TOCOPHERYL ACETATE
化粧品における 酢酸トコフェロール (TOCOPHERYL ACETATE) のグローバル配合基準と処方特性とは?
酢酸トコフェロール(標準 INCI: TOCOPHERYL ACETATE、CAS番号: 7695-91-2)は、化粧品処方において主に抗酸化剤, 皮膚コンディショニング剤として配合される原料です。日本厚労省/JCIA(配合制限)、韓国MFDS(規制なし)、欧州CosIng(規制なし)など6大法域の法定基準下で管理され、通常 0.1–1%(適正安定域 pH 4–8)で処方されます。
7大トラック 国別・用途別 公式全成分表示名称マトリクス
各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ| 法域・規制トラック | 公式全成分表示名称 | ワンクリックコピー |
|---|---|---|
| ① 韓国 (MFDS 化粧品標準名称) | TOCOPHERYL ACETATE (KR MFDS Registered) | |
| ② 韓国旧名称履歴 (301 リダイレクト) | — | — |
| ③ 欧州連合 (EU CosIng EC 1223/2009) | TOCOPHERYL ACETATE | |
| ④ 米国一般化粧品 (US PCPC / MoCRA INCI) | TOCOPHERYL ACETATE | |
| ⑤ 米国 FDA OTC モノグラフ有効成分名 | — (米国 OTC 対象外 / 一般化粧品原料) | — |
| ⑥ 中国 (NMPA IECIC 標準中国語名称) | 生育酚乙酸酯 | |
| ⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (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 — 6大法域 法定配合上限および規制ステータス
| 法域 | 規制ステータス | 配合上限 | 制限条件および一次法源出典 |
|---|---|---|---|
| 韓国 (MFDS) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 欧州 (EU) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 米国 (FDA) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 中国 (NMPA) | 配合可能 | GMP | IECIC Entry #6043 |
| 日本 (MHLW) | 配合制限 | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| ASEAN (ACD) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)
「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。
| 安全性評価基準 | 適用範囲・用途 | 安全濃度範囲 | 判定結果および文献参照 |
|---|---|---|---|
| 中国 IECIC 最高歴史使用量 | leave_on | ≤ 36% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 05895 (2025) |
| 中国 IECIC 最高歴史使用量 | rinse_off | ≤ 5% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 05895 (2025) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剤形別通常配合濃度 (四分位数 n≥5) & 物理化学・相溶性ガイド
| 剤形グループ | Min – Q1 – Median – Q3 – Max (%) | 処方役割・作用機序 | Source ID |
|---|---|---|---|
| 剤形群 E — 無水オイル・バーム・リップケア | 0.1% · 0.4375% · 0.5% · 0.625% · 1% | Anhydrous balm, oil & stick structural emollient | Global Starter Formulation Library Statistical Distribution (n=8, EVONIK 4 · GRANT 4) |
| 剤形群 A — 水성化粧水・美容液・アンプル | 0.1% · 0.1% · 0.2% · 0.225% · 1% | Aqueous serum, toner & hydrogel matrix formulation component | Global Starter Formulation Library Statistical Distribution (n=15, GRANT 13 · SEPPIC 2) |
| 剤形群 C — 洗い流し用クレンザー・シャンプー | 0.1% · 0.2% · 0.2% · 0.2% · 0.35% | Rinse-off cleanser & surfactant system modifier | Global Starter Formulation Library Statistical Distribution (n=9, GRANT 5 · EVONIK 3 · SEPPIC 1) |
| 剤形群 B — 乳液・エマルジョン・クリーム | 0.1% · 0.2% · 0.275% · 0.5% · 1% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=46, EVONIK 23 · GRANT 21 · SEPPIC 2) |
| 剤形群 D — 日焼け止め (UV)・メイクアップ・ファンデーション | 0.1% · 0.1% · 0.2% · 0.5% · 1% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=29, GRANT 20 · EVONIK 7 · SEPPIC 2) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 4–8, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 50°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名は研究者がグレードを識別するための参考表記であり、各商標権は原メーカーに帰属します。
学術・毒性・処方統合モノグラフ
Tier 1 Synthesis本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。
関連査読付き学術論文 (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.
よくある質問 (FAQ)
- Q1. 酢酸トコフェロール (TOCOPHERYL ACETATE) の各国公式全成分表示名称(7トラック)はどのように異なりますか?
- 日本化粧品工業連合会(JCIA)表示名称は '酢酸トコフェロール'、米国PCPC・欧州CosIng INCIは 'TOCOPHERYL ACETATE'、中国NMPA IECIC標準中国語名は '生育酚乙酸酯' です。
- Q2. 酢酸トコフェロール (TOCOPHERYL ACETATE) のグローバル6大法域における法定配合基準 (Layer 1) は?
- 6大法域規制ステータス — 日本(JP): restricted、韓国(KR): none、欧州(EU): none、米国(US): none、中国(CN): allowed、ASEAN: none。
- Q3. 処方設計における 酢酸トコフェロール (TOCOPHERYL ACETATE) の通常配合濃度 (Layer 3) と適正 pH は?
- 主要剤形 (anhydrous_balm) において通常 0.1〜1%(中央値 0.5%)で配合され、適正pH範囲は 4〜8 です。
- Q4. 酢酸トコフェロール (TOCOPHERYL ACETATE) の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
- 推奨シナジーペアは GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL、配合上の注意点は Verify phase compatibility under extreme pH or high electrolyte loads です。