Date of Award

2022

Document Type

Dissertation

Degree Name

Doctor of Philosophy in Pharmaceutical Sciences

Department

Pharmaceutical Sciences

First Advisor

Rutesh Dave

Committee Chair and Members

Rutesh Dave, Chair

Rahul Haware

Almas Babar

Qing Cai

Devang Patel

Keywords

Compression, Cooling crystallization, Crystal anisotropy, Heckel analysis, Material deformation, Metastable curve

Abstract

Tablets are the most preferred drug delivery dosage from compares to all other delivery forms. Tablet sizes are very important to consider with respect to the patient compliance. During the early development stage, it is very important to screen out the material based on their compressibility at each plane for further formulation. There are mainly three type of crystallization method like evaporation, cooling, and antisolvent method. Slow cooling method is a useful method to determine the crystal property at a different temperature point. Metastable curves assist in identifying the nucleation point of crystal during cooling method. A limited quantity of the drug and time constraint makes it difficult to adopt trial and error techniques for optimizing tablet formulations using directly compressible excipients. Hence, characterizing the compression properties of API is desirable in the early development stage. Single macro size crystal was nucleated at a different temperature point using a slow cooling method. These crystal x, y, and z plane were identified by using the simulated PXRD pattern from the Mercury software. Crystal characterized using PXRD, DSC, and TGA. A compression stage was mounted in a x-ray diffractor for microscopic studies of crystal. Microscopic studies showed that the crystal nucleated from 65 °C saturated solution was having low Young’s moduli compared to crystal nucleated at a 55 °C. Compaction simulator were used to calculate the macroscopic level studies of crystal. Force-Displacement data were used to calculate the Heckel analysis and Work-related parameters. Elastic recovery of tablet was affecting the strength of a tablet.

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