Product formulation chapter

In addition to the studies listed in Figure 4.5, stability characteristics of the protein with regard to e.g. temperature, pH and incubation with various potential excipients are studied. Such information is required in order to identify a suitable final product formulation, and to give an early indication of the likely useful shelf-life of the product (Chapter 6). 

Intimately related to these factors is the design of the device, formulation, and the interface with the patient. Much of the discussion below will focus on the implications of excipients on formulation challenges for inhaled aerosol products. This chapter summarizes excipients for pulmonary formulations from several perspectives (i) excipient selection based on principles of delivery, (ii) physicochemical requirements for excipients, and (iii) specific challenges for formulations faced with aerosol drug delivery systems, including (a) biological aspects, (b) microbiological aspects, (c) analytical issues, and (d) future prospects. 

Softgel capsules come in a variety of shapes, sizes, and colors that may be speciLcto the mani facturer. In Figure 21.1, some representative shapes and sizes are presented. This chapter providi an overview of the manufacturing methods, formulation of the content medicament, composition of the shell, quality control procedures, stability, and shelf-life testing. V fe also discuss in some detail examples of the products formulated in softgel dosage form. 

This chapter reviews the pharmacokinetics and pharmacodynamics of the enantiomers of verapamil and examines their impact on verapamil bioavailability. In addition, new information on the influence of product formulation on the differential bioavailabiUty of the enantiomers of verapamil is presented and discussed. 

The evaluation of synergism in the laboratory must always be related to ils practical use in formulated products. This chapter aims to present some basic principles using products in commercial use and reference is made to both published and unpublished experimental data. 

Product formulations are complex, consisting of numerous additives designed to perform certain functions. The performance of these additives depends on other components of a mixture. Similarly, fillers are added to perform certain tasks, and their performance might be enhanced or retarded by other components of the mixture. This chapter reviews the current understanding of these interactions, in order to highlight potential improvements or potential risks related to the application of fillers in complex formulations, which contain components that may interact due to physical or chemical forces. 

In 2003, I wrote a book, Applied Statistical Designs for the Researcher (Marcel Dekker, Inc.), in which I covered experimental designs commonly encountered in the pharmaceutical, applied microbiological, and healthcare-product-formulation industries. It included two sample evaluations, analysis of variance, factorial, nested, chi-square, exploratory data analysis, nonpara-metric statistics, and a chapter on linear regression. Many researchers need more than simple linear regression methods to meet their research needs. It is for those researchers that this regression analysis book is written. 

This chapter illustrates the application of cellulosic fibrils in paper. However, research shows additionally that cellulosic fibrils find wide application across the manufacturing sector, in areas such as plastics, medical applications, and new novel product formulations. 

A detailed discussion about these phases is beyond the scope of this chapter. It is worthwhile to mention briefly some of the relevant properties of these phases and their significance in product formulation, process, and user properties. 

Administration devices for medicines used to treat asthma and COPD are prescriptirm products, with an exception for some nebulised (medicine) formulations. Medicines such as amphotericin B or antibiotics (coUstimethate sodium, tobramycin sulphate or gentamicin) for nebulisation in CF therapy are sometimes stUl partly prepared by hospital pharmacists, and so are nebulised solutions for bronchial challenge testing. Although product formulation and the method of preparation of formulations for inhalation are not the main subjects of this chapter, recommendations are given in the subparagraphs about nebulisation. 

FAB and LSIMS ionise samples from a liquid matrix. They are applicable to involatile, high-molecular-weight and ionic species and therefore to most species of surfactant. For this reason a large part of this chapter is devoted to these techniques. Ionisation by FAB and LSIMS is soft. The spectra are dominated by molecular ions and quasimolecular ions. The high level of such ions allows identiflcation of species even from complex mixtures, for example whole-product formulations or environmental... 

The risk assessment procedure for human health is usually a quantitative assessment and the stages of the assessment follow those outlined in the introduction of this Chapter. For biocidal products, the risk assessment focuses on the health effects arising specifically from the product itself. However, the majority of the data and endpoints used in the assessment will have been conducted on the active substance(s), substances of concern or other constituents within the product formulation. 

Bonazzi, C., Dumoulin, E. (2011). Quality changes in food materials as influtaicedby drydng processes. In E. Tsotsas A. S. Mujumda (Eds.), Modern drying technology. Volume 3 Product quality and formulation (Chapter 1) (pp. 1-20). Weinheim Wiley-VGH. 

The information presented in this chapter is intended to provide a brief overview of the composition, performance, and formulation properties of LAS by itself and in combination with other surfactants. The particular performance synergies and processing characteristics of certain combinations of surfactants are discussed briefly. The examples of mixed active formulations provided herein represent to the best of the author s knowledge the approximate levels of major surfactants in actual household detergent products both past and present. This does not imply that these formulations are complete because many additives, such as bleaches, enzymes, builders, hydrotropes, thickeners, perfumes, and coloring agents, may also be present in varying amounts. 

---