Date of Award

1982

Degree Type

Thesis

Degree Name

Master of Science in Pharmacy

Department

Pharmacy

First Advisor

Christopher T. Rhodes

Abstract

Scanning Electron Micrographs of soy cellulose (Emcosoy) particles were studied to further the understanding of the morphology of the substance and thereby to increase the comprehension of how the excipient functions in tablet systems. Bulk swelling and water uptake were studied for Emcosoy, CLD II, corn Starch, and Ac-Di-Sol. Emcosoy had maximum swelling about 56%; followed by CLD II 49% and Ac-Di-Sol 9%. No swelling was observed in Corn Starch. An ideal disintegrant should perform uniformly in pH range of gastrointestinal tract in order to disintegrate the tablet. When Emcosoy and Ac-Di-Sol were tested against various pH values, there was no significant difference in swelling of these disintegrants. Since alcohol and sodium lauryl sulfate are often used as dissolution media, the effect of different concentrations were also observed on Emcosoy and Ac-Di-Sol. There was no significant effect. Another important preformulation test reported in this thesis is a comparative study of the viscosity of different concentrations of various disintegrants. When a tablet disintegrant reacts with water a gel may be formed. If the gel is too viscous, it impedes the water penetration in the tablet. Generally it can be said that the cellulose group of disintegrants (Ac-Di-Sol, CLD II and Emcosoy) had a viscous gel compared to starch group of disintegrants (Corn Starch, Explotab and Sta-Rx 1500). If the viscosity of the gel of starch group of disintegrants has to be arranged indescending order then Explotab is followed by Sta-Rx 1500 which is followed by corn starch. If the viscosity of the gel of cellulose group of disintegrants had to be arranged in descending order then CLD II is followed by Emcosoy which is followed by Ac-Di-Sol. Plastic deformation and elasticity of various disintegrants were studied using a Universal Instron Testing Machine. High plastic deformation of the disintegrant particles, may be advantageous since the deformed particles are " energy-rich " and that energy is released when the particles are exposed to water. The energy-rich particles probably swell more rapidly in water, unlike undeformed grains, which require more energy of swelling in order to well. Ac-Di-Sol particles have good plastic deformation compared to Emcosoy and Explotab particles. The three major mechanisms of disintegrant action are : (i) swelling (ii) capillary action (wicking) and (iii) deformation. Emcosoy particles swell considerably and they have good wicking effect, but they have poor plastic deformation. Following the performulation study, Emcosoy (soy cellulose) was compared with other disintegrants in about 45 formulations. About 100 dissolution profiles were obtained on various vitamin formulations using either Emcompress or Endex as the tablet matrix. Emcosoy is as effective a disintegrant as Ac-Di-Sol and very much more effective than Corn Starch. The results of preformulation study and formulation study strongly indicate that Emcosoy is a powerful tablet disintegrant which deserves careful consideration by all formulators.

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