Abstract
Objective: The aim of the current research is optimization, preparation and evaluation of starch tartrate (novel super disintegrant) and preparation of fast dissolving oral films of cetirizine dihydrochloride by employing starch tartrate.
 Methods: To check the drug excipient compatibility studies of the selected drug (Cetrizine dihydrochloride) and the prepared excipient i. e starch tartrate, different studies like FTIR (Fourier-transform infrared spectroscopy), DSC (Differential scanning calorimetry) and thin-layer chromatography (TLC) were carried out to find out whether there is any interaction between cetirizine dihydrochloride and starch tartrate. The solvent casting method was used for the preparation of fast dissolving films. The prepared films were then evaluated for thickness, folding endurance, content uniformity, tensile strength, percent elongation, in vitro disintegration time and in-vitro dissolution studies. Response surface plots and contour plots were also plotted to know the individual and combined effect of starch tartrate (A), croscarmellose sodium (B) and crospovidone (C) on disintegration time and drug dissolution efficiency in 10 min (dependent variables).
 Results: Films of all the formulations are of good quality, smooth and elegant by appearance. Drug content (100±5%), thickness (0.059 mm to 0.061 mm), the weight of films varies from 51.33 to 58.06 mg, folding endurance (52 to 67 times), tensile strength (10.25 to 12.08 N/mm2). Fast dissolving films were found to disintegrate between 34 to 69 sec. Percent dissolved in 5 min were found to be more in F1 formulation which confirms that starch tartrate was effective at 1%.
 Conclusion: From the research conducted, it was proved that starch tartrate can be used in the formulation of fast dissolving films of cetirizine dihydrochloride. The disintegration time of the films was increased with increase in concentration of super disintegrant.
Highlights
Among different routes of drug delivery, oral route is the preferred route for systemic effects because of their advantages like convenient, drug withdrawal, low cost and stability [1]
Fast dissolving films mainly consist of water-soluble polymers that dissolve rapidly and drug reaches to the systemic circulation through mucosal absorption [6]
Some of the incidents has reported with fast-dissolving tablets that patients are chewing or swallowing the tablets after giving the proper instruction. These incidents are not possible with fast dissolving films and they are new approaches under fast dissolving systems so that 90% of the drug will reach to systemic circulation bypassing hepatic metabolism
Summary
Among different routes of drug delivery, oral route is the preferred route for systemic effects because of their advantages like convenient, drug withdrawal, low cost and stability [1]. Fast dissolving systems are dosage forms that delivers drug with 5 to 10 min [2]. Fast dissolving systems was developed in the late 1970s to over the conventional solid oral dosage forms [3]. Fast dissolving films are solid dosage forms developed on the transdermal patches technology [4]. These orally disintegrating films contains drug in the form of the thin patch. Some of the incidents has reported with fast-dissolving tablets that patients are chewing or swallowing the tablets after giving the proper instruction . Cetrizine dihydrochloride belongs to antihistaminic drugs used to get relief from symptoms like running nose, watery eyes, itching, and hives It belongs to BCS class III drugs having high solubility but low permeability. In this research a novel super disintegrant was synthesized and optimized it as a super disintegrant in the formulation of fast dissolving films of cetirizine dihydrochloride
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