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Particle Size Analysis

Particle Size Analysis. Kausar Ahmad Kulliyyah of Pharmacy. http://staff.iiu.edu.my/akausar. Contents. Types of methods Factors influencing selection of methods. Fundamental knowledge. molecules become particles particles become granules granules become tablets etc.

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Particle Size Analysis

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  1. Particle Size Analysis Kausar Ahmad Kulliyyah of Pharmacy http://staff.iiu.edu.my/akausar PHM3133 Dosage Design 1 2010/11

  2. Contents Types of methods Factors influencing selection of methods PHM3133 Dosage Design 1 2010/11

  3. Fundamental knowledge • molecules become particles • particles become granules • granules become tablets etc PHM3133 Dosage Design 1 2010/11

  4. Process requirements • From crystallization to formulation • formation of particles • drying • granulation • mixing compression • dissolution • Specific operations dehydration/impregnation, spherical crystallization and the series of operations involved in micro-encapsulation. PHM3133 Dosage Design 1 2010/11

  5. Examples of particle-related advances use of cholesteric liquid crystals and custom microencapsulation technologies in the personal care industry… www.hallcrest.com/about microencapsulation technology to deliver omega-3 oils and other ingredients into functional foods.... www.ocean-nutrition.com/inside.asp?cmPageID PHM3133 Dosage Design 1 2010/11

  6. http://www.swri.org/3pubs/brochure/d01/microen/microen.htm PHM3133 Dosage Design 1 2010/11

  7. Interactions between materials and processes • Influenced by particle size • Need to choose • correct scale of observation e.g.right sizing method • appropriate parameters e.g. right aperture, lens, medium • right measurements e.g. calibrated, good quality standards • to prepare the right material for the expected function PHM3133 Dosage Design 1 2010/11

  8. Example After size reduction, lots of fines were generated because of bad process condition. To separate fines from product, a series of cyclones were used. Eventually, the fines must be trapped using a dust filter. WHAT IS THE SPECIFICATION of the filter cloth? PHM3133 Dosage Design 1 2010/11

  9. How to determine spec of cloth? • Filter cloth is used to trap dust • Pore size of cloth must be smaller than dust • Hence, must know size of fines!! • To control processes IN manufacturing, need to knowsize of raw materials, in-process materials and finished goods. PHM3133 Dosage Design 1 2010/11

  10. Size distribution of products & fines • How to detect the size of a sample that contains • Products? ………………. normal distribution • Fines?....................................normal distribution • Products + fines?..............SKEWED PHM3133 Dosage Design 1 2010/11

  11. What method to choose? • Can sieving be used? • Must consider screen size…. • Coulter counter? • Size range for a particular aperture? • Microscopy? • Magnification? Limitation? PHM3133 Dosage Design 1 2010/11

  12. Sample with wide size distribution • Not desirable as a product • Rate of dissolution differs • Processing problem • Fines tend to agglomerate • Fines may affect flow • Measurements must be carried out more than once • Coulter counter - at least two apertures • Exercise: how about laser diffraction? PHM3133 Dosage Design 1 2010/11

  13. What to analyse? • Powders • Granules • Liquids • Emulsions • Creams • Suspensions/dispersions PHM3133 Dosage Design 1 2010/11

  14. Powder samples • Flowability/dispersibility • Poor if too fine. Why? • Exercise: how to counter this problem when using Coulter? • Shape • Crystalline – geometric shape • Acicular – needle-shape • Granular equidimensional irregular shape • Spherical PHM3133 Dosage Design 1 2010/11

  15. Emulsion samples • Will the size change upon dilution? • Can you use Coulter principle to measure size of fine sugar? • Will there be changes in zeta potential that may affect stability? • Can the technique employed analyseneat sample? PHM3133 Dosage Design 1 2010/11

  16. Dimensions • Diameter • Most of the time not actual diameter BUT equivalent diameter • Mean • Mode • Size distribution • Normal • Skewed • Polydispersity • Particle shape • Statistics PHM3133 Dosage Design 1 2010/11

  17. Availability and cost Cheap • Sieves • Moderate • Light microscopy • Coulter counter • Laser diffraction • Sedimentation Expensive • Electron microscopy • Light scattering • Laser microscopy PHM3133 Dosage Design 1 2010/11

  18. Sieves Suitable for: Powder Slurry Dispersion Right sieves with appropriate size interval PHM3133 Dosage Design 1 2010/11

  19. Laser diffraction Suitable for: Powder Diluted liquid Concentrated liquid? Right lens and parameters e.g. density PHM3133 Dosage Design 1 2010/11

  20. Microscopy Almost all types of samples Depends on type of microscopy Depends on magnification Sample preparation is important PHM3133 Dosage Design 1 2010/11

  21. Light microscope Salicylic acid 10X Salicylic acid 40X PHM3133 Dosage Design 1 2010/11

  22. Light microscope O/W emulsion 10X O/W emulsion 40X PHM3133 Dosage Design 1 2010/11

  23. Salicylic acid 100X coalescence PHM3133 Dosage Design 1 2010/11

  24. Selecting instrument Need to consider: allowable range of sizes width & shape of the particle size distribution of sample PHM3133 Dosage Design 1 2010/11

  25. PHM3133 Dosage Design 1 2010/11

  26. Sizing technique for sulfur? Hint: How many types of sulfur preparation available? PHM3133 Dosage Design 1 2010/11

  27. References Aulton, M. E. (1988). Pharmaceutics: The Science of dosage form design. London: Churchill Livingstone. Llachman, L, Lieberman, H. A. and Kanig, J. L. (1986). The theory and practice of industrial pharmacy (3rd ed.). Philadelphia: Lea & Febiger. PHM3133 Dosage Design 1 2010/11

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