Browsing by Subject "high shear -rakeistus"

Tramadol products for cats are not commercially available. Problems may occur when dividing a tablet registered for humans due to uneven distribution of active ingredient within a tablet and bitter taste of tramadol. Minitablets have multiple benefits, including small size, better uniformity of content, coatability and fast administration, in comparison to a divided conventional tablet. The purpose of this study was to develop minitablets which are possible to coat with a taste masking coating. Physical and chemical properties of tramadol hydrochloride, such as water solubility, temperature behavior and hygroscopicity were studied. Additionally, compatibility of tramadol hydrochloride with excipients was studied by a 3-month stability exam. The pre-tests of granulation were carried out by using lactose or ascorbic acid as an active ingredient to model tramadol hydrochloride. The granulation was performed with high shear granulator and tableting with a rotary tablet press. The only variable factor between the granulation batches was the amount of granulation fluid. The impact of the amount of granulation fluid to the tableting properties was examined by determining particle size distribution, Carr index and Hausner ratio. Uniformity of mass, uniformity of content, hardness, disintegration time and dissolution were examined. The study revealed that tramadol hydrochloride did not have incompatibilities with the examined excipients. Tramadol hydrochloride was not hygroscopic even though it was found out to be freely soluble in water. Tablets with adequate hardness were successfully compressed of both granulated masses and the direct compression mass. However, the direct compression mass had more undesirable properties regarding the processes. Most batches fulfilled the requirements set for uniformity of mass and uniformity of content. Although the purpose of this study was to develop a tablet for veterinary medicine, the results in this study may be utilized in developing a formulation for pediatric medicine.