Allergy Relief at Scale: Plant Design for Diphenhydramine Hydrochloride; How have discriminatory and exclusionary policies in U.S. healthcare research shaped the way Asian Americans are represented in medical studies and clinical trials?

It’s a sunny day in the middle of the spring and suddenly your eyes start watering and your nose starts running. Seasonal allergies in the United States affect nearly 1 in 3 adults and more than 1 in 4 children. For millions, relief comes in the form of a small pink pill: Benadryl. Although the manufacturing process for this pill has been used for decades, some methods fail to consider environmental safety. Additionally, once the new method is developed, proper regulations and testing must be implemented to ensure the medication’s safety through a different process. The question we ask is: how does one exactly make this over-the-counter medication, and how can all Americans receive proper adequate assurance of effectiveness?
Diphenhydramine hydrochloride, the generic name for Benadryl, was first synthesized using bromo-diphenylmethane, a key component, but it raises safety concerns due to its corrosive and toxic nature. We plan to use a new chemical formula that replaces the toxic, bromine-based method with a safer, more environmentally friendly alternative. This method considerably reduces hazardous byproducts and improves overall process efficiency. While the approach has shown promise at the lab scale—creating a purity of 98% or greater—there is little precedent for using it commercially, making our proposed synthesis and plant design the first of its kind. Each batch yields 249.46 kg of diphenhydramine hydrochloride, and our total production capacity reaches 457,707 kg per year. At a wholesale price of $15,983 per kilogram, that equates to roughly $7.32 billion in annual revenue—assuming full sales. With consistent output and high market value, this system offers a strong foundation for growth and positions us competitively in pharmaceutical manufacturing.
To ensure that medical interventions are effective for diverse populations, it is important that clinical trials include participants from all racial and ethnic backgrounds. However, in the United States, equal participation in clinical trials has become increasingly disproportionate to racial and ethnic minority representation. Despite decades of US legislative efforts and supportive groups, systemic barriers such as inadequate data disaggregation, weak policy enforcement, and linguistic barriers continue to exclude Asian American subgroups from meaningful participation in clinical trials. This limits the number of accurate diagnoses among Asian populations, leading to frequent misdiagnoses. This research will use the social construct of race as a guiding framework to explain how discriminatory and exclusionary practices affect Asians in U.S. healthcare research.
To bridge this gap, policymakers must enforce stricter compliance with federal inclusion policies and allocate targeted funding to Asian American health research. Additionally, regulatory bodies such as the NIH and FDA should mandate disaggregated racial and ethnic data collection to ensure that clinical research accurately reflects the diverse health needs of Asian American communities. Although studies have shown that Asian Americans often lack access to appropriate clinical trial care, this is not just an Asian American issue—it is an issue affecting all minority groups across the United States. I would recommend looking at other demographics and comparing how the situation in the U.S. compares to clinical trial practices in other countries. Additionally, interviewing the researchers and exploring their decision-making process for selecting clinical trial participants could be an interesting data point. Most of the paper focused on participant opinions, but since researchers ultimately select trial participants, it would be valuable to understand their decision-making process.
Within my technical project, several assumptions had to be made when designing each component of our manufacturing plant. As a result, some outcomes were unrealistic, as further research would be necessary. However, due to time constraints, many of the processes were simplified. For future expansion of this plant, I recommend conducting thorough research on particle size, blower and fan design, and improvements to the dryer system.

School of Engineering and Applied Science

Bachelor of Science in Chemical Engineering

Technical Advisor: Eric Anderson

STS Advisor: Kent Wayland

Technical Team Members: Sabrina Liskey, Abigail Janiga, Vanessa Campbell, Yusra Babar