Formulation product performance

Specialty chemicals, however, differ in that they are used for thek performance properties and usuaHy are not specified chemical entities. Products from different suppHers usuaHy differ somewhat, and free interchangabHity is not always possible. Special chemical systems also exist in the market and these are formulated products that contain both commodity and specialty chemicals. 

Quality in the Chemical Industry. The chemical iadustry uses quahty as a strategic tool for financial success. Oae measure of quahty is the degree of product variatioa from lot to lot. Ia the chemical iadustry, it is oftea difficult to provide product speciftcatioas comprehensive eaough to easure product performance ia all apphcatioas (21). Therefore, the manufacture of product having a minimum of lot-to-lot variabihty allows the customer to use the product without modifying their formulation or process to accommodate such variation. 

In general, single tackifiers or blends of tackifiers may be used to formulate to optimum product performance, following the modulus//], criteria outlined... 

There is wide variation in the activity, specificity, compatibility, and mode of action of the many individual raw material organics used in product formulations. The quality of some raw materials, and ultimately supplier formulations, may be suspect. Not all competitive polymers or formulated products provide equal performance for an equivalent price. 

From the detailed studies performed either using individual alcohol sulfates and alcohol ether sulfates or formulated products by oral administration and skin contact, no evidence of carcinogen risk was found. Similar conclusions were obtained when these sulfates or formulated products were tested for mutagenic and teratogenic properties. 

Figure 1 shows a flow chart for part of a recursive modelling procedure, illustrated in this paper, which accepts as input a formula consisting of constituent raw material codes or formula names, and quantities. The procedure retrieves property data for each raw material in order to perform the required calculations. When the procedure encounters a constituent that is a formulated product, it calls itself using that product as input. The output of the procedure consists of the calculated properties of the formula, including those properties of the formula that would be retrieved from data files for non-formulated or purchased raw materials. By returning this latter set of properties, the procedure can treat formulas as raw materials. 

Dispersed pigment formulations must be adequately prepared to afford products with optimum commercial properties. This concerns both the application of concentrates and the conversion of concentrates to end use products, which should preferably exhibit good flow properties in combination with high tinctorial strength. Knowledge of the above correlations and mechanisms aid the manufacturer in achieving an optimum in product performance. 

Dissolution is also used to identify bioavailability (BA) problems and to assess the need for further BE studies relative to scale-up and post-approval Changes (SUPAC), where it functions as a signal of bioinequivalence. In vitro dissolution studies for all product formulations investigated (including prototype formulations) are encouraged, particularly if in vivo absorption characteristics can be defined for the different product formulations. With such efforts, it may be possible to achieve an in vitro/in vivo correlation. When an in vitro correlation or association is available, the in vitro test can serve not only as a quality control (QC) specification for the manufacturing process, but also as an indicator of in vivo product performance. 

Similar PET-PC and PBT-PET-PC blends have been developed in unfilled, glass-filled and mineral-filled versions. One can begin to see how all of the building blocks of PBT formulation can be used interchangeably to tailor product performance. 

For any new excipients, APIs or drug products (where new does not necessarily mean novel, but new to the receiving site) there are additional testing criteria, e.g. supplier audits, third-party contract laboratory audits, analytical method transfers, sample management/tracking, etc. For those key excipients, where there is on-site historical experience, it still behoves both parties to check whether the local grade/supplier used by the CMO is equivalent to that used by the supplier (Worsham, 2010). There are many examples of differences in excipient physical properties, e.g. particle size, which have been attributed to different excipient sources that could ultimately impact on the performance of those excipients in formulated products (Frattini and Simioni, 1984 Dansereau and Peck, 1987 Phadke et al., 1994 Lin and Peck, 1994). 

Soaps and detergents are formulated products designed to meet various cost and performance standards. The formulated products contain many components, such as surfactants to tie up... 

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