Assessment of Alginate Gel Films as the Orodispersible Dosage Form for Meloxicam.

The aim of this study was to obtain films based on sodium alginate (SA) for disintegration in the oral cavity. The films were prepared with a solvent-casting method, and meloxicam (MLX) as the active ingredient was suspended in a 3% sodium alginate solution. Two different solid-dosage-form additives containing different disintegrating agents, i.e., VIVAPUR 112® (MCC; JRS Pharma, Rosenberg, Germany) and Prosolve EASYtabs SP® (MIX; JRS Pharma, Rosenberg, Germany), were used, and four different combinations of drying time and temperature were tested. The influence of the used disintegrant on the properties of the ODFs (orodispersible films) was investigated. The obtained films were studied for their appearance, elasticity, mass uniformity, water content, meloxicam content and, finally, disintegration time, which was studied using two different methods. The films obtained with the solvent-casting method were flexible and homogeneous in terms of MLX content. Elasticity was slightly better when MIX was used as a disintegrating agent. However, these samples also revealed worse uniformity and mechanical durability. It was concluded that the best properties of the films were achieved using the mildest drying conditions. The type of the disintegrating agent had no effect on the amount of water remaining in the film after drying. The water content depended on the drying conditions. The disintegration time was not affected by the disintegrant type, but some differences were observed when various drying conditions were applied. However, regardless of the formulation type and manufacturing conditions, the analyzed films could not be classified as fast disintegrating films, as the disintegration time exceeded 30 s in all of the tested formulations.

Is catheter-tissue contact force value important for ablation of ventricular arrhythmias originating from the left ventricular papillary muscles?

Background: Good catheter-tissue contact is mandatory to create effective ablation lesions. The minimal contact force value for ablation of arrhythmias originating from the left ventricle is 8.0-10.0 grams but is not known for arrhythmias arising from papillary muscles. Purpose: To analyze contact force values during successful ablation procedures of arrhythmias originating from the left ventricular papillary muscles. Methods: 24 consecutive patients (mean age 57.9 ± 11.9 years, 16 males) underwent ablation of premature ventricular complexes originating from left ventricular papillary muscles with the use of CARTO electro-anatomical system and intracardiac echocardiography. Results: Acute complete abolition of ventricular ectopy was obtained in 23 (96%) patients. The fluoroscopy time was 3.9 ± 3.5 min and procedure duration - 114.8 ± 37.9 min. The mean contact force during successful ablations was 3.0 ± 1.1 grams and 3.18 ± 1.8 grams for antero-lateral and postero-medial papillary muscle, respectively (NS). The mean contact force during a single unsuccessful ablation was 3.0 grams. At control Holter ECG, the mean Ectopy Burden was Reduced in the Antero-Lateral Papillary Muscle Group from 18.0% ± 7.9% to 2.6% ± 2.9% (p = 0.005415) and in the Postero-Medial Papillary Muscle Group - from 34.8% ± 13.7%-1.7% ± 1.3% (p = 0.012694). During Median 27 (IQR: 17-34) Months of Follow-up There one Recurrence of Arrhythmia. Conclusion: The values of contact force for successful ablation of ventricular ectopy originating from the left ventricular papillary muscles may be much lower than those for ablation of other foci which questions the role of contact force measurement when ablating these arrhythmias.