Preformulation

Preformulation:

Definition:
·         It can be defined as an investigation of physical and chemical properties of a drug substance - alone and or when combined with excipients.
·         Preformulation is a link between drug discovery and drug development.
·         It is the first step in the rational development of dosage form of drug substance.
Objectives
·         To establish the physico-chemical parameter of new drug entity.
·         To develop the elegant dosage forms (stable, effective & safe} 
·         It is important to have an understanding of the physical description of a drug substance before dosage form development.
·         To determine kinetics and stability of the new drug entity.
·         It is 1st step in rational development of a dosage form of a drug substance before dosageform development.
Goals
·         To establish the physico-chemical parameters of new drug substance.
·         To establish the physical characteristics
·         To establish the kinetic rate profile.
·         To establish the compatibility with the common excipient.
·         To choose the correct form of a drugsubstance.

PREFORMULATIONPARAMETERS:
1.      PHYSICAL CHARACTERISTICS.
                                i.            Organolepticproperties
                              ii.            Bulk characteristics
a.      Solid state characteristics
b.      Flowproperties
c.       Densities
d.      Compressibility
e.      Crystalline
f.        Polymorphism
g.      Hygroscopicity
h.   Dielectric constant
i.    Wettability
                            iii.            Solubility analysis
a.      Ionization constant(Pka)
b.      Partition co-efficient
c.       Solubilization
d.      Thermal effect
e.      Common ion effect(Ksp)
f.        Dissolution
                             iv.            Stability analysis
a.      Solution-state stability
b.      Solid-state stability
c.       Drug-excipients compatibility
2.      CHEMICAL CHARACTERISTICS
                                i.            Hydrolysis
                              ii.            Oxidation
                            iii.            Photolysis
                             iv.            Recemization
                               v.            Polymerization
                 vi.       Isomerization

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