Product life cycle formulation

Chemical manufacturers, formulators, and distributors must make health, safety, and environmental protection an integral part of the product. Several guides have been created to help develop and implement policies and practices that ensure protection through the product life cycle. One of these, developed by the Epoxy Resin Formulators Group of the Society of Plastics Industry, has been found to be most useful for the epoxy formulator.6... 

Thirty years on from the explosion of commercially successful applications of targeted and controlled release pharmaceutical formulations, it is evident that there remains a need for further refinements and innovations in the field of drug delivery. Many of the larger corporations focus on the use of novel technology for extension of a product life cycle however, in many cases solubility and permeability issues limit the application of such technologies. Additional complications arise due to inter- and intrasubject variability, compliance, and chronobiological variation in disease incidence. 

Registration and commercialization of agrochemicals in Europe by M. Wei-denauer (Battelle, Switzerland) and the importance of formulation development in agchem product life cycle management by M. Bell (Battelle, UK)... 

Quality by design Product validation Critical quality attributes Process parameters Product life cycle Target product quality profile Formulation... 

A quality management system (QMS) is an important tool for process control and continual improvement. After a brief section about development of the quality principle in the preparation of medicines over the years, this chapter lists the processes in preparation and in the manufacture of medicines that have to be controlled. A medicine, whether developed in a pharmacy or in industry, starts with defining the needs of the patient. Then the formulation and the method of preparation are designed to meet product specifications. The next step of the product life cycle is the production, including quality control and release. 

Microbial insecticides are very complex materials in their final formulation, because they are produced by fermentation of a variety of natural products. For growth, the bacteria must be provided with a source of carbon, nitrogen, and mineral salts. Sufficient nutrient is provided to take the strain of choice through its life cycle to complete sporulation with concomitant parasporal body formation. Certain crystalliferous bacilli require sources of preformed vitamins and/or amino acids for growth. Media for growing these bacilli may vary from completely soluble, defined formulations, usable for bench scale work, to rich media containing insoluble constituents for production situations (10,27). Complex natural materials such as cottonseed, soybean, and fish meal are commonly used. In fact, one such commercial production method (25) is based on use of a semisolid medium, a bran, which becomes part of the final product. 

We start with a definition of the problem and based on this, we identify the candidates (such as, molecules, mixtures and formulations) through expert knowledge, database search, model-based search, or a combination of all. The next step is to perform experiments and/or model-based simulations (of product behavior) to identify a feasible set of candidates. At this stage, issues related to process design are introduced and a process-product match is obtained. The final test is related to product quality and performance verification. Other features, such as life cycle assessment could also be introduced at this stage. 

Many cosmetics manufacturers have used the lower phthalates (diethyl phthalate, dimethyl and dibutyl phthalates) for many years as solvents and diluents in perfumes. On the whole, the cosmetic industry is able to innovate guickly because cosmetic products have a relatively short life cycle this provides short to medium-term opportunities to formulate out the problem ingredients in the next version of the product. Raw materials come at different costs and to reformulate-out chemicals of concern may result in a temporary increase in material cost. However, as more companies switch to alternatives, economies of scale are realised and the price will fall. ... 

It is in the development and support of formulated products that Raman spectroscopy probably has most to offer the life cycle of a pharmaceutically active molecule. Due to there being few limitations to sample presentation prior to analysis, Raman spectroscopy is particularly versatile and can be applied to both macro- and microsamples. 

None of these is independent of the other products may be brought into development along the timeline of vintages these may be inserted into one or more therapeutic areas and matched for their profit or market size. Major brands can be reinforced by life-cycle management initiatives including new formulations to extend the main franchise, different forms to suit a wider catchment of patients and the extension to new indications possibly by the use of different or novel formulations at the same time. 

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