원료 사전 탐색/stearic-acid/STEARIC ACID
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합성 (Synthetic)

STEARIC ACID

식약처 한글 표준명: 스테아릭애씨드
세정제향료유화제유화안정제재지방화제
[식약처 공정서 기원 및 정의] 이 원료는 주로 다음의 구조를 갖는 지방산이다.
결론 선행 Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

화장품에서 스테아릭애씨드 (STEARIC ACID)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?

스테아릭애씨드(표준 INCI: STEARIC ACID, CAS 번호: 57-11-4)은 화장품 처방에서 주로 세정제, 향료, 유화제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.5–16.5%(적정 pH 4–8) 범위에서 안정적으로 처방됩니다.

7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스

각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건
7-Track Official Statutory Label Names for STEARIC ACID
국가·규제 트랙공식 고시 전성분 표기명원클릭 복사
① 한국 (MFDS 화장품 한글 표준명)스테아릭애씨드
② 한국 구명칭 (개정 전 이력 · 301 리다이렉트)——
③ 유럽 (EU CosIng EC 1223/2009)STEARIC ACID
④ 미국 일반화장품 (US PCPC / MoCRA INCI)STEARIC ACID
⑤ 미국 OTC (FDA Active Ingredient Monograph)— (비-OTC 일반 화장품 원료)—
⑥ 중국 (NMPA IECIC 표준 중문명)硬脂酸
⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW)ステアリン酸 · [QD: ステアリン酸]

Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태

Layer 1 Statutory Regulatory Limits Across 6 Regions for STEARIC ACID
권역규제 상태배합 한도제한 조건 및 1차 법원 출처
한국 (MFDS)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
유럽 (CosIng)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
미국 (FDA/CIR)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
중국 (NMPA)등재·허용GMPIECIC Entry #8028
일본 (MHLW)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
아세안 (ACD)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)

Layer 2 — 독성·안전성 평가 한도 (US CIR · EU SCCS MoS≥100 · CN IECIC 최고역사사용량)

「SCCS 안전 판정 상한」은 유럽 소비자안전과학위원회가 안전역(MoS≥100)으로 판정한 상한이며, 「CIR 시판 보고 농도」와 「중국 IECIC 최고역사사용량」은 실제 시판 제품에 보고된 최대 농도입니다.

Layer 2 Toxicological & Historical Safe Use Concentrations for STEARIC ACID
안전성 평가 기준적용 부위·유형안전 농도 범위판정 결과 및 문헌 번호
중국 IECIC 최고역사사용량leave_on≤ 20%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 07918 (2025)
중국 IECIC 최고역사사용량rinse_off≤ 15%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 07918 (2025)
⚠️ 참조용 안내 (법적 면책 공지): 이 사전의 성분명·규제 한도·배합 가이드는 연구·개발 참조용으로만 제공됩니다. 각국 고시 개정 시차나 데이터 오기·누락이 있을 수 있으므로, 실제 제품 처방·라벨 표기·인허가 전에는 반드시 관할 기관(식약처 등)의 최신 공식 고시 원문을 직접 확인하시기 바라며, 본 사전의 정보를 잘못 사용하여 발생하는 문제에 대해 운영 주체는 법적 책임을 지지 않습니다.
제형군별 사분위수(Min–Q1–Median–Q3–Max) 분포 그래프

Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조

O/W · W/O 에멀전·크림n=15
Min 0.5% · Q1 1.25% · Median 2% · Q3 10% · Max 16.5%
자외선차단·색조n=12
Min 0.6% · Q1 1.875% · Median 2.95% · Q3 4.2% · Max 11%
O/W · W/O 에멀전·크림 — 유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝
공식 검증 원천: Global Starter Formulation Library Statistical Distribution (n=15, EVONIK 9 · GRANT 3 · SEPPIC 3) (cir_safety) · EVONIK 9 · GRANT 3 · SEPPIC 3
권장 중앙값: 2%

Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드

Layer 3 Formulation Concentration Quartiles by Product Category for STEARIC ACID
제형군 분류Min – Q1 – Median – Q3 – Max (%)처방 역할 및 기전Source ID
제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O)0.5% · 1.25% · 2% · 10% · 16.5%유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝Global Starter Formulation Library Statistical Distribution (n=15, EVONIK 9 · GRANT 3 · SEPPIC 3)
제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션0.6% · 1.875% · 2.95% · 4.2% · 11%선케어·색조 메이크업 분산 안정화 및 발림성 조절Global Starter Formulation Library Statistical Distribution (n=12, EVONIK 6 · GRANT 5 · SEPPIC 1)
피부 투과 과학 시각화 (Bos & Meinardi 500 Dalton Rule)MW: Macro/Complex · LogP: N/A

각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션

각질층 (Stratum Corneum · 10~20 µm)500 Dalton 장벽 (고분자·친수성 성분 차단)생존 표피층 (Viable Epidermis · 50~100 µm)멜라닌세포 · 각질형성세포 타깃 (미백·장벽·턴오버)진피 유두층 (Papillary Dermis · 150~300 µm)섬유아세포 콜라겐 I/III · 엘라스틴 · PDRN 재생 타깃표피~상부 진피 확산 (<500 Da)
분자량(MW) & 친유성(LogP) 투과 판정
저분자 영역 (320 Da ≤ 500 Da) — 각질층 수동 확산 가능

단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.

예상 도달 깊이
40–90 µm
권장 전달 시스템
Polyol Enhancer / Serum
계면화학 · pH · 열역학 공정 시각화

pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동

Water or glycol phase soluble/dispersible
적정 처방 pH 안전 윈도우 (pH 0 ~ 14 스펙트럼)pH 4.0 – 8.0
0245.5791114

권장 구간 밖(pH < 4 또는 pH > 8)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.

공정 가열 한계 온도 (Max Process Temp)≤ 50°C
25°C45°C60°C75°C85°C100°C

최대 50°C 가열 공정에서 열적 안정성이 유지됩니다.

계면활성·유화 HLB 스펙트럼 (0 ~ 20) & 미셀/액정 배열 시뮬레이터
O/W 수중유형 미셀 에멀전 (수분 크림·로션)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
생화학 신호전달 경로 (Biochemical Pathway Map)

세포·분자 타깃 작용 기전 플로우 다이어그램

1. 각질층·표피 작용→ 촉진·활성 (Activation)
각질층 세포간 지질 & 수분 결합 네트워크
→
경피수분손실(TEWL) 억제 및 피부결 개선
2. 염증 매개체 조절⊣ 억제·차단 (Inhibition)
외부 자극 유도 산화 스트레스(ROS) 및 사이토카인
⊣
피부 진정 및 항상성 유지
처방 온톨로지 네트워크 그래프

권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도

+ GLYCERIN+ CAPRYLIC/CAPRIC TR…+ TOCOPHEROL✕ 처방 내 극단적 pH 조건 및 고농도…STEARIC ACID
노드 인터랙션 가이드

🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.

대표 상용명 참고 (상표법 제90조 제1항 제2호 설명적 표기)
STEARIC ACID

상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.

학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)

Tier 1 Synthesis

이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.

■ [1. 화학적 정체성 및 규격 (Chemical Identity & Standard Nomenclature)] - 표준명: 스테아릭애씨드 | INCI: STEARIC ACID | CAS No.: 57-11-4 | EC No.: 200-313-4 - 기원 및 분류: SYNTHETIC | 주요 기능: 세정제, 향료, 유화제, 유화안정제, 재지방화제 - 물리화학 스펙: 분자식 복합 조성이거나 단일 화학식 미지정 | 분자량 고분자/복합물(Polymer/Complex) | 친수/친유 밸런스 특화 | 이온성: non-ionic | CosIng/MFDS 등재 - 7대 권역 공식 라벨 표기: KR [스테아릭애씨드] · EU [STEARIC ACID] · US [STEARIC ACID] · CN [硬脂酸] · JP [ステアリン酸] · JP의약부외품 [ステアリン酸] ■ [2. 피부과학적 작용 기전 및 제형 내 역할 (Mechanism of Action & Function)] - 이 원료는 주로 다음의 구조를 갖는 지방산이다. 물리화학적 분류상 기원(synthetic)에 기반하여 피부 장벽 및 제형 매트릭스 내에서 고유한 기능(세정제, 향료, 유화제, 유화안정제, 재지방화제)을 수행하며, 계면 안정화·보습·피부 컨디셔닝 또는 유효성분 전달에 기여합니다. ■ [3. 글로벌 6대 권역 법정 규제 및 안전성 한도 (Layer 1 & Layer 2 Regulatory Matrix)] - 6개국 요약: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (중국 IECIC(2025) 등재번호 8028 (硬脂酸)) - 6대 주요 권역(KR·EU·US·CN·JP·ASEAN) 별도 배합금지/특수제한 고시 없음 (GMP 일반 안전 기준 내 배합 허용). - 공인 안전성·역사적 사용 농도(Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): 최대 20.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): 최대 15.0% ■ [4. 제형군별 통상 배합 가이드 (Layer 3-A Formulation Dosage Guide)] - [emulsion_cream] 권장 범위: 0.5 ~ 16.5% (중앙값 2.0%, 근거: Global Starter Formulation Library Statistical Distribution (n=15, EVONIK 9 · GRANT 3 · SEPPIC 3)) — 유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝 - [sun_color] 권장 범위: 0.6 ~ 11.0% (중앙값 2.95%, 근거: Global Starter Formulation Library Statistical Distribution (n=12, EVONIK 6 · GRANT 5 · SEPPIC 1)) — 선케어·색조 메이크업 분산 안정화 및 발림성 조절 ■ [5. 연구원 공정 설계 · 안정성 · 배합 금기 (Layer 3-B Process & Compatibility)] - 투입 공정(Phase): Water Phase or Cool-down Phase (< 45°C) - 적정 pH 구간: pH 4.0 ~ 8.0 | 공정 내열 온도: 최대 50°C | 전해질(염) 내성: MEDIUM - 배합 주의/금기: 처방 내 극단적 pH 조건 및 고농도 전해질과의 상용성 사전 확인 권장 - 시너지 추천 원료: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | 참고 상용 원료명: STEARIC ACID ■ [6. 학술 논문 및 공인 문헌 근거 (Peer-Reviewed Literature & Compendia)] - PMID 42142203 (2026, Discov Nano): Development and preclinical evaluation of quiniodochlor-loaded nanostructured lipid carrier-chitosan gel for topical ant - PMID 41844721 (2026, Sci Rep): Bioactive-fat engineered nanostructured lipid carriers from Illipe butter: optimized design and enhanced in vitro anti-i - PMID 41556321 (2026, Pharm Dev Technol): Clobetasol propionate loaded nanostructured lipid carrier gel: formulation strategy and in vitro performance evaluation

근거 동료심사 학술 논문 (미국 NIH PubMed) (12)

Development and preclinical evaluation of quiniodochlor-loaded nanostructured lipid carrier-chitosan gel for topical antifungal therapy [PMID: 42142203 · 2026]
Biswas UK, Bose A, Naskar S, Jana M · Discov Nano (2026)

The rising incidence of superficial fungal infections and the limitations of conventional topical therapies necessitate the development of advanced, targeted delivery systems. This study aimed to develop and evaluate a novel quiniodochlor (QD)-loaded nanostructured lipid carrier (NLC) gel for enhanced topical antifungal therapy. QD-loaded NLCs were prepared by hot homogenization using stearic acid (solid lipid) and cinnamon oil (liquid lipid), stabilized with Tween &#xae; 80, and incorporated into a chitosan hydrogel. Formulations were characterized for particle size, polydispersity index (PDI), zeta potential, entrapment efficiency (EE%), drug release, and physicochemical stability. The developed gel was further evaluated for spreadability, extrudability, ex vivo skin permeation/retention, in vitro antifungal activity against Candida albicans, and in vivo skin irritation. The optimized NLCs exhibited nanoscale particle sizes (141.86-250.79) high EE% (&gt;&#x2009;98%), and low PDI (0.28-0.43). Despite a near-neutral zeta potential, colloidal stability was maintained, attributed to steric stabilization. The NLC gel showed a sustained drug release profile, significantly higher skin retention, and about 1.6-fold larger zone of inhibition against C. albicans compared to a marketed QD cream. Ex vivo studies confirmed enhanced dermal accumulation with negligible transdermal permeation. The formulation demonstrated excellent spreadability and extrudability, and elicited no signs of erythema or edema in an in vivo skin irritation model. The developed QD-NLC-chitosan gel presents a promising, safe, and effective topical strategy with enhanced skin targeting, sustained local release, and superior antifungal activity, demonstrating strong potential as an advanced therapeutic alternative for superficial mycoses.

Bioactive-fat engineered nanostructured lipid carriers from Illipe butter: optimized design and enhanced in vitro anti-inflammatory performance [PMID: 41844721 · 2026]
Kurniawansyah IS, Chaerunisaa AY, Akmalia NNN · Sci Rep (2026)

Despite the extensive use of synthetic and semi-synthetic lipids in nanostructured lipid carrier (NLC) systems, the utilization of Shorea spp. (Illipe butter or tengkawang fat), an indigenous natural solid lipid from Indonesia, remains unexplored. This study aimed to develop and optimize a Nanostructured Lipid Carrier (NLC) formulation using Illipe butter (Shorea spp.) as a natural solid lipid source. The NLC system was designed through a Box-Behnken design to evaluate the influence of solid lipid (Illipe butter and glyceryl monostearate), liquid lipid (oleic acid), and surfactant mixture (Tween 80 and glycerin) on physicochemical characteristics. The optimized formulation Nanostructured Lipid Carrier-Illipe Butter (NLC-IB) was incorporated into a gel base to produce an NLC gel formulation suitable for topical anti-inflammatory application. Characterization of the optimized NLC revealed a particle size of 276.9&#xa0;nm, PDI of 0.393, and zeta potential of&#x2009;-&#x2009;53.5&#xa0;mV, indicating good stability. Transmission electron microscopy showed spherical particles with an imperfect crystal (Type I) matrix. GC-MS analysis confirmed the retention of major fatty acids, particularly stearic acid (31.9%) and palmitic acid (18.2%), in the NLC system. In vitro anti-inflammatory evaluation using the BSA denaturation assay demonstrated moderate activity, with IC&#x2085;&#x2080; values of 197.23&#xa0;ppm (Illipe butter), 146.46&#xa0;ppm (NLC-IB), and 238.49&#xa0;ppm (E-NLC-IB). To our knowledge, this study represents one of the first systematic investigations of Illipe butter (Shorea spp.) as a solid lipid matrix in nanostructured lipid carrier systems.

Clobetasol propionate loaded nanostructured lipid carrier gel: formulation strategy and in vitro performance evaluation [PMID: 41556321 · 2026]
Diril M, Karata&#x15f; E, Karasulu HY · Pharm Dev Technol (2026)

Clobetasol propionate (CP) is a potent Class I corticosteroid widely used to treat dermatological conditions; however, its poor aqueous solubility limits bioavailability. In this study, a nanostructured lipid carrier (NLC)-based gel was developed via the microemulsion method to improve the topical delivery of CP. The formulation was optimized using stearic acid (solid lipid), Captex 300 (liquid lipid), Tween 20 and Span 80 (surfactants), and propylene glycol (co-surfactant), based on solubility and thermodynamic stability assessments. Vitamin E acetate was incorporated as an antioxidant to inhibit lipid oxidation and enhance formulation stability. The optimized CP-NLC (F5) formulation had a particle size of 75.96&#x202f;&#xb1;&#x202f;4.87&#x202f;nm, a zeta potential of -23.88&#x202f;&#xb1;&#x202f;4.10&#x202f;mV, and a polydispersity index (PDI) of 0.27&#x202f;&#xb1;&#x202f;0.11. Encapsulation efficiency was 93.72&#x202f;&#xb1;&#x202f;0.26%, and drug loading reached 100.69&#x202f;&#xb1;&#x202f;0.62%. Transmission electron microscopy (TEM) confirmed spherical morphology. The gel (CP-NLC-F5-G) prepared with Carbopol 934 demonstrated a pH of 5.58&#x202f;&#xb1;&#x202f;0.68 and drug content uniformity of 99.03&#x202f;&#xb1;&#x202f;1.18%. In vitro release studies using Franz diffusion cells revealed sustained CP release compared to a commercial product. Stability studies indicated long-term encapsulation retention, attributed to the antioxidant effect of Vitamin E acetate. These findings suggest the potential of CP-NLC systems for effective, sustained corticosteroid delivery with enhanced dermal retention.

Comparative in vivo assessment of hair-growth efficacy using nanostructured lipid carriers individually loaded with lavender oil or tea seed oil [PMID: 41552988 · 2026]
Sarhan OM, El-Noby EM, El-Shaat HA, Mostafa MSA, Gebril MI · Pharm Dev Technol (2026)

This study aimed to formulate nanostructured lipid carriers loaded with tea seed or lavender oil to enhance hair regrowth via improved follicular penetration, as an alternative to conventional alopecia therapies. NLCs were prepared by ultrasonication of stearic acid: essential oil mixtures into an aqueous phase containing either Tween 80 or Pluronic F127 as surfactants. Particle size, polydispersity index, zeta potential and TEM were measured. In vivo efficacy was evaluated in female Wistar albino rats given selected once-daily topical NLCs for 30&#x2009;days. DLS analysis showed that formulations F2 and F5 had mean particle sizes of 165&#x2009;&#xb1;&#x2009;3&#x2009;nm and 181&#x2009;&#xb1;&#x2009;6&#x2009;nm, respectively, whereas the mixed-oil formulation F3 aggregated into large droplets. Zeta potentials of -65&#x2009;&#xb1;&#x2009;2&#x2009;mV (F2) and -42&#x2009;&#xb1;&#x2009;3&#x2009;mV (F5) confirmed excellent electrostatic stability. TEM images verified roughly spherical, core-shell nanoparticles. In the in&#xa0;vivo study, F2 and F5 treatments increased mean hair lengths by 120% and 132% versus placebo ( p &#x2009;&lt;&#x2009;0.001), respectively, compared to a 116% increase with the commercial product. NLCs significantly enhanced follicular density, with the lavender oil formulation showing superior hair shaft integrity. These results demonstrate that Pluronic F127-stabilized NLCs carrying natural oils possess optimal physicochemical properties and promote hair regrowth.

Broad-Spectrum Antibacterial Activity of Postbiotic From Lacticaseibacillus paracasei BGP1 Against Multidrug-Resistant Skin Wound Pathogens [PMID: 41355606 · 2025]
Mohammadhosseinzadeh F, Arefian E, Khaleghi M, Keshmiri Neghab H, Kashef N · Microbiologyopen (2025)

The increasing problem of antibiotic resistance indicates the need for alternative therapeutic strategies for skin wound infections. While probiotics exhibit potential for developing such alternatives, the majority of antimicrobial studies focus on live cells or lysates and oral delivery. Notably, in dermatology, formulating products with live strains poses technical challenges due to stability issues in water-based systems. Postbiotics, substances made from probiotics, offer a promising, stable, and safe alternative. This study addresses the gap by evaluating the antibacterial potential of cell-free supernatants (CFSs) from six probiotic strains, with a specific focus on Lacticaseibacillus paracasei BGP1, against clinically relevant skin pathogens. CFSs were screened in vitro using agar well diffusion and broth microdilution assays against Staphylococcus aureus ATCC 25923, methicillin-resistant S. aureus (MRSA; UTMC 1442), Pseudomonas aeruginosa ATCC 27853, and P. aeruginosa PAO1. GC-MS analysis was used to identify bioactive compounds in the most promising CFS. Among the tested strains, BGP1 demonstrated both consistent inhibitory (MIC: 6.25&#x2009;mg/mL) and bactericidal (MBC: 12.5&#x2009;mg/mL) effects. GC-MS analysis identified palmitic acid (33.24%) and stearic acid (46.45%) as dominant bioactive compounds. These findings provide novel evidence that postbiotic metabolites from L. paracasei BGP1 represent a promising, broad-spectrum, stable, and nonliving candidate to conventional therapies for antibiotic-resistant skin wound infections. Further in vivo research is needed to evaluate their therapeutic potential and formulation in clinical settings.

Guerbet Alcohols, Ideal Substrates for the Sustainable Production of Branched Esters [PMID: 41303974 · 2025]
Montiel MC, M&#xe1;ximo F, G&#xf3;mez M, Murcia MD, Ortega-Requena S, Bastida J · Materials (Basel) (2025)

Saturated and branched high molecular weight organic esters are highly valued as emollients in the cosmetic industry due to their superior properties. Their saturated character provides resistance to oxidation and rancidity. Additionally, their branched structure endows them with low melting temperatures, enabling them to remain liquid over a broad temperature range. These esters can be obtained from branched alcohols, branched fatty acids or both, using chemical or enzymatic processes. Among branched alcohols, Guerbet alcohols stand out. Due to their characteristic properties as branched, saturated alcohols with superior oxidative stability and extremely low volatility, they are proposed as excellent substrates for the enzymatic synthesis of these compounds. This study represents the first investigation into the biocatalytic synthesis of three specific esters: those formed between 2-octyl-1-dodecanol (C20 Guerbet alcohol) and the fatty acids myristic (MA), palmitic (PA), and stearic acid (SA). To achieve this, an environmentally sustainable biocatalytic process was developed. The synthesis involves a solvent-free esterification catalyzed by the commercial immobilized lipase, Lipozyme &#xae; 435, conducted within a vertically stirred, thermostated batch tank reactor. Optimal conditions for lipase concentration and temperature were established, and the sustainability of the process was successfully quantified using various "green metrics".

Development and optimization of Moxifloxacin solid lipid nanoparticles via double emulsion organic solvent free technique applying Box-Behnken experimental design [PMID: 41291000 · 2025]
Elshazly EM, Arafa MG, Nour SA · Sci Rep (2025)

The current research proposes the preparation of Moxifloxacin-loaded solid lipid nanoparticles through a solvent-free double emulsion technique, to overcome chronic wound healing limitation. The independent variables: stearic acid, Span 80, and Tween 80 were optimized via Box-Behnken design, based on entrapment efficiency (EE%), zeta potential (ZP), and particle size (PS). To statistically optimize the formulation variables, a three-factor, three-level (3&#xb3;) design involving 15 runs was employed and optimization was carried out to attain maximum EE% and ZP and minimum PS yielding an overall desirability of 0.851. Results indicated that increasing stearic acid enhanced EE%, Span 80 increase PS, and Tween 80 improved ZP. The Optimized SLNs formula had a ZP of -&#x2009;52.4 mV, EE% of ~&#x2009;79.6% and PS of 257&#xa0;nm. Chemical compatibility was emphasized using FTIR, and XRD studies revealed reduced drug crystallinity within the lipid matrix, which confirmed successful encapsulation. Transmission electron microscopy (TEM) and scanning electron microscopy (SEM) imaging revealed nanoparticles with defined spherical shape and smooth surface. The optimized formula is anticipated to enhance dermal distribution and prolonged antibiotic release, thereby offering an efficient therapeutic strategy for the management of chronic wounds.

Development and Evaluation of Nystatin-Loaded Novasomal Gel for the Treatment of Candida albicans Infection: In Vitro Microbiological and Skin Compatibility Study [PMID: 41149379 · 2025]
Mustafa MA, Fahad M, Mughal M, Rasheed N, Alqahtani SS, Iqbal MZ · Gels (2025)

Candida infections pose a significant health threat, and conventional antifungal drugs like nystatin are limited due to poor solubility, skin permeability, and frequent dosage requirements. Nystatin effectively targets Candida species by disrupting cell membranes, but formulation issues hinder clinical use. Lipid-based vesicular carriers, or novasomes, provide controlled, prolonged drug release and enhanced skin penetration. This study focuses on developing nystatin-loaded novasomal gels as an advanced drug delivery system to enhance therapeutic efficacy, bioavailability, and patient compliance. The formulation was prepared using a modified ethanol injection technique, combining stearic acid, oleic acid, Span 60, cholesterol, and Carbopol to produce a stable transdermal gel. Comprehensive in vitro characterization using FTIR, SEM, XRD, and thermal analysis confirmed the chemical compatibility, morphological uniformity, and physical stability of the nystatin-loaded novasomal gel. Entrapment efficiency differed significantly among the formulations ( p &lt; 0.05), with F7 achieving the highest value (80%). All formulations maintained pH levels within the skin-friendly range of 5.5 to 7.0. Viscosity measurements, ranging from 3900 &#xb1; 110 to 4510 &#xb1; 105 cP, confirmed their appropriate consistency for dermal use. Rheological analysis showed a dominant elastic response, as indicated by storage modulus values consistently higher than the loss modulus. Particle size ranged from 4143 to 9570 nm, while PDI values remained below 0.3, reflecting uniform particle distribution. Zeta potential values were strongly negative, supporting physical stability. XRD studies indicated reduced crystallinity of nystatin within the formulations, while FTIR confirmed drug-excipient compatibility. SEM images showed spherical particles within the micrometer range. In vitro release studies demonstrated sustained drug release over 12 h, with F6 releasing the highest amount. The novasomal gel formulations-maintained stability for 30 days, with no notable alterations in pH, viscosity, or entrapment efficiency. Antifungal evaluation showed a larger inhibition zone (23 &#xb1; 2 mm) compared with the plain drug solution (15 &#xb1; 1.6 mm), while the MIC value was reduced (4.57 &#xb5;g/mL), indicating greater potency. Skin irritation assessment in rats revealed only minor, temporary erythema, and the calculated Primary Irritation Index (0.22) confirmed a non-irritant profile. These findings suggest that the developed novasomal gel offers a promising approach for enhancing the treatment of fungal infections by enabling prolonged drug release, minimizing dosing frequency, and improving patient compliance.

Structural color generation in lipid-based cosmetics: Lamellar nanosheets from skin-identical fatty acids [PMID: 41033243 · 2026]
Eom JS, Park G, Liu X, Lee DS, Shin J, Choi YN, Jang J, Lee JB, Bae JK, Oh H, Hong SK · Colloids Surf B Biointerfaces (2026)

There is growing interest in pigment-free, biocompatible systems that generate structural color for cosmetic applications. This study presents pearlescent cosmetic formulations composed of skin-identical long-chain fatty acids, stearic acid (C18) and behenic acid (C22), that self-organize into multilamellar nanosheet structures in aqueous media. These formulations exhibited vivid, composition-dependent structural colors in the visible region, consistent with constructive interference of reflected light within nanosheet-based lamellar domains. Wavelength shifts were observed in the reflectance spectra as the ratio of stearic to behenic acid varied, indicating tunable optical properties. SAXS confirmed multilamellar structures with interlamellar spacing that varied systematically with composition. This study is the first to demonstrate structural color generation from physiologically relevant fatty acids naturally present in the human stratum corneum. These findings offer a skin-compatible, pigment-free design strategy for multifunctional cosmetic formulations that combine visual aesthetics with biological relevance.

Dual-drug nanostructured lipid carriers of spironolactone and 2-deoxy-D-ribose for targeted follicular delivery in androgenetic alopecia [PMID: 42218358 · 2026]
Kayal P, Mishra MK, Jawahar N · Drug Deliv Transl Res (2026)

Androgenetic alopecia (AGA) is a multifactorial condition driven by dihydrotestosterone (DHT)-induced follicular miniaturization and reduced perifollicular angiogenesis. Existing treatments such as finasteride, minoxidil, and dutasteride often show limited efficacy and systemic side effects like sexual dysfunction or cardiovascular issues, necessitating targeted approaches. The present study developed dual-drug nanostructured lipid carriers (NLCs) co-delivering spironolactone (SL), an anti-androgen, and 2-deoxy-D-ribose (2dDR), a pro-angiogenic agent, for synergistic follicular regeneration. NLCs were prepared by the hot microemulsion method, incorporating stearic acid as a solid lipid and fenugreek oil as a liquid lipid, with Span 80/Tween 80 surfactants. A Central Composite Design (CCD) was optimised to achieve minimal particle size and optimal zeta potential by varying lipid ratios and surfactant levels. The formulations were characterized by particle size analysis and zeta potential measurements, differential scanning calorimetry (DSC), X-ray diffraction (XRD), Fourier-transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), and in vitro drug release kinetics. Cytotoxicity and dihydrotestosterone (DHT)-protection assays were performed using human dermal papilla cells (hDPCs). Optimized SL-2dDR NLCs exhibited a particle size of 343.03&#x2009;&#xb1;&#x2009;9.0&#xa0;nm, a PDI of 27.97&#x2009;&#xb1;&#x2009;2.84%, and a zeta potential of -20.13&#x2009;&#xb1;&#x2009;0.40&#xa0;mV. Entrapment efficiency reached 99.00&#x2009;&#xb1;&#x2009;0.5% for SL and 98.75&#x2009;&#xb1;&#x2009;0.7% for 2dDR. DSC and XRD confirmed amorphous drug dispersion, while SEM revealed irregular, porous morphology favorable for follicular adhesion. In vitro release followed Higuchi kinetics for SL (R 2 &#x2009;=&#x2009;0.994) and Hixson-Crowell for 2dDR (R 2 &#x2009;=&#x2009;0.985). MTT assays demonstrated concentration-dependent cytoprotection against DHT-induced cytotoxicity, maintaining 82% cell viability at 50&#xa0;&#xb5;g/mL. The dual-drug NLC system represents a promising targeted therapy for AGA, combining anti-androgenic and pro-angiogenic mechanisms while minimizing systemic exposure.

Emulsome-Based Nanocarrier System for Controlled 4-Phenylbutyric Acid Delivery and Mechanistic Mitigation of Arsenical-Induced Skin Injury via Foam Application [PMID: 41599160 · 2025]
Viswaroopan N, Ghosh M, Kshirsagar SM, Khan J, Toral-Orduno J, Srivastava RK, Athar M, Banga AK · Pharmaceutics (2025)

Background : Lewisite, a potent chemical warfare agent, induces rapid and progressive cutaneous damage, necessitating treatment strategies that offer both immediate decontamination and prolonged therapeutic action. This study aimed to develop and evaluate a composite topical formulation comprising 4-phenylbutyric acid (4-PBA)-loaded emulsomes embedded within a foam vehicle to address both aspects of vesicant-induced skin injury intervention. Methods : Emulsomes composed of a stearic acid-cholesterol solid lipid core stabilized by a lecithin shell were prepared via thin film hydration and optimized by varying lipid ratios and drug loading parameters. Formulations were characterized for drug loading, particle size, and zeta potential. Physicochemical compatibility was assessed using Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) analyses. Stability was evaluated under accelerated refrigerated (25 &#xb0;C/60% RH) and room temperature (40 &#xb0;C/75% RH) conditions. The optimized formulation was incorporated into a foam base and evaluated for decontamination efficiency, drug release kinetics, in vitro permeation, and in vivo efficacy. Results : The selected formulation (E2) exhibited high drug loading (17.01 &#xb1; 0.00%), monodisperse particle size (PDI = 0.3 &#xb1; 0.07), and stable zeta potential (-40 &#xb1; 1.24 mV). FTIR and DSC confirmed successful encapsulation with amorphous drug dispersion. The emulsome-foam demonstrated dual functionality: enhanced decontamination (66.84 &#xb1; 1.27%) and sustained release (~30% over 24 h), fitting a Korsmeyer-Peppas model. In vitro permeation showed significantly lower 4-PBA delivery from E2 versus free drug, confirming sustained release, while in vivo studies demonstrated therapeutic efficacy. Conclusions : This emulsome-foam system offers a promising platform for topical treatment of vesicant-induced skin injury by enabling both immediate detoxification and prolonged anti-inflammatory drug delivery.

Fatty Acids Pattern, Essential Oil Content and Constituents of Some Sage Species (Salvia sp.) Native to Iran: Usable in Food Industry [PMID: 41334231 · 2025]
Mohammadi YV, Khorshidi J, Nazari F · Food Sci Nutr (2025)

The genus Salvia is a rich source of bioactive compounds with diverse applications in traditional medicine, as well as in the food, and pharmaceutical industries. This study evaluated the essential oil content and composition, seed oil yield, and fatty acid profiles of five native Iranian Salvia species ( S. nemorosa , S. spinosa , S. syriaca , S. palaestina , and S. multicaulis ) cultivated under uniform ecological conditions. Essential oils were extracted using a Clevenger apparatus based on the hydrodistillation method, while seed oils were obtained via Soxhlet extraction with hexane as the solvent. Both were subsequently analyzed by GC-MS and GC-FID. Results revealed significant interspecific variation. Essential oil content ranged from 0.014% (v/w) in S. nemorosa to 0.37% (v/w) in S. multicaulis . In contrast, the highest seed oil content (53.3% v/w) was found in S. nemorosa , while the lowest (18% v/w) was recorded in S. syriaca . S. nemorosa was rich in spathulenol and caryophyllene derivatives, whereas S. spinosa was dominated by isopentyl isovalerate. S. syriaca and S. palaestina primarily contained germacrene D, while S. multicaulis showed high levels of isoborneol, bornyl acetate, and 1,8-cineole. Palmitic, stearic, linoleic, and linolenic acids were detected in the seed oil of all studied Salvia species. S. multicaulis exhibited the highest levels of palmitic (10.92%&#x2009;&#xb1;&#x2009;0.33% v/w) and linoleic acid (52.57%&#x2009;&#xb1;&#x2009;4.57% v/w), S. palaestina had the highest stearic acid content (2.92%&#x2009;&#xb1;&#x2009;0.045% v/w), and S. nemorosa contained the highest linolenic acid level (46.3%&#x2009;&#xb1;&#x2009;0.594% v/w). Overall, S. multicaulis stood out for its high essential oil content, rich in isoborneol and bornyl acetate, whereas S. nemorosa exhibited the highest seed oil content dominated by linolenic acid. These findings suggest that S. multicaulis and S. nemorosa are promising candidates for essential oil and edible oil production, respectively, offering valuable potential for application in the pharmaceutical, cosmetic, and food industries.

자주 묻는 질문 (AEO 스니펫 최적화 FAQ)

Q1. 스테아릭애씨드 (STEARIC ACID)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
한국 식약처 표준명은 '스테아릭애씨드', 미국 PCPC 및 유럽 CosIng INCI 표기는 'STEARIC ACID', 중국 NMPA IECIC 표준명은 '硬脂酸', 일본 화장품 표시명칭은 'ステアリン酸'입니다.
Q2. 스테아릭애씨드의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: none), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
Q3. 제형 설계 시 스테아릭애씨드의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
대표 제형군(emulsion_cream) 기준 통상 0.5~16.5%(권장 중앙값 2%) 범위로 투입하며, 적정 pH는 4~8입니다.
Q4. 스테아릭애씨드 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
주요 권장 시너지 조합은 GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL이며, 배합 주의사항은 처방 내 극단적 pH 조건 및 고농도 전해질과의 상용성 사전 확인 권장입니다.