*Corresponding Author: Rumita Kumawat, Research Scholar, Bhupal Nobles' Institute of Pharmaceutical Sciences, Bhupal Nobles' University, Udaipur, Rajasthan - 313001, India. Email: 1990.riddhi@gmail.com
The present study aimed to evaluate the stability profile of Betahistine Dihydrochloride in its pure active pharmaceutical ingredient (API) form and as an Oral Thin Film (OTF) formulation through forced degradation studies under various stress conditions. Degradation studies were performed under acidic (0.1N HCl), alkaline (0.1N NaOH), oxidative (3% H₂O₂), and thermal (100°C) conditions to assess the intrinsic stability of the drug and to establish the stability-indicating capability of the developed analytical method. Samples were analyzed at predetermined time intervals up to 48 hours.
The results demonstrated that Betahistine Dihydrochloride is susceptible to all applied stress conditions, with oxidative degradation showing the highest extent of degradation (20.76% for API and 13.23% for OTF at 48 hours). Acidic and thermal stress also produced significant degradation, with 17.64% and 18.23% degradation observed for the API, respectively. Alkaline degradation was comparatively moderate (16.56% at 48 hours). In all stress conditions, the OTF formulation exhibited lower degradation than the pure API, indicating a protective effect of the polymeric film matrix. Chromatographic analysis confirmed clear separation of degradation products from the parent drug peak, demonstrating the specificity and stability-indicating nature of the analytical method.
Overall, the study concludes that Betahistine Dihydrochloride is particularly susceptible to oxidative and thermal stress, while the OTF formulation offers improved stability compared to the pure drug. These findings emphasize the importance of appropriate storage conditions and provide essential data for formulation development and stability assessment in accordance with ICH guidelines.
Keywords: Betahistine dihydrochloride, Oral thin film, Forced degradation, Stability-indicating HPLC, Oxidative degradation, ICH guidelines.
How to cite this article: Kumawat R, Bharkatiya M. Forced degradation studies of oral thin film of betahistine dihydrochloride. Int J Drug Deliv Technol. 2026;16(7s): 425-432; DOI: 10.25258/ijddt.16.7s.45
Source of support: Nil.
Conflict of interest: None