Excipient Filler

Incompatibilities have also been observed in solid dosage forms. A typical tablet contain binders, disin-tegrants, lubricants and fillers. Compatibility screening for a new drug should consider two or more excipients from each class. Serajuddin et al. have developed a drug-excipient compatibility screening model to predict interactions of drug substances with excipients [49],... 

Excipients are sub-divided into various functional classifications, depending on the role that they are intended to play in the resultant formulation, for example, fillers, disintegrants, binders, lubricants and glidants. An added complexity is the fact that certain excipients can have different functional roles in different formulation types. Thus, lactose is widely used as a filler or diluent in solid oral dosage forms, for example, tablets and capsules [2] and as a carrier for inhalation products [3]. 

In this section a study is described in which tablets prepared with binary blends of a filler-binder and a disintegrant are evaluated, with respect to their physical stability after storage under tropical conditions. With the results of this study a selection from the excipients can be made, which are suitable for use in tropical countries. Tablet formulations can be developed with the thus selected excipients. 

Also the influence of the adjustable variables (disintegrant concentration and storage temperature and relative humidity), on the SIR of disintegration time (SIR(D)) was calculated for each combination of disintegrant and filler-binder. This was expressed as in equation (10). The coefficients of the equations for the different combinations of excipients are given in Table 8.9. 

Coprocessed excipients have been mainly used in DC tableting because of their better flow ability and compressibility, and the excipient formed is a filler-binder. The compressibility of several coprocessed excipients such as Cellactose (45), SMCC (42,44), and Ludipress (BASF AG, Ludwigshafen, Germany) (46) have been reported to be superior to the physical mixtures of their constituent excipients. While comparing the compressibility profile of SMCC with MCC in the presence of high compression forces, the former was found to retain the compaction properties,... 

For the pharmaceutical product development scientist, there is clearly a need for objective information about the practical performance of different excipients and their various grades. In this chapter we set out to bring together the results of some of our ongoing evaluations of the physical and mechanical properties of excipients commonly used for the manufacture of solid oral dosage forms. In this particular article, we have chosen to focus on the fillers that are most commonly used in the manufacture of immediate release tablets microcrystalline cellulose (MCC), lactose, calcium phosphate, and mannitol (1). 

Components and composition Example Deletion or partial deletion of ingredient —> color, flavor, or ink. Changes in excipients as % (w/w) of total < specified ranges8 Filler +5 Disintegrant Starch +3 Other +1 Binder +0.5 Lubricant Ca or Mg stearate +0.25 Other +1 Glidant Talc +1 Other +0.1 Film coat +1 Note total NGT 5%... 

Change in technical grade of excipient (Avicel 102 vs. 200) Change in excipients as % w/w total formulation15 GT level 1 but LT 2x level 1 Filler +10 Disintegrant Starch +6 Other +... 

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