Molecular Solids can Exist in Crystalline - Medical Science Assignment Help

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1.1 Introduction 1.1.1 Solid forms 
Molecular solids can exist in crystalline or noncrystalline phases depending on the extent of three-dimensional order and the relative thermodynamic stability (Figure U. Active pharmaceutical ingredients (APIs) are nowadays mass produced in the solid state in a variety of crystalline forms. Any change in the physical arrangements of the molecules or inclusion of other compounds results in the formation of different phases termed polymorphs. co-crystals or hydrates/solvates respectively (11. The multiplicity of the pharmaceutical solid-state forms is constructed on the repetitive non-covalent interactions resulting in control of chemical stability, solubility, dissolution. bioavailability and performance characteristics of the APIs 121. Depending on the mode of delivery such as parenteral. oral, pulmonary. transdermal, etc. the optimal solid form differs drastically making the choice and design strategy for API formulation critically important. Inadequate solubility or dissolution rates resulting in poor bioavailability has motivated the investigation of alternative solid forms 131. 
 

Supersaturation as defined as the difference of the chemical potential of solute molecules in supersaturated ip) and saturated tp,) states respectively For a molecule in solution the equation C) is: 
3p p - 0, 11 gnit 
where 
(2) 
k is the Boltzmann constant. T is the absolute temperature and 13 is supersaturation. Supersaturation is also presented as S (3). If C is the concentration of solute in solution and its saturated or equilibrium concentration then 
S = = C/Cs 
(3) 
Hence if 0).1 then crystals will form: if fi<I. then crystals will dissolve and if 0=1, then the crystals and the solution are at equilibrium Is]. 
Supersaturation can be generated by cooling. antisolvent addition, evaporation and reactive solution crystallisation. Figure 4 presents a schematic representation of the solution diagram of an API. indicating different nucleation zones. the undersaturated region contains a lower proportion of solute than the equilibrium solubility at that temperature while a supersaturated zone contains a higher proportion of solute than the equilibrium solubility at that temperature. The metastable zone limit is the boundary for the solution to remain homogeneous in a supersaturated state under a constant set of conditions such as cooling rate, agitation, volume 
 

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