Abstract:Since natural-origin, sustainable ingredients are preferred by modern consumers, novel emulsifiers and emollients keep entering the market. This study hypothesizes that a combination of in silico, instrumental tools and simplified sensory studies could be used to efficiently characterize emulsions in a shorter timeframe. A total of 22 rather simple o/w emulsions were prepared by a time/energy-saving emulsification process. A natural mixed emulsifier (Lauryl Glucoside/Myristyl Glucoside/Polyglyceryl-6 Laurate) … Show more
“…The reasons for the widespread use of low-viscosity O/W emulsions (lotions) in skin care products are their high water content (which means lower cost), their light, non-greasy feel, and their good spreadability on the skin. Emulsions must meet numerous requirements and expectations in terms of stability, safety, efficacy (both actual and perceived), and appropriate aesthetic and sensory properties [34]. Bioactive peptides have attracted considerable attention in the cosmetic industry due to their potential to improve skin health and appearance.…”
Section: Discussionmentioning
confidence: 99%
“…The most cohesive sample was the emulsion containing EG L19 and the 3% NM hydrolysate, which also correlates with the cylindrical probe results. The conical probe provided a smoother appearance of the negative portion of the curve, which is often considered a desirable characteristic in topical formulations [34].…”
Section: Texture Analysismentioning
confidence: 99%
“…Two probes were used to investigate the importance of geometric effects, i.e., different forces generated during the measurement. Both probes were made of the same material to assume similar surface energies and force magnitudes [34]. A typical response of a semisolid sample, shown in Figure 4a-d, consists of a positive and a negative curve with the following standard parameters: firmness (maximum on the positive curve; the higher the value, the firmer the sample), consistency (area under the positive curve; the higher the value, the ticker the sample), cohesiveness, a parameter that indicates the strength of internal bonds (maximum on the negative curve), and work of the cohesion/index of viscosity (area under the negative curve) [35,36].…”
Section: Texture Analysismentioning
confidence: 99%
“…The lower intrinsic viscosity (4.5 mPa s) and contact angle value (3.3) of this emollient make it more sensitive to processing parameters, such as mixing time and rotor speed, which affects the total interfacial area. As a result, the breakup of the oil into a droplet population during this turbulent flow can sometimes occur simultaneously and sometimes in sequence, resulting in different rheological parameters [34]. The most cohesive sample (with the best substantivity) is the emulsion with EG L19 and the 3% NM hydrolysate.…”
Bioactive peptides are promising cosmetic active ingredients that can improve skin health and appearance. They exhibit a broad spectrum of activity, including anti-aging, antioxidant, antimicrobial, and anti-inflammatory effects. The aim of this study was to develop a safe, stable, and efficacious environmentally friendly (“green”) emulsion using a milk protein hydrolysate as a model active ingredient. Potential emulsions were formulated with biodegradable emollients, stabilized with naturally derived mixed emulsifier, and prepared by cold process. They were evaluated for rheological behavior (continuous rotation and oscillation tests), physical stability (dynamic mechanical thermal analysis—DMTA test), and texture profiles, as well as cytotoxic, antioxidant, and antimicrobial effects. Rheological characterization revealed shear-thinning flow behavior with yield point from continuous rotation tests and predominantly elastic character from oscillation (amplitude and frequency sweep) tests, with small structural change detected in the DMTA test. These results implied satisfactory rheological properties and good stability. Texture analysis revealed acceptable spreadability and substantivity of the emulsions. The protein hydrolysate showed antioxidant activity. The developed emulsions showed low antibacterial activity against selected microorganisms, but this was due to the action of preservatives, not peptides. All potential emulsions showed a desirable safety profile. The results obtained provide the basis for the next stage of formulation development, i.e., in vivo efficacy tests.
“…The reasons for the widespread use of low-viscosity O/W emulsions (lotions) in skin care products are their high water content (which means lower cost), their light, non-greasy feel, and their good spreadability on the skin. Emulsions must meet numerous requirements and expectations in terms of stability, safety, efficacy (both actual and perceived), and appropriate aesthetic and sensory properties [34]. Bioactive peptides have attracted considerable attention in the cosmetic industry due to their potential to improve skin health and appearance.…”
Section: Discussionmentioning
confidence: 99%
“…The most cohesive sample was the emulsion containing EG L19 and the 3% NM hydrolysate, which also correlates with the cylindrical probe results. The conical probe provided a smoother appearance of the negative portion of the curve, which is often considered a desirable characteristic in topical formulations [34].…”
Section: Texture Analysismentioning
confidence: 99%
“…Two probes were used to investigate the importance of geometric effects, i.e., different forces generated during the measurement. Both probes were made of the same material to assume similar surface energies and force magnitudes [34]. A typical response of a semisolid sample, shown in Figure 4a-d, consists of a positive and a negative curve with the following standard parameters: firmness (maximum on the positive curve; the higher the value, the firmer the sample), consistency (area under the positive curve; the higher the value, the ticker the sample), cohesiveness, a parameter that indicates the strength of internal bonds (maximum on the negative curve), and work of the cohesion/index of viscosity (area under the negative curve) [35,36].…”
Section: Texture Analysismentioning
confidence: 99%
“…The lower intrinsic viscosity (4.5 mPa s) and contact angle value (3.3) of this emollient make it more sensitive to processing parameters, such as mixing time and rotor speed, which affects the total interfacial area. As a result, the breakup of the oil into a droplet population during this turbulent flow can sometimes occur simultaneously and sometimes in sequence, resulting in different rheological parameters [34]. The most cohesive sample (with the best substantivity) is the emulsion with EG L19 and the 3% NM hydrolysate.…”
Bioactive peptides are promising cosmetic active ingredients that can improve skin health and appearance. They exhibit a broad spectrum of activity, including anti-aging, antioxidant, antimicrobial, and anti-inflammatory effects. The aim of this study was to develop a safe, stable, and efficacious environmentally friendly (“green”) emulsion using a milk protein hydrolysate as a model active ingredient. Potential emulsions were formulated with biodegradable emollients, stabilized with naturally derived mixed emulsifier, and prepared by cold process. They were evaluated for rheological behavior (continuous rotation and oscillation tests), physical stability (dynamic mechanical thermal analysis—DMTA test), and texture profiles, as well as cytotoxic, antioxidant, and antimicrobial effects. Rheological characterization revealed shear-thinning flow behavior with yield point from continuous rotation tests and predominantly elastic character from oscillation (amplitude and frequency sweep) tests, with small structural change detected in the DMTA test. These results implied satisfactory rheological properties and good stability. Texture analysis revealed acceptable spreadability and substantivity of the emulsions. The protein hydrolysate showed antioxidant activity. The developed emulsions showed low antibacterial activity against selected microorganisms, but this was due to the action of preservatives, not peptides. All potential emulsions showed a desirable safety profile. The results obtained provide the basis for the next stage of formulation development, i.e., in vivo efficacy tests.
“…Risk quantification is to be performed by considering the severity (S), probability of occurrence (O), and detectability (D) of each parameter using a numerical scale 1–5, with 1 being the lowest severity, probability, and undetectability, and 5 the highest. For each factor, the rank and prioritization of the risk were conducted according to the risk priority number (RPN) given by RPN = S × O × D. The factors presenting higher RPN values were subjected to a further optimization analytical process [ 39 , 40 , 41 ].…”
Analytical method validation ensures that a method provides trustworthy information about a particular sample when applied in accordance with the predefined protocol. According to regulatory standards, the rheological characteristics of topically applied semisolid formulations are one of the key elements involved in microstructure equivalence documentation. Therefore, for generic drug product manufacturers, it is a dire need to take a step forward in rheology method development and validation procedures. This paper aims to apply Analytical Quality by Design (AQbD) principles towards the development and validation of rheology methods for topical creams, as complex semisolid formulations. Risk assessment was carried out through an Ishikawa diagram and an estimate failure mode, effects, and criticality analysis (FMECA). Sample application, peltier temperature control, and sample rest time were identified as critical method variables (CMVs), and a 23 full factorial design was applied to understand their impact on rotational, creep recovery and, oscillatory measurements. The development of the method was carried out as per the ICH Q8-Q10, and Q14 guidelines and validated according to ICH Q2 (R2) guideline. The method demonstrated adequate precision (RSD < 15%), as well as selectivity. AQbD provided a comprehensive framework for developing a reliable and effective rheology method for this type of formulation.
Bioactive peptides are promising cosmetic active ingredients that can improve skin health and appearance. They exhibit a broad spectrum of activity, including anti–ageing, antioxidant, antimicrobial and anti–inflammatory. The aim of this study was to develop a safe, stable and efficacious environmentaly friendly ("green") emulsion using milk protein hydrolysate as a model active ingredient. Potential emulsions were formulated with biodegradable emollients, stabilised with a naturally-derived mixed emulsifier and prepared by cold process. They were evaluated for rheological behavior (continuous rotation and oscillation tests), physical stability (dynamic mechanical thermal analysis - DMTA test) and texture profiles, as well as for cytotoxic, antioxidant and antimicrobial effects. Rheological characterization revealed shear-thinning flow behaviour with yield point from continuous rotation tests and predominantly elastic character from oscillation (amplitude and frequency sweep) tests, with small structural change detected in the DMTA test. These results implied satisfactory rheological properties and good stability. Texture analysis revealed acceptable spreadability and substantivity of the emulsions. The protein hydrolysate showed antioxidant activity. The developed emulsions showed low antibacterial activity against selected microorganisms, but this was due to the action of preservatives, not peptides. All potential emulsions showed desirable safety profile. The results obtained provide the basis for the next stage of formulation development, i.e. in vivo efficacy tests.
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