Pharmacokinetics of theophylline after administration of suppositories formulation

Area of Science:

• Pharmacology
• Pediatrics
• Public Health

Background:

• Asthma is a significant public health concern, particularly affecting children.
• Theophylline ethanoate of piperazine suppositories provide a treatment option for pediatric asthma.
• Limited healthcare access in rural and desert areas necessitates alternative drug delivery methods.

Purpose of the Study:

• To evaluate the pharmacokinetics of theophylline ethanoate of piperazine administered rectally via suppositories.
• To compare the pharmacokinetic profile of rectal theophylline suppositories with intravenous theophylline administration.
• To assess the suitability of theophylline suppositories for pediatric asthma management in underserved regions.

Main Methods:

• The study involved 24 healthy male subjects.
• Pharmacokinetic parameters were assessed after rectal administration of theophylline ethanoate of piperazine suppositories (500 mg).
• Theophylline serum levels were quantified using an ELISA method, with comparisons to intravenous administration.

Main Results:

• Peak theophylline plasma concentration (Cmax) was 21.5 +/- 2.10 microg/mL for IV and 14 +/- 0.90 microg/mL for suppositories.
• Area Under the Curve (AUC(0-t)) values were 80.9 microg x ml x hr for IV and 67.4 microg x ml x hr for suppositories.
• The median peak time (Tmax) for rectal administration was 0.5 hours.

Conclusions:

• Theophylline ethanoate of piperazine suppositories demonstrate a favorable pharmacokinetic profile.
• These suppositories are a potential therapeutic option for managing asthma in children, particularly in areas with limited healthcare access.
• The findings support the use of Minophylline suppositories in rural and desert settings for pediatric asthma patients.