Mouth dissolving tablets

The present work describes the formulation development of mouth dissolving tablets of Promethazine HCl with an optimum dispersion time along with sufficient hardness. The formulation employed three different super disintegrants, namely crospovidone (CP), sodium starch glycolate (SSG) and crosscarmellose sodium (CCS), each in three different ratios. Microcrystalline cellulose and mannitol were used as binder and diluent respectively. FT-IR and DSC were used to study the drug-excipient compatibility. Preformulation studies were carried out so as to study the compression characteristics and the flow properties of the powder mix, which was within satisfactory limits. Formulations were made by direct compression method and evaluated for in vitro dispersion time (DT), hardness, friability, wetting time, and in vitro dissolution rate. The effect of DCP and lactose as a diluent was evaluated. All the formulations showed a DT below 4 min. with hardness of 2.9 kg.cm-2 or above. Tablets containing CP at 10%W/W with a hardness of 3.25 kg.cm-2 and DT of 17 S was chosen as the most satisfactory formulation which released the complete drug in 4 min. The other super disintegrants yield tablets of nearly lesser hardness (upto 2.9 kg.cm-2) with higher DT (upto 216 S). DCP and lactose increased the DT without major effect hardness of tablets.

Sidenafil citrate is the first oral therapy for erectile dysfunction and pulmonary arterial hypertension. Sildenafil is a selective inhibitor of cGMP specific phosphodiesterase type (PDE5).It is reported to be effective in men with ED associated with diabetes, prostrate cancer, psychological conditions. Pulmonary hypertension is a progressive disease of diverse origin with devastating consequences in adults as well as in children. The phosphodiesterase 5 inhibitor sildenafil successfully lowers pulmonary vascular resistance. However, it is reported,Sildenafil citrate because of its poor enteral absorption results in ineffective plasma concentrations(41%) in infants and children. The major objective of this study is to prepare rapidly disintegrating, mouth dissolving tablets of Sildenafil citrate to achieve rapid onset of action and to circumvent first pass loss. Various tablet formulations were prepared by direct compression method using well known excipients. The tablets prepared using Pharmaburst® (a co-processed excipient system) in comparison with well known super disintegrants showed better results in terms of tablet hardness, content uniformity, disintegration time and wettebility. Tablets containing sildenafil citrate 10mg,20mg & 40mg were prepared Pharmaburst® and the bioavailability in rabbits was compared with conventional enteral. The Cmax values were found to be 0.72µg for 10mg tablet, 0.92µg for 20mg tablet, 1.38 µg for 40mg tablet, 0.64µg for the 100mg conventional tablets and the corresponding Tmax readings were at 2.5mins, 2.5mins, 5mins and 45mins. The study indicate mouth dissolving tablets of Sildenafil citrate prepared using Pharmaburst® provide rapid onset of action , better bioavailability over entral tablets.

Mouth dissolving tablets (MDT) have received ever increasing demand during last decade and It is a rapidly a growing area in the pharmaceutical industry. After introduction into the mouth these tablets dissolve or disintegrate in the mouth and leaving an easy to swallow residue. Novel MDTs address the patient and pharmaceutical needs of convenient dosing particularly for busy or traveling patient, pediatric, geriatric and psychiatric patients who have difficulty in swallowing (dysphagia) conventional tablets and capsules. These tablets also have faster onset of action due to buccal absorption of the drug. The popularity and usefulness of the formulation resulted in development of several MDT Technologies. It is expected that this delivery system will get more importance in future as that of conventional delivery systems.

Mouth dissolving tablets (MDTs) prepared by the crystalline / phase transition method has focused on decreasing the dissolution (or disintegration) time of the tablets in the mouth, while maintaining sufficiently high mechanical strength to withstand handling during manufacturing, packaging, and transportation. The key to developing a successful MDTs formulation by the phase transition method is to select the right excipients. In general, MDTs are made of highly hydrophilic materials and possess highly porous structures for fast water absorption into the tablet. After heating MDTs, the median pore size of the tablets was increased and tablet hardness was also increased due to phase conversion into the tablets. It is concluded that a combination of low and high melting point sugar alcohols, as well as a phase transition in the manufacturing process, are important for making MDTs without any special apparatus.