Assessing and Predicting Physical Stability of Emulsion-Based Topical Semisolid Products: A Review

Badruddoza, Abu Zayed Md; Yeoh, Thean; Shah, Jaymin; Walsh, Taylor

doi:10.1016/j.xphs.2023.03.014

Cited by 17 publications

(8 citation statements)

References 163 publications

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“…Figure 4 shows the evolution of light transmission with time for OT1 to OT3 measured by the LUMiSizer, together with the corresponding photographs of the samples after measurement. The transmission profiles showed that bleeding (syneresis) [ 19 , 20 ] is observed on the top part of all three ointments (OT1 to OT3). A larger amount of syneresis can be observed for OT3, while the extents of syneresis for OT1 and OT2 are comparable.…”

Section: Resultsmentioning

confidence: 99%

Influence of Manufacturing Process on the Microstructure, Stability, and Sensorial Properties of a Topical Ointment Formulation

Chow,

Lim,

Cyriac

et al. 2023

Pharmaceutics

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The manufacturing process for ointments typically involves a series of heating, cooling, and mixing steps. Precise control of the level of mixing through homogenization and the cooling rate, as well as temperature at different stages, is important in delivering ointments with the desired quality attributes, stability, and performance. In this work, we investigated the influence of typical plant processing conditions on the microstructure, stability, and sensorial properties of a model ointment system through a Design of Experiments (DoE) approach. Homogenization speed at the cooling stage after the addition of the solvent (propylene glycol, PG) was found to be the critical processing parameter that affects stability and the rheological and sensorial properties of the ointment. A lower PG addition temperature was also found to be beneficial. The stabilization of the ointment at a lower PG addition temperature was hypothesized to be due to more effective encapsulation by crystallizing mono- and diglycerides at the lower temperature. The in vitro release profiles were found to be not influenced by the processing parameters, suggesting that for the ointment platform studied, processing affects the microstructure, but the effects do not translate into the release profile, a key performance indicator. Our systematic study represents a Quality-by-Design (QbD) approach to the design of a robust manufacturing process for delivering stable ointments with the desired performance attributes and properties.

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Section: Resultsmentioning

confidence: 99%

Influence of Manufacturing Process on the Microstructure, Stability, and Sensorial Properties of a Topical Ointment Formulation

Chow,

Lim,

Cyriac

et al. 2023

Pharmaceutics

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“…Centrifugation was done to ensure that whether the nanoemulsion was stable or not, which implicates the use of centripetal force to split two liquids that are immiscible with each other. 14 The capability of nanoemulsions to show resistance to changes in its physical and chemical properties with time defines the stability of nanoemulsion. Physical characteristics confirm whether the formulation is physically stable or not, and it is based on visual observations.…”

Section: Discussionmentioning

confidence: 99%

Development and Characterization of Honey-containing Nanoemulsion for Topical Delivery

Ahmad,

Ali,

Khan

2024

J Explor Res Pharmacol

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Background and objectives: Honey is a viscous, hygroscopic liquid in nature. It has the ability to treat wounds, wrinkles, aging, and inflammation. This study's objective was to create and characterize a nanoemulsion containing honey and evaluate its stability. Methods:A pseudo-ternary phase diagram was retraced with several concentrations of the S mix , water, and liquid paraffin oil to formulate nanoemulsions containing honey. From the results of pre-formulation stability studies, formulation HNE-19, with a hydrophilic lipophilic balance value of 10, and a surfactant and oil ratio of 1:1, was selected as the most stable formulation. HNE-19 and base (B-19) were further subjected to thermodynamic studies of heating and cooling cycles and centrifugation. HNE-19 and its respective base B-19 were characterized for physical changes, droplet size analysis, pH measurements, turbidity, viscosity, and rheological parameters for a period of 90 days. Results:Results showed that the nanoemulsion containing honey was clear and milky white. There was no evidence of phase separation in HNE-19 and B-19 after the thermodynamic study. The droplet size of fresh HNE-19 was 91.07 nm with a zeta potential of −38.5 mV. After three months, the droplet size and zeta potential were 197.06 nm and −32.5 mV respectively. The observed pH was between 5.8 and 6.7, which corresponds with the pH of the skin. HNE-19 showed non-Newtonian flow and pseudo-plastic behaviour.Conclusions: Stability and characterization showed that the nanoemulsion containing honey is a remarkable topical delivery formulation and could be evaluated comparatively with conventional topical applications against skin-related diseases like wounds, wrinkles, aging, and inflammations.

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“…Especially in the context of generic drug development, the microscale organization of matter in semi-solids is often described as “microstructure.” Physical characterization may include microscopy, rheology, light scattering and laser diffraction techniques for particle size characterization, and a number of spectroscopic techniques. For comprehensive overviews of microstructure characterization in topicals, the reader can be referred to the book by Langley, Michniak–Kohn and Osborn [ 60 ] and the article by Badruddoza et al [ 11 ]. What will be discussed in the following are applications of rheology for formulation characterization, an area that gained importance during the last years and were interesting case studies became available.…”

Section: Characterization Of Semi-solid Formulationsmentioning

confidence: 99%

“…In the past decades, advances have been made in the understanding of topical drug delivery. This includes knowledge of the skin barrier function and driving forces for skin penetration [ 4 , 5 ], the influence of solvents [ 6 , 7 ] and formulation parameters that influence skin penetration [ 8 ], advances in spectroscopic tools to investigate skin penetration [ 9 , 10 ], improved instruments and approaches for assessing physical stability of formulations [ 11 ], and a better understanding of the role of excipients in topical drug delivery [ 3 ]. Still, in terms of formulation types, traditional formats like ointments and creams prevail, and the nomenclature of the formats is more historically based than technically justified [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

Rational Design of Topical Semi-Solid Dosage Forms-How Far Are We?

Herbig¹,

Evers²,

Gorissen³

et al. 2023

Pharmaceutics

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Specific aspects of semi-solid dosage forms for topical application include the nature of the barrier to be overcome, aspects of susceptibility to physical and chemical instability, and a greater influence of sensory perception. Advances in understanding the driving forces of skin penetration as well as the design principles and inner structure of formulations, provide a good basis for the more rational design of such dosage forms, which still often follow more traditional design approaches. This review analyses the opportunities and constraints of rational formulation design approaches in the industrial development of new topical drugs. As the selection of drug candidates with favorable physicochemical properties increases the speed and probability of success, models for drug selection based on theoretical and experimental approaches are discussed. This paper reviews how progress in the scientific understanding of mechanisms and vehicle-influence of skin penetration can be used for rational formulation design. The characterization of semi-solid formulations is discussed with a special focus on modern rheological approaches and analytical methods for investigating and optimizing the chemical stability of active ingredients in consideration of applicable guidelines. In conclusion, the combination of a good understanding of scientific principles combined with early consideration of regulatory requirements for product quality are enablers for the successful development of innovative and robust semi-solid formulations for topical application.

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Assessing and Predicting Physical Stability of Emulsion-Based Topical Semisolid Products: A Review

Cited by 17 publications

References 163 publications

Influence of Manufacturing Process on the Microstructure, Stability, and Sensorial Properties of a Topical Ointment Formulation

Influence of Manufacturing Process on the Microstructure, Stability, and Sensorial Properties of a Topical Ointment Formulation

Development and Characterization of Honey-containing Nanoemulsion for Topical Delivery

Rational Design of Topical Semi-Solid Dosage Forms-How Far Are We?

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