A systematic approach to formulate and evaluate the stability of topical creams with high concentrations of Transcutol HP
Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
In this study the authors developed stable anhydrous and hydrous creams containing 40% Transcutol® HP, using predictive techniques to select appropriate excipients.
TAM Technique for Identifying API-Lipid Excipient Compatibility Issues Upstream in the Development Process
Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
In this study the authors showed that Thermal Activity Monitoring is a useful technique to detect at early stage potential interaction between API and excipients, using less time and resources than conventional techniques.
TAM technique is used routinely in Gattefossé North American Technical Center of Excellence to speed up formulation development.
Gelucire 48/16®: A Versatile Non-Ionic Solid Solubilizer for Tablets of Poorly Water-Soluble Drugs
Agnivesh Shrivastava, Ketkee Deshmukh, Nabil Farah, Sharda Gurram, Sunil Bambarkar
A solid dispersion of ticagrelor and Gelucire® 48/16 is prepared to increase drug solubility. The solid dispersion is converted into tablets. The formulated tablets showed improved dissolution rate compared to the market reference.
Poor solubility, poor permeability, and pre-systemic elimination are factors that can limit absorption of somedrugs. Lipid excipients have the capability to overcome these hurdles and enhance oral bioavailability throughdifferent mechanisms.
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How to develop lipid-based formulation?
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An optimized LBF enables solubilization of the entire therapeutic dose andmaintains the drug in solubilized state throughout the digestion process.
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To speed up LBF development, we have produced tools to guide you at each stageof development:
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1 – methods for saturation solubility screening
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2 – database of solubility of drugs in common pharmaceutical excipients
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3 – methods for miscibility and dispersability testing
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4 – miscibility table
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5 – in vitro lipolysis procedure
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6 – guideline for preclinical studies
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What are the different types of lipid-based formulations?
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Depending on their composition, LBF exhibit different in vivo behaviors. They typically consist of biocompatible excipients falling into four main categories: oils, low-HLB surfactants, high HLB surfactants and co-solvents. To facilitate their identification, Poutonet al. introduced the Lipid Formulation Classification System based on the composition, size of the droplets generated after the dispersion of the formulation in aqueous media, and the impact of natural lipid digestion process on the in vivo performance of the formulation classes.
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What functional excipients for oral bioavailability enhancement do Gattefossé deliver?
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Our range of functional excipients includes oils, low HLB surfactants, high HLB surfactants and solvents. They can be combined to formulate all types of lipid-based formulations
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What are self-emulsifying formulations?
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Self-emulsifying lipid formulations form emulsions upon contact with aqueous fluids without the need for mechanical or thermal energy.The size of the dispersion depends on the composition of excipients in the formulation.
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How to use lipid excipients and lipid-based formulations in early stage development?
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A vehicle or formula intended for preclinical studies must allow adequate administration of the test compound with little or no effect on the test species. The vehicle or formulation must be suitable for the intended route of administration, maintain the stability of the active ingredient, and preferably, maximize the systemic bioavailability of the drug. Lipid excipients provide a solution to these challenges and have proven utility in preclinical studies. Further information is available from Gattefossé guideline
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Day after day, skin and hair face stress, pollution, UV, and other harsh elements. This constant assault leads to dryness, dullness, and loss of radiance. Additionally, the damage to skin cells can lead to a loss of energy and efficiency. An effective way to restore radiance and energy is to bring more oxygen to cells and thereby boost their metabolism. By increasing their energetic potential, Phylderm® Vegetal stimulates cell renewal, amplifying skin radiance and making hair more resistant to environmental damage.
Soy is one of the richest sources of vegetable protein. As the starting point of the soy life cycle, soybeans contain all components necessary for the synthesis of major skin proteins.
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Phylderm® Vegetal is extracted from GMO-free soybeans using a gentle extraction process that guarantees the presence of important peptides in the final product.
\nSoy beans in a Bowl\n","":false,"origin_video":"","key_benefits_carousel":[{"content":"
In vitro tests prove Phylderm® Vegetal C effectively
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increases oxygen consumption by 30%,
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boosts cell metabolism,
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stimulates renewal of keratinocytes and fibroblasts.
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Lipids and polymers in pharmaceutical technology: Lifelong companions
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Juergen Siepmann, Amina Faham, Sophie-Dorothée Clas, Ben J. Boyd, Vincent Jannin, Andreas Bernkop-Schnürch, Hang Zhao, Sébastien Lecommandoux, James C.Evans, Christine Allen, Olivia M. Merkel, Gabriella Costabile, Morgan R. Alexander, Ricky D.Wildman, Clive J.Roberts, Jean-Christophe Leroux
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International Journal of Pharmaceutics, Volume 558, 10 March 2019, Pages 128-142
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This article reviews the uses of lipids and polymers in pharmaceutical applications, alone or in combination, with a main focus on oral administration.
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These topics were discussed at the Journées galéniques de Saint-Rémy de Provence in 2018, the Scientific Meeting sponsored by Gattefossé Foundation.
A non-ionic pure surfactant for lipid-based formulation to solubilize and increase oral bioavailability of poorly soluble API. Forms micellar solution in aqueous media.
\n","names_kv":[{"keys":"USP NF Name","value":"
Polyoxyl-32 stearate (type I) NF
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Macrogol-32 stearate (type I) EP
\n"},{"keys":"UNII Code (FDA)","value":"
33GX5WQC0M
\n"},{"keys":"Preferred Substance Name (FDA)","value":"
PEG-32 STEARATE
\n"},{"keys":"Handbook of Pharmaceutical Excipients","value":"
Polyoxylethylene stearates
\n"},{"keys":"Chemical description","value":"
Consists of PEG-32 (MW 1500) esters of palmitic (C16) and stearic (C18) acids
Solubilizer for low log P APIs and bioavailability enhancer. Single excipient formulation system: self-emulsifies in aqueous fluid into micellar solution—LFCS Type IV. Use in melt processes (granulation, extrusion), granulation, and compression. Wetting agent. Safety of use is inferred by precedence of use in approved pharmaceutical products.
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A thixotropic suspension vehicle for pharmaceutical APIs. Ready-to-use in a cold process for thermosensitive actives in soft gel capsule.
\n","names_kv":[{"keys":"USP NF Name","value":"
Mixture of refined soybean oil USP-NF, glyceryl distearate USP-NF and polyglyceryl-3 dioleate USP-NF
\n"},{"keys":"EP Name","value":"
Mixture of refined soybean oil EP, glyceryl distearate EP and polyglyceryl-3 dioleate
\n"},{"keys":"UNII Code (FDA)","value":"
241ATL177A 73071MW2KM XRQ165498B
\n"},{"keys":"Preferred Substance Name (FDA)","value":"
Vehicle to suspend pharmaceutical ingredients in soft gelatin capsule. \n Good dispersibility in aqueous fluid. \n High drug load achievable. \n Thixotropic behavior: can be processed only by mixing—ideal for sensitive actives. \n Safety of use is inferred by food additive status and precedence of use.
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Soft capsule filling
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Blind trust in companies, brands, institutions or the media is a thing of the past.
\n
As consumers’ suspicion grows, the attraction for transparency and authenticity in consumer packaged goods progresses. This article highlights initiatives from different industries.
\n
\n
In a world of distrust
\n
\n
According to Mintel, most industries are in a distrust crisis. Figures speak for themselves:
\n
\n
\n
\n
68% of French adults agree that companies are more interested in making profits than making high quality food and drink(1).
\n
In the UK, only 39% of consumers trust the beauty industry as a whole to ensure products are safe for use(1).
\n
\n
\n
Where does it come from?
\n
\n
The past years have seen lots of broadcasted cases of product recall in the food but also in the beauty industry. Besides the financial consequences, it impacts the brand image on a long-term and it is also damaging for the whole industry. As example, the French company Lactalis has recently been charged over baby milk salmonella cases dated from 2017. Earlier, in 2013, 54 whitening products from the brand Kanebo were recalled, accused of favoring vitiligo-like symptoms.
\n
\n
Generally speaking, consumers have become more and more worried about what they consider as hidden “nasties” in the food (preservatives, sugar, fat…) or beauty products (paraben, silicones…).
\n
Moreover, new generations of consumers (generation Z and current teens) are characterized by an increased health anxiety and are more prone to suspicion and criticism towards consumerism.
\n
Facing a distrust context, different levers are successfully activated by brands to regain consumers’ confidence.
\n
\n
Authenticity as an answer
\n
\n
\n
The locavore movement primarily appeared in the USA West Coast with consumers giving the priority to food farmed closed to their home. It progressively expanded to the beauty industry, benefitting to both brands and consumers. The cosmetic industry finds in the locavore movement the opportunity to highlight forgotten local ingredients and to inject dynamism into regional economies. Consumers find in this “local spirit” a resonance with their value and a kind of reassurance.
\n
Thus, cosmetic creams containing algae from the Mont St Michel bay, lavender from the French Provence area, green tea from Jeju Island in Korea are promoting the ingredients’ origin at the service of safety and efficacy.
\n
\n
The ”farm to face” skin care is the apogee of this idea of enhancing the value of lands and ingredients with a well-defined geographical origin. In this brand model, cosmetics companies are also farm owners, thus able to guarantee the control of the whole supply chain at the service of freshness and qualitative ingredients.
\n
\n
The “Made in” claim is as a sign of excellence, which stimulates curiosity and engagement from consumers.
\n
\n
A view from behind the scene
\n
\n
Besides authenticity, the initiatives of brands to increase their transparency are booming.
\n
\n
The adoption of an « open-kitchen approach » is relevant in a context where consumers request more information, clarity and honesty from brands.
\n
\n
\n
It takes different forms:
\n
\n
\n
\n
The transparency in communication with the use of the brand website, packaging, advertising to reveal manufacturing secrets. The emphasis here is made on manufacturing costs, composition and the people (workers) behind the products. As an example, an American brand of clothing built its communication on transparency diffusing pictures and videos of its factories as well as information regarding the production’s costs for a T-shirt.
\n
\n
\n
In beauty, formulations can also leverage trust in recognizable ingredients. Transparent textures and inclusion of pieces of plant like rose petals are giving reassurance to consumers, skeptical about the content in the jar.
\n
\n
\n
\n
The new beauty heroes
\n
\n
For years, big players have established trends in the beauty industry.
\n
But as consumer changes, so does the brands landscape. Indie brands are creating a market revolution, reshaping the cosmetic industry with new communication standards.
\n
\n
In 2023, Kline estimates that retail sales of independent beauty brands in the US are expected to increase at a compound annual growth rate of 14% by 2027(2).
\n
Their business model strongly resonates with younger consumers’ philosophy, especially those of millennials and teens. Independently funded, they offer artisanal qualitative skin care products designed to answer the needs of a niche target. Doing so, they provide convenience and personalization to consumers who expect being considered as unique. Moreover, their innovative use of social media reinvents marketing rules and compels strong brand stories placing them under the radar system of big beauty players.
\n","box_links":[{"title":"5 things to know about natural formulating","image":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/07/5natural-right-box.jpg","link":"https://www.gattefosse.com/personal-care-trend/5-things-natural-formulating/","external_link":"","description":""}],"useful_links":[],"":false,"main_img_article":{"id":13946,"alt":"","title":"crystal-clear-beauty","caption":"","description":"","mime_type":"image/jpeg","url":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty.jpg","width":1536,"height":510,"sizes":{"thumbnail":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty-150x150.jpg","thumbnail-width":150,"thumbnail-height":150,"medium":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty-300x100.jpg","medium-width":300,"medium-height":100,"medium_large":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty-768x255.jpg","medium_large-width":474,"medium_large-height":157,"large":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty-1024x340.jpg","large-width":474,"large-height":157,"post-thumbnail":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty-672x372.jpg","post-thumbnail-width":672,"post-thumbnail-height":372,"twentyfourteen-full-width":"https://www.gattefosse.com/wordpress/wp-content/uploads/2018/01/crystal-clear-beauty-1038x510.jpg","twentyfourteen-full-width-width":1038,"twentyfourteen-full-width-height":510}},"description":"Transparency and authenticity: the new consumer 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A systematic approach to formulate and evaluate the stability of topical creams with high concentrations of Transcutol HP \n
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Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
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In this study the authors developed stable anhydrous and hydrous creams containing 40% Transcutol® HP, using predictive techniques to select appropriate excipients.
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Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
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A systematic approach to formulate and evaluate the stability of topical creams with high concentrations of Transcutol HP \n
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Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
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In this study the authors developed stable anhydrous and hydrous creams containing 40% Transcutol® HP, using predictive techniques to select appropriate excipients.
TAM Technique for Identifying API-Lipid Excipient Compatibility Issues Upstream in the Development Process
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Masumi Dave, M.S., Jason Le Pree, Ph.D., R.Ph. – Gattefossé USA
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In this study the authors showed that Thermal Activity Monitoring is a useful technique to detect at early stage potential interaction between API and excipients, using less time and resources than conventional techniques.
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Gelucire 48/16®: A Versatile Non-Ionic Solid Solubilizer for Tablets of Poorly Water-Soluble Drugs \n Agnivesh Shrivastava, Ketkee Deshmukh, Nabil Farah, Sharda Gurram, Sunil Bambarkar
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