Handbook of Formulating Dermal Applications

A Definitive Practical Guide

Nava Dayan

• Publisher: Wiley-Scrivener
• Year: 2016
• Print ISBN: 9781119363620
• eBook ISBN: 9781119364245
• Edition: 1
• Topic: Physical Sciences
• Subtopic: Organic Chemistry

The conceptualization and formulation of skin care products intended for topical use is a multifaceted and evolving area of science. Formulators must account for myriad skin types, emerging opportunities for product development as well as a very temperamental retail market.

Originally published as "Apply Topically" in 2013 (now out of print), this reissued detailed and comprehensive handbook offers a practical approach to the formulation chemist's day-to-day endeavors by:

• Addressing the innumerable challenges facing the chemist both in design and at the bench, such as formulating with/for specific properties; formulation, processing and production techniques; sensory and elegancy; stability and preservation; color cosmetics; sunscreens;
• Offering valuable guidance to troubleshooting issues regarding ingredient selection and interaction, regulatory concerns that must be addressed early in development, and the extrapolation of preservative systems, fragrances, stability and texture aids;
• Exploring the advantages and limitations of raw materials;
• Addressing scale-up and pilot production process and concerns;
• Testing and Measurements Methods.

The 22 chapters written by industry experts such as Roger L. McMullen, Paul Thau, Hemi Nae, Ada Polla, Howard Epstein, Joseph Albanese, Mark Chandler, Steve Herman, Gary Kelm, Patricia Aikens, and Sam Shefer, along with many others, give the reader and user the ultimate handbook on topical product development.

SECTION I:
Preliminary Considerations and Selection of Raw Materials

CHAPTER 1
Pre-formulation Design and Considerations

Howard Epstein, PhD

EMD Chemicals

Key Words

Oil-in-Water Emulsification, Water-in-Oil Emulsification, Emulsifier Quaternary, Formulation Design, Global Intellectual Property, Marker Compounds, Oil/Water (octanol) Partition Coefficient, Anionic / Cationic / Amphoteric / Nonionic Sufactants, Tyrosinase

Introduction

The novice formulation chemist may be overwhelmed when challenged with developing a topical product suitable for a local or global market. The basic questions that come to mind are: Where does one start? What criteria should a formulation chemist consider when selecting the ingredients to incorporate into a new product? How are safety and product performance claims established in different countries? What are the criteria for a patent? How does one ensure a patented formulation is not inadvertently being violated? Are any ingredients in the new formulation incorporated at levels restricted in a respective country where the formulation will be sold? The ability to freely exchange information globally via the internet is a blessing and a curse. It is a blessing to have the ability to communicate and research information instantaneously and to conduct preliminary research conveniently from the desk prior to starting formulation activities. The curse is that the seeker of reliable information must have the ability to discriminate between opinion, facts and misinformation when accessing information from this resource.

This chapter is aimed at providing guidance to formulation chemists and other professionals involved in skin care product development, assisting them to produce innovative products. The goal is to provide insight with respect to planning and executing formulation development in an efficient and cost-effective process that is well-planned and intelligently executed.

Project Goals and Formulation Design

Prior to initiating project activity at the bench, a detailed description of the product design plan should be written. The project design sheet should provide a brief description of the project, including relevant background information of the rationale for the product. Product concept, goals, and objectives should be stated. The project description should contain the value proposition to the consumer, i.e., a statement of benefits that will be delivered by the product. It should include answers to the following questions: what unmet consumer need or needs will the new formulation provide and what is the formulation’s cost constraints? Regulatory and other constraints should also be considered during the early phase in the design sheet. A thorough product description will assist the formulation chemist in the determination of appropriate technologies for consideration. The following product design checklist describes the types of questions a formulation chemist must satisfy before pressing forward on a potentially viable project:

• Project objective is clear and the concept and goals are stated.
• Value proposition is clear; benefit provided to the consumer is stated, budget for project is specified.
• Distribution (limited vs. global) is determined.
• Budget limitations are identified and isolated.
• Desired technologies are described in general terms.
• Desired claims for the product are defined; what is this product’s end game?
• Target site of application is determined (i.e. the hair, face, body, or a combination of sites).
• An intellectual property search is conducted, where in known regulatory and patent restrictions are identified.
• Potential market analysis observations are conducted.

Once these questions have been considered and given a preliminary response, a product design flow will begin to form, following the logical tenets of initial formulative product scale-up. Such a workflow is shown in the following diagram:

Fleshing out a product design plan requires both satisfactory detail and the formulation chemist’s willingness to address tough and complex questions. Table 1 offers an example planning sheet for an SPF product, along with further questions the chemist must consider in pursuing the process.

Table 1. Cosmetic Ingredient Reference Sources

Reference Source	Publisher
International Cosmetic Ingredient Dictionary and Handbook	Personal Care Products Council, Washington, DC
British Pharmacopoeia	The British Pha...

Table of contents

• Cover
• Title page
• Copyright page
• Preface
• Section I: Preliminary Considerations and Selection of Raw Materials
• Section II: Formulation, Processing and Production Techniques
• Section III: Testing and Measurements Methods
• Section IV: Sensory and Elegancy
• Section V: Stability and Preservation
• Section VI: Color Cosmetics
• Section VII: Sunscreens
• Glossary of Terms, by Chapter
• Author Biographies
• Index
• End User License Agreement