Abstract
Objective: The intension of the present study includes fabrication and optimization of mouth dissolving film loaded with Chlorothalidone by solvent evaporation techniques using two components and their three levels as multilevel Categoric design.
 Methods: Major problem associated with the development of film loaded with BCS class II drug is to increase its solubility. Here the Chlorothalidone solubility achieved by co-solvents, such as methanol. After dissolving the drug in co-solvent, this drug solution is poured into an aqueous dispersion of Hydroxypropyl Methylcellulose E5 (HPMC E5) and Polyethylene glycol 400 (PEG 400). The two independent variables selected are factor A (concentration of HPMC E5) and factor B (concentration of PEG 400) was selected on the basis of preliminary trials. The percentage drug release (R1), Disintegration time in sec (R2) and folding endurance (R3) were selected as dependent variables. Here HPMC E5 used as a film former, PEG 400 as plasticizer, mannitol as bulking agent, Sodium starch glycolate as a disintegrating agent, tween 80 as the surfactant, tartaric acid as saliva stimulating agent, sodium saccharin as a sweetener and orange flavour etc. These fabricated films were evaluated for physicochemical properties, disintegration time and In vitro drug release study.
 Results: The formulation F6 has more favorable responses as per multilevel categoric design is % drug release about 98.95 %, average disintegration time about 24.33 second and folding endurance is 117. Thus formulation F6 was preferred as an optimized formulation.
 Conclusion: The present formulation delivers medicament accurately with good therapeutic efficiency by oral administration, this mouth dissolving films having a rapid onset of action than conventional tablet formulations.
Highlights
Around all drug delivery systems, drug administration by the oral route is being considered more suitable
Infrared spectroscopy (IR) spectrum of Chlorothalidone and physical mixture with excipients was recorded and it was found in accordance with the reported peaks
In physical mixtures of Chlorothalidone and excipients, there was neither masking of single characteristic peak nor the existence of an additional peak in drug spectra
Summary
Around all drug delivery systems, drug administration by the oral route is being considered more suitable. Various fast disintegrating drug delivery systems developed instead of capsules, tablet and syrups for the patient who having struggled in swallowing. Mouth dissolving film is preferable path to increase patient compliance [1]. Mouth dissolving film becomes a trending drug delivery system because of its various merits. Drug from film directly reaches into systemic circulation, it avoids the first-pass effect [2]. Chlorothalidone is used in the present study and widely accepted for its excellent antihypertensive as well as anti-diuretic effect. It improves blood pressure and swelling by preventing water absorption from the kidneys through inhibition of the Na+/Cl− symporter in the distal convoluted tubule cells in the kidney [3]
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