Uji BA/BE 2 Formulasi Ibuprofen

Summary

In this presentation, Group 8 discusses a study on the bioavailability and bioequivalence of two ibuprofen formulations, Doloras and Bruven. They compare the protocol with BPOM regulations and present the methodology used, including the random crossover design, pharmacokinetic analysis, and criteria for selecting participants. The study involved 24 healthy male subjects and measured plasma concentrations of ibuprofen over 14 hours. The results show that Doloras meets the bioequivalence criteria of 80-125%, indicating that the generic formulation performs similarly to the innovator drug. The conclusion emphasizes the importance of bioequivalence testing for ensuring generic drug quality.

Takeaways

• 😀 The presentation discusses the bioavailability and bioequivalence testing of two Ibuprofen formulations.
• 😀 The research cited is from a 2011 study by Zeat et al., comparing two Ibuprofen formulations.
• 😀 The protocol used for the study is based on BPOM Regulation No. 11 of 2022.
• 😀 The study design was a randomized, open-label, two-sequence, two-period, crossover study with a 7-day washout period.
• 😀 A single 100 mg/5 mL dose of Ibuprofen was given orally after fasting overnight.
• 😀 Blood samples were taken 15 times at specified intervals up to 14 hours after dosing to assess pharmacokinetics.
• 😀 The primary pharmacokinetic parameters analyzed were AUC and CMAX, and bioequivalence was assessed using ANOVA and a 90% confidence interval for the mean ratio of the test and reference products.
• 😀 The study involved 24 healthy male participants, aged 19-46, with strict inclusion and exclusion criteria to ensure reliable results.
• 😀 The test product was Doloras, a 100 mg/5 mL Ibuprofen suspension, produced by Aldrazi Pharmaceutical Company.
• 😀 The comparator product was Bruven, a 100 mg/5 mL Ibuprofen suspension from Boots Company, UK, and was registered in Indonesia.
• 😀 The results indicated that Doloras was bioequivalent to Bruven, with a bioequivalence range of 80-125%, confirming the generic's effectiveness and safety.

Q & A

What is the main objective of the bioequivalence study discussed in the presentation?

The main objective is to compare the bioequivalence of two formulations of ibuprofen, focusing on the safety and efficacy of a generic formulation (Doloras) against the innovator product (Bruven).

What was the design of the study used in the bioequivalence assessment?

The study was designed as an open-label, randomized, two-period, two-sequence, crossover design with a washout period of 7 days between each treatment phase.

What were the inclusion criteria for the subjects in this study?

Subjects had to be healthy males aged 19-46, with a body weight between 53-101 kg and a height between 164-187 cm. They also had to be willing to participate in the study, including fasting, blood sample collection, and staying at the clinical facility.

What are the two formulations of ibuprofen compared in the study?

The two formulations are Doloras (generic ibuprofen, produced by Aldrazi Pharmaceutical Company, Jordan) and Bruven (innovator ibuprofen, produced by Boots Company, UK).

What are the pharmacokinetic parameters used to assess bioequivalence in this study?

The key pharmacokinetic parameters used in the bioequivalence assessment are AUC (Area Under the Curve) and CMAX (Maximum Concentration).

What method was used to measure the concentration of ibuprofen in the plasma samples?

The concentration of ibuprofen in plasma was measured using High Performance Liquid Chromatography (HPLC) with a UV detector.

What was the dosing regimen used in the study for both formulations?

A single 100 mg/5 ml dose of ibuprofen was administered orally after a 12-hour fast, and the dose was taken with 240 ml of water.

How were the blood samples collected and processed during the study?

Blood samples of 10 ml were collected at specific time points before and after the dose, ranging from 15 minutes to 14 hours. The samples were then centrifuged, and the serum was frozen at -35°C for analysis.

What was the conclusion regarding the bioequivalence of Doloras and Bruven?

The study concluded that Doloras (the generic formulation) demonstrated bioequivalence to Bruven (the innovator formulation) within the accepted bioequivalence range of 80-125%, indicating that both formulations have similar safety and efficacy.

Why is the concept of bioequivalence important in the context of generic drugs?

Bioequivalence ensures that the generic drug performs in the same way as the innovator drug in terms of absorption and effectiveness, which guarantees that generic drugs can be used as alternatives without compromising on safety or efficacy.