Track: Formulation and Delivery - Biomolecular - Drug Delivery - Other Routes of Administration - Otic
Category: Poster Abstract
Developing a Double Layered Film Dosage Form for Drug and Vaccine Delivery Using Lidocaine as Model Drug
Purpose: Oral dissolving films are extremely useful for pediatric, geriatric, and psychiatric patients since it minimizes the risk of choking or suffocation and ensures patient safety. Film dosage forms are easy to prepare, cost effective, and patient complaint. When films are administered in buccal or sublingual area, drugs are absorbed systematically. The systemic route can avoid the first pass effect and can increase the bioavailability of the drug. Another advantage of film dosage form is it can be designed in multilayer forms, where the outer layer can be a protective layer, which can prevent the destruction or swallowing of the drug. Double layer film can increase efficacy of drug delivery. In this research we have developed a double layer film through a screen process in lidocaine has been used as model drug to evaluate the efficiency. Methods: Single layered film dosage forms have been prepared by solvent casting method in petri dishes. Polymers Kollidon F90 and Kollidon VA64 were used as hydrophilic polymeric carriers, and PEG 3350 was used as plasticizer. To make double layer film, a backing layer was prepared separately in a similar way to the single layered film using HPMC polymer. The physical features of the single layer and double layer films were characterized. Microscopic images were taken to observe the surface morphology of the films using a fluorescence microscope. Disintegration time of the film were measured in artificial saliva. Film thickness was measured using Mitutoyo digital caliper and the tensile strength of the films were determined using Mark-10 digital force gauge. The permeation study of single and double layered films using lidocaine as sample drug was conducted using a Franz Cell. This study was conducted with a silicone membrane. A study will be conducted with porcine buccal membrane in an in vitro study. Permeability of the drug was measured using a UV-spectrophotometer. Results: The results show the average disintegration time for single layer study was 27.8 seconds, average thickness 0.1188 mm, and the tensile strength 10.69 N. On the other hand the average disintegration time for back layer of the double layer film the disintegration time is 1.22 minutes, thickness 0.075 mm and the tensile strength 9.76 N. The standard curve for lidocaine drug concentration measurement was generated from a serial dilution of concentration using UV spectrophotometer which follows a linear curve. The permeation study of the drug in silicone membrane shows almost all drugs are permeable within few minutes for both single layer and double layer film. Conclusion: The single and double films were prepared and characterized. The back layer of the double layer film shows slow dissolve time which confirms that drug will be protected. Both types of films show high permeability of lidocaine drug through silicone membrane. However, an ex-vivo permeation study using a porcine buccal membrane and an in vitro cell layer study will be conducted to compare the efficiency of the drug permeability in single layer and double layer film. References: 1. N.M.G. Almeida, R. Lima, T.F.R. Alves, M.A. De Rebelo, P. Severino, M.V. Chaud, A novel dosage form for buccal administration of bupropion, Brazilian J. Pharm. Sci. 51 (2015) 91–100. https://doi.org/10.1590/S1984-82502015000100010. 2. P.C. Chougule, M.R. Bhat, R.M. Chimkode, Design and Evaluation of Formulated Mouth Dissolving Film of Domperidone and Study the Effect of Concentration of Polymers on Drug Release, Asian J. Pharm. 11 (2017) 846–853. 3. V. Hearnden, V. Sankar, K. Hull, D.V. Juras, M. Greenberg, A.R. Kerr, P.B. Lockhart, L.L. Patton, S. Porter, M.H. Thornhill, New developments and opportunities in oral mucosal drug delivery for local and systemic disease, Adv. Drug Deliv. Rev. 64 (2012) 16–28. https://doi.org/10.1016/j.addr.2011.02.008.