Chemistry
Formulations
Formulations in chemistry refer to the specific composition and arrangement of ingredients in a chemical product. This includes the precise proportions of each component and the methods used to combine them. Formulations are crucial for creating products with desired properties and functions, such as pharmaceuticals, cosmetics, and industrial chemicals.
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eBook - PDF- Jeffrey S. Barrett(Author)
- 2022(Publication Date)
- Wiley(Publisher)
281 Fundamentals of Drug Development, First Edition. Edited by Jeffrey S. Barrett. © 2022 John Wiley & Sons, Inc. Published 2022 by John Wiley & Sons, Inc. Companion website: www.wiley.com/go/Barrett/FundamentalsDrugDevelopment Introduction In common terms, a pharmaceutical formulation can be viewed as a recipe of your favorite food or drink, like’s Mom’s apple pie or a bartender’s special concoc- tion. However, in the highly regulated pharmaceutical industry, a pharmaceutical formulation is a drug preparation, process, and manufacturing recipe that have a continuing lifecycle that demonstrates the drug product can be made consistently with known quality attributes throughout development to commercialization and beyond. Formulation development encompasses a very wide range of activities that include pre-formulation, analytical assay development, testing and chemical characterization, excipient screening, dosage form development, delivery, design and manufacture, and the stability of the chosen dosage form such as a solid, topi- cal, aerosol, liquid, or lyophilized dosage form. The point of pharmaceutical formulation development is to design a quality drug dosage product and its manufacturing process to consistently deliver the intended performance and specifications of the product. This is usually evaluated by the design of experiments (DoE) with the drug substance (known also as the active pharmaceutical ingredient (API)), excipients (excipients are pharmaceuti- cal inactive ingredients that solubilize, suspend, thicken, dilute, bind, emulsify, stabilize, preserve, color, and flavor drug products into safe, efficacious and appealing dosage forms), container closure systems, and the subsequent manu- facturing processes.
eBook - PDFIndustrial Chemicals
Their Characteristics and Development
- G. Agam(Author)
- 2012(Publication Date)
- Elsevier Science(Publisher)
Most certainly, we began and ended our acquaintance with the concept of Formulations at school, when in our first or second chemistry lesson our teacher said: There is a pure compound, and there is a mixture. In fact, it is surprising that the matter ended so abruptly, 34 Chapter 3 Antioxidants Pigments and dyes Bactericides and biocides Chelating agents Curing agents Specialty monomers Emulsifiers Flavors and fragrances Flame retardants UV absorbers Flocculants Wetting agents Anticaking agents Water repellents Defoamers Insecticides Thickening agents Diagnostic materials Food preservatives Electronic materials T A B L E 3.2: SPECIALTY CHEMICALS — Formulations Adhesives and sealants Photographic materials Fertilizers and pesticides Plastic materials Cosmetics Inks Foods Rubber Lubricating oils and greases Textile chemicals Paints and coatings Paper chemicals Soaps and cleaning materials Pharmaceutical preparations Metal finishing products Corrosion inhibitors Oil field chemicals Leather chemicals because as we shall discover below the average consumer usually comes up in his daily life against Formulations rather than defined chemical compounds. Table 3.1 details products marketed mostly as specific and func-tional chemicals (those which become part of Formulations). Table 3.2 represents groups of materials marketed as Formulations. It is worth remembering that the drugs we use (pills, syrups, capsules, injections) are Formulations. The essential material (the ac-tive ingredient) is only a part of the product. The drug manufacturer buys the active ingredient as a bulk medicinal and, by formulation, turns it into the dose-form product. The components of a formulation are sometimes called ingredients, and sometimes additives. The distinction between the terms is not clear. However, it can be generalized that additives are agents added in small amounts (up to 10%), and that their purpose is to cover up the defects of the main material or to improve its properties.
eBook - PDFModern Pharmaceutics Volume 1
Basic Principles and Systems, Fifth Edition
- Alexander T. Florence, Juergen Siepmann, Alexander T. Florence, Juergen Siepmann(Authors)
- 2009(Publication Date)
- CRC Press(Publisher)
10 Preformulation Gavin W. Halbert Cancer Research UK Formulation Unit, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, U.K. INTRODUCTION Drug discovery occurs in silico, in chemistry laboratories, in cell-free assays or tissue culture systems, or in vivo in animal models on a molecule synthesized by the chemist. Final drug usage however occurs in patients using tablets, creams, injections, or other products that are a combination of the drug and various excipients, which together constitute the final medicinal product intended to produce the desired therapeutic effect. Preformulation is the initial stage of the conversion of molecule to drug where various important pharmaceutical (physical, chemical, and biological) properties of the putative drug molecule are assessed. It is difficult to define fully what constitutes preformulation (Fig. 1) or where it starts and ends within a drug discovery/development program. In an innovator setting, studies will be conducted in an expedient fashion on the small experimental amounts of material available in competition with other equally or more important studies related to preclinical pharmacology. Assuming acceptable results and continuation of drug development the drug quantities available will increase and the range of preformulation studies (including pharmacology) expanded to encompass all aspects of preclinical and preformulation development of drugs. In a generic development setting, these restrictions in general will not apply since preexisting information may be available and compound supplies are already established. Excessive early studies in an innovator program on candidate drugs that may never progress beyond preclinical development is a resource drain.
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