Formulation changes

The relative effectiveness of nucleating agents in a polymer can be determined by measuring recrystallization exotherms of samples molded at different temperatures (105). The effect of catalyst concentration and filler content has been determined on unsaturated polyesters by using dynamic thermal techniques (124). Effects of formulation change on the heat of mbber vulcanization can be determined by dsc pressurized cells may be needed to reduce volatilization during the cure process (125). 

Figure 18-42 provides a guide for typical appheations. Individual formulation changes may require more power than indicated in the figure. Parker [Chem. Eng., 72(18), 121 (1965)] has described in greater detail howto selecl double-arm mixers. 

Typical changes in material or operating variahles which improve wetting uniformity Appropriate routes to alter variahle through formulation changes Appropriate routes to alter variahle through process changes... 

Appropriate routes to alter variahle through formulation changes... 

Biopharmaceutical issues to be addressed will include a discussion of the pharmaceutical development process as it relates to in vivo and in vitro performance and the general approach taken concerning bioavailability, bioequivalence, and in vitro dissolution profiles. There should be a comparative analysis of relevant studies—objectives, study design, conduct, outcome, and data analyses. The effects of formulation changes (including different strengths of product and... 

The availability of unpreserved and preserved dosage forms is considered. Mention is made of formulation changes necessitated by multidose products. The need for adequate antimicrobial preservative efficacy can be discussed if this was an issue during product development. 

Combinations of active ingredients, specific pharmaceutical formulations, specific use, and company names can be included in the product name. Examples of this are shown in Table 8.2. This combinations and mixes of names can be very complicated and disturbing for the health-care and for the patients, especially for the elderly. It not easy to know what is important. Is ZOC a company or a pharmaceutical formulation changing the dosing schedule Patient safety in the reconciliation of medicines as described in Chapter 10 is very important and must not be neglected. 

In assuring performance characteristics when formulation change occurs. 

The extent of revalidation required for formulation changes should be determined on a case-by-case basis. Slight adjustments to the formulation may not require further validation work. This would include an adjustment of the excipient ratios, a change in tablet shape, etc. Specificity and accuracy should be re-evaluated for the inclusion of a new excipient into the formulation (e.g., antioxidants, dyes, preservatives). A change in the formulation such as going from a tablet to a capsule or from a liquid to a solid would mean a significant change to the formulation and complete validation should be performed. 

At this juncture. It was decided to make a radical formulation change. First, because of the Incompatibility of the Freon 11 with the polyol, the Freon 11 would be removed from the polyol and placed In the Isocyanate component. Second, since 1/1 component ratios are necessary to accommodate the mixing machine, different Isocyanate and polyol components were formulated to establish appropriate viscosities. The final formulation Is shown below. 

Pigment slurries are one of the major components in paints and coatings that contribute to or affect the performance of a formulation. The nature of pigment slurries makes them extremely susceptible to microbiological contamination that can degrade the final formulation. Often biodeterioration can be prevented with plant sanitation and the use of a preservative, but formulators must not rely on the precept that a particular preservative that works today will always remain effective down the road. In complex environments, contaminants can enter the system at different points, or a formulation change may render the original preservative less effective. Manufacturers must remain aware of trends in the industry to ensure their products are properly protected. 

Soluble insulin = regular insulin = unmodified insulin any insulin solution from any source which is not formulated/changed in any way in order to prolong its duration of action... 

The parameters selected should be appropriate for the process, in those cases where the manufacturing process has been controlled and validated as specified in the foregoing discussion, batch scale-up, changes in site of manufacture, allowance for equipment change (where the operating principle is the same), minor formulation changes, etc., should be determined on the basis of the comparability of both the blend/granulation and the final product as assured by (1) appropriate tests, (2) specifications, (3) process validation, and (4) comparative accelerated stability . 

Local exhaust improved-canopy inclosed on 3 sides Rubber formulation change n-nitrosodiphenylamine not used. 

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