Purpose: To use differential
scanning calorimetry (DSC) to predict the liquefaction
time and dissolution profile of some commercial
paracetamol suppositories as well as paracetamol
suppositories formulated with palm oil base.
Methods: The suppository base was
prepared by mixing hydrogenated palm oil and palm kernel
stearin in a ratio of 8:2. Three commercial paracetamol
suppositories (A, B, and C) were purchased, while
product D, paracetamol suppository was formulated with
suppository base using the double casting method.
In-vitro drug release from suppositories was determined
using DSC and the effect of liquefaction on drug release
was studied. The relationship between suppository
melting and dissolution was analysed statistically.
Results: The melting temperature of
products A and B were 41.0 and 40.0 ºC respectively,
whereas those of products C and D were 35.9 and 33.1 ºC,
respectively. The liquefaction time of the suppositories
were 61.4 (A), 54.2 (B), 9.0 (C) and 7.4 min (D). Less
than 40 % paracetamol was released from products A and B
in 2 h, while products C and D showed good dissolution
with > 95 % drug release in 15 min. Statistical analysis
using Pearson’s test indicates that the proportion of
melt in the suppository base correlates well with drug
release (p < 0.05).
Conclusion: Paracetamol release from
palm oil suppositories is rapid and correlates with
melting of the base. DSC can be used to predict drug
release in paracetamol suppository formulations.
Keywords:
Palm oil,
Liquefaction time, Paracetamol, Suppositories, Thermal
analysis.