Formulation support product

Choice As the second review regulation is enacted we will see the immediate removal of non-identified active substances and the gradual removal of identifi-ed/non-notified active substances (and their formulated biocidal products) from the market. Cost-driven product line rationalisation by the formulators in preparation for authorisation will similarly lead to a reduction in the number of biocidal products. Ultimately there will be less choice for the end-user. Undoubtedly the industries supported by these biocides may be presented with the following potential issues (1) a decrease in functional protection, (2) hygiene decline, resistance/tolerance, (3) process modifications, (4) end-product re-formulation and (5) higher costs. 

These data tell us that to be a successful player in the pesticide industry you must be a large organisation with the ability to invest a great deal of support into the discovery (in most cases), development, manufacture and marketing of your products. There are some organisations that have built their successful position on their ability to manufacture and formulate commodity products, those products that were discovered some years ago and whose patents have lapsed, thereby allowing organisations, other than the inventor to make, formulate and sell the product internationally. 

Supporting Data — Data, other than those from formal stability studies, that support the analytical procedures, the proposed retest period or shelf life, and the label storage statements. Such data include (1) stability data on early synthetic route batches of drug substance, small-scale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in containers and closures other than those proposed for marketing (2) information regarding test results on containers and (3) other scientific rationales. 

To Support Product Development. In addition to supporting the use of clinical trial materials, stability studies are carried out on both the API and different formulations in different container-closure systems to guide the development of the final formulation and container-closures. Stability studies may be carried out on either the formulation to be marketed or a representative formulation to evaluate different API suppliers, drug product manufacturing processes and sites, and drug product container-closures. 

During the process of lead optimization, characterization work is performed that would include a number of parameters that are critical to formulation and analytical development scientists. The following information is a minimalist look at what information should be available to support product development scientists ... 

Medical Information supporting products released to market can exist in many different formats. The medical information produced for the finished product, whether in label format or as a package insert, should correspond with the actual ingredients that the product is formulated to contain and the method and dosage that corresponds with its license. 

In order to improve efficiencies within the pilot plant, many firms are abandoning the practice of having separate clinical supplies manufacturing staff and formulation process development staff in favor of a more flexible, responsive group capable of supporting product development from beginning to end. The staff must be trained in formulation development, process... 

Change of product formulation involving excipients Major (DRA-3) Product full formula (in sealed envelope) Stability data to support new formulation Finished product specifications Certificate of analysis of finished product Product samples for both new and old formulation C2(c)... 

The chemical industry would offer a great service to clients such as SC Johnson by providing materials that meet positive design criteria and providing appropriate data to support the characterization and prioritization of material attributes. It would also help formulators and product manufacturers assure their customers that the products they are making meet environmentally preferable criteria identified by external markets. 

An additional insight into the importance of specific media components on production of secondary products can be gained by examining the case history of shikonin production. It had been shown that callus cultures of Lithospermum erythrorhizon could be induced to produce shikonin on Linsmaier-Skoog medium supplemented with lpM indole acetic acid (IAA) and lOpM kinetin (KIN) (52). The effects of specific nutritional components of the tissue culture medium on growth of the cell cultures and production of shikonin were also investigated i53). Fujita et al. (54,55) found that the levels of NO,, Cu+, and SO had profound effects of shikonin biosynthesis. Optimal concentrations were identified for each ion (I 8 ) as well as optimal levels of key organic components. The resultant medium supported production of shikonin at a rate approximately 13 times that obtained on previous media formulations. 

Before formulation development, extensive data must be generated to aid the process. In addition, stability, incompatibility, and solid-state characteristics of a drug must be studied to support product development and improvement. 

To be consistent with an ingredient-based monograph approach, a regimen incorporating both in vitro and in vivo tests is used to demonstrate the speed of action and spectrum of activity of a final formulation and its ability to meet the effectiveness criteria to support product claims and indications. The monograph criteria should correspond to a reduction in risk in a given situation. 

Generally any structural adhesive range will include the primary adhesive itself plus two different types of supporting products which have structural adhesive properties in their own right the chemistries and formulations of these supporting products are often strongly related to that of the primary adhesive which they accompany. 

Catalysts. Commercial sulfuric acid catalysts typically consist of vanadium and potassium salts supported on sUica, usually diatomaceous earth (see Diatomite). Catalyst peUets are available in various formulations, shapes, and sizes depending on the manufacturer and the particular converter pass in which they are to be used. A detailed discussion of oxidation catalysts for sulfuric acid production is available (107). 

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