Developing Cream Formulations: Renewed Interest in an Old Problem

Simões, Ana Lúcia de Assis; Veiga, Francisco; Vitorino, Carla

doi:10.1016/j.xphs.2019.06.006

Cited by 19 publications

(25 citation statements)

References 45 publications

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“…According to preliminary studies and risk assessment analyses, glycerol monostearate amount (x 1 ), isopropyl myristate amount (x 2 ) and homogenization rate (x 3 ) were recognized as the most significant factors affecting cream CQAs and were varied at high (+1), medium (0) and low (−1) levels. The selection of range factors was determined based on previous experimental results [1]. A total of fifteen runs, with three center points, were generated.…”

Section: Doementioning

confidence: 99%

“…Experiments were randomly carried out. The effects of independent variables on different responses/CQAs were investigated using the following non-linear quadratic model (1):…”

Section: Doementioning

confidence: 99%

“…HC cream formulations were prepared following a conventional manufacturing method, resorting to a high energy emulsification technique, as previously described [1]. Briefly, excipients from the dispersed and the continuous phases were separately dissolved while heating at 70 • C. The temperature of each unit operation was based on raw material melting point, ensuring that all ingredients were in the molten state.…”

Section: Preparation Of Hydrocortisone Cream Formulationsmentioning

confidence: 99%

“…In dermatological therapy, semisolid dosage forms, including cream formulations, remain the gold-standard vehicles for topical drug delivery [1]. Topical therapeutic efficacy is highly dependent on skin conditions, physicochemical properties of the active substance and vehicle/formulation characteristics because of their significant impact on drug release and permeation.…”

Section: Introductionmentioning

confidence: 99%

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Progressing Towards the Sustainable Development of Cream Formulations

2020

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This work aims at providing the assumptions to assist the sustainable development of cream formulations. Specifically, it envisions to rationalize and predict the effect of formulation and process variability on a 1% hydrocortisone cream quality profile, interplaying microstructure properties with product performance and stability. This tripartite analysis was supported by a Quality by Design approach, considering a three-factor, three-level Box–Behnken design. Critical material attributes and process parameters were identified from a failure mode, effects, and criticality analysis. The impact of glycerol monostearate amount, isopropyl myristate amount, and homogenization rate on relevant quality attributes was estimated crosswise. The significant variability in product droplet size, viscosity, thixotropic behavior, and viscoelastic properties demonstrated a noteworthy influence on hydrocortisone release profile (112±2-196±7 μg/cm2/√h) and permeation behavior (0.16±0.03-0.97±0.08 μg/cm2/h), and on the assay, instability index and creaming rate, with values ranging from 81.9 to 120.5%, 0.031±0.012 to 0.28±0.13 and from 0.009±0.000 to 0.38±0.07 μm/s, respectively. The release patterns were not straightforwardly correlated with the permeation behavior. Monitoring the microstructural parameters, through the balanced adjustment of formulation and process variables, is herein highlighted as the key enabler to predict cream performance and stability. Finally, based on quality targets and response constraints, optimal working conditions were successfully attained through the establishment of a design space.

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Section: Doementioning

confidence: 99%

“…Experiments were randomly carried out. The effects of independent variables on different responses/CQAs were investigated using the following non-linear quadratic model (1):…”

Section: Doementioning

confidence: 99%

Section: Preparation Of Hydrocortisone Cream Formulationsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Progressing Towards the Sustainable Development of Cream Formulations

2020

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“…Reasons fueling this expansion include, among other factors, elderly population increase, demand for a superior topical therapeutic effect, and major patent expiration. Semisolid dosage forms intended for topical application enable prolonged in situ release, and for this reason are the preferred therapeutic vehicles when addressing topical conditions [3].…”

Section: Introductionmentioning

confidence: 99%

Fast Screening Methods for the Analysis of Topical Drug Products

Miranda

Cardoso²,

Vitorino

2020

Processes

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Considering the recent regulatory requirements, the overall importance of in vitro release testing (IVRT) methods regarding topical product development is undeniable, especially when addressing particulate systems. For each IVRT study, several hundreds of samples are generated. Therefore, developing rapid reversed-phase high-performance liquid chromatography (RP-HPLC) methods, able to provide a real-time drug analysis of IVRT samples, is a priority. In this study, eight topical complex drug products exhibiting distinct physicochemical profiles were considered. RP-HPLC methods were developed and fully validated. Chromatographic separations were achieved on a XBridgeTM C18 (5 µm particle size, 150 mm × 2.1 mm), or alternatively on a LiChrospher® 100 RP-18 (5 µm particle size, 125 mm × 4.6 mm) at 30 °C, under isocratic conditions using UV detection at specific wavelengths. According to the physicochemical characteristics of each drug, different mobile phases were selected. Irrespective of the drug (hydrocortisone, etofenamate, bifonazole, clotrimazole, acyclovir, tioconazole, clobetasol, and diclofenac) and formulation, retention time values did not exceed 6.5 min. All methods were linear, specific, precise, and accurate at the intraday and interday levels, robust, and stable. These were successfully applied to establish product-specific IVRT profiles, thus providing a key database useful for topical pharmaceutical manufacturers.

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Optimization‐based cosmetic formulation: Integration of mechanistic model, surrogate model, and heuristics

Zhang

Zhou

2020

AIChE Journal

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Multiple functional and hard‐to‐quantify sensorial product attributes that can be satisfied by a large number of cosmetic ingredients are required in the design of cosmetics. To overcome this problem, a new optimization‐based approach for expediting cosmetic formulation is presented. It exploits the use of a hierarchy of models in an iterative manner to refine the search for creating the highest‐quality cosmetic product. First, a systematic procedure is proposed for optimization problem formulation, where the cosmetic formulation problem is defined, design variables are specified, and a set of models for sensorial perception and desired product properties are identified. Then, a solution strategy that involves iterative model adoption and two numerical techniques (i.e., generalized disjunctive programming reformulation and model substitution) is applied to improve the efficiency of solving the optimization problem and to find better solutions. The applicability of the proposed procedure and solution strategy is illustrated with a perfume formulation example.

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Developing Cream Formulations: Renewed Interest in an Old Problem

Cited by 19 publications

References 45 publications

Progressing Towards the Sustainable Development of Cream Formulations

Progressing Towards the Sustainable Development of Cream Formulations

Fast Screening Methods for the Analysis of Topical Drug Products

Optimization‐based cosmetic formulation: Integration of mechanistic model, surrogate model, and heuristics

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