Development and Optimization of Andrographis paniculata Extract-Loaded Self-Microemulsifying Drug Delivery System Using Experimental Design Model

The objectives of this study were to develop an optimized formulation for an extract (AGPE)-loaded self-microemulsifying drug delivery system (SMEDDS) using an experimental design and evaluate the characteristics of the developed SMEDDS. The solubility of andrographolide (AGP) in various solvents wa...

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Bibliographic Details
Published in:Pharmaceutics 2024-01, Vol.16 (2), p.166
Main Authors: Pornpitchanarong, Chaiyakarn, Akkaramongkolporn, Prasert, Nattapulwat, Nattawat, Opanasopit, Praneet, Patrojanasophon, Prasopchai
Format: Article
Language:English
Subjects:
Andrographis paniculata
andrographolide
Bioavailability
COVID-19
Drug delivery systems
Drug dosages
experimental design
Microemulsions
Nanoparticles
Pharmacokinetics
Polyethylene glycol
Product development
self-microemulsifying drug delivery system
Severe acute respiratory syndrome coronavirus 2
Surfactants
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Summary:The objectives of this study were to develop an optimized formulation for an extract (AGPE)-loaded self-microemulsifying drug delivery system (SMEDDS) using an experimental design and evaluate the characteristics of the developed SMEDDS. The solubility of andrographolide (AGP) in various solvents was investigated. The pseudo-ternary phase was constructed to provide an optimal range for each component to form microemulsions (MEs). The formulation was optimized using an I-optimal design mixture type, where the physical stability, droplet size, polydispersity index, and zeta potential were examined. Soft capsules of the optimized AGPE-loaded SMEDDS were manufactured. The dissolution and ex vivo membrane permeation were studied. Oleic acid, Tween 80, and PEG 400 were the best solubilizers for AGP. The promising surfactant to co-surfactant ratio to generate ME was 3:1. The optimized SMEDDS contained 68.998% Tween 80, with 13.257% oleic acid and 17.745% PEG 400. The assayed content of AGP, uniformity of dosage unit, and stability complied with the expected specifications. The dissolution and membrane permeability of AGPE-loaded SMEDDS was significantly improved from the extract ( < 0.05). All in all, the developed optimized AGPE-loaded SMEDDS was proven to contain optimal composition and AGP content where a stable ME could spontaneously be formed with enhanced delivery efficacy.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics16020166