Influence of pH on the Stability of Pharmaceutical Compounds in Japan

Abstract

Purpose: The aim of the study was to assess the influence of pH on the stability of pharmaceutical compounds in Japan. Methodology: This study adopted a desk methodology. A desk study research design is commonly known as secondary data collection. This is basically collecting data from existing resources preferably because of its low cost advantage as compared to a field research. Our current study looked into already published studies and reports as the data was easily accessed through online journals and libraries. Findings: The study showed that the ionization state of a drug molecule can change with pH, leading to different degradation pathways. Acidic or basic conditions can catalyze hydrolysis, oxidation, and other chemical reactions, causing the drug to lose potency or form harmful by-products. For instance, ester and amide bonds in pharmaceuticals are prone to hydrolysis at extreme pH levels, while oxidative degradation is more prevalent at neutral or slightly basic pH. The stability of certain antibiotics, vitamins, and biologics is particularly pH-sensitive, necessitating careful formulation to maintain optimal pH levels. Buffer systems are often employed to stabilize the pH within a range that minimizes degradation. Additionally, the pH of the solution can influence the solubility and bioavailability of the drug, impacting its therapeutic efficacy. Thus, understanding and controlling the pH environment is crucial in pharmaceutical formulation to ensure drug stability, efficacy, and safety throughout its shelf life. Implications to Theory, Practice and Policy: Buffer theory, Arrhenius theory of acid-base reactions and Bronsted Lowry theory may be used to anchor future studies on assessing the influence of pH on the stability of pharmaceutical compounds in Japan. Practically, it is imperative for pharmaceutical companies to implement rigorous pH control in the formulation and storage of drugs. On a policy level, regulatory agencies should establish stringent guidelines for the pH stability of pharmaceutical compounds.