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[Experimental and clinical studies of an ampicillin suppository (KS-R1) in pediatrics]
Insights
Ampicillin suppositories (KS-R1) show effective absorption and a high clinical efficacy rate of 92.5% in children. This study confirms ampicillin
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Drug Delivery Systems
Context:
- Ampicillin is a widely used antibiotic for pediatric infections.
- Optimizing drug delivery methods is crucial for improving patient compliance and therapeutic outcomes in children.
- Suppository formulations offer an alternative route of administration, particularly when oral intake is difficult.
Purpose:
- To evaluate the pharmacokinetic profile and clinical effectiveness of a novel ampicillin suppository formulation (KS-R1) in pediatric patients.
- To assess the safety and tolerability of the ampicillin suppository in the target population.
Summary:
- Pharmacokinetic studies demonstrated rapid absorption of ampicillin (ABPC) from KS-R1, with peak serum levels achieved within 15-30 minutes.
- The elimination half-life of ampicillin was approximately 30 minutes, and urinary excretion ranged from 34.2-70.1% within 6 hours.
- A clinical trial involving 40 pediatric patients with various infections (tonsillitis, pharyngitis, bronchitis, etc.) showed a high efficacy rate of 92.5% (37 out of 40 cases), with no observed side effects or adverse laboratory findings.
Impact:
- The ampicillin suppository (KS-R1) presents a safe and highly effective treatment option for pediatric infections.
- This formulation may improve therapeutic adherence in pediatric patients, potentially leading to better infection control.
- The findings support the use of suppository formulations for ampicillin in pediatric care, especially for conditions requiring prompt antibiotic action.
Abstract:
Pharmacokinetic and clinical studies of ampicillin suppository (KS-R1) was performed in children. The results were as follows. Peak serum level of ampicillin (ABPC) after single administration of KS-R1 contains 125 mg or 250 mg of ABPC in potency was 6.03 micrograms/ml after 15 minutes and 5.78 micrograms/ml after 30 minutes, respectively. The half-life was 30.4 minutes and 30.9 minutes, respectively. Urinary excretion rate was 34.2-70.1% within 6 hours. A clinical study of KS-R1 was performed in 40 patients including purulent tonsillitis (10 cases), pharyngitis (9 cases), bronchitis (6 cases), bronchopneumonia (2 cases), scarlet fever (8 cases), otitis media (1 case) and urinary tract infection (4 cases). The clinical effects, excellent and good responses, were showed in 37 cases (efficacy rate; 92.5%). No side effects and abnormal laboratory findings were observed.