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The pharmacokinetics of recombinant human interferon-alpha-2b poly(lactic-co-glycolic acid) microspheres in rats
Fan Yang1, Ya-jun Shu, Yi-qun Yang
1Department of Pharmacy, Guangdong Pharmaceutical University , Guangzhou 510006 , People's Republic of China.
Abstract:
Interferon-alpha2b (IFN α-2b) microspheres were prepared at various concentrations (5%, 10%, 15%, 20% and 25%) and viscosities (0.39, 0.6, 0.89 and 1.13 dL/g) of poly(lactic-co-glycolic acid) (PLGA) using double emulsion solvent evaporation. The optimal formulation of IFN α-2b microspheres was determined to be 0.89 dL/g PLGA, as assessed by the in vitro release test. The pharmacokinetics of IFN α-2b microspheres was investigated. Nine groups of rats were injected intramuscularly with three doses (0.5, 1 and 2 MIU) of commercial lyophilized IFNα-2b injection or IFN α-2b microspheres. At a dose of 0.5 MIU, the IFN α-2b microsphere released significantly longer than that of the IFN α-2b injection. At a dose of 2 MIU, each pharmacokinetics parameter of microspheres prepared with the IFNa-2b stock solution was manifestly greater than those of the injection. Our study indicated that the IFN α-2b microspheres prepared in 15% of 0.89 dL/g PLGA provided a sustained drug effect for up to 21 days in rats.
Insights
Interferon-alpha2b (IFN α-2b) microspheres offer sustained drug delivery. Optimized formulations using poly(lactic-co-glycolic acid) (PLGA) demonstrated prolonged drug release and enhanced pharmacokinetic profiles in rats.
Area of Science:
- Biomedical Engineering
- Drug Delivery Systems
- Pharmacology
Background:
- Interferon-alpha2b (IFN α-2b) is a therapeutic protein with a short half-life.
- Developing sustained-release formulations is crucial for improving IFN α-2b efficacy.
- Poly(lactic-co-glycolic acid) (PLGA) is a biodegradable polymer commonly used in drug delivery.
Purpose of the Study:
- To formulate and characterize Interferon-alpha2b (IFN α-2b) microspheres using poly(lactic-co-glycolic acid) (PLGA).
- To evaluate the in vitro drug release and in vivo pharmacokinetics of the developed IFN α-2b microspheres.
- To determine the optimal formulation for sustained drug delivery.
Main Methods:
- Microspheres were prepared using the double emulsion solvent evaporation method with varying PLGA concentrations and viscosities.
- In vitro release studies were conducted to assess drug release profiles.
- Pharmacokinetic studies were performed in rats following intramuscular injection of microspheres and conventional injection.
Main Results:
- The optimal formulation utilized 0.89 dL/g PLGA, confirmed by in vitro release tests.
- IFN α-2b microspheres exhibited significantly longer release durations compared to conventional IFN α-2b injection, especially at higher doses.
- Pharmacokinetic parameters were notably improved with the microsphere formulation, indicating sustained drug exposure.
Conclusions:
- IFN α-2b microspheres formulated with 15% of 0.89 dL/g PLGA provide sustained drug release.
- This formulation demonstrated a prolonged therapeutic effect for up to 21 days in a rat model.
- PLGA microspheres represent a promising approach for enhancing the pharmacokinetic profile and therapeutic efficacy of Interferon-alpha2b.
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