TOCOPHERYL ACETATE
화장품에서 토코페릴아세테이트 (TOCOPHERYL ACETATE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?
토코페릴아세테이트(표준 INCI: TOCOPHERYL ACETATE, CAS 번호: 7695-91-2)은 화장품 처방에서 주로 항산화제, 피부컨디셔닝제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.1–1%(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| 국가·규제 트랙 | 공식 고시 전성분 표기명 | 원클릭 복사 |
|---|---|---|
| ① 한국 (MFDS 화장품 한글 표준명) | 토코페릴아세테이트 | |
| ② 한국 구명칭 (개정 전 이력 · 301 리다이렉트) | — | — |
| ③ 유럽 (EU CosIng EC 1223/2009) | TOCOPHERYL ACETATE | |
| ④ 미국 일반화장품 (US PCPC / MoCRA INCI) | TOCOPHERYL ACETATE | |
| ⑤ 미국 OTC (FDA Active Ingredient Monograph) | — (비-OTC 일반 화장품 원료) | — |
| ⑥ 중국 (NMPA IECIC 표준 중문명) | 生育酚乙酸酯 | |
| ⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW) | 酢酸トコフェロール · [QD: 酢酸dl-α-トコフェロール] |
Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태
| 권역 | 규제 상태 | 배합 한도 | 제한 조건 및 1차 법원 출처 |
|---|---|---|---|
| 한국 (MFDS) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 유럽 (CosIng) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 미국 (FDA/CIR) | 미규제 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 중국 (NMPA) | 등재·허용 | GMP | IECIC Entry #6043 |
| 일본 (MHLW) | 제한 | GMP | 공식 화장품 원료 목록 등재 (GMP 기준 사용) |
| 아세안 (ACD) | 미규제 | GMP | 공식 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.
| 안전성 평가 기준 | 적용 부위·유형 | 안전 농도 범위 | 판정 결과 및 문헌 번호 |
|---|---|---|---|
| 중국 IECIC 최고역사사용량 | leave_on | ≤ 36% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 05895 (2025) |
| 중국 IECIC 최고역사사용량 | rinse_off | ≤ 5% | 안전 판정(MoS≥100)NMPA IECIC (2025) Entry 05895 (2025) |
Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조
Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드
| 제형군 분류 | Min – Q1 – Median – Q3 – Max (%) | 처방 역할 및 기전 | Source ID |
|---|---|---|---|
| 제형군 E — 무수 오일 · 멀티밤 · 립케어 | 0.1% · 0.4375% · 0.5% · 0.625% · 1% | 무수 밤·스틱·오일 처방 유상 골격 및 보습막 형성 | Global Starter Formulation Library Statistical Distribution (n=8, EVONIK 4 · GRANT 4) |
| 제형군 A — 수성 토너 · 세럼 · 고농축 앰플 | 0.1% · 0.1% · 0.2% · 0.225% · 1% | 수성 세럼·토너·하이드로겔 처방 베이스 및 기능성 부여 | Global Starter Formulation Library Statistical Distribution (n=15, GRANT 13 · SEPPIC 2) |
| 제형군 C — 세정 워시오프 · 폼 · 샴푸 · 바디워시 | 0.1% · 0.2% · 0.2% · 0.2% · 0.35% | 린스오프 세정·클렌징 처방 계면 안정화 및 사용감 개선 | Global Starter Formulation Library Statistical Distribution (n=9, GRANT 5 · EVONIK 3 · SEPPIC 1) |
| 제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O) | 0.1% · 0.2% · 0.275% · 0.5% · 1% | 유화 로션·크림 제형 구조 형성 및 피부 컨디셔닝 | Global Starter Formulation Library Statistical Distribution (n=46, EVONIK 23 · GRANT 21 · SEPPIC 2) |
| 제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션 | 0.1% · 0.1% · 0.2% · 0.5% · 1% | 선케어·색조 메이크업 분산 안정화 및 발림성 조절 | Global Starter Formulation Library Statistical Distribution (n=29, GRANT 20 · EVONIK 7 · SEPPIC 2) |
각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션
단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.
pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동
권장 구간 밖(pH < 4 또는 pH > 8)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.
최대 50°C 가열 공정에서 열적 안정성이 유지됩니다.
세포·분자 타깃 작용 기전 플로우 다이어그램
권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도
🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.
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 Synthesis이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.
근거 동료심사 학술 논문 (미국 NIH PubMed) (19)
Final report on the safety assessment of Tocopherol, Tocopheryl Acetate, Tocopheryl Linoleate, Tocopheryl Linoleate/Oleate, Tocopheryl Nicotinate, Tocopheryl Succinate, Dioleyl Tocopheryl Methylsilanol, Potassium Ascorbyl Tocopheryl Phosphate, and Tocophersolan [PMID: 12537931 · 2002]
Percutaneous absorption of alpha-tocopheryl acetate [PMID: 5723132 · 1968]
Uptake and bioconversion of alpha-tocopheryl acetate to alpha-tocopherol in skin of hairless mice [PMID: 8506388 · 1993]
The photoprotective effect of topically applied alpha-tocopheryl acetate (vitamin E acetate), a stable derivative of alpha-tocopherol (vitamin E), and its possible bioconversion to the active antioxidant species (alpha-tocopherol) was examined in skin tissue of female hairless mice (HRS/J) exposed to UV-B irradiation. Our results indicate that topically applied alpha-tocopheryl acetate is absorbed into and retained by skin tissue. Furthermore, skin tissue from UV-B-irradiated animals that received daily topical alpha-tocopheryl acetate treatments contained significantly higher levels (P < 0.001) of alpha-tocopheryl acetate than non-UV-B-irradiated mice that received identical daily topical alpha-tocopheryl acetate treatments. Finally, free alpha-tocopherol levels in skin also were significantly increased (P < 0.001) by topical applications of alpha-tocopheryl acetate and skin levels of free alpha-tocopherol were significantly greater (P < 0.001) in UV-B-irradiated animals that received daily topical alpha-tocopheryl acetate treatments than in non-UV-B-irradiated animals. These results suggest that UV-B irradiation enhances both the absorption of alpha-tocopheryl acetate and its bioconversion to free alpha-tocopherol.
TPGS Modified Phospholipid-free and Cholesterol-free Ethosomes Enhance Chemical Stability and Transdermal Permeation Of Retinol [PMID: 41981221 · 2026]
Retinol has emerged as a star ingredient in the cosmetics industry owing to its remarkable skincare efficacy. However, its major limitations-high irritation potential and chemical instability-necessitate further improvement. We developed a liposome primarily composed of glyceryl monooleate and poloxamer (F127). By hybridizing this with a binary alcohol system comprising a 1:1 (v/v) mixture of propylene glycol and dipropylene glycol, an ethosome (ES) capable of efficiently encapsulating retinol was obtained. Retinol-loaded ES (Ret-ES) was further modified with D-α-tocopheryl polyethylene glycol 1000 succinate (TPGS@Ret-ES), thereby optimizing particle size distribution and drug loading capacity. Increasing the binary alcohol concentration from 10 to 30% caused TPGS@Ret-ES hydrated particle size to sharply decrease from 100 to 50 nm, without significant changes in drug loading or encapsulation efficiency. Compared with retinol aqueous solutions, TPGS@Ret-ES substantially reduced degradation rates at room temperature while maintaining excellent particle size stability. Additionally, incorporating antioxidants tocopheryl acetate and Irganox 1010 further improved chemical stability. Notably, TPGS@Ret-ES simultaneously enhanced transdermal drug permeation and skin retention, with no significant irritation observed following repeated application to the same skin site in guinea pigs. In conclusion, ES represents a highly promising topical delivery carrier, and TPGS@Ret-ES shows considerable potential as a novel formulation for retinol. Riboflavin (vitamin B2) is a water-soluble, heat-stable vitamin essential for cellular energy metabolism, acting as a precursor to the coenzymes flavin mononucleotide (FMN) and flavin adenine dinucleotide (FAD). These cofactors are required by flavoproteins such as succinate dehydrogenase (Complex II), which participate in both the citric acid cycle and the mitochondrial electron transport chain, enabling adenosine triphosphate (ATP) production, maintaining redox balance, and supporting antioxidant defenses. Beyond energy metabolism, riboflavin contributes to immune function and to maintaining the health of skin, hair, and mucous membranes. Deficiency disrupts these pathways, leading to fatigue, normocytic anemia, neuromuscular symptoms, and secondary impairments in iron and other B-vitamin metabolism, including the activation of niacin (vitamin B3) and pyridoxine (vitamin B6). Because humans cannot synthesize riboflavin, adequate dietary intake is necessary, and absorption depends on normal gastrointestinal function. Excess riboflavin is excreted in urine, producing the characteristic yellow color that indicates adequate intake. Clinical deficiency is characterized by mucocutaneous manifestations (cheilosis, angular stomatitis, glossitis, dermatitis) and anemia; in severe or prolonged cases, it may lead to neurologic or ocular metabolic abnormalities, reduced physical performance, and developmental problems. Emerging evidence also links riboflavin deficiency to psoriasis, with decreased intake associated with a higher risk and upregulated riboflavin metabolism observed in psoriatic skin, suggesting a protective role for adequate riboflavin status, particularly in individuals older than 40 years. This article reviews the etiology, epidemiology, pathophysiology, clinical presentation, evaluation, management, complications, and prognosis of riboflavin deficiency. The article also highlights the roles of patient education and interprofessional healthcare team collaboration in optimizing patient outcomes.
Nanostructured Lipid Carrier Based Gel Containing α-Tocopherol and α-Tocopheryl Acetate for Synergistic Cutaneous Antiaging Efficacy [PMID: 41309687 · 2025]
Nanostructured lipid carrier represents a cutting edge drug delivery platform, offering enhanced encapsulation of lipophilic agents, high drug loading, controlled release and superior skin hydration effects due to occlusive properties. This study aimed to develop gel based NLC formulations by co-encapsulation of α-Tocopherol and α-Tocopheryl acetate (TTA) for enhanced anti-aging performance. Six formulations (TTA1-TTA6) were prepared using varying concentrations of solid and liquid lipids (lauric acid and oleic acid) and surfactant (Tween 80) with one placebo formulation (TTA0). NLC formulations were fabricated via hot melt encapsulation method and optimized based on particle size, polydispersity index and entrapment efficiency. The best optimised formulation underwent detailed characterization, including Dynamic Light Scattering, Fourier Transform Infrared Spectroscopy, X-ray Diffraction, Differential Scanning Calorimetry, and Thermo Gravimetric Analysis. All formulations showed high encapsulation efficiency (66-93%), particle sizes ranging 68-290 nm, spherical morphology, and thermal stability. A two phase release profile was seen including burst and then sustained release. Comparative in vitro and ex vivo evaluations of gels confirmed superior skin retention and minimal transdermal permeation. In vivo testing on human volunteers revealed significantly enhanced moisture retention (up to 68%) and improved skin elasticity for gel based NLC formulations (TTA2G) as compared to solution gel (TTAsolG). These results confirm the synergistic potential of co-encapsulation of TTA in nanostructured lipid carriers to improve topical delivery and anti-aging outcomes.
Effects of a Moisturizer Containing Colloidal Oatmeal and Filaggrin Technology on Staphylococcus Species In Vitro [PMID: 40196947 · 2025]
The pathophysiology of atopic dermatitis (AD) is multifactorial, with genetic predisposition, environmental exposures, and dysbiosis of the skin microbiome all associated with disease activity. Colonization by Staphylococcus aureus (S. aureus) is specifically associated with AD, and modifying the skin microbiota through topical skincare products may play a role in AD management. A moisturizer containing colloidal oatmeal, a patented filaggrin technology, niacinamide, and tocopheryl acetate was assessed for its impact on the growth, biofilm formation, and bacterial mix adhesion of S. aureus and/or S. epidermidis on reconstructed human epidermis (RHE). Compared to control conditions, the bacterial growth and adhesion of S. aureus were decreased compared to S. epidermidis in the presence of the moisturizer. Additionally, the moisturizer did not significantly induce nor inhibit the formation of S. aureus biofilm relative to control. Overall, the moisturizer improved the growth ratio of Staphylococcus species, shifting the predominant species from pathogenic S. aureus to commensal S. epidermidis, which may be clinically beneficial in the management of AD. J Drugs Dermatol. 2025;24(4):416-418. doi:10.36849/JDD.8706&nbsp.
Unraveling the Impact of the Oil Phase on the Physicochemical Stability and Skin Permeability of Melatonin Gel Formulations [PMID: 39330197 · 2024]
Melatonin's antioxidant properties make it a valuable component in anti-aging semisolid topical products. This study explores the role of Pemulen ® , an acrylic-based viscosifying agent, in stabilizing cream-gel formulations. Remarkably, even at low concentrations (0.4%), Pemulen ® successfully produced physicochemical stable topical formulations. In this work, the impact of the ratio of the oily phase-comprising olive oil and isopropyl myristate from 0 to 20%-was investigated to understand the internal microstructure effect on skin permeability, rheological properties, and stability. The formulations exhibited pseudoplastic behavior, with a significant positive correlation ( p -value < 0.1) between the oily phase ratio, viscosity, spreadability, skin adhesiveness, and permeability. Formulations without the oil phase exhibited greater skin permeability. However, higher oily phase content enhanced viscosity, spreadability, and skin adhesion. Given that melatonin primarily degrades through oxidation, incorporating antioxidant excipients in semisolid formulations is crucial for maintaining its chemical stability. A quality by design (QbD) approach was used to assess the impact of four excipients-(a) DL-α-tocopheryl acetate (0.05%), (b) ascorbic acid (0.1%), (c) ethylene diamine tetraacetic acid (0.1%), and (d) sodium metabisulphite (0.5%)-on melatonin's stability. Our findings indicate that maintaining the physical stability of the formulation with a 20% oil phase is more critical for protecting melatonin from oxidation than merely adding antioxidant excipients.
Topical treatment of anal condylomata with Propionibacterium acnes lysate: results of a multicentric observational study [PMID: 37539504 · 2023]
Condylomata are a manifestation of HPV infection of the ano-genital epithelium. Recurrence is frequent after any type of treatment (from 20% up to 50%). We assessed the use of a gel containing panthenol, tocopheryl acetate and Propionibacterium extract in the treatment of anal warts. Enrollment period was from January 15 to June 15, 2018. Main exclusion criteria were immunodepression, extensive condylomatosis and other treatments (topical/ablative) in the previous six months. Seventy-nine patients were included. Median age was 33 years (19-65), 72.2% were males. Median number of partners and symptoms duration were 6 (1-98) and 3 months (1-18), respectively. Almost all cases had perianal disease (97.5%), while endoanal warts were present in 51.9% of cases. After 30 days of treatment, complete regression occurred in 17 (21.5%) patients, while partial or absent response was reported in 36 (45.6%) and 26 (32.9%) cases, respectively. Forty-seven (59.5%) patients underwent a second month of topical therapy. After a 6-month follow-up, complete or partial response was reported in 53 (67.1%) patients, while in 26 (32.9%) cases the disease remained stable or even worsened. Nineteen (24.1%) patients required cryotherapy, 23 (29.1%) surgical excision, while 2 (2.5%) needed both cryotherapy and surgery. Absence of clinical response was associated with a number of partners ≥10 and symptoms duration of 6 months or shorter (P<0.001 and P=0.050). In our study, the gel containing P. acnes lysate was a safe topical treatment for perianal and endoanal condylomata and could help to overcome HPV infection. A high number of partners and short symptoms duration appeared to worsen the outcome.
Safety assessment on comedogenicity of dermatological products containing d-alpha tocopheryl acetate in Asian subjects: A double-blind randomized controlled trial [PMID: 34471722 · 2021]
A double-blind randomized controlled trial was used to assess the comedogenic potential of the dermatological products containing d-Alpha tocopheryl acetate. A total of 15 healthy males (20-45 years old) with prominent follicular orifices and the ability to form comedones on the upper aspect of the back were enrolled. Each participant was given pads containing 4 test products. The positive control arm received a pad containing octyl palmitate which is a reported comedogenic material. The negative control arm received a pad without any test material. Participants were randomized to apply either the positive, negative or the active test cream to the application area for 4 weeks. Comedones were identified using epidermal biopsy under a stereomicroscope. The average number of microcomedone before exposure (baseline) with octyl palmitate was 6.1 ± 0.6 (mean ± SEM), and changed to 27.3 ± 4.7 which was more than 50% increase in comedone formation in every subject with the average change from base line was 365.4 ± 87.6%. In the negative control arm the average number of microcomedone at baseline was 6.4 ± 1.1 and at 4 week-application was 3.4 ± 0.6 (-43.0 ± 9.5% increased). All tested products produced less than a 50% increase in the number of microcomedones. Analyzed data from 12 subjects indicated non-comedogenic potential of the tested products containing-alpha tocopheryl acetate and other ingredients including lanolin, kernel oil and avocado oil and sunflower oil, etc. The octyl palmitate produced more than 50% increase in comedone formation in every analyzed subject.
Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse [PMID: 24004959 · 2013]
Tocopheryl acetate is viscous oily fluid used in a range of preparations for skin and scalp care in Italy. Observational and in vitro data have suggested a high level of efficacy against head louse infestation. The purpose of this investigation was to confirm the activity of tocopheryl acetate in a clinical setting in comparison with a standard widely used preparation. A spray formulation containing tocopheryl acetate 20% in cyclomethicone was compared with permethrin 1% creme rinse for treatment of head louse infestation in a randomised, assessor blind, trial. Forty-five people were treated on two occasions 7 days apart. The spray was applied to dry hair for 20 minutes then washed. Participants treated with permethrin washed their hair and towel dried it before treatment for 10 minutes. Assessments were made by dry detection combing 1, 6, 9, and 14 days after first treatment. The tocopheryl acetate 20% spray was significantly (p = 0.033) more effective than permethrin 1%, using intention to treat worst case analysis, in which there were 13/23 (56.5%) successful treatments for tocopheryl acetate compared with 5/22 (22.7%) for permethrin. After unprecedented issues of re-infestation within households had been taken into account the underlying cure rate was 17/23 (73.9%) for tocopheryl acetate compared with 5/22 (22.7%), Odds Ratio 9.63 (95% CI, 2.46 to 37.68) (p < 0.001). The tocopheryl acetate spray was significantly more effective than the permethrin product, was cosmetically acceptable, and not affected by current problems with resistance. Current Controlled Trials ISRCTN45553737.
Isomers of alpha-tocopheryl acetate and their biological activity [PMID: 4996747 · 1971]
Isomers of alpha-tocopheryl acetate and their biological activity [PMID: 4999545 · 1971]
Effect of long- or short-term feeding of alpha-tocopheryl acetate to Holstein and crossbred beef steers on performance, carcass characteristics, and beef color stability [PMID: 1429281 · 1992]
Three experiments were conducted to examine the effects of vitamin E supplementation on feedlot cattle. Vitamin E supplementation did not affect feedlot performance or carcass characteristics of cattle fed a high-concentrate diet (P greater than .1). The major finding was the effectiveness of vitamin E in extending the color stability of displayed beef (P less than .01). Color stability during display of longissimus lumborum steaks from cattle supplemented with 300 IU/d for 266 d, 1,140 IU/d for 67 d, or 1,200 IU/d for 38 d was extended by 2.5 to 4.8 d. Gluteus medius steaks had an extended color display life of 1.6 to 3.8 d. The accumulation of lipid oxidation products, but not aerobic microbes, associated with displayed longissimus lumborum was suppressed for muscle from vitamin E-supplemented steers. Taste panelists detected no difference among longissimus lumborum steaks from control and vitamin E-supplemented steers but found (P less than .01) steaks aged for 21 d to be more tender than steaks aged for 7 d. Supplementing cattle with vitamin E should reduce economic losses associated with discolored beef during retail display.
Efficacy of a topical polyphenol-based formulation in palmoplantar psoriasis: an observational study [PMID: 40631809 · 2026]
This single-arm observational study evaluated the efficacy and safety of a novel topical formulation containing a complex mixture of polyphenols (CMP) - a proprietary blend rich in oleocanthal and oleuropein aglycone (each >60%), along with hydroxytyrosol and other extra virgin olive oil (EVOO)-derived polyphenols - combined with triticum vulgare germ (TVG) oil, betaine, propanediol, and tocopheryl acetate in patients with mild palmoplantar psoriasis (PPP). Twenty participants (aged 20-55) applied the formulation twice daily for 8 days, with assessments conducted on days 0 (baseline), 5, and 8. Participants underwent a 60-day follow-up to assess the durability of benefits and potential late-onset adverse events. Clinical evaluations measured lesion extent, keratinization, inflammation, desquamation, and infiltration. A patient-reported questionnaire evaluated quality of life (QoL) and symptom burden. By day 8, the mean lesion extent had decreased by approximately 40%, inflammation had improved by about 50%, and desquamation had resolved fully in most cases. Patient-reported outcomes improved alongside clinical measures. At day 60, these improvements persisted in 85% of participants, and no adverse events emerged. The formulation's mechanism of action is hypothesized to involve the concerted antioxidant and anti-inflammatory activities of polyphenols (oleocanthal, oleuropein aglycone, and hydroxytyrosol) in synergy with TVG oil's supportive lipid matrix and other excipients. These findings suggest that EVOO-derived polyphenols formulated in TVG oil may serve as a valuable adjunct for managing PPP with good tolerability and sustained benefits.
Topical Nanoemulsion Hydrogel Formulated from Supercritical Fluid Extracted Palm-Pressed Fiber Oil and Virgin Coconut Oil with Antioxidant and Antibacterial Effects [PMID: 38556283 · 2024]
Skincare industries are growing rapidly around the globe but most products are formulated using synthetic chemicals and organic solvent extracted plant extracts, thus may be hazardous to the users and incur higher cost for purification that eventually leads to phytonutrient degradation. Therefore, this study aimed to formulate a stable natural formulation with antioxidant and antimicrobial activities by using supercritical carbon dioxide (SC-CO 2 ) extracted palm-pressed fiber oil (PPFO) as an active ingredient with virgin coconut oil (VCO) as a formulation base. PPFO was extracted from fresh palm-pressed fiber (PPF) while VCO was from dried grated coconut copra using SC-CO 2 before being subjected to the analyses of physicochemical properties, phytonutrient content and biological activities including antioxidant and antimicrobial. The nanoemulgel formulations were then developed and examined for their stability through accelerated stability study for 3 months by measuring their pH, particle size, polydispersity index and zeta potential. The results showed that PPFO contained a high amount of phytonutrients, especially total carotenoid (1497 ppm) and total tocopherol and tocotrienol (2269 ppm) contents. The newly developed nanoemulgels maintained their particles in nano size and showed good stability with high negative zeta potentials. Sample nanoemulgel formulated with 3% PPFO diluted in VCO as effective concentration showed significantly stronger antioxidant activity than the control which was formulated from 3% tocopheryl acetate diluted in mineral oil, towards DPPH and ABTS radicals, with IC 50 values of 67.41 and 44.28 µL/mL, respectively. For the antibacterial activities, the sample nanoemulgel was found to inhibit Gram positive bacteria S. aureus and S. epidermidis growth but not the Gram negative strain E. coli. Overall, this study revealed the potential of SF-extracted PPFO as an active ingredient in the antioxidant topical formulations thus future study on in vitro skin cell models is highly recommended for validation.
Failure of head lice treatment with tocopheryl acetate spray: results of a sponsor-free clinical study [PMID: 37153953 · 2023]
Darier disease successfully treated with a topical agent containing vitamin A (retinyl palmitate), vitamin E, and urea [PMID: 35437850 · 2022]
Darier disease (DD), also called keratosis follicularis, is an autosomal dominant hereditary keratinization disorder that manifests as keratotic papules with plaques in seborrheic areas. There are no validated curative treatments for DD, with the majority of cases treated symptomatically. We report the efficacy of a topical over-the-counter agent which contains retinyl palmitate, vitamin E, and urea for a patient with DD. A 13-year-old girl had brown papules on her scalp, neck, shoulders, and axillae since entering elementary school. A skin biopsy revealed hyperkeratosis, suprabasal acantholysis, and dyskeratosis manifested as corps ronds and grains in the epidermis. Sanger sequencing found the previously reported heterozygous mutation c.1484C>T in ATP2A2. The application of an over-the-counter topical agent containing retinyl palmitate 2750 μg/g (5000 IU/g), tocopheryl acetate 20 mg/g, urea 200 mg/g, and monoammonium glycyrrhizinate 5 mg/g twice daily for 2 months improved the papules without serious adverse events. Oral or topical aromatic vitamin A analogs (retinoids) are often used to treat DD. However, several adverse events are associated with retinoid treatment, and many patients only undergo their intermittent use or discontinue the treatments. Retinyl palmitate is more stable and has a lower irritative profile than other retinoic acids. When applied topically, however, retinyl palmitate cannot penetrate the skin as well as retinol can. Some reports have noted that vitamin E increases the biological availability of vitamin A and that urea helps mechanical percutaneous drug delivery. Our case suggests that retinyl palmitate has a sufficient therapeutic effect when combined with vitamin E and urea. In conclusion, we propose that topical agents containing retinyl palmitate, vitamin E, and urea might have a satisfactory effect on the skin lesions of DD patients, without the serious risks of adverse events.
Assessment of a feed additive consisting of all-rac-alpha-tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (Jilin Beisha Pharmaceutical Co., Ltd) [PMID: 34900006 · 2021]
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all-rac-alpha-tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all-rac-alpha-tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all-rac-alpha-tocopheryl acetate in the context of the renewal of the authorisation.
A Clinical Study on the Efficacy and Tolerability of a New Topical Gel and Toothpaste in Patients with Xerostomia: A Randomized Controlled Trial [PMID: 34884343 · 2021]
xerostomia is a very common problem in the general population. The objective of this study was to determine the efficacy of a new gel and toothpaste in patients with xerostomia, analyze the role of salivary cytokines as biomarkers of xerostomia and assess the possible changes in salivary cytokines following treatment. A randomized, controlled double-blind clinical study was carried out in 73 patients with xerostomia divided into two groups: placebo and active treatment (cymenol; tocopheryl acetate; D-panthenol; Aloe barbadensis; citrate tribasic dihydrate; fluoride) with oral gel and toothpaste three times a day for four consecutive weeks. The Thomson Xerostomia Inventory was applied, with the assessment of oral quality of life (OHIP-14) at baseline and after four weeks of application of the product. Sialometry was also performed in both groups, with analysis of the IL-1b, IL-6, IL-8 and TNFa levels in saliva. In the active treatment group, the xerostomia scores decreased significantly at the end of the study versus baseline, from 33.47 to 27.93 ( p < 0.001). No significant decrease was recorded in the placebo group (34.5 to 32.75; p = 0.190). There were no adverse effects in either group. Regarding the saliva samples, the active treatment group showed significant differences in IL-6 concentration versus the control group (18.55 pg/mL (8-38.28) and 5.83 pg/mL (1.19-12.04), respectively; p = 0.002). No significant differences in salivary cytokines were observed in either the treatment group or the control group. The use of a new toothpaste and gel developed for patients with xerostomia proved effective, with greater symptom relief than in the placebo group. Further clinical studies involving longer time periods and larger samples are advisable in order to confirm the benefits of the described treatment.
자주 묻는 질문 (AEO 스니펫 최적화 FAQ)
- Q1. 토코페릴아세테이트 (TOCOPHERYL ACETATE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
- 한국 식약처 표준명은 '토코페릴아세테이트', 미국 PCPC 및 유럽 CosIng INCI 표기는 'TOCOPHERYL ACETATE', 중국 NMPA IECIC 표준명은 '生育酚乙酸酯', 일본 화장품 표시명칭은 '酢酸トコフェロール'입니다.
- Q2. 토코페릴아세테이트의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
- 한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: restricted), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
- Q3. 제형 설계 시 토코페릴아세테이트의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
- 대표 제형군(anhydrous_balm) 기준 통상 0.1~1%(권장 중앙값 0.5%) 범위로 투입하며, 적정 pH는 4~8입니다.
- Q4. 토코페릴아세테이트 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.