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Development and Optimization of Andrographis paniculata Extract-Loaded Self-Microemulsifying Drug Delivery System
Chaiyakarn Pornpitchanarong1, Prasert Akkaramongkolporn1, Nattawat Nattapulwat1
1Pharmaceutical Development of Green Innovations Group (PDGIG), Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand.
Pharmaceutics
|February 24, 2024
Summary
This study optimized an Andrographis paniculata extract (AGPE)-loaded self-microemulsifying drug delivery system (SMEDDS). The developed SMEDDS formulation significantly enhanced AGPE dissolution and membrane permeability.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Natural Product Chemistry
Background:
- Andrographis paniculata extract (AGPE) has therapeutic potential but suffers from poor solubility and bioavailability.
- Self-microemulsifying drug delivery systems (SMEDDS) offer a promising approach to enhance the delivery of poorly soluble compounds.
- Andrographolide (AGP) is the primary active compound in A. paniculata.
Purpose of the Study:
- To develop and optimize an AGPE-loaded SMEDDS using an experimental design.
- To characterize the physical properties and stability of the optimized SMEDDS.
- To evaluate the dissolution and ex vivo membrane permeation of the optimized AGPE-SMEDDS.
Main Methods:
- Solubility studies of andrographolide (AGP) were performed.
- Pseudo-ternary phase diagrams were constructed to identify microemulsion (ME) regions.
- An I-optimal design was employed to optimize the SMEDDS formulation based on physical stability, droplet size, PDI, and zeta potential.
- Assay, uniformity of dosage, stability, dissolution, and ex vivo permeation studies were conducted.
Main Results:
- Oleic acid, Tween® 80, and PEG 400 were identified as optimal excipients for AGP solubilization.
- The optimal surfactant to co-surfactant ratio was determined to be 3:1.
- The optimized SMEDDS formulation consisted of 68.998% Tween® 80, 13.257% oleic acid, and 17.745% PEG 400.
- The optimized AGPE-SMEDDS met all specifications for content, uniformity, and stability.
- Significant improvements in dissolution and membrane permeability were observed for AGPE-SMEDDS compared to the raw extract (p < 0.05).
Conclusions:
- An optimized AGPE-loaded SMEDDS formulation was successfully developed.
- The optimized SMEDDS demonstrated spontaneous formation of stable MEs with enhanced delivery efficacy.
- The developed SMEDDS represents a viable strategy for improving the bioavailability of AGPE.
