Design And Evaluation Of Self Emulsifying Mouth Dissolving Film Of Ranolazine By Solvent Casting Method
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Abstract
A novel self-emulsifying mouth dissolving film (SEMDF) containing ranolazine (RZ) is being produced in the current study with the aid of a mouth dissolving film (MDF) mixed with self-emulsifying components. Using a solvent casting process, the films for ranolazine were made from the water-soluble polymer HPMC K15M. Ethyl oleate was used as the oil phase, Tween 80 as the surfactant, PEG 400 as the co-surfactant, and distilled water as the solvent to create the pseudoternary phase diagram (aqueous phase). There are ten different possible surfactant mixture to oil combinations with different Km values for the phase diagram investigation of RZ SEDDS (1, 2, 3, and 4 were employed). The phase diagram at Km value 3 shows better microemulsion existence zones when compared to Km values 1, 2, and 4. In this study, a 32-factorial design was used to evaluate two factors at each of three levels, and experimental batches were conducted in all conceivable combinations. In testing of their physical characteristics, such as uniformity of weight, thickness, folding durability, drug content uniformity, surface pH, and tensile strength, the developed mouth-dissolving films functioned satisfactorily. The formulations underwent disintegration, in-vitro drug release testing, and stability studies. The FTIR and DSC analyses showed no physicochemical interaction between the excipients and the medicine. F5 showed a maximal drug release of 93.85% at 5 minutes. Studies on stability demonstrated the dependability of the modified formulation. When a dosage form must have a quicker onset of action and be suitable for administration, ranolazine self-emulsifying mouth dissolving film (SEMDF) might be viewed as an anti-anginal formulation.
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