Date of Award

1984

Degree Type

Dissertation

Degree Name

Doctor of Philosophy in Pharmaceutical Sciences

Department

Interdepartmental Program

First Advisor

Christopher T. Rhodes

Abstract

The potential of several new sugar matrices as direct compression vehicles has been investigated using a systematically organized series of tests. These matrices, produced by California and Hawaiian Sugar Company (C & H), were evaluated in a comparative manner with two commercially available products (DiPac and NuTab). In some cases, Emdex (another commercially available product) was also used. Moisture content, density, and flow properties were studied. Scanning electron micrographs were obtained to determine the morphology of the particles. Particles size spectra were generated for all the matrices. For some of the C & H Products (AI, B, and C), a computer-interfaced instrumented tablet press was used to generate compression profiles from which the compressibility of the materials was assessed.

The formulation efficiency of four C & H Products (AI, AII, B, and Brown), DiPac, and NuTab was determined by incorporating the matrices in several chewable formulations (ascorbic acid, multivitamin, dextromethorphan, antihistamine, antidiarrhea, and antacid) and one non-chewable formulation (pediatric strength aspirin). A computer-interfaced tablet press, from which compression peak heights were obtained, was used to prepare the ascorbic acid, multivitamin, and aspirin tablets. The results show that the C & H matrices, particularly Product B, have considerable potential as direct compression vehicles. It was also demonstrated that the utility of sugar matrices is not limited to the formulation of chewable tablets. Further, the results indicate that although matrices maybe chemically alike, differences in their physical properties may indeed produce gubstantial differences in their intrinsic properties and overall formulation behavior.

The effect of aging on in- vitro performance of the antacid tablets was evaluated. It was found that samples stored under relatively mild stress conditions (30°C with 80% relative humidity) for three months had reduced acid neutralization rates. It was also found that these storage conditions were sufficient to induce substantial aging in sugar coated and enteric coated tablets (chlorpromazine and aspirin respectively) over a four week period.

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