Phytocheical properties

1. Flow properties

1.1. Factor affecting ( density, particle size, shape, eclectrostatic charges, adsorped moisture)

1.2. Determinantion of Flow properties by ( angles of repose, bulk density)

2. Organoleptic priperties

2.1. Color, odour, taste

3. Crystallinity and polymorphism

3.1. Internal structure : arrangement with the solid include cubic, tetragonal, hexagonal 1: crystalline 2: amorphous

3.2. External Description of the outer Appearance of crystal as acicular

3.3. Polymorphism Ability of compound to exit as two or more crystalline phases that have different arrangement (polymorph) have different in their physical properties even though chemically identical

3.3.1. Example : chloramohenicol exist in A, B, C forms B form is more stable

3.3.2. Polymorph is two Types 1: enantiotropic : if one form stable over certain pressure and temperature range while other polymorph is stable over different pressure and temperature 2: monotropic : only one polymorph is stable at all temperature below the Melting point with all other polymorph being un stable

3.4. Techniques for studying crystal properties 1: x ray crystallography 2: hot stage microscopy 3: infrared spectrophotometry 4 : thermal analysis

4. Dissolution Is a process in which solid substance solubilize in a given solvent

4.1. Rate of dissolution : amount of drug slibulize per unit time

4.2. Immediate release : means that 75 % of API is dissolved with 45 min Rapidly dissolve : > 85 % in < 30 min Very rapidly : >85% in 15 min

4.3. Factor affecting dissolution rate 1: physiochemical properties 2: formulation factor 3:processing factor 4: dissolution apparatus

4.4. Dissolution medium PH 6.8 buffer ( intestinal) PH 4.5 buffer PH 1.2 ( gastric)

4.4.1. Sink condition should maintain

4.5. Dissolution rate can be either determine for 1: compressed disc 2: dispersed powder

4.6. IDR IDR tendency of the test material to dissolve without formulation excipients

4.7. IVIC MATHEMATICAL MODEL description for relationship between in vitro and in vivo properties of drug

4.8. Biowavier Means that in vivo bioavailabilty may be waived ( not necessary for product approval)

5. Hygriscopicity ( measurements of material Ability to absorb or release water)

5.1. Non hygroscopic ( no mositure increase at RH <90)

5.2. Slightly hygroscopic : no mositure increase at RH < 80

5.3. Moderately hygroscopic : mositure content not increase > 5% after storage 1 week at RH < 60%

5.4. Very hygroscopic : mositure increase at RH as low as 40 % to 50 %

6. Particle size

6.1. P. S determinantion by 1: optical microscope 2:sieving 3:sedimentation 4: coulter counter 5: surface area 6:zetasizer

7. Pka ( property determine extent of ionization, ionized and unionized form

7.1. Factor affecting absorption 1: pH at the site of absorbtion 2: ionization constant 3:lipid solubility of unionized species 4: pH _partition theory

8. Purity ( is a parameter to detect Purity or homogenity of the drug

8.1. Techniques used for detecting purity 1: TLC 2:HPLC 3:GC 4: DSC 4: Melting point depression

9. Solubility

9.1. Class 1 High solubility High permeability

9.2. Class 2 Low solubility High permeability

9.3. Class 3 High solubility Low permeability

9.4. Class 4 Low solubility Low permeability

9.5. Importance of solubility 1: assess the purity of drug 2: determine the possible dosage form 3: qualitative and quantitavely analysis of analysis 4: expect of bioavailabilty

9.6. Method of increase the solubity 1: more soluble polymorph 2: use amorphous form 3 : reduction particle size 4: salt Formation 5: temperature change