The Characterization Of Natural Ingredients As Pharmaceutical Excipients In Paracetamol Tablets

Author

Nigel Patrick Brooks Jr, Prairie View A&M University

Date of Award

12-2022

Document Type

Thesis

Degree Name

Master of Science in Engineering (MSE)

Degree Discipline

Chemical Engineering

Abstract

Excipients used in pharmaceuticals are inactive ingredients that play a big role in drug formulations, and drug delivery systems. Binders are a type of pharmaceutical excipient that is crucial to the stability, physical characteristics, and cohesiveness of the tablet. Fully synthetic binders, such as polyethylene glycol (PEG), are commonly used due to their great formulation traits; however, these materials may have a slow dissolution rate, reduced bioavailability, or the potential to cause allergic reactions. Due to these limitations, natural excipients would be a great alternative due to their biocompatibility and faster dissolution rate. The purpose of this research was to characterize natural ingredients including d-sorbitol, d-allulose, tamarind gum, xanthan gum, guar gum, and pectin as pharmaceutical excipients with active pharmaceutical ingredient (API) paracetamol (APAP, acetaminophen). One excipient is used per tablet formulation with APAP to determine the influence on tablet characteristics. Another purpose of the research is to develop a better method for the formulation of 325 mg tablets. APAP tablets are created through wet granulation within 3D-printed molds, before being left to dry in a desiccant cabinet. After drying the tablets are characterized through image analysis with image pro software, dissolution using the BIO-DIS reciprocating Cylinder Apparatus, disintegration using 100 Disintegration Apparatus, Fourier-transform infrared spectroscopy (FTIR) absorbance accomplished with the Cary 630 FTIR, thermal stability with the Mettler Toledo DSC 3 STARe System, and crystal structure analysis with the XRD-7000 X-Ray Diffractometer Maxima. It has been concluded that natural excipients are compatible with APAP within the tablet matrix. 3D molds were an effective medium to produce granules through wet granulation due to the method's efficiency and yielding granules with consistent shapes. Sugar excipients were found to have a rapid disintegration time compared to polysaccharides and synthetic PEG. The dissolution test found that all the excipients except for xanthan gum had a faster rate of dissolution than PEG. Natural excipients also have little effect on APAP’s crystal structure and melting point temperature shown through XRD and DSC respectively. FTIR analysis has shown that natural excipients will have less of an impact on APAP’s structure than synthetic PEG.

Committee Chair/Advisor

Sheena M. Reeves

Committee Member

Kazeem Olanrewaju

Committee Member

Merlyn Pulikkathara

Committee Member

Nabila Shamim

Publisher

Prairie View A&M University

Rights

Date of Digitization

1-27-2023

Contributing Institution

John B Coleman Library

City of Publication

Prairie View

MIME Type

Application/PDF

Recommended Citation

Brooks Jr, N. P. (2022). The Characterization Of Natural Ingredients As Pharmaceutical Excipients In Paracetamol Tablets. Retrieved from https://digitalcommons.pvamu.edu/pvamu-theses/1513