原料辞典検索/1-2-hexanediol/1,2-HEXANEDIOL
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
合成 (Synthetic)

1,2-HEXANEDIOL

日本化粧品工業連合会 (JCIA) 表示名称: 1,2-ヘキサンジオール
皮膚コンディショニング剤溶剤・溶媒
結論先行 エグゼクティブ規制・安全性ファクトボックスAEO / GEO CITATION ANCHOR

化粧品における 1,2-ヘキサンジオール (1,2-HEXANEDIOL) のグローバル配合基準と処方特性とは?

1,2-ヘキサンジオール(標準 INCI: 1,2-HEXANEDIOL、CAS番号: 6920-22-5)は、化粧品処方において主に皮膚コンディショニング剤, 溶剤・溶媒として配合される原料です。日本厚労省/JCIA(規制なし)、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 0.5–3%(適正安定域 pH 3–10)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
7-Track Official Statutory Label Names for 1,2-HEXANEDIOL
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)1,2-HEXANEDIOL (KR MFDS Registered)
② 韓国旧名称履歴 (301 リダイレクト)Former KR Nomenclature Redirect Active—
③ 欧州連合 (EU CosIng EC 1223/2009)1,2-HEXANEDIOL
④ 米国一般化粧品 (US PCPC / MoCRA INCI)1,2-HEXANEDIOL
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)1,2-己二醇
⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW)1,2-ヘキサンジオール · [QD: 1,2-ヘキサンジオール]

Layer 1 — 6大法域 法定配合上限および規制ステータス

Layer 1 Statutory Regulatory Limits Across 6 Regions for 1,2-HEXANEDIOL
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GMPIECIC Entry #4
日本 (MHLW)規制なし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。

Layer 2 Toxicological & Historical Safe Use Concentrations for 1,2-HEXANEDIOL
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
米国 CIR 市販製品最大報告濃度total0.00005~10%安全判定 (MoS≥100)116_tent_capryl.pdf ()
米国 CIR 市販製品最大報告濃度bath0.0004~0.2%安全判定 (MoS≥100)116_tent_capryl.pdf ()
米国 CIR 市販製品最大報告濃度eye0.3~0.7%安全判定 (MoS≥100)116_tent_capryl.pdf ()
米国 CIR 市販製品最大報告濃度dermal0.00005~10%安全判定 (MoS≥100)116_tent_capryl.pdf ()
米国 CIR 市販製品最大報告濃度hair0.0003~0.3%安全判定 (MoS≥100)116_tent_capryl.pdf ()
米国 CIR 市販製品最大報告濃度leave_on0.2~10%安全判定 (MoS≥100)117_draft_cg.pdf ()
米国 CIR 市販製品最大報告濃度ingestion0.3~0.3%安全判定 (MoS≥100)119_final_12glc.pdf ()
米国 CIR 市販製品最大報告濃度spray10~10%安全判定 (MoS≥100)119_final_12glc.pdf ()
米国 CIR 市販製品最大報告濃度nail0.4~0.4%安全判定 (MoS≥100)119_final_12glc.pdf ()
米国 CIR 市販製品最大報告濃度mucous0.3~0.3%安全判定 (MoS≥100)119_final_12glc.pdf ()
米国 CIR 市販製品最大報告濃度rinse_off0.00005~0.8%安全判定 (MoS≥100)119_final_12glc.pdf ()
中国 IECIC 最高歴史使用量leave_on≤ 15%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00004 (2025)
中国 IECIC 最高歴史使用量rinse_off≤ 10%安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00004 (2025)
⚠️ 参考用案内 (免責事項): 本辞典の成分名・規制上限・処方ガイドは研究開発の参考用です。法改正の時差やデータの誤記・漏れがあり得るため、実際の処方・ラベル表示・届出前には必ず管轄当局の最新告示原文をご確認ください。本情報の利用により生じた問題について運営主体は法的責任を負いません。
Interactive Quartile Box-Plot (Min–Q1–Median–Q3–Max)

Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit

Aqueous Serum / Ampoulen=148
Min 0.5% · Q1 1.5% · Median 2% · Q3 2.2% · Max 3%
Emulsion / Creamn=186
Min 0.5% · Q1 1.2% · Median 1.8% · Q3 2% · Max 2.5%
Aqueous Serum / Ampoule — pH-independent antimicrobial humectant & solvent booster
Verified Source: CIR Alkane Diols Safety Assessment & CN IECIC (cir_safety) · Symrise 52 · Evonik 48 · SEPPIC 48
Typical Median: 2%

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

Layer 3 Formulation Concentration Quartiles by Product Category for 1,2-HEXANEDIOL
剤形グループMin – Q1 – Median – Q3 – Max (%)処方役割・作用機序Source ID
剤形群 A — 水성化粧水・美容液・アンプル0.5% · 1.5% · 2% · 2.2% · 3%pH-independent antimicrobial humectant & solvent boosterCIR Alkane Diols Safety Assessment & CN IECIC
剤形群 B — 乳液・エマルジョン・クリーム0.5% · 1.2% · 1.8% · 2% · 2.5%Preservative-free system main diol boosterCIR 1,2-Hexanediol Assessment
Cutaneous Permeation Science (500 Dalton Rule)MW: 118.17 Da · LogP: 0.6

Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery

Stratum Corneum (Brick & Mortar Barrier · 10–20 µm)500 Da Molecular Weight Cutoff BarrierViable Epidermis (Keratinocytes & Melanocytes · 50–100 µm)Target for Brightening (Tyrosinase/Melanosome) & Barrier LipidsPapillary Dermis (Fibroblasts & ECM Collagen · 150–300 µm)Target for Collagen I/III Synthesis, Peptides, PDRN & ExosomesEpidermal Passive Permeation (<500 Da)
Molecular Weight & LogP Permeation Diagnosis
Low Molecular Weight (118.17 Da ≤ 500 Da) — Passive Permeation Feasible

Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.

Estimated Target Depth
40–90 µm
Optimal Delivery System
Polyol Enhancer / Serum
Colloid Interface, pH Spectrum & Thermal Stability

pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior

Miscible with water, glycols, alcohols
Optimal Formulation pH Stability Window (0–14)pH 3.0 – 10.0
0245.5791114

Outside pH 3–10, risk of hydrolysis, viscosity loss, or ionic dissociation increases.

Maximum Thermal Processing Limit (°C)≤ 80°C
25°C45°C60°C75°C85°C100°C

Thermally stable up to 80°C during standard emulsification.

HLB Scale (0–20) & Colloidal Micelle / Lamellar Phase Simulator
O/W Oil-in-Water Micelle Emulsion (Lotion / Cream)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
Biochemical Signaling & Mechanism Pathway

Cellular & Molecular Target Mechanism Flow

1. Epidermal Interaction→ Upregulation / Activation
Intercellular Lipid & Hydration Matrix
→
TEWL Reduction & Barrier Conditioning
2. Homeostasis Modulation⊣ Inhibition / Blockade
Oxidative Stress (ROS) & Irritant Cascade
⊣
Cutaneous Soothing & Homeostasis
Formulation Ontology Radial Graph

Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)

+ ETHYLHEXYLGLYCERIN+ HYDROXYACETOPHENONE+ PENTYLENE GLYCOL+ CAPRYLYL GLYCOL✕ Concentrations > 2.2…1,2-HEXANEDIOL
Interactive Node Guide

Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.

代表商品名参考 (商標法第90条第1項第2号 記述的表示)
SymDiol® 68 (with Caprylyl Glycol)Hydrolite® 6

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。

■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: 1,2-HEXANEDIOL | CAS No.: 6920-22-5 | EC No.: 230-029-6 - Origin: SYNTHETIC | Functions: Skin Conditioning, - Physicochemical Profile: Formula C6H14O2 | MW 118.17 g/mol | LogP 0.6 | Ionic Nature: non-ionic | PubChem CID 13583 - Official Regional Label Names: US [1,2-HEXANEDIOL] · EU [1,2-HEXANEDIOL] · CN [1,2-己二醇] · JP [1,2-ヘキサンジオール] · JP Quasi-Drug [1,2-ヘキサンジオール] ■ [2. Dermatological Mechanism of Action & Functional Role] - 1,2-HEXANEDIOL functions primarily as , in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , performance and structural formulation stability. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 4 (1,2-己二醇)) - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment). - Official Safety & Historical Use Concentration (Layer 2): cir (reported_use, total): 5e-05~10% / cir (reported_use, bath): 0.0004~0.2% / cir (reported_use, eye): 0.3~0.7% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.5 ~ 3.0% (Median 2.0%, Ref: CIR Alkane Diols Safety Assessment & CN IECIC) — pH-independent antimicrobial humectant & solvent booster - [emulsion_cream] Typical range: 0.5 ~ 2.5% (Median 1.8%, Ref: CIR 1,2-Hexanediol Assessment) — Preservative-free system main diol booster ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase or Cool-down Phase (< 80°C) - Optimal pH Range: pH 3.0 ~ 10.0 | Max Process Temp: Max 80°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: Concentrations > 2.2% may reduce emulsion viscosity due to interfacial partitioning; pair with 0.05% Ethylhexylglycerin - Synergy Pairings: ETHYLHEXYLGLYCERIN, HYDROXYACETOPHENONE, PENTYLENE GLYCOL, CAPRYLYL GLYCOL | Reference Trade Names: SymDiol® 68 (with Caprylyl Glycol), Hydrolite® 6 ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 39805611 (2024, J Microorg Control): Synergistic/antagonistic antimicrobial effects of cosmetic ingredients in combination with 1,2-hexanediol - PMID 39248485 (2024, J Vis Exp): Microwave-Assisted Extraction of Phenolic Compounds and Antioxidants for Cosmetic Applications Using Polyol-Based Techno - PMID 39203006 (2024, Molecules): New Natural and Sustainable Cosmetic Preservative Based on Sugarcane Straw Extract

関連査読付き学術論文 (NIH PubMed) (12)

Synergistic/antagonistic antimicrobial effects of cosmetic ingredients in combination with 1,2-hexanediol [PMID: 39805611 · 2024]
Gim H, Hong S, Park H, Im S, Kim JI · J Microorg Control (2024)

With the rise of the clean beauty trend in the cosmetics and personal care industry, consumers' interest in cosmetic ingredients, especially preservatives, continues to grow. Paraben, previously the most used preservative in cosmetics, has been excluded from many products owing to its potential risks. Therefore, a movement to lower the content of various preservatives is ongoing. One approach to achieve a suitable level of preservation is to use multifunctional ingredients as preservative boosters. In this study, we aimed to confirm the synergistic antimicrobial interactions between various cosmetic ingredients and 1,2-hexanediol, a preservative introduced as a substitute for paraben, using the checkerboard assay. We also measured the antagonistic effect by measuring the fold changes in the minimum inhibitory concentration of 1,2-hexanediol. Niacinamide, a form of vitamin B3, showed synergistic antifungal activity with 1,2-hexanediol, which lowered the content of 1,2-hexanediol in the oil-solubilized toner formulation. Among the substances, 50000 ppm of methyl methacrylate crosspolymer elevated the minimum inhibitory concentration of 1,2-hexanediol against bacteria and fungi by 2&#x2012;8 times. Through this study, we suggest applying the synergistic effects of various cosmetic ingredients in the formulation as a method to effectively reduce the content of preservatives.

Microwave-Assisted Extraction of Phenolic Compounds and Antioxidants for Cosmetic Applications Using Polyol-Based Technology [PMID: 39248485 · 2024]
Myat Win S, Saelee M, Myo H, Khat-Udomkiri N · J Vis Exp (2024)

The utilization of polyols as green solvents for extracting bioactive compounds from plant materials has gained attention due to their safety and inert behavior with plant bioactive chemicals. This study explores the sustainable extraction of phenolic compounds and natural antioxidants from coffee silverskin using the microwave-assisted extraction (MAE) method with polyol-based solvents: glycerin, propylene glycol (PG), butylene glycol (BG), methylpropanediol (MPD), isopentyldiol (IPD), pentylene glycol, 1,2-hexanediol, and hexylene glycol (HG). A comparative analysis was conducted on conventional and non-conventional solvent extractions, focusing on their impact on the bioactive compounds of MAE, encompassing parameters such as total phenolic content (TPC), total flavonoid content (TFC), and antioxidant activities like the 1,1-diphenyl-2-picrylhydrazyl radical scavenging assay (DPPH), the 2,2'-azino-bis(-3-ethylbenzothiazoline-6-sulphonic acid) radical scavenging assay (ABTS), and the ferric reducing antioxidant power assay (FRAP). The highest values were observed for TPC with aqueous-1,2-hexanediol extraction (52.0 &#xb1; 3.0 mg GAE/g sample), TFC with aqueous-1,2-hexanediol extraction (20.0 &#xb1; 1.7 mg QE/g sample), DPPH with aqueous-HG&#xa0;extraction (13.6 &#xb1; 0.3 mg TE/g sample), ABTS with aqueous-pentylene glycol extraction (8.2 &#xb1; 0.1 mg TE/g sample), and FRAP with aqueous-HG extraction (21.1 &#xb1; 1.3 mg Fe (II) E/g sample). This research aims to advance eco-friendly extraction technology through natural plant components, promoting sustainability by minimizing hazardous chemical use while reducing time and energy consumption, with potential applications in cosmetics.

New Natural and Sustainable Cosmetic Preservative Based on Sugarcane Straw Extract [PMID: 39203006 · 2024]
Carvalho MJ, Pedrosa SS, Pintado M, Oliveira ALS, Madureira AR · Molecules (2024)

Preservative ingredients in cosmetic formulations undertake a necessary role in the prevention of microbial contamination. In this field, there is an unmet need for natural, sustainable, and effective preservatives. Thus, the main goal of this work was to evaluate a sugarcane straw extract-based ingredient and investigate its potential as a preservative for cosmetic applications. Different ingredients were developed using several cosmetic solvents to improve the solubility of the extracted compounds. The antimicrobial activity was assessed against Staphylococcus aureus , Escherichia coli , Pseudomonas aeruginosa , and Candida albicans . The 1,2-hexanediol was the solvent that allowed us to achieve the ingredient (20% dry extract dispersed in 25% 1,2-hexanediol in water) with the best antimicrobial performance, showing a minimum inhibitory concentration of between 5% and 3% ( I ). The 5% ( w / v ) concentration of this ingredient complied with the USP51 standards for cosmetic preservatives. Real-time (25 &#xb0;C, 65% RH) and accelerated stability (40 &#xb0;C, 75% RH) tests were conducted to determine the ingredient stability, and it was found that one month of storage time at room temperature would be ideal for better ingredient stability and performance in terms of composition, pH, color, and antioxidant activity.

Deciphering trends in replacing preservatives in cosmetics intended for infants and sensitive population [PMID: 39153997 · 2024]
Chen T, Chang H · Sci Rep (2024)

The present study aims to investigate the current trends in replacing conventional preservatives with multifunctional ingredients with antimicrobial properties for preservation of cosmetics for infants or sensitive population, to decrease their potential for contact dermatitis. We first reviewed the labels of cosmetics purchased from the Chinese market for conventional preservatives and multifunctional ingredients with antimicrobial properties, of which the actual contents were further quantified by chromatographic methods. We identified 7 traditional preservatives (phenoxyethanol, benzoic acid (salts), methylparaben, benzyl alcohol, sorbic acid (salts), propylparaben, and methylisothiazolinone), and 11 alternative ingredients with antimicrobial activities (ethylhexylglycerin, butylene glycol, caprylyl glycol, propylene glycol, 1,2-hexanediol, p-anisic acid, hydroxyacetophenone, pentylene glycol, decylene glycol, caprylhydroxamic acid, and aminomethyl propanol) in descending order of prevalence. The contents of all identified preservatives and ingredients were either below regulatory limits or in the range that is generally regarded to be safe. Further challenge with microorganisms indicated irrespective of the composition of preservation systems, product preservation could be compromised under test conditions. We conclude that multifunctional ingredients with antimicrobial properties in cosmetics have the potential to completely replace or significantly reduce the use of traditional preservatives while retaining comparative preservative efficacy. Future attentions may need to be shifted to the safety of those multifunctional ingredients with antimicrobial properties.

Influence of Panax ginseng formulation on skin microbiota: A randomized, split face comparative clinical study [PMID: 35509819 · 2022]
Hou JH, Shin H, Shin H, Kil Y, Yang DH, Park MK, Lee W, Seong JY, Lee SH, Cho HS, Yuk SH, Lee KY · J Ginseng Res (2022)

Skin microbiota is important for maintenance of skin homeostasis; however, its disturbance may cause an increase in pathogenic microorganisms. Therefore, we aimed to develop a red ginseng formulation that can selectively promote beneficial bacteria. The effects of red ginseng formulation on microorganism growth were analyzed by comparing the growth rates of Staphylococcus aureus , S.&#xa0;epidermidis , and Cutibacterium acnes . Various preservatives mixed with red ginseng formulation were evaluated to determine the ideal composition for selective growth promotion of S.&#xa0;epidermidis . Red ginseng formulation with selected preservative was loaded into a biocompatible polymer mixture and applied to the faces of 20 female subjects in the clinical trial to observe changes in the skin microbiome. Red ginseng formulation promoted the growth of S.&#xa0;aureus and S.&#xa0;epidermidis compared to fructooligosaccharide. When 1,2-hexanediol was applied with red ginseng formulation, only S.&#xa0;epidermidis showed selective growth. The analysis of the release rates of ginsenoside-Rg1 and -Re revealed that the exact content of Pluronic F-127 was around 11%. The application of hydrogel resulted in a decrease in C.&#xa0;acnes in all subjects. In subjects with low levels of S.&#xa0;epidermidis , the distribution of S.&#xa0;epidermidis was significantly increased with the application of hydrogel formulation and total microbial species of subjects decreased by 50% during the clinical trial. We confirmed that red ginseng formulation with 1,2-hexanediol can help maintain skin homeostasis through improvement of skin microbiome.

Impact of Alkanediols on Stratum Corneum Lipids and Triamcinolone Acetonide Skin Penetration [PMID: 34575527 · 2021]
Sigg M, Daniels R · Pharmaceutics (2021)

Alkanediols are widely used as multifunctional ingredients in dermal formulations. In addition to their preservative effect, considering their possible impact on drug penetration is also essential for their use. In the present study, the influence of 2-methyl-2,4-pentanediol, 1,2-pentanediol, 1,2-hexanediol and 1,2-octanediol on the skin penetration of triamcinolone acetonide from four different semisolid formulations was investigated. Furthermore, confocal Raman spectroscopy measurements were performed to examine the influence of the alkanediols on stratum corneum lipid content and order. Alkanediols were found to increase the penetration of triamcinolone acetonide. However, the extent depends strongly on the formulation used. In certain formulations, 1,2-pentanediol showed the highest effect, while in others the penetration-enhancing effect increased with the alkyl chain length of the alkanediol used. None of the tested alkanediols extracted lipids from the stratum corneum nor reduced its thickness. Notwithstanding the above, the longer-chained alkanediols cause the lipids to be converted to a more disordered state, which favors drug penetration. This behavior could not be detected for the shorter-chained alkanediols. Therefore, their penetration-enhancing effect is supposed to be related to an interaction with the hydrophilic regions of the stratum corneum.

Assessment of the potential risk of 1,2-hexanediol using phytotoxicity and cytotoxicity testing [PMID: 32505050 · 2020]
Song U, Kim J · Ecotoxicol Environ Saf (2020)

1,2-Hexanediol is commonly used in the cosmetic industry as a preservative, an emollient, and a moisturizing agent. However, studies on the scientific toxicity of 1,2-hexanediol are limited. In this study, we evaluated the potential toxic effects of 1,2-hexanediol using phytotoxicity and cytotoxicity testing methods. Phytotoxicity tests using Brassica campestris subsp. napus and Latuca sativa L. showed that 1,2-hexanediol significantly inhibited seed germination and root elongation at the lowest concentration (0.1%). Additionally, plants treated with 1,2-hexanediol failed to survive. In cytotoxicity tests, RAW 264.7 and HK-2&#xa0;cells treated with 1.0% 1,2-Hexanediol showed a significant decline in viability, followed by death. Since most personal care products contain &gt;2% 1,2-hexanediol, it is highly likely that 1,2-hexanediol is toxic to humans. Moreover, if 1,2-hexanediol enters the human body either via oral intake or through an open wound, it could have critical effects. Furthermore, upon release into the environment, 1,2-hexanediol could cause considerable damage to plants and other organisms. Therefore, further investigation of 1,2-hexanediol is required to prevent toxicity to humans and other living organisms.

Topical delivery of niacinamide: Influence of neat solvents [PMID: 32057889 · 2020]
Iliopoulos F, Sil BC, Monjur Al Hossain ASM, Moore DJ, Lucas RA, Lane ME · Int J Pharm (2020)

Niacinamide (NIA) has been widely used in cosmetic and personal care formulations for several skin conditions. Permeation of topical NIA has been confirmed in a number of studies under infinite dose conditions. However, there is limited information in the literature regarding permeation of NIA following application of topical formulations in amounts that reflect the real-life use of such products by consumers. The aim of the present work was therefore to investigate skin delivery of NIA from single solvent systems in porcine skin under finite dose conditions. A secondary aim was to probe the processes underlying the previously reported low recovery of NIA following in vitro permeation and mass balance studies. The solubility and stability of NIA in various single solvent systems was examined. The solvents investigated included Transcutol&#xae; P (TC), propylene glycol (PG), 1-2 hexanediol (HEX), 1-2 pentanediol (1-2P), 1-5 pentanediol (1-5P), 1-3 butanediol (1-3B), glycerol (GLY) and dimethyl isosorbide (DMI). Skin permeation and deposition of the molecule was investigated in full thickness porcine skin in vitro finite dose Franz-type diffusion experiments followed by mass balance studies. Stability of NIA for 72&#xa0;h in the solvents was confirmed. The solubility of NIA in the solvents ranged from 82.9&#xa0;&#xb1;&#xa0;0.8 to 311.9&#xa0;&#xb1;&#xa0;4.5&#xa0;mg/mL. TC delivered the highest percentage permeation of NIA at 24&#xa0;h, 32.6&#xa0;&#xb1;&#xa0;12.1% of the applied dose. Low total recovery of NIA after mass balance studies was observed for some vehicles, with values ranging from 55.2&#xa0;&#xb1;&#xa0;12.8% to 106.3&#xa0;&#xb1;&#xa0;2.3%. This reflected the formation of a number of NIA degradation by-products in the receptor phase during the permeation studies. Identification of other vehicles for synergistic enhancement of NIA skin delivery will be the subject of future work.

3-O-ethyl-l-ascorbic acid: Characterisation and investigation of single solvent systems for delivery to the skin [PMID: 31517290 · 2019]
Iliopoulos F, Sil BC, Moore DJ, Lucas RA, Lane ME · Int J Pharm X (2019)

l-ascorbic acid (AA), commonly known as vitamin C, has been widely used in topical formulations for many years as an antioxidant and anti-aging ingredient. However, the physicochemical properties of AA are not optimal for skin uptake and the molecule is also unstable, readily undergoing oxidation on exposure to air. The compound 3-o-ethyl-l-ascorbic acid (EA) has been developed as a stable vitamin C derivative and has been used in topical products. The aims of this work were to conduct a comprehensive characterisation of physicochemical properties of EA as well as to investigate the influence of various neat solvents on EA skin delivery. Nuclear magnetic resonance (NMR), mass spectroscopy, differential scanning calorimetry (DSC) and thermogravimetric analysis (TGA) were used to characterise the molecule. The pK a of the compound and the partition coefficient logP (o/w) were experimentally determined. A new HPLC method for analysis of the molecule was also developed and validated. A number of solvents for topical preparations were selected based on their wide use as excipients in topical formulations, their potential to act as skin penetration enhancers and their favourable safety profiles. The solubility and stability of EA was examined. Skin permeation of the molecule in full thickness porcine skin in vitro was investigated using Franz-type diffusion cells. The melting point, log P (o/w) value and pK a value of EA were determined to be 114.39&#x202f;&#xb1;&#x202f;0.5&#x202f;&#xb0;C, -1.07&#x202f;&#xb1;&#x202f;0.03 and 7.72&#x202f;&#xb1;&#x202f;0.01 respectively. Skin penetration of EA was evident for the following vehicles 1,2 hexanediol (HEX), glycerol (GLY), propylene glycol (PG), 1,2 pentanediol (1-2P), isopropyl alcohol (IPA), propylene glycol monolaurate (PGML) and propylene glycol monocaprylate (PGMC). Skin uptake but no permeation through the skin was observed for Transcutol&#xae; (TC) and dipropylene glycol (DiPG), while no penetration was observed for the solvents 1,5 pentanediol (1-5P) and tripropylene glycol (TriPG). The findings of the permeation experiments confirm the potential of simple formulations to deliver EA to the skin. Studies are ongoing to identify complex vehicles for synergistic enhancement of EA skin penetration. To our knowledge this is the first study to conduct a comprehensive characterization of EA and examine its skin uptake and permeation properties in porcine skin.

Insights into the structure of sunscreen lotions: a small-angle neutron scattering study [PMID: 35423975 · 2021]
Mansour OT, Venero DA · RSC Adv (2021)

Sunscreen lotions and creams are arguably the most popular products used to protect the skin against harmful UV radiation. Several studies have been conducted to untangle the internal microstructure of creams and lotions. However, the effect of UV filters and other materials such as preservatives, on the internal microstructure and the aesthetics of these products is not yet fully understood. Using small-angle neutron scattering (SANS), we were able to investigate the effect of adding the commonly used organic UV filters (avobenzone (AVB), ethylhexyl methoxycinnamate (EMC), ethylhexyl triazone (EHT) and bemotrizinol (BMT)) and the water soluble preservatives (1,5-pentanediol (1,5-PD) and 1,2-hexanediol (1,2-HD)), on the internal architecture and microstructure of an oil-in-water (o/w) based sunscreen lotion. Our findings highlight the complexities of these formulations, and how the introduction of different additives could influence their structure and possibly their performance.

The effect of alkanediols on the release of triamcinolone acetonide from semisolid dosage forms [PMID: 34216765 · 2021]
Sigg M, Daniels R · Int J Pharm (2021)

Alkanediols are frequently used as alternative antimicrobial preservatives for dermal formulations. However, these substances can also have an influence on the biopharmaceutical properties of the applied preparations. Therefore, the influence 2-methyl-2,4-pentanediol, 1,2-pentanediol, 1,2-hexanediol and 1,2-octanediol on the release of triamcinolone acetonide (TAA) from four different commonly used semi-solid vehicles was investigated. In addition, the solubility of TAA in aqueous alkanediol solutions was evaluated. It was observed that its solubility increases as a function of chain length of the alkanediol, with exception of 1,2-octanediol. This can be related to the corresponding solubility parameters. Despite alkanediols increase the aqueous solubility of TAA, polarization microscopic images revealed that a significant amount of the drug is present in the suspended state in all formulations. Therefore, TAA release was proportional to the square root of time, indicating Higuchi kinetic. Alkanediols modify the release of TAA depending on the used base. The addition of alkanediols to the hydrogel formulation result in a slightly augmented release rate of the drug with increasing chain length of the added alkanediol. In contrast, alkanediols having longer chain lengths diminish the TAA release rate from all tested creams. Consequently, TAA release revealed to be partially inequivalent upon the addition of alkanediols.

Investigations on Alkanediols as Alternative Preservatives in a Nonionic Hydrophilic Cream [PMID: 33233527 · 2020]
Sigg M, Daniels R · Pharmaceutics (2020)

Alkanediols are often used as alternative antimicrobial preservatives for dermal formulations, e.g., hydrophilic creams. These substances show an antimicrobial effect due to their amphiphilic structure. At the same time, their amphiphilic behavior enables various interactions with the cream base itself. Therefore, the effect of four different alkanediols, namely 1,2-pentanediol, 2-methyl-2,4-pentanediol (hexylene glycol), 1,2-hexanediol, and 1,2-octanediol on the physical stability of a nonionic hydrophilic cream was investigated. Further, the incorporation of the alkanediols into lamellar structures of the cream was evaluated using differential scanning calorimetry (DSC) and small-angle X-ray scattering (SAXS) measurements. The interaction with the mixed crystals of the cream was found to increase with raising alkyl chain length of the added alkanediol. As a result, consistency and stability of the cream are slightly impaired. A test for efficacy of antimicrobial preservation according to the European Pharmacopoeia (Ph.Eur.) revealed that the antimicrobial activity is directly linked to the length of the alkyl chain of the alkanediols. 2-Methyl-2,4-pentanediol differs from both findings. This compound has non-vicinal hydroxy groups which result in a reduced amphiphilicity compared to the others. Consequently, it has a smaller impact on the colloidal structure of the cream and shows a comparatively low antimicrobial activity.

よくある質問 (FAQ)

Q1. 1,2-ヘキサンジオール (1,2-HEXANEDIOL) 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 '1,2-ヘキサンジオール'、米国PCPC・欧州CosIng INCIは '1,2-HEXANEDIOL'、中国NMPA IECIC標準中国語名は '1,2-己二醇' です。
Q2. 1,2-ヘキサンジオール (1,2-HEXANEDIOL) 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): none、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 1,2-ヘキサンジオール (1,2-HEXANEDIOL) の通常配合濃度 (Layer 3) と適正 pH は?
主要剤形 (aqueous_serum) において通常 0.5〜3%(中央値 2%)で配合され、適正pH範囲は 3〜10 です。
Q4. 1,2-ヘキサンジオール (1,2-HEXANEDIOL) 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 ETHYLHEXYLGLYCERIN, HYDROXYACETOPHENONE, PENTYLENE GLYCOL, CAPRYLYL GLYCOL、配合上の注意点は Concentrations > 2.2% may reduce emulsion viscosity due to interfacial partitioning; pair with 0.05% Ethylhexylglycerin です。