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)
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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.
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6. Cont......
API can have unpleasant organoleptic properties.
API can be degraded at the site of administration.
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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.
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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
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14. Manufacturing problems in solid
Product weight variation.
Content non uniformity during mixing.
Loss of excipients.
dosage
forms
Poor disintegration time of product.
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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
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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
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18. Properties of co-processed excipients
Absence of chemical change
Improved flow properties
Improved compressibility
Reduced lubricant sensitivity
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19. Advantages
Provide a single excipient with multiple functionalities.
Better mouth feel and improved palatibility.
Removal of undesirable properties.
Improvement of organoleptic properties.
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20. Evaluation parameters for co-processed excipients
Particle size distribution-
The particle size distribution can be calculated by
statistical method.
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21. Cont......
Carr’s index-
Carr’s index can be calculated by-
Carr’s index= Tapped Density-Bulk Density 100
Tapped Density ˟
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22. Cont......
Hausner Ratio-
Hausner ratio can be calculated by-
Hausner Ratio= Tapped Density
Bulk Density
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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
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