Solubility analysis:Solubility determination,pKa determination-For acidic compounds pH = pKa + log (ionised drug / unionised drug) For basic compounds pH = pKa + log (unionised drug / ionised drug)Partition coefficient,Dissolution behavior,Common ion effect,Membrane permeabilty

1. PRE FORMULATION
STUDIES

2. PRINCIPLE AREAS OF PREFORMULATION
ORGANOLEPTIC PROPERTIES
●
Colour
●
Odour and taste
BULK CHARECTERIZATION
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Crystallinity and polymorphism
●
Hygroscopicity
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Fine particle characterisation

3. ●
Powder flow
ANALYTICAL METHODS FOR THE CHARACTERISATION
OF SOLID FORMS

4. 1.Microscopy
2. Hot stage microscopy
3.Thermal analysis

5. 4.X-ray diffraction
5.Infrared (IR) spectroscopy
6.Proton magnetic resonance (PMR)
7.Nuclear magnetic resonance (NMR)
8.Scanning electron microscopy (SEM)

6. PARTICLE SIZE
●
Particle size is characterised using
theese terms
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Very coarse,coarse,moderately
coarse,fine,very fine.
●
Particle size can influence variety of
important factors:
- Dissolution rate
-Suseptability
-Uniform distribution
-Penetrability
-Lack of grittiness
METHODS TO DETERMINE
PARTICLE SIZE
●
Sieving (5µ-150µ)
●
Microscopy(0.2µ-100µ)
●
Sedimentation rate method(1µ-
200µ)
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Light energy diffraction(0.5µ-500µ)
●
Laser hollography(1.4µ-100µ)

7. SOLUBILITY ANALYSIS
●
Solubility determination
●
pKa determination
●
Partition coefficient
●
Dissolution behavior
●
Common ion effect
●
Membrane permeabilty
For acidic compounds pH = pKa + log (ionised drug / unionised drug)
For basic compounds pH = pKa + log (unionised drug / ionised drug)

8. STABILITY ANALYSIS
●
Hydrolysis
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Isomerisation
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Oxidation
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Polymerisation
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Solid-state phase trasformation
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Dehydration or dissolvation
●
Cyclization
●
Photolytic degredation
●
Microbial attack

9. BCS CLASSIFICATION

10. CLASS 1:Metaprlol,Diltiazem,
Verapamil,Propanalol
CLASS 2:Phenytoin,Danazol,
Mefenamic acid,Nifedipine
CLASS 3:Cimetidine,Acyclovir,
Neomycin B ,Captopril
CLASS 4: Taxol,Griseofulivin
EXAMPLES

11. THANK YOU