Title

The Production Cycle Of Ketamine Hydrochloride Injection In A Pharmaceuticals Corporation: From Raw Material To Commercial Product With A Focus On Chemical Laboratory Processes

School Name

South Carolina Governor's School for Science and Mathematics

Grade Level

12th Grade

Presentation Topic

Consumer Science

Presentation Type

Mentored

Abstract

Behind the bottle of pills at the store or the anesthetic used during surgery is a web of materials and processes. As a pharmaceuticals corporation, Nephron manages all areas of drug development--procurement, formulation, packaging. We conducted an in-depth examination of this development process using Ketamine Hydrochloride, a Schedule III controlled substance, to explore each step of product development. To understand production operations of Ketamine Hydrochloride, we interviewed experts, made observations, conducted chemical testing, read SOPs and studied monographs by USP. We identified specifics of each phase of the cycle. Phase I focuses on preparing formulation components. Phase II includes processes which ensure quality. Phase III involves producing the commercial product and post-release testing and verification. Finally, we performed lab tests to explore how drugs are tested from specific acceptance criteria. We focused on extractables testing, or chemicals from the packaging that have potential to break down and diffuse throughout the drug, therefore affecting the product. In our extractables assessment, we followed two procedures to compare the negative control to the extraction solution: buffering capacity, which uses a pH titration to neutralize the pH of each samples, and nonvolatile residue, which uses a steam bath to evaporate the water, and recorded the weights of residue left. Through these examinations and lab tests, we were able to study the process of drug creation and see how things that may seem trivial are actually important in ensuring the safety and quality of a drug you might see at the pharmacy.

Location

HSS 113

Start Date

4-2-2022 10:15 AM

Presentation Format

Oral Only

Group Project

Yes

COinS
 
Apr 2nd, 10:15 AM

The Production Cycle Of Ketamine Hydrochloride Injection In A Pharmaceuticals Corporation: From Raw Material To Commercial Product With A Focus On Chemical Laboratory Processes

HSS 113

Behind the bottle of pills at the store or the anesthetic used during surgery is a web of materials and processes. As a pharmaceuticals corporation, Nephron manages all areas of drug development--procurement, formulation, packaging. We conducted an in-depth examination of this development process using Ketamine Hydrochloride, a Schedule III controlled substance, to explore each step of product development. To understand production operations of Ketamine Hydrochloride, we interviewed experts, made observations, conducted chemical testing, read SOPs and studied monographs by USP. We identified specifics of each phase of the cycle. Phase I focuses on preparing formulation components. Phase II includes processes which ensure quality. Phase III involves producing the commercial product and post-release testing and verification. Finally, we performed lab tests to explore how drugs are tested from specific acceptance criteria. We focused on extractables testing, or chemicals from the packaging that have potential to break down and diffuse throughout the drug, therefore affecting the product. In our extractables assessment, we followed two procedures to compare the negative control to the extraction solution: buffering capacity, which uses a pH titration to neutralize the pH of each samples, and nonvolatile residue, which uses a steam bath to evaporate the water, and recorded the weights of residue left. Through these examinations and lab tests, we were able to study the process of drug creation and see how things that may seem trivial are actually important in ensuring the safety and quality of a drug you might see at the pharmacy.