Geriatrik kullanım için hızlı çözünen desloratadin oral film hazırlanması ve karakterizasyonu

The aim of this study was to develop 5 mg desloratadine orodispersible film (ODF) with fast disintegration time and suitable mechanical strength to treat allergic symptoms in geriatric and to increase patient compliance and convenience. Hydroxypropyl methylcellulose (HPMC), polyvinyl alcohol, and Eudragit RS 100 were used as the film forming agent. HPMC was selected for further studies for being the best in terms of film forming ability, transparency, and lack of stickiness. Polyethylene glycol 400 and glycerol (Gly) were used as the plasticizers. Many batches of films with drug were prepared using different ratios of HPMC and plasticizers. The resultant films were evaluated for disintegration time, folding endurance, surface pH, weight variation, thickness, surface morphology using scanning electron microscopy, drug content, content uniformity, moisture loss, moisture uptake, drug-excipient compatibility using differential scanning calorimetry and fourier transform infrared spectroscopy, and dissolution. All the selected films started to disintegrate in less than 14 seconds. Most films exhibited good mechanical properties with a folding endurance value greater than 100. The uniformity in weight, thickness, and drug content in most of the selected films were obtained. Surface pH was within the normal range (6.4-6.8). Although there was no significant moisture loss in all films, moisture uptake has occurred in the films containing Gly as plasticizer. A smooth surface of the films was obtained and drug-excipient compatibility has been proved. The dissolution test wasn't done for all films due to the challenges associated with simulating the oral cavity physiological conditions using the conventional dissolution test apparatuses. However, more than 87% of the drug was released by the 4th minute.