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Phases in drug developments I: Pre-clinical studies. Kausar Ahmad Department of Pharmaceutical Technology Kulliyyah of Pharmacy [email protected] http://staff.iium.edu.my/akausar. Phases in drug development. Preformulation. Physicochemical properties. Physicochemical properties.

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Phases in drug developments i pre clinical studies

Phases in drug developments I: Pre-clinical studies

Kausar Ahmad

Department of Pharmaceutical Technology

Kulliyyah of Pharmacy

[email protected]

http://staff.iium.edu.my/akausar

RM-KAHS






Spectroscopy
Spectroscopy

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pKa

  • Determination of the dissociation constant for a drug - capable of ionization within a pH range of 1 to 10

  • This is important since solubility, and consequently absorption, can be altered by changing pH (buffer).

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Rate of dissolution
Rate of dissolution

  • Determination of the rate is important when it is the rate limiting step in the drug absorption process.

  • If solubility of drug > 10 mg/ml, at pH7, there will be no problem of bioavailability or dissolution (Kaplan,1972)

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Melting point
Melting Point

  • Affected by purity

  • Affected by types of polymorphs

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Polyamide: Carrier for insoluble ingredients; Protector for sensitive ingredients; Slow delivery & long lasting effect

7 m, empty spheres

10 m, porous

PHM4153 Dosage Design 2 2011/12


Excipient particle size distribution
Excipient: Particle size distribution

PHM4153 Dosage Design 2 2011/12


Excipient pore volume pore diameter
Excipient: Pore volume & pore diameter

PHM4153 Dosage Design 2 2011/12



Excipients product stability
Excipients & Product Stability

  • Excipients are important for processing and efficacy

    • For tablets: binders, disintegrants, lubricants, and fillers.

    • For liquids: preservatives, thickener, colorants, flavours, sweeteners, buffer and water

  • Techniques to screen drug-excipient compatibility:

    • Thin-layer chromatography

    • Differential thermal analysis

    • Diffuse reflectance spectroscopy

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Incompatibility
Incompatibility

PHM4153 Dosage Design 2 2011/12


Detection of incompatibility
Detection of Incompatibility

PHM4153 Dosage Design 2 2011/12


Other factors to be considered in preformulation
Other factors to be considered in preformulation

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Dosage form
Dosage form

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Formulation
Formulation

PHM4153 Dosage Design 2 2011/12


Formulation requirement efficacy safety and quality
Formulation requirement: efficacy, safety, and quality

PHM4153 Dosage Design 2 2011/12


Categories of excipients
Categories of excipients

PHM4153 Dosage Design 2 2011/12


Choosing excipients
Choosing excipients

PHM4153 Dosage Design 2 2011/12



Example
Example

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Summary
Summary

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References
References

Aulton, M.E. (2002). Pharmaceutics – The Science of Dosage Form Design (2nd Ed.). Churchill Livingstone.

Bugay, D. E. (1999). Pharmaceutical excipients : characterization by IR, Raman, and NMR spectroscopy.

Kibbe, A. H. (2000). Handbook of pharmaceutical excipients.

Rowe, R. C., Sheskey, P. J. & Owen, S. C. (2006). Handbook of pharmaceutical excipients

Rowe, R. C. (2009). Handbook of pharmaceutical excipients.

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