P. Vora et al., A preformulation study of nicotinic acid with an emphasis on the effect ofcompaction and grinding on its thermal behavior, INSTR SCI T, 29(3), 2001, pp. 231-245
Nicotinic acid belongs to the B group of vitamins and is often referred to
as Vitamin B-3 It is an essential component of a balanced diet and is presc
ribed as tablet, and in parenteral dosage forms in cases of vitamin deficie
ncy. This study involves a preliminary preformulation study to assess wheth
er nicotinic acid is a good candidate for tablet and capsule manufacture.
The manufacturing process for solid dosage forms involves high energy-inten
sive processes, which mainly include grinding and compaction. The effect of
these high-energy processes on the stability of nicotinic acid was evaluat
ed using thermogravimetry (TG) as the primary analytical tool. The initial
stage involved characterizing the thermal behavior of the material. It was
found that nicotinic acid shows a solid-solid state phase transition, which
is reversible. This transition appears as a small endothermic peak on the
differential thermal analysis (DTA) curve, just before the dual sublimation
-evaporation stage. This was followed by studying the impact of the high-en
ergy processes on the kinetic parameters of the dual sublimation-evaporatio
n stage.
The kinetic parameters and mechanism for the two stage thermal behavior rem
ain unaffected even after exposure to the grinding and compaction processes
. This indicates that the material is a suitable candidate for formulation
as a solid dosage form. In addition to this, the vapor pressure of nicotini
c acid was also determined.