Background/Objectives: The Self-Nanoemulsifying Drug Delivery System (SNEDDS) has been widely applied in oral drug delivery, particularly for poorly water-soluble compounds. The successful development of SNEDDS largely depends on the precise composition of its components. This narrative review provides an in-depth analysis of Quality by Design (QbD), Design of Experiment (DoE), and in silico approach applications in SNEDDS development. Methods: The review is based on publications from 2020 to 2025, sourced from reputable scientific databases (Pubmed, Science direct, Taylor and francis, and Scopus). Results: Quality by Design (QbD) is a systematic and scientific approach that enhances product quality while ensuring the robustness and reproducibility of SNEDDS, as outlined in the Quality Target Product Profile (QTPP). DoE was integrated into the QbD framework to systematically evaluate the effects of predefined factors, particularly Critical Material Attributes (CMAs) and Critical Process Parameters (CPP_S), on the desired responses (Critical Quality Attributes/CQA), ultimately leading to the identification of the optimal SNEDDS formulation. Various DoEs, including the mixture design, response surface methodology, and factorial design, have been widely applied to SNEDDS formulations. The experimental design facilitates the analysis of the relationship between CQA and CMA/CPP, enabling the identification of optimized formulations with enhanced biopharmaceutical, pharmacokinetic, and pharmacodynamic profiles. As an essential addition to this review, in silico approach emerges as a valuable tool in the development of SNEDDS, offering deep insights into self-assembly dynamics, molecular interactions, and emulsification behaviour. By integrating molecular simulations with machine learning, this approach enables rational and efficient optimization. Conclusions: The integration of QbD, DoE, and in silico approaches holds significant potential in the development of SNEDDS. These strategies enable a more efficient, rational, and predictive formulation process.

Glimepiride is a third generation sulphonylurea antidiabetic drug. Glimepiride is poorly water soluble drug that may cause poor dissolution and unpredicted bioavailability. Self nanoemulsifying drug delivery systems (SNEDDS) have become a popular formulation option as nanocarriers for poorly water-soluble drugs. The objective of this research was to develop SNEDDS formulation of glimepiride to improve oral dissolution and bioavailability. Glimepiride SNEDDS was formulated using oleic acid as oil phase, tween 80 as surfactant, and transcutol as co-surfactant due to their higher solubilization effect. The formulated SNEDDS were evaluated for % transmittance, dispersibility, thermodynamic stability, dissolution, globule size and morphology analysis. The results showed that the glimepiride SNEDDS was rapidly formed clear emulsion and stabile based on thermodynamic test. Transmission electron microscopy demonstrated the spherical droplets morphology in nanometer range. The globule average diameter size was 45 nm. The SNEDDS formulation significantly increase dissolution of glimepiride compared with pure drug.

Ezetimibe is a cholesterol absorption inhibitor widely used in the treatment of dyslipidemia. However, its clinical efficacy is limited by poor aqueous solubility and low oral bioavailability. Therapeutic guidelines on dyslipidemia recommend ezetimibe as an adjunct or alternative to statins, particularly in patients who are intolerant to high-dose statins or have inadequate LDL-C reduction. This review summarizes recent advances in ezetimibe formulations, including single-active and combination systems, and discusses their effects on solubility, pharmacokinetics, and therapeutic outcomes. The analysis is based on literature published within the last decade (2015– 2025) from reputable scientific databases. Advanced strategies such as solid-state modification, particle size reduction, and lipid or surfactant-based delivery systems have significantly enhanced drug dissolution. In vivo studies report relative bioavailability improvements of approximately 120 to 800% compared to pure drug suspensions/marketed products, translating into favorable pharmacodynamic profiles. Beyond single-active systems, innovative co-delivery with statins such as simvastatin, atorvastatin, rosuvastatin, and lovastatin has demonstrated added pharmacological synergy and supports the development of fixed-dose combination products. Collectively, these advances provide strong evidence that optimized ezetimibe formulations in single-active or combination systems have strong potential to improve the biopharmaceutical profile and future therapeutic application in dyslipidemia management.

Abstrak Jerawat adalah penyakit kulit yang paling sering terjadi dan timbul akibat penyumbatan atau inflamasi pada kelenjar pilosebasea. Propionibacterium acnes diketahui merupakan bakteri utama pemicu terjadinya inflamasi pada jerawat. Minyak jinten hitam dan minyak zaitun diketahui memiliki aktivitas antibakteri sehingga dapat dikembangkan untuk pengobatan jerawat karena infeksi. Penelitian ini bertujuan untuk menguji aktivitas antibakteri kombinasi minyak jinten hitam dan minyak zaitun terhadap P. acnes dan memformulasikannya ke dalam bentuk sediaan mikroemulsi gel. Pengujian aktivitas antibakteri dilakukan dengan metode difusi agar pada konsentrasi kombinasi minyak 0,25; 0,5; dan 1%. Formulasi sediaan mikroemulsi gel dilakukan dengan menggunakan cremophor RH 40 sebagai surfaktan, gliserin sebagai kosurfaktan, dan viscolam mac 10 sebagai gelling agent. Karakterisasi sediaan meliputi pengujian organoleptis, pH, viskositas, sifat alir, ukuran globul, dan stabilitas termodinamik. Hasil penelitian menunjukkan bahwa konsentrasi minyak 0,5% sudah memberikan aktivitas antibakteri terhadap P. acnes dengan diameter hambat 12,47±1,07mm. Formula optimum mikroemulsi gel adalah formula yang mengandung minyak (6%), cremophor RH 40 (35%), gliserin (35%), dan gel viskolam 20%. Sediaan mikroemulsi gel memiliki rata rata ukuran globul 120 nm yang memenuhi persyaratan ukuran globul mikroemulsi. Sediaan mikroemulsi gel stabil berdasarkan hasil uji stabilitas termodinamik dengan tidak terlihat adanya pemisahan fase. Kata kunci : Minyak jinten hitam, Minyak zaitun, P. acnes, Mikroemulsi gel Formulation of anti acne microemulsion gel containing combination of black seed oil (Nigella sativa L.) and olive oil (Olea europaea L.) Abstract Acne vulgaris is the most common skin disease involving blockage and/or inflammation of pilosebaceous unit. Propionibacterium acnes has been recognized as pus-forming bacteria triggering an inflammation in acne. Black seed and olive oil are herbal medicines that known have antibacterial activity, that could be develop for acne treatment. This research was conducted to determine antibacterial activity of black seed and olive oil combination against P. acnes and develop the microemulsion gel preparation containing of the oil. Antibacterial activity test was conducted by agar diffusion method at concentration at 0,25; 0,5; and 1% of oil combination. Microemulsion gel was made using cremophor RH 40 as surfactant, glycerine as cosurfactant, and viscolam mac 10 as gelling agent. Microemulsion gel was evaluated by organoleptic, pH, rheologycal properties, spreadability, droplet size, and thermodinamic stabilitiy test. The result showed that concentration 0,5% of oil combination has antibacterial activity towards P. acnes with inhibitory diameter 12,47 ± 1,069 mm. Optimum formula microemulsion gel with the finest characteristic, containing the oil combination (6%), cremophor RH 40 (35%), gliserin (35%), and viscolam gel 20%. The average of droplet size microemulsion gel is 120 nm and those size are qualify with the droplet size of microemulsion. The microemulsion gel was stabile based on thermodinamic stability tests without phase separation. Keywords: black seed oil, olive oil, P. acnes, microemulsion gel

Self-nanoemulsifying drug delivery systems (SNEDDS) have been widely developed as a practical approach to enhance the bioavailability of poorly water-soluble drugs through nanoscale emulsification. To improve the stability and practicality of liquid systems, solidification is commonly performed to obtain solid SNEDDS (S-SNEDDS) by incorporating appropriate solid carriers. Among various options, mesoporous materials have attracted significant attention due to their high surface area, tunable pore sizes, and excellent adsorption capacity. This review aims to summarize and critically analyze recent advances in mesoporous-based S-SNEDDS, focusing on formulation design, solidification strategies, and associated biopharmaceutical outcomes. The review is based on research articles published between 2020 and 2025 retrieved from reputable scientific databases (PubMed, ScienceDirect, Taylor & Francis, Springer, Scopus, and Web of Science) and selected for their relevance to mesoporous carriers and S-SNEDDS development. Findings reveal that carriers such as mesoporous magnesium alumino-metasilicate (eg, Neusilin ®) and mesoporous silica (eg, Syloid ®) have primarily been reported in studies employing physical adsorption. These systems generally exhibit favorable micromeritic properties and solid-state characteristics, suggesting successful drug incorporation within the carrier matrix and improved physical stability. These systems consistently demonstrate enhanced dissolution and permeation, and subsequently translate into superior pharmacokinetic and pharmacodynamic performances. Overall, the solidification of SNEDDS using mesoporous carriers successfully yields systems with desirable physical properties and improved in vitro and in vivo performances. Future research should address regulatory considerations for mesoporous excipients, deepen mechanistic insights into drug-carrier interactions, and include comparative evaluations among different carriers to support clinical and industrial advancement.