Formulation, development and evaluation of novel oral soluble films of ziprasidone hydrochloride in the treatment of schizophrenia.

Objective: The Present investigation deals with the formulation development and evaluation of rapid dissolving oral films of ziprasidone HCl, an atypical antipsychotic agent, belongs to class-II of BCS classification. Methods: Ziprasidone is a poorly soluble bitter drug and hence inclusion complexes of drug with beta cyclodextrin in different compositions were prepared using kneading technique. Among the prepared compositions, the composition PM8 was chosen to incorporate the ziprasidone HCl into the films. Various film forming water soluble polymers were explored for the casting of oral soluble films. Based on their physical and mechanical properties HPMC E5 and HPMC E15 were selected for the casting of the ziprasidone HCl loaded films. The films were evaluated for various physicochemical, mechanical and thermal properties such as drug loading efficiency, disintegration time, in vitro drug release characters, folding endurance, tensile strength etc. X-Ray diffraction studies, Differential scanning calorimetry, Fourier transform infrared spectroscopy and stability studies were performed for the optimized formulation in order to determine the stability of the formulation and the presence of drug excipient interactions Scanning electron microscopic studies were carried out to find the morphology and the texture of the film. Results: All the physical and mechanical properties of the films were in acceptable limits. The film F4 formulated with 20% w/v HPMC E5 showed good drug loading efficiency and 100% drug release in less than 6 min. X-Ray diffraction studies, Differential scanning calorimetry, Fourier transform infrared spectroscopy and stability studies of formulation F4 revealed the stability of the formulation. Scanning electron microscopic studies showed the morphology of the films suggesting that the films have uniform surface. Conclusion: Overall findings suggested that ziprasidone HCl oral soluble films of HPMC E5 exhibited a desired disintegration time ≤ 50 seconds, good drug loading efficiency and stability.