. Pharmaceutics)
                                                     2
Contents…………
        Definition of excipients
          Need of excipients
   Ideal characteristics of excipients
          Roles of excipients
      Classification of excipients
 Excipients used in solid dosage forms
 Excipients used in liquid dosage forms
Excipients used in semi-solid dosage forms
       Co-processed excipients
      Co-processing methodology
              Conclusion
              References                     3
What are Excipients?



                       4
Need of Excipients

Direct clinical use of the active drug substances is rare
 due to the number of reasons:


 API handling is difficult or impossible.

 Accurate drug dosing is difficult or impossible.

 API may cause local irritations or injury.




                                                            5
Cont......


 API can have unpleasant organoleptic properties.


 API can be degraded at the site of administration.




                                                              6
Ideal characteristics of excipients
 It should be non toxic.
 It should be physically and chemically stable.
 It should be commercially available.
 It should have pleasant organoleptic properties.
 Economic.




                                                     7
Roles of excipients in different dosage forms
 Impart consistency and volume
 Improve stability
 Increase solubility
 Enhance bioavailability
 Increase patient compliance and acceptability
 Impart weight




                                                  8
Classification of excipients
  Primary excipients :   Diluents
                          Binders
                          Disintegrants
                          Lubricants
                          Antiadhesives
                          Glidents

  Secondary excipients : Flavoring agents
                          Sweetening agents


                                              9
Commonly used excipients in solid dosage
forms


 Diluents
 Binders
 Disintegrants
 Lubricants

 Antiadhesives
 Glidents
                                           10
Commonly used excipients in liquid dosage
                    forms

    SUSPENSION              EMULSION

       Vehicle               Vehicle
 Flocculating agents     Antimicrobial agents
Antimicrobial agents    Antioxidants
Sweetening agents       Flavoring agents
Suspending agents
 Preservatives



                                                11
Commonly used excipients in semi-solid dosage
                  forms
Bases


Preservatives


Antioxidants


Chelating agents


                                            12
Co-Processed Excipients




                          13
Manufacturing problems in solid

 Product weight variation.

 Content non uniformity during mixing.


 Loss of excipients.
                                          dosage
        forms
 Poor disintegration time of product.




                                                   14
Particle Properties Achieving Excipient
        Functionality
   Particle property          Achieving Excipient functionality

Particle size                Flow ability, compressibility,
                             disintegration, dissolution rate.
Particle size distribution   Segregation potential.

Particle shape               Flow ability, content uniformity,
                             compressibility.
Particle porosity            Compressibility, solubility.



                                                                 15
Co-processing methodology
Excipient selection on the basis of material characteristics




         Selection of proportion of excipients



           Homogenous dispersion or solution




                     Co-drying



                 Co-processed excipient
                                                               16
Manufacturing of co-processed excipiets
e.g. Dicalcium phosphate (diluent) and magnesium stearate (lubricant)

  Steps:


   1. Solubalisation
   2. Solvent evaporation
   3. Drying
   4. Sifting




                                                                        17
Properties of co-processed excipients

 Absence of chemical change

 Improved flow properties

 Improved compressibility

 Reduced lubricant sensitivity




                                        18
Advantages

 Provide a single excipient with multiple functionalities.

 Better mouth feel and improved palatibility.

 Removal of undesirable properties.

 Improvement of organoleptic properties.




                                                     19
Evaluation parameters for co-processed excipients


         Particle size distribution-


   The particle size distribution can be calculated by
   statistical method.




                                                         20
Cont......



      Carr’s index-

 Carr’s index can be calculated by-


Carr’s index= Tapped Density-Bulk Density 100
                     Tapped Density    ˟




                                                 21
Cont......

      Hausner Ratio-

Hausner ratio can be calculated by-


Hausner Ratio= Tapped Density
                Bulk Density




                                              22
REFERENCES
Aulton’s Pharmaceutics, the design and
 manufacture of medicines, third edition by Michael E.
 Aulton.
  Page no: 298-301.
B. M. Mithal, A textbook of Pharmaceutical formulation,
 vallabh prakashan. Page no. 57-120.
Remington- The science & practice of Pharmacy. Page
 no. 896-910.
Ansel’s Pharmaceutical dosage form. Page no.198-
 199, 240-242.
www.google.com
www.wikipedia.com/coprocessed excipients
                                                           24
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co-processed excipients ppt

  • 1. 1
  • 2. CO-PROCESSED Presented by- Under the guidance of Mr. Bhaskar N. Bangar Dr. N. H. Aloorkar EXCIPIENTS M. Pharm. (Sem. I) (H.O.D. Pharmaceutics) 2
  • 3. Contents………… Definition of excipients Need of excipients Ideal characteristics of excipients Roles of excipients Classification of excipients Excipients used in solid dosage forms Excipients used in liquid dosage forms Excipients used in semi-solid dosage forms Co-processed excipients Co-processing methodology Conclusion References 3
  • 5. Need of Excipients Direct clinical use of the active drug substances is rare due to the number of reasons:  API handling is difficult or impossible.  Accurate drug dosing is difficult or impossible.  API may cause local irritations or injury. 5
  • 6. Cont......  API can have unpleasant organoleptic properties.  API can be degraded at the site of administration. 6
  • 7. Ideal characteristics of excipients  It should be non toxic.  It should be physically and chemically stable.  It should be commercially available.  It should have pleasant organoleptic properties.  Economic. 7
  • 8. Roles of excipients in different dosage forms  Impart consistency and volume  Improve stability  Increase solubility  Enhance bioavailability  Increase patient compliance and acceptability  Impart weight 8
  • 9. Classification of excipients  Primary excipients : Diluents Binders Disintegrants Lubricants Antiadhesives Glidents  Secondary excipients : Flavoring agents Sweetening agents 9
  • 10. Commonly used excipients in solid dosage forms  Diluents  Binders  Disintegrants  Lubricants  Antiadhesives  Glidents 10
  • 11. Commonly used excipients in liquid dosage forms SUSPENSION EMULSION Vehicle Vehicle Flocculating agents Antimicrobial agents Antimicrobial agents Antioxidants Sweetening agents Flavoring agents Suspending agents Preservatives 11
  • 12. Commonly used excipients in semi-solid dosage forms Bases Preservatives Antioxidants Chelating agents 12
  • 14. Manufacturing problems in solid  Product weight variation.  Content non uniformity during mixing.  Loss of excipients. dosage forms  Poor disintegration time of product. 14
  • 15. Particle Properties Achieving Excipient Functionality Particle property Achieving Excipient functionality Particle size Flow ability, compressibility, disintegration, dissolution rate. Particle size distribution Segregation potential. Particle shape Flow ability, content uniformity, compressibility. Particle porosity Compressibility, solubility. 15
  • 16. Co-processing methodology Excipient selection on the basis of material characteristics Selection of proportion of excipients Homogenous dispersion or solution Co-drying Co-processed excipient 16
  • 17. Manufacturing of co-processed excipiets e.g. Dicalcium phosphate (diluent) and magnesium stearate (lubricant) Steps: 1. Solubalisation 2. Solvent evaporation 3. Drying 4. Sifting 17
  • 18. Properties of co-processed excipients  Absence of chemical change  Improved flow properties  Improved compressibility  Reduced lubricant sensitivity 18
  • 19. Advantages  Provide a single excipient with multiple functionalities.  Better mouth feel and improved palatibility.  Removal of undesirable properties.  Improvement of organoleptic properties. 19
  • 20. Evaluation parameters for co-processed excipients  Particle size distribution- The particle size distribution can be calculated by statistical method. 20
  • 21. Cont......  Carr’s index- Carr’s index can be calculated by- Carr’s index= Tapped Density-Bulk Density 100 Tapped Density ˟ 21
  • 22. Cont......  Hausner Ratio- Hausner ratio can be calculated by- Hausner Ratio= Tapped Density Bulk Density 22
  • 23.
  • 24. REFERENCES Aulton’s Pharmaceutics, the design and manufacture of medicines, third edition by Michael E. Aulton. Page no: 298-301. B. M. Mithal, A textbook of Pharmaceutical formulation, vallabh prakashan. Page no. 57-120. Remington- The science & practice of Pharmacy. Page no. 896-910. Ansel’s Pharmaceutical dosage form. Page no.198- 199, 240-242. www.google.com www.wikipedia.com/coprocessed excipients 24
  • 25. 25