Disintegrates starches

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 +... 

Filler +10 Disintegrant Starch +6 Other +2 Binder +1 Lubricant... 

Ghdants are needed to faciUtate the flow of granulation from the hopper. Lubricants ensure the release of the compressed mass from the punch surfaces and the release/ejection of the tablet from the die. Combinations of siUcas, com starch, talc (qv), magnesium stearate, and high molecular weight poly(ethylene glycols) are used. Most lubricants are hydrophobic and may slow down disintegration and dmg dissolution. 

Impression plasters are manufactured from the finest finishing plasters, selected for color and purity. Setting time accelerators, setting expansion control agents, fillers, flavors, colors, or other special modifying agents may be added, eg, starch, to cause disintegration of the plaster impression when it is boiled. 

Carboxymethyl groups make the starch more hydrophilic (water-loving), and aid in cross-linking. This makes carboxymethyl starch useful in aspirin and other tablets to make them disintegrate quickly. 

Starch is often cited as a filler, but it is more commonly used in its dry state as a disintegrating agent. However, modified starches such as StaRx 1500 and National 1551 (partially hydrolyzed, or pregelatinized starch) are marketed for direct compression and appear to offer the advantage of substantial mechanical strength and rapid drug release. 

Fig. 9 Effect of starch concentration and location on tablet disintegration time. (From Ref. 54.)...

Although untreated starches do not swell sufficiently, certain modified forms, such as sodium starch glycolate, do swell in cold water and are better as disintegrants. Various cellulose derivatives, including methylcellulose and carboxymethylcellulose, have been used in this role, but with limited success due to the marked increase in viscosity they produce around the dispersing tablet mass. 

DS Desai, BA Rubitski, SA Varia, AW Newman. Physical interactions of magnesium stearate with starch-derived disintegrants and their effects on capsule and tablet dissolution. Int J Pharm 91 217-226, 1993. 

This optimization method, which represents the mathematical techniques, is an extension of the classic method and was the first, to our knowledge, to be applied to a pharmaceutical formulation and processing problem. Fonner et al. [15] chose to apply this method to a tablet formulation and to consider two independent variables. The active ingredient, phenylpropanolamine HC1, was kept at a constant level, and the levels of disintegrant (corn starch) and lubricant (stearic acid) were selected as the independent variables, X and Xj. The dependent variables include tablet hardness, friability, volume, in vitro release rate, and urinary excretion rate in human subjects. 

Desizing by chemical decomposition is applicable to starch-based sizes. Since starch and its hydrophilic derivatives are soluble in water, it might be assumed that a simple alkaline rinse with surfactant would be sufficient to effect removal from the fibre. As is also the case with some other size polymers, however, once the starch solution has dried to a film on the fibre surface it is much more difficult to effect rehydration and dissolution. Thus controlled chemical degradation is required to disintegrate and solubilise the size film without damaging the cellulosic fibre. Enzymatic, oxidative and hydrolytic degradation methods can be used. 

Surface area and moisture uptake have been related to the disintegration properties of excipients such as crosspovidone, starch, and alginic acid [17]. The surface areas of the three materials were measured, and a linear correlation was found between the maximum moisture sorption and specific surface area for the three disintegrants. The greater the surface area of the material, the more numerous were the sites for capillary attraction of water to its surface. It was postulated that the capillary action appears to be responsible for the disintegration properties of the materials. 

Meuser, F., Wittig, J., and Huster, H. 1989. Effects of high pressure disintegration of steeped maize grits on the release of starch granules from the protein matrix. Starch/Stdrke 41, 225-232. 

Protein content of field peas is negatively correlated with lipid, cell wall material (CWM), sugar, and ash content and positively correlated with starch separation efficiency and protein separation efficiency in air classification of pea flour. The lower separation efficiency of low protein peas may be due to their high lipid and CWM content which makes disintegration of seeds and separation into protein and starch particles by pin milling difficult. It is suggested that peas with a specific protein content should be used in order to control the protein and starch fraction contents (18). 

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