Evaluation of new flavors for feline mini-tablet formulations

• Published in: Journal of excipients and food chemicals Vol. 5; no. 2
• Main Authors: Jaana Hautala, Sari Airaksinen, Noora Naukkarinen, Outi Vainio, Anne Mari Juppo
• Format: Journal Article
• Language: English
• Published: International Pharmaceutical Excipients Council 01.10.2016
• ISSN: 2150-2668

Despite a global interest in companion animal pharmaceuticals, feline peroral medication is still lacking in palatable and voluntarily acceptable drugs of suitable size and attractive taste. As a consequence, treating cats with canine or human medicinal products has weakened patient compliance and treatment commitment resulting in many pet cats going untreated. In the future, the companion animal pharmaceutical business is expected to focus particularly on cats and the development of palatable feline medication. Based on this, the overall aim of this study was to facilitate voluntary drug administration to felines. Specifically the aim was to develop sophisticated and tailor-made feline medicinal products, in the form of mini-tablets, focusing on flavors palatable to felines. Rapid preformulation compatibility and stability screening tests of synthetic flavors were carried out using readily available oral solid form excipients. On the basis that felines are carnivorous, Lmethionine, L-leucine, L-proline and thiamine hydrochloride were investigated as possible flavors for improving palatability. These flavors, together with a model substance for a bitter taste, denatonium benzoate, were evaluated for their physicochemical properties, stability and physical compatibility. This evaluation was carried out with the substances alone and in binary combinations of flavors and excipients. Stability and compatibility were examined using differential scanning calorimetry (DSC) and X-ray powder diffraction (XRPD). The results showed that L-proline and denatonium benzoate anhydrate were hygroscopic. Thiamine hydrochloride was incompatible with talc and sodium stearyl fumarate. The known incompatibility between the amines contained in flavors, and α-lactose monohydrate was used to assess method sensitivity. Overall, this study provided new information on the compatibility of novel flavors with oral solid form excipients. This study also showed the applicability of using XRPD and DSC for the rapid evaluation of instability and incompatibility.